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F 3 audit & gap analysis checklist

T
TRUNG HUYNH

This document is an audit checklist for conducting an ISO 9001:2008 audit and gap analysis. It contains over 50 questions addressing the requirements of ISO 9001:2008's clauses for quality management systems. The checklist identifies conformance levels of yes, no, opportunity for improvement, minor nonconformance, and major nonconformance. It also includes spaces for audit evidence and references. The checklist will be used to audit an organization's quality management system against the ISO 9001:2008 standard.

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Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 1 of 54 Audit Date: Audit Description: Lead Auditor: Audit Team Members: ISO 9001:2008 Auditable Clauses (Tick those to be evaluated during this audit) Each auditor should complete the section of the checklist they have been assigned by the Quality Manager (Internal audits) or Lead Auditor (external audits) [delete as appropriate]. The auditor may provide additional notes and questions regarding the audit trail for each element in the blank space on the checklist. The Quality Manager or Lead Auditor [delete as appropriate] is responsible for reviewing completed sections of the checklist and to organize all individual sections into one sequential checklist at the conclusion of the audit. 4.1 4.2.1 4.2.2 4.2.3 4.2.4 5.1 5.2 5.3 5.4.1 5.4.2 5.5.1 5.5.2 5.5.3 5.6.1 5.6.2 5.6.3 6.1 6.2.1 6.2.2 6.3 6.4 7.1 7.2.1 7.2.2 7.2.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.4.1 7.4.2 7.4.3 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6 8.1 8.2.1 8.2.2 8.2.3 8.2.4 8.3 8.4 8.5.1 8.5.2 8.5.3 PRODUCT REALIZATION PROCESS EXCLUSIONS ISO 9001:2008 Permissible Exclusions (Tick those applicable, if any) 7.1 7.2.1 7.2.2 7.2.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.4.1 7.4.2 7.4.3 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6 Legend Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 2 of 54 A = Opportunity for Improvement B = Minor Non-conformance C = Major Non-conformance SQ = Supplementary Question Conformance: Adherence with the requirements of the standard. No major or minor non-conformances found Opportunity for Improvement (OFI): A situation or condition of a management system that may be weak, cumbersome, redundant, overly complex, or in some other manner, may, in the opinion of the auditor, offer an opportunity for an organization to improve its current status. OFIs do not require any action on the part of the organization; however, the organization should give them serious consideration in view of the auditor’s knowledge and exposure to similar systems. An OFI may be an improvement to the management system or could prevent future problems. Minor Non-conformance: A non-conformity that, based on the judgment and experience of the auditor, is not likely to result in the failure of the management system or reduce its ability to assure controlled processes or products. It may be either: A failure in some part of the supplier's management system relative to a specified requirement. A single observed lapse in following one item of a company's management system. Major Non-conformance: The absence (omission, not addressed) or total breakdown (commission, failure, not implemented) of a system to meet a specified requirement. A number of minor non-conformities against one requirement can represent a total breakdown of the system and thus be considered a major non-conformity. Any non-compliance that would result in the probable shipment of a non-conforming product. Conditions that may result in the failure of or materially reduce the usability of the products or services for their intended purpose. A non-compliance that, in the judgment and experience of the auditor, is likely to either to result in the failure of the management system or to materially reduce its ability to assure controlled processes and products. Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 3 of 54 4.1 General Requirements QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 4.1 Has the organization established, documented, implemented and maintained a QMS and continually improved its effectiveness? 2 4.1a Has the organization identified the processes needed for the QMS and their application throughout the organization? 3 4.1b Has the organization determined the sequence and interaction of QMS processes? 4 4.1c What are the criteria and methods the organization uses to ensure that the operation and control of QMS processes are effective? 5 4.1d Has the organization provided resources and information needed to support the operation and monitoring of QMS processes? 6 4.1e Does the organization monitor, measure and analyze QMS processes? Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 4 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 7 4.1f Has the organization implemented actions necessary to achieve planned results and continual improvement of processes needed for the QMS? 8 4.1 Are processes needed for the QMS managed by the organization in accordance with the requirements of ISO 9001:2008? 9 4.1 How does the organization maintain control over outsourced processes? 10 4.1 Are the necessary controls for outsourced processes that affect product conformity with requirements identified within the QMS? 11 4.1 Does organization have adequate control over outsourced processes to ensure conformity to all customer requirements? 4.2.1 General Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 5 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 4.2.1a Does the organization have a documented quality policy? 2 4.2.1a Does the organization have a set of documented quality objectives? 3 4.2.1b Does the organization have a quality manual? 4 4.2.1c Does the organization operate a set of documented procedures? 5 4.2.1d Are adequate documents in place to ensure the effective planning, operation and control of organization’s processes? 6 4.2.1d Does documentation include the records required by ISO 9001:2008? 4.2.2 Quality Manual Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 6 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 4.2.2a Where in the quality manual is the scope of the QMS identified, including details of and justification for exclusions? 2 4.2.2b Where does the quality manual contain or reference the documented procedures established for the QMS? 3 4.2.2c Where does the quality manual include a description of the interaction between the processes of the QMS? 4.2.3 Control of Documents QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 4.2.3 Does the organization operate an establish document control procedure? (If yes, proceed with questions 22 to 28) 2 4.2.3a Does the document control procedure define the controls needed to approve documents for adequacy prior to issue? Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 7 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 3 4.2.3b Does the document control procedure define the controls needed to review and update as necessary and re-approve documents? 4 4.2.3c Does the document control procedure define the controls needed to ensure that changes and the current revision status of documents are identified? 5 4.2.3d Does the document control procedure define the controls needed to ensure that relevant versions of applicable documents are available at points of use? 6 4.2.3e Does the document control procedure define the controls needed to ensure that documents remain legible and readily identifiable? 7 4.2.3f Does the document control procedure define the controls needed to ensure that documents of external origin are identified and their distribution controlled? 8 4.2.3g Does the document control procedure define the controls needed to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose? 4.2.4 Control of Records Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 8 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 4.2.4 Do records exist that provide evidence of conformity to requirements and of the effective operation of the QMS? (Should be reviewed throughout the audit) 2 4.2.4 Does the organization have a documented procedure defining the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records? 3 4.2.4 Are records legible, readily identifiable and retrievable? (Should be reviewed throughout the audit) 4 4.2.4 Have the record requirements been reviewed to ensure conformance with contractual and customer requirements? 5 Management Responsibility 5.1 Management Commitment Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 9 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 5.1a Does the organization communicate the importance of meeting customer, statutory and regulatory requirements? 2 5.1b Does the organization have an established quality policy? 3 5.1c Are the quality objectives established by top management? 4 5.1d Does top management conduct management reviews? 5 5.1e Does top management ensure the availability of resources to support and continually improve the QMS? 5.2 Customer Focus Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 10 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 5.2 Does top management ensure that customer requirements are determined and met? 5.3 Quality Policy QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 5.3a Is the quality policy appropriate to the organization? 2 5.3b Does the quality policy include a commitment to continually improve the effectiveness of the QMS? 3 5.3c Does the quality policy provide a framework to establish and review quality objectives? 4 5.3d Is the quality policy communicated effectively throughout the organisation? Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 11 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 5 5.3e Is the quality policy reviewed to confirm suitability? 5.4 Planning 5.4.1 Quality Objectives QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 5.4.1 Has top management established quality objectives at relevant functions and levels within the organization? 2 5.4.1 Are the quality objectives measurable? 3 5.4.1 Are the quality objectives consistent with quality policy? Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 12 of 54 5.4.2 Quality Management System Planning QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 5.4.2a Is the planning of the QMS consistent with the organisation’s quality objectives and general requirements of ISO 9001:2008 (Clause 4.1)? 2 5.4.2b Does the organization ensure that the integrity of the QMS is maintained when changes to the QMS are planned and implemented? 5.5 Responsibility, Authority and Communication 5.5.1 Responsibility and Authority QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 5.5.1 Has the organization defined and communicated responsibility and authority? (e.g. organizational chart) Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 13 of 54 5.5.2 Management Representative QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 5.5.2 Does the organization have a Management Representative? 2 5.5.2a Does the Management Representative have responsibility and authority to ensure that processes needed for the QMS are established, implemented and maintained? 3 5.5.2b Does the Management Representative have responsibility and authority to report to top management on the performance of the QMS and any need for improvement? 4 5.5.2c Does the Management Representative have responsibility and authority to ensure the promotion of awareness of customer requirements throughout the organization? 5.5.3 Internal Communication Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 14 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 5.5.3 Is information regarding the effectiveness of the QMS communicated within the organization? 2 SQ If yes, how is the effectiveness of the QMS communicated? 5.6 Management Review 5.6.1 General QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 5.6.1 Does top management undertake management review? 2 5.6.1 Are the records of management reviews maintained in accordance with Clause 4.2.4? Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 15 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 3 SQ What is the frequency of management reviews? 4 SQ What sort of information is reviewed in management reviews? 5 SQ Please show me what records are available from the most recent management review? 5.6.2 Review Input QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 5.6.2a Does the review process consider the results of audits? 2 5.6.2b Does the review process consider customer feedback? Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 16 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 3 5.6.2c Does the review process consider process performance and product conformity? 4 5.6.2d Does the review process consider the status of the corrective and preventive actions? 5 5.6.2e Does the review process follow up actions from previous management reviews? 6 5.6.2f Does the review process consider changes that could affect the QMS? 7 5.6.2g Does the review process make recommendations for improvement? 5.6.3 Review Output Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 17 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 5.6.3a Do the outputs of the review process include decisions and actions concerning the improvement of the effectiveness of the QMS and its processes? 2 5.6.3b Do the outputs of the review process include decisions and actions concerning the improvement of product related customer requirements? 3 5.6.3c Do the outputs of the review process include decisions and actions concerning the resource requirements? Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 18 of 54 6 Resource Management 6.1 Provision of Resources QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 6.1.1a Has the organization provided the necessary resources to implement and maintain the QMS and continually improve its effectiveness? 2 6.1.1b Has the organization provided the necessary resources to ensure that customer requirements are met? 6.2 Human Resources 6.2.1 General QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 6.2.1 Does the organization ensure that personnel have the necessary competence to ensure product conformity? 6.2.2 Competence, Training & Awareness Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 19 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 6.2.2a Does the organization determine the necessary education, training, skills and experience for people performing work affecting product quality? 2 6.2.2b Does the organization initiate training or other actions to achieve the necessary level of competence? 3 6.2.2c Does the organization evaluate the effectiveness of training or other actions taken? 4 6.2.2d Does the organization ensure that personnel are aware of the relevance and importance of their activities? 5 6.2.2d Does the organization ensure that personnel are aware of how they contribute to the achievement of the quality objectives? 7 6.2.2e Does the organization maintain training records in accordance with Clause 4.2.4? 6.3 Infrastructure Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 20 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 6.3 Has the organization identified any shortcomings in its infrastructure and is it taking appropriate action? 2 6.3a Are the buildings, workspace and utilities appropriate for the organization product or service? 3 6.3b Is process equipment (including computer software) appropriate for the organization’s product or service? 4 6.3c Are support services (e.g. transport, communications, and waste disposal) appropriate for the organization’s product or service? Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 21 of 54 6.4 Work Environment QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 6.4 Is the work environment appropriate for achieving product or service requirements? 2 6.4 Is safety and protective equipment provided where necessary? 3 6.4 Are workstations set out ergonomically? 4 6.4 Are kitchen and toilet facilities adequate? 5 6.4 Are heat, humidity, light levels and airflow controllable? 6 6.4 Are factors affecting hygiene, cleanliness, noise, vibration and pollution controllable? 7 6.4 Has the organization identified any shortcomings and is it taking appropriate action? Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 22 of 54 7 Product Realization QuestionNo. ClauseRef. Audit Question Finding Audit Evidence/Comment YES NO A B C N.B. Provide references to documentation where necessary 1 7 Has the organization excluded itself from the requirements of the Product Realization process? 2 7 Has the organization justified any permissible exclusion in the relevant section of the quality manual? 7.1 Planning & Product Realization QuestionNo. ClauseRef. Audit Question Finding Audit Evidence/Comment YES NO A B C N.B. Provide references to documentation where necessary 1 7.1 Have the processes needed for product realization identified? 2 7.1 Is the planning of product realization consistent with the requirements of the other processes of the QMS? Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 23 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence/Comment YES NO A B C N.B. Provide references to documentation where necessary 3 7.1a Has the organisation determined quality objectives for its products? 4 7.1b Has the organisation identified processes, documents and resources required by specific products? 5 7.1c Has the organisation identified methods for verification, validation, monitoring and inspection and test activities to meet acceptance criteria? 6 7.1d Has the organisation determined what records are needed to provide evidence that requirements for specific products have been met? 7 7.1e Is there an identifiable output from the planning process, in an appropriate format in accordance with 4.2.4? 7.2 Customer-related Processes 7.2.1 Determination of Requirements Related to the Product Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 24 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7..2 Has the organisation determined product requirements prior to commitment to supply? 2 7.2.1a Customer’s specified requirements, delivery, warranty and service? 3 7.2.1b Requirements necessary for the product’s intended use? 4 7.2.1c Statutory and regulatory requirements? 5 7.2.1d Any additional requirements determined by the organisation? 7.2.2 Review of Requirements Related to the Product Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 25 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.2.2 Does the organization undertake a review to ensure that the organization has the ability to meet requirements before committing to supply product? 2 7.2.2a Does the organization ensure that product requirements are defined and reviewed before committing to supply product? 3 7.2.2b Does the organization ensure that contract or order requirements differing from those previously expressed are resolved before committing to supply product? 4 7.2.2c Does the organization ensure that it has the ability to meet the defined requirements? 5 SQ Can you show me records of the product requirement review results and actions resulting from them? 6 SQ When customers don’t have documented requirements, how do you confirm their requirements before accepting orders? 7 SQ When product requirements are changed, how do you ensure that relevant documents are changed and that relevant personnel are made aware of the changes? 7.2.3 Customer Satisfaction Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 26 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.2.3a Has the organization implemented effective arrangements for communicating product information? 2 7.2.3b Has the organization implemented effective arrangements for communicating enquiries? 3 7.2.3b Has the organization implemented effective arrangements for communicating contracts or order handling including amendments? 4 7.2.3c Has the organization implemented effective arrangements for communicating customer feedback? 5 7.2.3c Has the organization implemented effective arrangements for communicating customer complaints? 7.3 Design & Development 7.3.1 Design & Development Planning Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 27 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.3.1a Have stages of design and development been determined for the product? 2 7.3.1b Are requirements for review, verification and validation defined for each stage? 3 7.3.1b Is validation completed prior to delivery or use, where practical? 4 7.3.1c Are responsibilities for design and development defined? 5 7.3.1 Is there effective communication between different members or groups in the design team? 6 7.3.1 Is planning output updated as appropriate as the design and development progresses? 7.3.2 Design & Development Inputs Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 28 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.3.2 Are records of design inputs maintained in accordance with Clause 4.2.4? 2 7.3.2a Are requirements defined for function and performance? 3 7.3.2b Are applicable statutory and regulatory requirements defined? 4 7.3.2c Is information to be used from previous designs defined? 5 7.3.2d Are other requirements essential for design and development adequately defined? 6 7.3.2 Are design inputs reviewed for adequacy to confirm that they are complete, unambiguous and not in conflict? 7.3.3 Design & Development Outputs Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 29 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.3.3a Do the outputs meet input requirements for design and development? 2 7.3.3b Do the outputs provide information required for purchasing, production and service provision? 3 7.3.3c Do the outputs contain or reference product acceptance criteria? 4 7.3.3d Do outputs specify characteristics for the product’s safe and proper use? 7.3.4 Design & Development Review Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 30 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.3.4 Have design and development reviews taken place (involving representatives of all relevant functions) in accordance with the design and development plan? 2 7.3.4 Do participants in design reviews include representatives of functions concerned with the design development stage being reviewed? 3 7.3.4 Are records of reviews available in accordance with Clause 4.2.4? 4 7.3.4a Can the organization confirm that the results of design and development have been evaluated? 5 7.3.4b Were problems identified and were actions taken for resolution? 7.3.5 Design & Development Verification Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 31 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.3.5 Has verification been completed in accordance with the design and development plan to confirm that design and development outputs meet requirements of inputs? 2 7.3.5 Are records maintained of the results of verification and any necessary actions in accordance with Clause 4.2.4? 7.3.6 Design & Development Validation QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.3.6 Has validation been completed in accordance with the design and development plan to confirm that the product is suitable for its specified application or intended use? 2 7.3.6 Are records maintained of the results of validation and any necessary actions in accordance with Clause 4.2.4? 7.3.7 Control of Design & Development Changes Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 32 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.3.7 Have changes been reviewed to evaluate their effect on constituent parts and on product already delivered? 2 7.3.7 Have changes been approved prior to implementation? 3 7.3.7 Have changes been appropriately verified and validated? 4 7.3.7 Are records maintained of the results of change reviews and any necessary actions in accordance with Clause 4.2.4? 7.4 Purchasing 7.4.1 Purchasing Process Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 33 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.4.1 Are verification requirements appropriate for the product’s application? 2 7.4.1 Are suppliers evaluated and selected (in accordance with established criteria) on the basis of their ability to meet specified requirements? 3 7.4.1 Are suppliers periodically re-evaluated in accordance with established criteria? 4 7.4.1 Are records maintained of the results of supplier evaluations in accordance with Clause 4.2.4? 7.4.2 Purchasing Information Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 34 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.4.2 Does purchasing information adequately describe the product to be purchased? 2 7.4.2a Does purchasing information adequately describe the requirements for approval of product, procedures and equipment? 3 7.4.2b Does purchasing information adequately describe the requirements for qualification of personnel? 4 7.4.2c Does purchasing information adequately describe quality management system requirements? 5 7.4.2 Does the organisation ensure that purchasing information is adequate prior to issue to the supplier? 7.4.3 Verification of Purchased Product Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 35 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.4.3 Is purchased product verified in accordance with specified requirements? 2 7.4.3 Does purchasing information contain details of any verification to be performed at the supplier’s premises? 7.5 Product & Service Provision 7.5.1 Control of Production & Service Provision QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.5.1a Is required information available to describe product characteristics? 2 7.5.1b Are necessary work instructions available? Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 36 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 3 7.5.1c Is suitable equipment available? 4 7.5.1d Are required monitoring and measuring devices available? 5 7.5.1e Are required monitoring and measuring devices used in accordance with work instructions and/or the quality plan? 6 7.5.1f Are requirements for release, delivery and post delivery activities implemented? 7.5.2 Validation Processes for Production & Service Provision Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 37 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.5.2a Is production or provision of service which cannot be verified by subsequent monitoring or measuring adequately validated to demonstrate that planned results are being achieved? 2 7.5.2b Are criteria defined for review and approval of the processes? 3 7.5.2c Are personnel qualified and is equipment approved? 4 7.5.2d Are required records maintained in accordance with Clause 4.2.4? 5 7.5.2e Is the time interval for process re-validation defined? 6 7.5.2f Does validation demonstrate the ability of the process to achieve planned results? 7.5.3 Identification & Traceability Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 38 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.5.3 Is product identification and traceability required to be maintained throughout production (for any products)? 2 7.5.3 Is inspection and test status adequately defined maintained throughout production? 3 7.5.3 If traceability is a requirement are records of unique identification of the product available in accordance with Clause 4.2.4? 7.5.4 Customer Property QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.5.4 Does the organisation adequately identify, verify, protect and safeguard customer property? 2 7.5.4 Is the customer’s intellectual property controlled? Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 39 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 3 7.5.4 Are records maintained of any loss or damage to customer property in accordance with Clause 4.2.4? 7.5.5 Preservation of Product QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.5.5 Are components adequately identified, handled, packaged, stored and protected prior to use? 2 7.5.5 Are finished products adequately identified, handled, packaged, stored and protected prior to delivery? 7.6 Control of Monitoring & Measuring Equipment Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 40 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.6 Are monitoring and measuring devices required by the QMS controlled? 2 7.6a Is each device calibrated or verified at specified intervals (or prior to use) against measurement standards traceable to national or international standards? 3 7.6a Where no such standards exist is the basis of calibration or verification defined? 4 7.6b Is each device adjusted or re-adjusted as necessary (in accordance with manufacturer’s instructions)? 5 7.6c Is each device identified to enable calibration status to be determined? 6 7.6d Is each device safeguarded from adjustment, which would invalidate the measurement result? 7 7.6e Is each device protected from damage or deterioration during handling, maintenance or storage? Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 41 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 8 7.6 Is the validity of previous results assessed and appropriate action taken, when a device is found not to conform to requirements? 9 7.6 Are records of the results of calibration and verification maintained in accordance with Clause 4.2.4? 10 7.6 When computer software is used in the monitoring and measuring equipment is it validated prior to initial use? 11 7.6 When computer software is used in the monitoring and measuring equipment is it re-confirmed as necessary? 8.0 Measurement, Analysis & Improvement 8.1 General Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 42 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 8.1a Has the organization implemented appropriate measurement, analysis and improvement processes needed to demonstrate product conformity? 2 8.1b Has the organization implemented appropriate measurement, analysis and improvement processes needed to ensure conformity of the QMS 3 8.1c Has the organization implemented appropriate measurement, analysis and improvement processes needed to continually improve the effectiveness of the QMS? 4 8.1 Does the organization apply statistical techniques and determine the extent of their use? 8.2 Monitoring & Measurement 8.2.1 Customer Satisfaction Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 43 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 8.2.1 Does the organization monitor customer satisfaction? 2 8.2.1 Does the organization use this information in accordance with defined methods? 8.2.2 Audit QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 8.2.2 Is there a documented procedure which defines responsibility and requirements for planning and conducting audits? 2 8.2.2 Is there a documented procedure which defines responsibility and requirements for reporting audit results? 3 8.2.2 Is there an audit programme in place defining audit criteria, scope, frequency and methods? Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 44 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 4 8.2.2 Are records of audits maintained? 5 8.2.2 Do audit records confirm that audits were conducted? 6 8.2.2 Do audit records confirm that audits were conducted in accordance with the audit schedule? 7 8.2.2 Were appropriate follow up actions taken to eliminate non-conformances and their root cause? 8 8.2.2 Were the results of any follow up actions verified? 9 8.2.2 Are effective methods used to monitor (and measure if applicable) the processes of the QMS and the organisation? 10 8.2.2 Do the results confirm that they are capable of achieving planned results? Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 45 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 11 8.2.2 If planned results are not achieved has appropriate action been taken? 8.2.3 Monitoring & Measurement of Processes QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 8.2.3 Are effective methods used to monitor and measure the processes of the QMS and the organisation? 2 8.2.3 Do the results confirm that the processes are capable of achieving planned results? Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 46 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 3 8.2.3 If planned results are not achieved has appropriate action been taken? 8.2.4 Monitoring & Measurement of Product QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 8.2.4 Are product characteristics measured to confirm that product requirements are met? 2 8.2.4 Do monitoring and measuring activities take place at predetermined stages during the product realization process? Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 47 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 3 8.2.4 Are records of evidence of conformity with acceptance criteria maintained in accordance with Clause 4.2.4? 4 8.2.4 Are records that indicate authorized release of a product to the next stage available? 5 8.2.4 Do arrangements exist to ensure that a product is not released until the all requirements have been met 6 8.2.4 Do arrangements exist to ensure that if a product must be released prior satisfying the requirements, is it approved? 8.3 Control on Non-conforming Product QuestionNo. ClauseRef. Audit Question Finding Audit Evidence/Comment YES NO A B C N.B. Provide references to documentation where necessary 1 8.3 Is there a documented procedure which describes how non-conforming product is dealt with? Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 48 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence/Comment YES NO A B C N.B. Provide references to documentation where necessary 2 8.3 Is there a documented procedure which describes the identification of non- conformities and actions to prevent unintended use or delivery? 3 8.3 Is there a documented procedure which describes the necessary responsibility and authority for dealing with non-conforming product? 4 8.3 Is there a documented procedure which describes methods of dealing with non-conforming product? 5 8.3 Is there a documented procedure which describes the action to be taken if non-conformity is detected after delivery? 6 8.3 Are there records of action taken following identification of a non-conformity maintained in accordance with Clause 4.2.4? 7 8.3 Do the records detail any re-work undertaken to eliminate the detected non- conformity? 8 8.3 Do the records detail methods and criteria for re-verification to demonstrate conformity? Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 49 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence/Comment YES NO A B C N.B. Provide references to documentation where necessary 9 8.3 Do the records detail acceptances under concession by a relevant authority? 10 8.3 Do the records detail if non-conforming products were withdrawn from intended use? 8.4 Analysis of Data QuestionNo. ClauseRef. Audit Question Finding Audit Evidence/Comment YES NO A B C N.B. Provide references to documentation where necessary 1 8.4 Are data collected and analyzed to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of its effectiveness can be made? Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 50 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence/Comment YES NO A B C N.B. Provide references to documentation where necessary 2 8.4 Does the analysis of data include information relating to customer satisfaction? 3 8.4 Does the analysis of data include information relating to the conformity to product requirements? 4 8.4 Does the analysis of data include information relating to characteristics and trends of processes and products? 5 8.4 Does the analysis of data include information relating to improvement opportunities and preventive action? 6 8.4 Does the analysis of data include information relating to suppliers? 8.5 Improvement 8.5.1 Continual Improvement Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 51 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 8.5.1 Does the organisation continually improve the effectiveness of the QMS through use of the quality policy? 2 8.5.1 Does the organisation continually improve the effectiveness of the QMS through use of quality objectives? 3 8.5.1 Does the organisation continually improve the effectiveness of the QMS through use of audit results? 4 8.5.1 Does the organisation continually improve the effectiveness of the QMS through use of data analysis? 5 8.5.1 Does the organisation continually improve the effectiveness of the QMS through use of corrective and preventive action? 6 8.5.1 Does the organisation continually improve the effectiveness of the QMS through use of management reviews? 8.5.2 Corrective Action Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 52 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 8.5.2 Is there a documented procedure which describes how corrective action is undertaken? 2 8.5.2 Do corrective actions records identify and address root cause(s)? 3 8.5.2 Are actions taken appropriate to the severity of the problem? 4 8.5.2a Does the corrective action procedure define the requirements for the review of non-conformities (including customer complaints)? 5 8.5.2d Does the corrective action procedure define the requirements for the review of determining the causes of non-conformities? 6 8.5.2c Does the corrective action procedure define the requirements for evaluating the need for action to ensure that non-conformities do not recur? 7 8.5.2d Does the corrective action procedure define the requirements for determining and implementing action needed? Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 53 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 8 8.5.2e Does the corrective action procedure define the requirements for the records of the results of action taken? 9 8.5.2f Does the corrective action procedure define the requirements for reviewing the effectiveness of corrective actions taken? 10 8.5.2 Have corrective actions been implemented in accordance with the documented procedure? 8.5.3 Preventive Action Auditor Name (print): Initials: Date:
Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 54 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 8.5.3a Does the preventive action procedure define the requirements for determining causes of potential non-conformities? 2 8.5.3b Does the preventive action procedure define the requirements for evaluating whether action needs to be taken to prevent occurrence? 3 8.5.3c Does the preventive action procedure define the requirements for determining what action is required and ensuring that it is implemented? 4 8.5.3d Does the preventive action procedure define the requirements for maintaining records (in accordance with Clause 4.2.4) of the results of action taken? 5 8.5.3e Does the preventive action procedure define the requirements for reviewing preventive action taken? 6 8.5.3 Has preventive action been implemented in accordance with the documented procedure? Auditor Name (print): Initials: Date:

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F 3 audit & gap analysis checklist

  • 1. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 1 of 54 Audit Date: Audit Description: Lead Auditor: Audit Team Members: ISO 9001:2008 Auditable Clauses (Tick those to be evaluated during this audit) Each auditor should complete the section of the checklist they have been assigned by the Quality Manager (Internal audits) or Lead Auditor (external audits) [delete as appropriate]. The auditor may provide additional notes and questions regarding the audit trail for each element in the blank space on the checklist. The Quality Manager or Lead Auditor [delete as appropriate] is responsible for reviewing completed sections of the checklist and to organize all individual sections into one sequential checklist at the conclusion of the audit. 4.1 4.2.1 4.2.2 4.2.3 4.2.4 5.1 5.2 5.3 5.4.1 5.4.2 5.5.1 5.5.2 5.5.3 5.6.1 5.6.2 5.6.3 6.1 6.2.1 6.2.2 6.3 6.4 7.1 7.2.1 7.2.2 7.2.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.4.1 7.4.2 7.4.3 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6 8.1 8.2.1 8.2.2 8.2.3 8.2.4 8.3 8.4 8.5.1 8.5.2 8.5.3 PRODUCT REALIZATION PROCESS EXCLUSIONS ISO 9001:2008 Permissible Exclusions (Tick those applicable, if any) 7.1 7.2.1 7.2.2 7.2.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.4.1 7.4.2 7.4.3 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6 Legend Auditor Name (print): Initials: Date:
  • 2. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 2 of 54 A = Opportunity for Improvement B = Minor Non-conformance C = Major Non-conformance SQ = Supplementary Question Conformance: Adherence with the requirements of the standard. No major or minor non-conformances found Opportunity for Improvement (OFI): A situation or condition of a management system that may be weak, cumbersome, redundant, overly complex, or in some other manner, may, in the opinion of the auditor, offer an opportunity for an organization to improve its current status. OFIs do not require any action on the part of the organization; however, the organization should give them serious consideration in view of the auditor’s knowledge and exposure to similar systems. An OFI may be an improvement to the management system or could prevent future problems. Minor Non-conformance: A non-conformity that, based on the judgment and experience of the auditor, is not likely to result in the failure of the management system or reduce its ability to assure controlled processes or products. It may be either: A failure in some part of the supplier's management system relative to a specified requirement. A single observed lapse in following one item of a company's management system. Major Non-conformance: The absence (omission, not addressed) or total breakdown (commission, failure, not implemented) of a system to meet a specified requirement. A number of minor non-conformities against one requirement can represent a total breakdown of the system and thus be considered a major non-conformity. Any non-compliance that would result in the probable shipment of a non-conforming product. Conditions that may result in the failure of or materially reduce the usability of the products or services for their intended purpose. A non-compliance that, in the judgment and experience of the auditor, is likely to either to result in the failure of the management system or to materially reduce its ability to assure controlled processes and products. Auditor Name (print): Initials: Date:
  • 3. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 3 of 54 4.1 General Requirements QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 4.1 Has the organization established, documented, implemented and maintained a QMS and continually improved its effectiveness? 2 4.1a Has the organization identified the processes needed for the QMS and their application throughout the organization? 3 4.1b Has the organization determined the sequence and interaction of QMS processes? 4 4.1c What are the criteria and methods the organization uses to ensure that the operation and control of QMS processes are effective? 5 4.1d Has the organization provided resources and information needed to support the operation and monitoring of QMS processes? 6 4.1e Does the organization monitor, measure and analyze QMS processes? Auditor Name (print): Initials: Date:
  • 4. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 4 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 7 4.1f Has the organization implemented actions necessary to achieve planned results and continual improvement of processes needed for the QMS? 8 4.1 Are processes needed for the QMS managed by the organization in accordance with the requirements of ISO 9001:2008? 9 4.1 How does the organization maintain control over outsourced processes? 10 4.1 Are the necessary controls for outsourced processes that affect product conformity with requirements identified within the QMS? 11 4.1 Does organization have adequate control over outsourced processes to ensure conformity to all customer requirements? 4.2.1 General Auditor Name (print): Initials: Date:
  • 5. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 5 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 4.2.1a Does the organization have a documented quality policy? 2 4.2.1a Does the organization have a set of documented quality objectives? 3 4.2.1b Does the organization have a quality manual? 4 4.2.1c Does the organization operate a set of documented procedures? 5 4.2.1d Are adequate documents in place to ensure the effective planning, operation and control of organization’s processes? 6 4.2.1d Does documentation include the records required by ISO 9001:2008? 4.2.2 Quality Manual Auditor Name (print): Initials: Date:
  • 6. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 6 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 4.2.2a Where in the quality manual is the scope of the QMS identified, including details of and justification for exclusions? 2 4.2.2b Where does the quality manual contain or reference the documented procedures established for the QMS? 3 4.2.2c Where does the quality manual include a description of the interaction between the processes of the QMS? 4.2.3 Control of Documents QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 4.2.3 Does the organization operate an establish document control procedure? (If yes, proceed with questions 22 to 28) 2 4.2.3a Does the document control procedure define the controls needed to approve documents for adequacy prior to issue? Auditor Name (print): Initials: Date:
  • 7. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 7 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 3 4.2.3b Does the document control procedure define the controls needed to review and update as necessary and re-approve documents? 4 4.2.3c Does the document control procedure define the controls needed to ensure that changes and the current revision status of documents are identified? 5 4.2.3d Does the document control procedure define the controls needed to ensure that relevant versions of applicable documents are available at points of use? 6 4.2.3e Does the document control procedure define the controls needed to ensure that documents remain legible and readily identifiable? 7 4.2.3f Does the document control procedure define the controls needed to ensure that documents of external origin are identified and their distribution controlled? 8 4.2.3g Does the document control procedure define the controls needed to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose? 4.2.4 Control of Records Auditor Name (print): Initials: Date:
  • 8. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 8 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 4.2.4 Do records exist that provide evidence of conformity to requirements and of the effective operation of the QMS? (Should be reviewed throughout the audit) 2 4.2.4 Does the organization have a documented procedure defining the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records? 3 4.2.4 Are records legible, readily identifiable and retrievable? (Should be reviewed throughout the audit) 4 4.2.4 Have the record requirements been reviewed to ensure conformance with contractual and customer requirements? 5 Management Responsibility 5.1 Management Commitment Auditor Name (print): Initials: Date:
  • 9. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 9 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 5.1a Does the organization communicate the importance of meeting customer, statutory and regulatory requirements? 2 5.1b Does the organization have an established quality policy? 3 5.1c Are the quality objectives established by top management? 4 5.1d Does top management conduct management reviews? 5 5.1e Does top management ensure the availability of resources to support and continually improve the QMS? 5.2 Customer Focus Auditor Name (print): Initials: Date:
  • 10. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 10 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 5.2 Does top management ensure that customer requirements are determined and met? 5.3 Quality Policy QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 5.3a Is the quality policy appropriate to the organization? 2 5.3b Does the quality policy include a commitment to continually improve the effectiveness of the QMS? 3 5.3c Does the quality policy provide a framework to establish and review quality objectives? 4 5.3d Is the quality policy communicated effectively throughout the organisation? Auditor Name (print): Initials: Date:
  • 11. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 11 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 5 5.3e Is the quality policy reviewed to confirm suitability? 5.4 Planning 5.4.1 Quality Objectives QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 5.4.1 Has top management established quality objectives at relevant functions and levels within the organization? 2 5.4.1 Are the quality objectives measurable? 3 5.4.1 Are the quality objectives consistent with quality policy? Auditor Name (print): Initials: Date:
  • 12. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 12 of 54 5.4.2 Quality Management System Planning QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 5.4.2a Is the planning of the QMS consistent with the organisation’s quality objectives and general requirements of ISO 9001:2008 (Clause 4.1)? 2 5.4.2b Does the organization ensure that the integrity of the QMS is maintained when changes to the QMS are planned and implemented? 5.5 Responsibility, Authority and Communication 5.5.1 Responsibility and Authority QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 5.5.1 Has the organization defined and communicated responsibility and authority? (e.g. organizational chart) Auditor Name (print): Initials: Date:
  • 13. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 13 of 54 5.5.2 Management Representative QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 5.5.2 Does the organization have a Management Representative? 2 5.5.2a Does the Management Representative have responsibility and authority to ensure that processes needed for the QMS are established, implemented and maintained? 3 5.5.2b Does the Management Representative have responsibility and authority to report to top management on the performance of the QMS and any need for improvement? 4 5.5.2c Does the Management Representative have responsibility and authority to ensure the promotion of awareness of customer requirements throughout the organization? 5.5.3 Internal Communication Auditor Name (print): Initials: Date:
  • 14. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 14 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 5.5.3 Is information regarding the effectiveness of the QMS communicated within the organization? 2 SQ If yes, how is the effectiveness of the QMS communicated? 5.6 Management Review 5.6.1 General QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 5.6.1 Does top management undertake management review? 2 5.6.1 Are the records of management reviews maintained in accordance with Clause 4.2.4? Auditor Name (print): Initials: Date:
  • 15. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 15 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 3 SQ What is the frequency of management reviews? 4 SQ What sort of information is reviewed in management reviews? 5 SQ Please show me what records are available from the most recent management review? 5.6.2 Review Input QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 5.6.2a Does the review process consider the results of audits? 2 5.6.2b Does the review process consider customer feedback? Auditor Name (print): Initials: Date:
  • 16. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 16 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 3 5.6.2c Does the review process consider process performance and product conformity? 4 5.6.2d Does the review process consider the status of the corrective and preventive actions? 5 5.6.2e Does the review process follow up actions from previous management reviews? 6 5.6.2f Does the review process consider changes that could affect the QMS? 7 5.6.2g Does the review process make recommendations for improvement? 5.6.3 Review Output Auditor Name (print): Initials: Date:
  • 17. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 17 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 5.6.3a Do the outputs of the review process include decisions and actions concerning the improvement of the effectiveness of the QMS and its processes? 2 5.6.3b Do the outputs of the review process include decisions and actions concerning the improvement of product related customer requirements? 3 5.6.3c Do the outputs of the review process include decisions and actions concerning the resource requirements? Auditor Name (print): Initials: Date:
  • 18. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 18 of 54 6 Resource Management 6.1 Provision of Resources QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 6.1.1a Has the organization provided the necessary resources to implement and maintain the QMS and continually improve its effectiveness? 2 6.1.1b Has the organization provided the necessary resources to ensure that customer requirements are met? 6.2 Human Resources 6.2.1 General QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 6.2.1 Does the organization ensure that personnel have the necessary competence to ensure product conformity? 6.2.2 Competence, Training & Awareness Auditor Name (print): Initials: Date:
  • 19. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 19 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 6.2.2a Does the organization determine the necessary education, training, skills and experience for people performing work affecting product quality? 2 6.2.2b Does the organization initiate training or other actions to achieve the necessary level of competence? 3 6.2.2c Does the organization evaluate the effectiveness of training or other actions taken? 4 6.2.2d Does the organization ensure that personnel are aware of the relevance and importance of their activities? 5 6.2.2d Does the organization ensure that personnel are aware of how they contribute to the achievement of the quality objectives? 7 6.2.2e Does the organization maintain training records in accordance with Clause 4.2.4? 6.3 Infrastructure Auditor Name (print): Initials: Date:
  • 20. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 20 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 6.3 Has the organization identified any shortcomings in its infrastructure and is it taking appropriate action? 2 6.3a Are the buildings, workspace and utilities appropriate for the organization product or service? 3 6.3b Is process equipment (including computer software) appropriate for the organization’s product or service? 4 6.3c Are support services (e.g. transport, communications, and waste disposal) appropriate for the organization’s product or service? Auditor Name (print): Initials: Date:
  • 21. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 21 of 54 6.4 Work Environment QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 6.4 Is the work environment appropriate for achieving product or service requirements? 2 6.4 Is safety and protective equipment provided where necessary? 3 6.4 Are workstations set out ergonomically? 4 6.4 Are kitchen and toilet facilities adequate? 5 6.4 Are heat, humidity, light levels and airflow controllable? 6 6.4 Are factors affecting hygiene, cleanliness, noise, vibration and pollution controllable? 7 6.4 Has the organization identified any shortcomings and is it taking appropriate action? Auditor Name (print): Initials: Date:
  • 22. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 22 of 54 7 Product Realization QuestionNo. ClauseRef. Audit Question Finding Audit Evidence/Comment YES NO A B C N.B. Provide references to documentation where necessary 1 7 Has the organization excluded itself from the requirements of the Product Realization process? 2 7 Has the organization justified any permissible exclusion in the relevant section of the quality manual? 7.1 Planning & Product Realization QuestionNo. ClauseRef. Audit Question Finding Audit Evidence/Comment YES NO A B C N.B. Provide references to documentation where necessary 1 7.1 Have the processes needed for product realization identified? 2 7.1 Is the planning of product realization consistent with the requirements of the other processes of the QMS? Auditor Name (print): Initials: Date:
  • 23. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 23 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence/Comment YES NO A B C N.B. Provide references to documentation where necessary 3 7.1a Has the organisation determined quality objectives for its products? 4 7.1b Has the organisation identified processes, documents and resources required by specific products? 5 7.1c Has the organisation identified methods for verification, validation, monitoring and inspection and test activities to meet acceptance criteria? 6 7.1d Has the organisation determined what records are needed to provide evidence that requirements for specific products have been met? 7 7.1e Is there an identifiable output from the planning process, in an appropriate format in accordance with 4.2.4? 7.2 Customer-related Processes 7.2.1 Determination of Requirements Related to the Product Auditor Name (print): Initials: Date:
  • 24. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 24 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7..2 Has the organisation determined product requirements prior to commitment to supply? 2 7.2.1a Customer’s specified requirements, delivery, warranty and service? 3 7.2.1b Requirements necessary for the product’s intended use? 4 7.2.1c Statutory and regulatory requirements? 5 7.2.1d Any additional requirements determined by the organisation? 7.2.2 Review of Requirements Related to the Product Auditor Name (print): Initials: Date:
  • 25. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 25 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.2.2 Does the organization undertake a review to ensure that the organization has the ability to meet requirements before committing to supply product? 2 7.2.2a Does the organization ensure that product requirements are defined and reviewed before committing to supply product? 3 7.2.2b Does the organization ensure that contract or order requirements differing from those previously expressed are resolved before committing to supply product? 4 7.2.2c Does the organization ensure that it has the ability to meet the defined requirements? 5 SQ Can you show me records of the product requirement review results and actions resulting from them? 6 SQ When customers don’t have documented requirements, how do you confirm their requirements before accepting orders? 7 SQ When product requirements are changed, how do you ensure that relevant documents are changed and that relevant personnel are made aware of the changes? 7.2.3 Customer Satisfaction Auditor Name (print): Initials: Date:
  • 26. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 26 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.2.3a Has the organization implemented effective arrangements for communicating product information? 2 7.2.3b Has the organization implemented effective arrangements for communicating enquiries? 3 7.2.3b Has the organization implemented effective arrangements for communicating contracts or order handling including amendments? 4 7.2.3c Has the organization implemented effective arrangements for communicating customer feedback? 5 7.2.3c Has the organization implemented effective arrangements for communicating customer complaints? 7.3 Design & Development 7.3.1 Design & Development Planning Auditor Name (print): Initials: Date:
  • 27. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 27 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.3.1a Have stages of design and development been determined for the product? 2 7.3.1b Are requirements for review, verification and validation defined for each stage? 3 7.3.1b Is validation completed prior to delivery or use, where practical? 4 7.3.1c Are responsibilities for design and development defined? 5 7.3.1 Is there effective communication between different members or groups in the design team? 6 7.3.1 Is planning output updated as appropriate as the design and development progresses? 7.3.2 Design & Development Inputs Auditor Name (print): Initials: Date:
  • 28. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 28 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.3.2 Are records of design inputs maintained in accordance with Clause 4.2.4? 2 7.3.2a Are requirements defined for function and performance? 3 7.3.2b Are applicable statutory and regulatory requirements defined? 4 7.3.2c Is information to be used from previous designs defined? 5 7.3.2d Are other requirements essential for design and development adequately defined? 6 7.3.2 Are design inputs reviewed for adequacy to confirm that they are complete, unambiguous and not in conflict? 7.3.3 Design & Development Outputs Auditor Name (print): Initials: Date:
  • 29. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 29 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.3.3a Do the outputs meet input requirements for design and development? 2 7.3.3b Do the outputs provide information required for purchasing, production and service provision? 3 7.3.3c Do the outputs contain or reference product acceptance criteria? 4 7.3.3d Do outputs specify characteristics for the product’s safe and proper use? 7.3.4 Design & Development Review Auditor Name (print): Initials: Date:
  • 30. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 30 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.3.4 Have design and development reviews taken place (involving representatives of all relevant functions) in accordance with the design and development plan? 2 7.3.4 Do participants in design reviews include representatives of functions concerned with the design development stage being reviewed? 3 7.3.4 Are records of reviews available in accordance with Clause 4.2.4? 4 7.3.4a Can the organization confirm that the results of design and development have been evaluated? 5 7.3.4b Were problems identified and were actions taken for resolution? 7.3.5 Design & Development Verification Auditor Name (print): Initials: Date:
  • 31. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 31 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.3.5 Has verification been completed in accordance with the design and development plan to confirm that design and development outputs meet requirements of inputs? 2 7.3.5 Are records maintained of the results of verification and any necessary actions in accordance with Clause 4.2.4? 7.3.6 Design & Development Validation QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.3.6 Has validation been completed in accordance with the design and development plan to confirm that the product is suitable for its specified application or intended use? 2 7.3.6 Are records maintained of the results of validation and any necessary actions in accordance with Clause 4.2.4? 7.3.7 Control of Design & Development Changes Auditor Name (print): Initials: Date:
  • 32. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 32 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.3.7 Have changes been reviewed to evaluate their effect on constituent parts and on product already delivered? 2 7.3.7 Have changes been approved prior to implementation? 3 7.3.7 Have changes been appropriately verified and validated? 4 7.3.7 Are records maintained of the results of change reviews and any necessary actions in accordance with Clause 4.2.4? 7.4 Purchasing 7.4.1 Purchasing Process Auditor Name (print): Initials: Date:
  • 33. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 33 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.4.1 Are verification requirements appropriate for the product’s application? 2 7.4.1 Are suppliers evaluated and selected (in accordance with established criteria) on the basis of their ability to meet specified requirements? 3 7.4.1 Are suppliers periodically re-evaluated in accordance with established criteria? 4 7.4.1 Are records maintained of the results of supplier evaluations in accordance with Clause 4.2.4? 7.4.2 Purchasing Information Auditor Name (print): Initials: Date:
  • 34. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 34 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.4.2 Does purchasing information adequately describe the product to be purchased? 2 7.4.2a Does purchasing information adequately describe the requirements for approval of product, procedures and equipment? 3 7.4.2b Does purchasing information adequately describe the requirements for qualification of personnel? 4 7.4.2c Does purchasing information adequately describe quality management system requirements? 5 7.4.2 Does the organisation ensure that purchasing information is adequate prior to issue to the supplier? 7.4.3 Verification of Purchased Product Auditor Name (print): Initials: Date:
  • 35. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 35 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.4.3 Is purchased product verified in accordance with specified requirements? 2 7.4.3 Does purchasing information contain details of any verification to be performed at the supplier’s premises? 7.5 Product & Service Provision 7.5.1 Control of Production & Service Provision QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.5.1a Is required information available to describe product characteristics? 2 7.5.1b Are necessary work instructions available? Auditor Name (print): Initials: Date:
  • 36. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 36 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 3 7.5.1c Is suitable equipment available? 4 7.5.1d Are required monitoring and measuring devices available? 5 7.5.1e Are required monitoring and measuring devices used in accordance with work instructions and/or the quality plan? 6 7.5.1f Are requirements for release, delivery and post delivery activities implemented? 7.5.2 Validation Processes for Production & Service Provision Auditor Name (print): Initials: Date:
  • 37. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 37 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.5.2a Is production or provision of service which cannot be verified by subsequent monitoring or measuring adequately validated to demonstrate that planned results are being achieved? 2 7.5.2b Are criteria defined for review and approval of the processes? 3 7.5.2c Are personnel qualified and is equipment approved? 4 7.5.2d Are required records maintained in accordance with Clause 4.2.4? 5 7.5.2e Is the time interval for process re-validation defined? 6 7.5.2f Does validation demonstrate the ability of the process to achieve planned results? 7.5.3 Identification & Traceability Auditor Name (print): Initials: Date:
  • 38. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 38 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.5.3 Is product identification and traceability required to be maintained throughout production (for any products)? 2 7.5.3 Is inspection and test status adequately defined maintained throughout production? 3 7.5.3 If traceability is a requirement are records of unique identification of the product available in accordance with Clause 4.2.4? 7.5.4 Customer Property QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.5.4 Does the organisation adequately identify, verify, protect and safeguard customer property? 2 7.5.4 Is the customer’s intellectual property controlled? Auditor Name (print): Initials: Date:
  • 39. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 39 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 3 7.5.4 Are records maintained of any loss or damage to customer property in accordance with Clause 4.2.4? 7.5.5 Preservation of Product QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.5.5 Are components adequately identified, handled, packaged, stored and protected prior to use? 2 7.5.5 Are finished products adequately identified, handled, packaged, stored and protected prior to delivery? 7.6 Control of Monitoring & Measuring Equipment Auditor Name (print): Initials: Date:
  • 40. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 40 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 7.6 Are monitoring and measuring devices required by the QMS controlled? 2 7.6a Is each device calibrated or verified at specified intervals (or prior to use) against measurement standards traceable to national or international standards? 3 7.6a Where no such standards exist is the basis of calibration or verification defined? 4 7.6b Is each device adjusted or re-adjusted as necessary (in accordance with manufacturer’s instructions)? 5 7.6c Is each device identified to enable calibration status to be determined? 6 7.6d Is each device safeguarded from adjustment, which would invalidate the measurement result? 7 7.6e Is each device protected from damage or deterioration during handling, maintenance or storage? Auditor Name (print): Initials: Date:
  • 41. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 41 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 8 7.6 Is the validity of previous results assessed and appropriate action taken, when a device is found not to conform to requirements? 9 7.6 Are records of the results of calibration and verification maintained in accordance with Clause 4.2.4? 10 7.6 When computer software is used in the monitoring and measuring equipment is it validated prior to initial use? 11 7.6 When computer software is used in the monitoring and measuring equipment is it re-confirmed as necessary? 8.0 Measurement, Analysis & Improvement 8.1 General Auditor Name (print): Initials: Date:
  • 42. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 42 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 8.1a Has the organization implemented appropriate measurement, analysis and improvement processes needed to demonstrate product conformity? 2 8.1b Has the organization implemented appropriate measurement, analysis and improvement processes needed to ensure conformity of the QMS 3 8.1c Has the organization implemented appropriate measurement, analysis and improvement processes needed to continually improve the effectiveness of the QMS? 4 8.1 Does the organization apply statistical techniques and determine the extent of their use? 8.2 Monitoring & Measurement 8.2.1 Customer Satisfaction Auditor Name (print): Initials: Date:
  • 43. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 43 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 8.2.1 Does the organization monitor customer satisfaction? 2 8.2.1 Does the organization use this information in accordance with defined methods? 8.2.2 Audit QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 8.2.2 Is there a documented procedure which defines responsibility and requirements for planning and conducting audits? 2 8.2.2 Is there a documented procedure which defines responsibility and requirements for reporting audit results? 3 8.2.2 Is there an audit programme in place defining audit criteria, scope, frequency and methods? Auditor Name (print): Initials: Date:
  • 44. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 44 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 4 8.2.2 Are records of audits maintained? 5 8.2.2 Do audit records confirm that audits were conducted? 6 8.2.2 Do audit records confirm that audits were conducted in accordance with the audit schedule? 7 8.2.2 Were appropriate follow up actions taken to eliminate non-conformances and their root cause? 8 8.2.2 Were the results of any follow up actions verified? 9 8.2.2 Are effective methods used to monitor (and measure if applicable) the processes of the QMS and the organisation? 10 8.2.2 Do the results confirm that they are capable of achieving planned results? Auditor Name (print): Initials: Date:
  • 45. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 45 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 11 8.2.2 If planned results are not achieved has appropriate action been taken? 8.2.3 Monitoring & Measurement of Processes QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 8.2.3 Are effective methods used to monitor and measure the processes of the QMS and the organisation? 2 8.2.3 Do the results confirm that the processes are capable of achieving planned results? Auditor Name (print): Initials: Date:
  • 46. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 46 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 3 8.2.3 If planned results are not achieved has appropriate action been taken? 8.2.4 Monitoring & Measurement of Product QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 8.2.4 Are product characteristics measured to confirm that product requirements are met? 2 8.2.4 Do monitoring and measuring activities take place at predetermined stages during the product realization process? Auditor Name (print): Initials: Date:
  • 47. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 47 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 3 8.2.4 Are records of evidence of conformity with acceptance criteria maintained in accordance with Clause 4.2.4? 4 8.2.4 Are records that indicate authorized release of a product to the next stage available? 5 8.2.4 Do arrangements exist to ensure that a product is not released until the all requirements have been met 6 8.2.4 Do arrangements exist to ensure that if a product must be released prior satisfying the requirements, is it approved? 8.3 Control on Non-conforming Product QuestionNo. ClauseRef. Audit Question Finding Audit Evidence/Comment YES NO A B C N.B. Provide references to documentation where necessary 1 8.3 Is there a documented procedure which describes how non-conforming product is dealt with? Auditor Name (print): Initials: Date:
  • 48. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 48 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence/Comment YES NO A B C N.B. Provide references to documentation where necessary 2 8.3 Is there a documented procedure which describes the identification of non- conformities and actions to prevent unintended use or delivery? 3 8.3 Is there a documented procedure which describes the necessary responsibility and authority for dealing with non-conforming product? 4 8.3 Is there a documented procedure which describes methods of dealing with non-conforming product? 5 8.3 Is there a documented procedure which describes the action to be taken if non-conformity is detected after delivery? 6 8.3 Are there records of action taken following identification of a non-conformity maintained in accordance with Clause 4.2.4? 7 8.3 Do the records detail any re-work undertaken to eliminate the detected non- conformity? 8 8.3 Do the records detail methods and criteria for re-verification to demonstrate conformity? Auditor Name (print): Initials: Date:
  • 49. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 49 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence/Comment YES NO A B C N.B. Provide references to documentation where necessary 9 8.3 Do the records detail acceptances under concession by a relevant authority? 10 8.3 Do the records detail if non-conforming products were withdrawn from intended use? 8.4 Analysis of Data QuestionNo. ClauseRef. Audit Question Finding Audit Evidence/Comment YES NO A B C N.B. Provide references to documentation where necessary 1 8.4 Are data collected and analyzed to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of its effectiveness can be made? Auditor Name (print): Initials: Date:
  • 50. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 50 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence/Comment YES NO A B C N.B. Provide references to documentation where necessary 2 8.4 Does the analysis of data include information relating to customer satisfaction? 3 8.4 Does the analysis of data include information relating to the conformity to product requirements? 4 8.4 Does the analysis of data include information relating to characteristics and trends of processes and products? 5 8.4 Does the analysis of data include information relating to improvement opportunities and preventive action? 6 8.4 Does the analysis of data include information relating to suppliers? 8.5 Improvement 8.5.1 Continual Improvement Auditor Name (print): Initials: Date:
  • 51. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 51 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 8.5.1 Does the organisation continually improve the effectiveness of the QMS through use of the quality policy? 2 8.5.1 Does the organisation continually improve the effectiveness of the QMS through use of quality objectives? 3 8.5.1 Does the organisation continually improve the effectiveness of the QMS through use of audit results? 4 8.5.1 Does the organisation continually improve the effectiveness of the QMS through use of data analysis? 5 8.5.1 Does the organisation continually improve the effectiveness of the QMS through use of corrective and preventive action? 6 8.5.1 Does the organisation continually improve the effectiveness of the QMS through use of management reviews? 8.5.2 Corrective Action Auditor Name (print): Initials: Date:
  • 52. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 52 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 8.5.2 Is there a documented procedure which describes how corrective action is undertaken? 2 8.5.2 Do corrective actions records identify and address root cause(s)? 3 8.5.2 Are actions taken appropriate to the severity of the problem? 4 8.5.2a Does the corrective action procedure define the requirements for the review of non-conformities (including customer complaints)? 5 8.5.2d Does the corrective action procedure define the requirements for the review of determining the causes of non-conformities? 6 8.5.2c Does the corrective action procedure define the requirements for evaluating the need for action to ensure that non-conformities do not recur? 7 8.5.2d Does the corrective action procedure define the requirements for determining and implementing action needed? Auditor Name (print): Initials: Date:
  • 53. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 53 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 8 8.5.2e Does the corrective action procedure define the requirements for the records of the results of action taken? 9 8.5.2f Does the corrective action procedure define the requirements for reviewing the effectiveness of corrective actions taken? 10 8.5.2 Have corrective actions been implemented in accordance with the documented procedure? 8.5.3 Preventive Action Auditor Name (print): Initials: Date:
  • 54. Company Name/Logo ISO 9001:2008 Audit & Gap Analysis Checklist (This checklist may be used for internal or external auditing purposes). F-3 Version 1 Page 54 of 54 QuestionNo. ClauseRef. Audit Question Finding Audit Evidence YES NO A B C N.B. Provide references to documentation where necessary 1 8.5.3a Does the preventive action procedure define the requirements for determining causes of potential non-conformities? 2 8.5.3b Does the preventive action procedure define the requirements for evaluating whether action needs to be taken to prevent occurrence? 3 8.5.3c Does the preventive action procedure define the requirements for determining what action is required and ensuring that it is implemented? 4 8.5.3d Does the preventive action procedure define the requirements for maintaining records (in accordance with Clause 4.2.4) of the results of action taken? 5 8.5.3e Does the preventive action procedure define the requirements for reviewing preventive action taken? 6 8.5.3 Has preventive action been implemented in accordance with the documented procedure? Auditor Name (print): Initials: Date: