Checklist_of_ISO_9001_2015_Mandatory_Documentation_EN
- 1. Checklist of Mandatory Documentation Required by ISO 9001:2015 Copyright ©2015 9001Academy. All rights reserved. WHITE PAPER October 15, 2015
- 2. 2Copyright ©2015 9001Academy. All rights reserved. BASICOVERVIEW It is easy to becomeoverwhelmed with documentation in the beliefthat every single process that is in place in an organization must be documented, withoutrealizing that this is not necessary to meet the requirements of the ISO 9001 standard. The 2015 revision ofthe standard become more liberal regarding documentation requirements, meaning that there areno longer six mandatory procedures as in the previous 2008 version of the standard. ISO9001 also identifies many records that need to be maintained, which are generated by the processes ofthe Quality Management System. Below is discussed which documents and records are mandatory,and which are optional. 1) Which documentsand recordsare required? Mandatory Documents ISO 9001:2015 Clause Scope ofthe Quality Management System 4.3 Quality Policy 5.2 Quality Objectives and Plans for Achieving Them 6.2 Procedure for Control ofExternally Provided Processes, Products and Services (outsourced processes) 8.4.1 Mandatory Records ISO 9001:2015 Clause Record ofMaintenanceand Calibration of Monitoring and Measuring Equipment 7 .1.5.1 Competence Records 7 .2 Product/Service Requirements Review Record 8.2.3.2 Record ofNew Requirements for Product orService 8.2.3.2 Design and Development InputsRecord 8.3.3
- 3. 3Copyright ©2015 9001Academy. All rights reserved. Record ofDesign and Development Controls 8.3.4 Design and Development Outputs Record 8.3.5 Record ofDesign and Development Changes 8.3.6 Record ofEvaluation of External Provider (supplier) 8.4.1 Record ofProduct/Service Characteristics 8.5.1 Record ofChanges on Customer’s Property 8.5.3 Record ofChanges in Production/Service Provision 8.5.6 Evidence of Product/ServiceConformity 8.6 Record ofNonconformity 8.7 .2, 10.2.2 Monitoring Performance Information 9.1.1 Internal Audit Program and Results 9.2.2 Management Review Results 9.3 Nonconformities and Corrective Action 10.2.2 These are the documents and records that are required to be maintained for the ISO9001 Quality Management System, but you should also maintain any otherrecords that you have identified as necessary to ensure your management system can function, be maintained, and improve over time. 2) Commonly used non-mandatorydocuments Non-Mandatory Procedures ISO 9001 Clause Determining Context ofthe Organization and Interested Parties 4.1, 4.2 Procedure for Addressing Risks and Opportunities 6.1. Competence, Training and Awareness Procedure 7 .2, 7 .3 Procedure for Control ofDocuments and Records 7 .5
- 4. 4Copyright ©2015 9001Academy. All rights reserved. Sales Procedure 8.2 Procedure for Design and Development 8.3 Procedure for Production and Service Provision 8.5 Warehousing Procedure 8.5.4 Procedure for Measuring Customer Satisfaction 9.1.2 Procedure for Internal Audit 9.2 Procedure for Management Review 9.3 Procedure for Nonconformity and Corrective Action 10.2 While ISO 9001 does not require that you document all ofthe procedures, there are several processes that are mandatory to be established in order to generate the required records that are outlined in the first section. Remember these processes and procedures are not required to be documented;however, many companies choose to do so.One rule ofthumb when deciding ifyou want to documenta process is this:if there is a chance that the process won’tbe carriedout as planned, then you should document it. I n many cases this is the best way to ensure that your Quality Management System is reliably implemented. 3) How to structuredocumentsand records DeterminingContext ofthe Organization and Interested Parties This is a new requirement ofthe standard that can bring someambiguities, and it is a good idea to document the process ofdetermining the context and identifying interested parties and their expectations, since it is being done for the first time. This document should contain all internal and external issues to be considered, as well as the process and responsibilities for identification ofinterested parties and their needs and expectations. Procedure for Determining Contextofthe Organization and InterestedParties can be ofgreat help in implementation ofthese new requirements. For more information, see: How to identify the context ofthe organization in ISO 9001:2015. QMS Scope This documentis usually rathershort, and written at the beginning ofthe ISO 9001 implementation. Its purpose is to define the boundaries ofthe QMS and to determineto which parts of the organization the QMS applies. Normally, it is a standalone document called Scope ofthe QMS, although it can be merged into a Quality Manual.
- 5. 5Copyright ©2015 9001Academy. All rights reserved. Quality Policy The Quality Policy is intended to be a company’s documented intention to comply with appropriate requirements, increase customersatisfaction, and continually improve. The policy is the focus for the company to work toward and should readily convey the goal ofthe organization.It is a standalone document , but is often documented in a Quality Manual and sometimes posted throughout the organization as a way of communicating to all employees, since it is important that every employee understand how the policy relates to his or her job. For more information,see How to Write a Good Quality Policy. Risks and Opportunitiesthat needto be addressed This is a new requirement that introduces significant changes to the QMS. According to the new version, the risks and opportunities regarding the QMS must be identified and addressed, but thereis no requirement to use any methodology or write a procedure. The process ofaddressing risks and opportunities includes consideration ofinternal and external issues relevant to the QMS, interested parties, and scopeofthe QMS. Considering the importance ofthis new requirement and the fact that it introduces a completely new process into the organization, it is recommendedthat it be documented in the form ofa procedure. For more information, read: Risk-based thinking replacing preventive action in ISO9001:2015 –The benefits and Methodology for ISO9001 Risk Analysis. Quality Objectives and Plans forAchievingThem The requirements regarding setting the quality objectives remained as they were in the previous version of the standard;they still need to be measurable and timed. However, the standard now requires plans for achieving the objectives, meaning that the organization will have to assign responsibilities and dedicate resourcesfor achieving the objectives. These requirements can be met in separate documents, but it is much easier to create a Quality Objectives document and fulfill all the above-mentioned requirements. For more information, see:How to Write Good Quality Objectives. Competence, Training and Awareness records Introducing quality management into an organization often requires additional training ofrelevant employees. Describing the process ofmanaging human resources by documenting a procedure that defines identification oftraining needs,training planning, conducting and evaluation oftraining effectiveness ,as well as assigning responsibilities for this, is the best way to ensure that the requirements are met. Although it is not a requirement ofthe standard, good practice shows that the Procedure for Competence, Training and Awarenesscan be ofgreat help to an organization. The standard explicitly requires only the evidence of competence,and that is the Training Record. See also: How to ensure competenceand awareness in ISO 9001:2015. Procedure for Control ofDocuments and Records Managing documented information is defined by many requirements within clause 7.5 in the standard. Activities ofapproval,update, managing changes, and ensuring that the relevantversion ofthe document is in use are best to be defined in a documented procedure.
- 6. 6Copyright ©2015 9001Academy. All rights reserved. The company must also define rules to maintain its records that show the QMS is implemented and maintained, including how they identify, store, and protect the records so that they can be retrieved as necessary, for the correct amount oftime, and destroyed when no longer needed butnot before . Ifyou need more information, see New approach to document and record control in ISO9001:2015. Sales procedure Although it is not a mandatory procedure, the standard prescribes numerous rules regarding communication with customers, determining requirements related to product and services, and activities regarding review of these requirements.Good practiceshows that the bestway to conform to all these requirements is to documentthem, togetherwith responsibilities.The only mandatory documented information here arethe records ofreviewing requirements relatedto product and service, as well as information aboutnew requirements for products and services. Procedure for Design and Development Requirements regarding the design and development process are among the most demanding in the standard. Every step ofthe design and development process needs to be documented in the form ofa record, from design and development inputs, controls, and outputs, to changes in design and development. Considering all the requirements regarding the design and development process, it is best to document the Procedure for Design and Development and define all mandatory records thatshould accompany the procedure. For more information, see: ISO9001 Design Verification vs. Design Validation. Procedure for control of externally provided processes, products and services(outsourced processes) Creators ofthe standard decided to use this rather robustformulation ofsomething that is basically the Procedure for Purchasing and Evaluation ofSuppliers. Although the purchasing processdoesn’t have to be documented, the standard requires companies to establish control overits externally provided processes, products, and services. The standard does requirethe criteria for evaluation, selection, monitoring, and re- evaluation ofthe suppliers to be documented, and the best way to do it is through the procedure. For more information, see: Purchasing in QMS – The Process &the Information Needed to Make it Work. Procedure for production and service provision The standard requires production and service provision processes to be under control in terms ofavailability of necessary documented information about product or service characteristics, intended results, availability of needed resources, monitoring and measurement activities,etc.This rather complex process will hardly achievethe intended outcomes without clearly defined rules documented in the Procedure for Production and Service Provision. See also: Understanding Product&Service Provision in ISO 9001 .
- 7. 7Copyright ©2015 9001Academy. All rights reserved. Warehousing procedure The importance and necessity ofthis procedure will vary depending on the typeofbusiness the company performs, but the requirement for productpreservation is one ofthe most crucial ones in the way ofthe productor servicetoward the end user.In cases when the storage conditions can have great influence on the productquality, rules for preservation ofthe product during storage should be documented in the Warehousing Procedure. Monitoring performance information The new version ofthe standard emphasizes the importanceofmeasuring and evaluation ofQMS performance. The organization needs to determine what should be monitored, how,and when. This doesn’t have to be in one document, meaning that necessary monitoring and measuring is usually included in related process procedures. But, it is good to havean overview ofkey performance indicators and their status in the form of a Matrix ofKey Performance Indicators. Learn more here: Analysis ofmeasuring and monitoring requirements in ISO 9001:2015. Internal audit How do you audit your Quality Management System to make sure that it is performing as planned and is effective?Who is responsible for planning and carrying out the audits? How do you report the results, and what records are kept?How do you follow up on correctiveactions noted in audits?Learn morein this article about the Five Main Steps in ISO 9001 Internal Audit. You must also keep records ofthese activities to show QMS conformanceand improvement. Management review Management review as a process hasn’t suffered any changes in the new ISO 9001:2015 revision in terms of how and how often it should be conducted. However, the mandatory inputs and outputs of the management review have changed. It is now required for the top management to review internal and external issues relevant to the QMS, as well as the effectiveness ofactions taken to address risks and opportunities. As a result ofthe management review, thereshould be decisions regarding opportunities for improvement ofthe QMS, need for changes ofthe system, and resources needed. The best way to keep track ofwhat needs to be reviewed and the expected results ofthe management review is to document the Procedure for Management Review. For more information, see: How to make Management Review more useful in the QMS. Nonconformityand corrective action What actions are in place, and who is responsible for making sure that a nonconformity is addressed?How do you ensure that corrections are made, and what records are kept ofthe process?Find out more here: Understanding dispositions for ISO9001 nonconforming product. How do you review nonconformities, determine causes, and evaluate the need for actions to correct them?How do you implement the necessary actions, review that the actions were effective, and keep records ofthe actions taken?With the Quality Management System you will find that you havenon-conformances occur within your processes that you will need to correct;and when you investigate the root cause ofthese problems,you will havecorrective actions
- 8. 8Copyright ©2015 9001Academy. All rights reserved. taken. Y ou will also need to keep records ofthese activities to show improvement. Learn how to do this with Seven Steps for Correctiveand Preventive Actions to supportContinual Improvement. 4) Sample DocumentationTemplates Here you can download a free preview ofthe ISO9001 Documentation Toolkit –in this free preview you will be able to see the Table ofContents ofeach ofthe mentioned documented procedures, as well as a few sections from each document.
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