Audit relating definitions
- 1. Organisation Organization Orderly arrangement of responsibilities, authorities and relationships between people Work Environment Set of condition under which a person operate Customer Organization or person that purchases product Supplier Organization or person that provides a product Interested property Person or group having an interest in the performing or success of an Organization QA Manager/Director In this QSM QA Director may be referred to as QA manager as well.
- 2. Management Management system System to establish policy and objectives and to achieve them Quality Management system System to establish a quality policy and quality objectives and to achieve them Quality Policy Overall intention and direction of an organization related to quality as formally expressed by the management Quality Objectives Something sought, or aimed for related to quality Quality planning Part of quality management focused on setting quality objectives and specifying necessary operational process and related resource to fulfill the quality objectives Quality control A system for achieving or maintaining the desired level of quality in a manufactured product by inspecting samples and assessing what changes may be needed in the manufacturing process Quality Improvement Part of the Quality management, focused on increase effectiveness and efficiency Quality Assurance A system of procedures carried out to ensure that a product or a system adheres or conforms to established standards.
- 3. Output of an organisation Process System of activities which uses resource to transform input into output Product Result of a process Service Intangible product that is the result of at least one activity performed at the Interface between the supplier and customer
- 4. Examination Objective Evidence Data supporting the existence or verity of something. Inspection Conformity evaluation by observation and judgment accompanied as appropriate by measurement, testing or gauging. Verification Confirmation and provision of objective evidence that specified requirements have been fulfilled. Validation Confirmation and provision of objective evidence that the requirements for a specific intended use or application have been fulfilled
- 5. Quality Quality Ability of a set of inherent characteristic of a product, system or process to fulfill requirement of customer and other interested parties. Quality Requirement Requirement for inherent characteristic of a product, process or system Customer Satisfaction Customer’s opinion of the degree to which a transaction has met the Customer’s needs and expectations Capability Ability of an organization, system, or process to realize a product that fulfills the requirement for the product Quality Characteristic Inherent characteristic of a product, process, or system derived from a requirement Traceability Ability to trace the history, application or location of that which is under requirement
- 6. Documents Document Information and its support medium Specification Document stating requirements Guideline Document stating recommendations or suggestions Quality Manual Document stating the quality management system of an organization Quality Plan Document specifying the quality management system elements and the resources to be applied in a specific case. Procedure Specified way to perform an activity or a process. Record Document stating results achieved or providing evidence of activities performed
- 7. Conformity Conformity Act as required Non-conformity Where the requirement is not followed Preventive Action Action taken to eliminate the causes of a potential non-conformity or other potential undesirable situation Corrective Action Action taken to eliminate the cause of a detected nonconformity or other undesirable situation. Correction Action taken to eliminate a detected nonconformity. Concession Authorization to use or release a product that does not conform to the specified requirements
- 8. Conformity Release Authorization to proceed to the next stage of a process Repair Action taken to a non-conforming to make it acceptable for the intended use Rework Action taken on a non-conforming product to make it conform to the requirements Re-grade Alteration of the grade of a non-conforming product in order to make it conformant with requirements differing from the initial ones Scrap Action taken on a non-conforming product to preclude its originally intended usage
- 9. Audit Relating Definitions 3.1.8 TERMS RELATING TO AUDIT Audit Systematic, independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.
- 10. Definitions (Contin) Audit Programme Set of audits to be carried out during a planned timeframe Audit Scope Extent and range of a given audit Audit Criteria Set of policies, procedures, or requirements against which collected audit evidence is compared
- 11. Audit Evidence Records, verified statements of fact or other information relevant to the audit. Audit Findings Results of the evaluation of the collected audit evidence against audit criteria Audit Conclusions Outcome of an audit decided by the audit team after consideration of all the audit findings
- 12. Types Of Audits Internal External 2nd Part 3rd Part Or Certification