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List of Records

The document outlines 31 clauses that require organizations to maintain records related to quality management systems and processes. Specifically, it requires maintaining records for personnel competence and training, customer requirements and reviews, nonconformities, design and development activities, supplier evaluations, identification and traceability, audits, corrective and preventive actions, and management reviews. All records must be maintained according to section 4.5 of the standard.

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Penguin QA
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29 views

List of Records

The document outlines 31 clauses that require organizations to maintain records related to quality management systems and processes. Specifically, it requires maintaining records for personnel competence and training, customer requirements and reviews, nonconformities, design and development activities, supplier evaluations, identification and traceability, audits, corrective and preventive actions, and management reviews. All records must be maintained according to section 4.5 of the standard.

Uploaded by

Penguin QA
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Records to be maintained

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1 4.3.2.2 Personnel Competence  Evidence of the determination of competence of personnel shall be recorded and maintained(see4.5).

2 4.3.2.3.e Training and Awareness The organization shall maintain appropriate records of education, training, skills, and experience (see 4.5).

3 5.1.1 Product Realization/Contract  Where the customer provides no documented statement of the requirements, the customer requirements 


Review/General shall be confirmed by the organization and records maintained (see 4.5).

4 5.1.3 Contract Review/Review of  Records of the results of the review, including resulting actions, shall be maintained (see 4.5)


Requirements

5 5.10.4 NC Customer Notification The organization shall notify customers of product not conforming to DAC or contract requirements, that has 


been delivered. The organization shall maintain records of such notifications (see 4.5).

6 5.10.5 NC Records Records of the nature of nonconformities and any subsequent actions taken, including concessions


obtained, shall be maintained (see 4.5).

7 5.11.1 Management of Change (MOC)  The organization shall maintain records of MOC activities (see 4.5).


(General)

8 5.2.h Planning In planning, the organization shall address the records needed to provide evidence that the product realization 


processes meet requirements (see 4.5).

9 5.3 Risk Assessment and Management Records of the risk assessment and management including actions taken shall be maintained (see 4.5)

10 5.4.2 Design and Development Inputs Records of design inputs shall be maintained (see 4.5)

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11 5.4.3 Design and Development Outputs Records of design outputs shall be maintained (see 4.5).

12 5.4.4 Design and Development Review Records of the results of the review(s) and any necessary actions


shall be maintained (see 4.5)

13 5.4.4.b Design and Development Review Records of the results of the review(s) and any necessary actions shall be maintained (see 4.5).

14 5.4.5 Design and Development  Records of the results of the review(s) and any necessary actions shall be maintained (see 4.5).


Verification and Final Review

15 5.4.6 Design and Development Validation  Records of the design and development validation, approval, and any necessary actions shall be


and Approval maintained (see 4.5).

16 5.4.7 Design and Development Changes Records of design and development changes, reviews of those changes, and any necessary actions shall be 


maintained (see 4.5).

17 5.6.1.5 Supplier Evaluation‐Records Records of the results of all evaluations and any necessary actions arising from the evaluations shall be


maintained (see 4.5).

18 5.6.1.6 Outsourcing Records of outsourced activities shall be maintained (see 4.5).

19 5.6.3 Verification of Purchased Products  The organization shall maintain records of verification activities (see 4.5).


or Activities

20 5.7.3 Identification and Traceability Records (see 4.5) of identification and traceability shall be maintained.

21 5.7.5 Customer‐supplied Property Records for the control and disposition of customer‐supplied property shall be maintained (see 4.5).

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22 5.7.6.2 Storage and Assessment Records of the results of assessments shall be maintained (see 4.5).

23 5.7.7.1 Inspection and Testing (General) Records of required inspection and testing shall be maintained per documented


procedures (see 4.5).

24 5.7.8 Preventive Maintenance Records of preventive maintenance shall be maintained (see 4.5).

25 5.8 Control of Testing, Measuring, and  Records of the results of calibration and verification shall be maintained (see 4.5).


Monitoring Equipment

26 5.9 Product Release Records shall be maintained to enable identification of the individual releasing the product (see 4.5)

27 6.2.1 Customer Satisfaction Records of the results of customer satisfaction information shall be maintained (see 4.5).

28 6.2.2.2 Performance of Internal Audit Records of the audits shall provide objective evidence that the quality management system is


implemented and maintained (see 4.5).

29 6.2.2.3 Audit Review and Closure Records of internal audits shall be maintained (see 4.5).

30 6.4.2 Corrective Action Records of the activities for control of a nonconforming process shall be maintained (see 4.5).

31 6.4.3 Preventive Action Records of the activities for control of potential process nonconformities shall be maintained (see 4.5).

32 6.5.3 Output Requirements Management reviews shall be documented and records of these reviews shall be maintained (see 4.5).

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