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Gap Analysis Checklist www.iso-9001-checklist.co.uk

Gap Analysis

Checklist

ISO 9001:2015 Self-assessment

Gap Analysis Checklist

ISO 9001:2015 Self-assessment

www.iso-9001-checklist.co.uk Page 1 of 49

Contents

Gap Analysis Checklist Part A _________________________________________________________________________________________________ 4

Clause 4 - Context of the Organization __________________________________________________________________________________________ 4

4.1 Understanding the Organization and its Context ________________________________________________________________________________ 4

4.2 Understanding the Needs and Expectations of Interested Parties __________________________________________________________________ 4

4.3 Determining the Scope of the Quality Management System _______________________________________________________________________ 5

4.4 Quality Management System and its Processes ________________________________________________________________________________ 6

Clause 5 - Leadership ________________________________________________________________________________________________________ 7

5.1 Leadership and Commitment _______________________________________________________________________________________________ 7

5.2 Quality Policy ___________________________________________________________________________________________________________ 8

5.3 Organizational Roles, Responsibilities and Authorities ___________________________________________________________________________ 9

Clause 6 - Planning _________________________________________________________________________________________________________ 11

6.1 Actions to Address Risks and Opportunities __________________________________________________________________________________ 11

6.2 Quality Objectives and Planning to Achieve Them _____________________________________________________________________________ 12

6.3 Planning for Changes ___________________________________________________________________________________________________ 13

Clause 7 - Support __________________________________________________________________________________________________________ 14

7.1 Resources ____________________________________________________________________________________________________________ 14

7.1.1 General ___________________________________________________________________________________________________________ 14

7.1.2 People ____________________________________________________________________________________________________________ 14

7.1.3 Infrastructure _______________________________________________________________________________________________________ 15

7.1.4 Environment for the Operation of Processes ______________________________________________________________________________ 15

7.1.5 Monitoring and Measuring Resources ___________________________________________________________________________________ 16

7.1.6 Organizational Knowledge ____________________________________________________________________________________________ 17

7.2 Competence ___________________________________________________________________________________________________________ 17

7.3 Awareness ____________________________________________________________________________________________________________ 18

7.4 Communication ________________________________________________________________________________________________________ 18

7.5 Documented Information _________________________________________________________________________________________________ 19

7.5.1 General ___________________________________________________________________________________________________________ 19

7.5.2 Creating and Updating _______________________________________________________________________________________________ 19

Gap Analysis Checklist

ISO 9001:2015 Self-assessment

www.iso-9001-checklist.co.uk Page 2 of 49

7.5.3 Control of Documented Information _____________________________________________________________________________________ 20

Clause 8 - Operation ________________________________________________________________________________________________________ 21

8.1 Operational Planning and Control __________________________________________________________________________________________ 21

8.2 Requirements for Products and Services ____________________________________________________________________________________ 22

8.2.1 Customer Communication _____________________________________________________________________________________________ 22

8.2.2 Determining the Requirements for Products and Services ____________________________________________________________________ 23

8.2.3 Review of Requirements for Products and Services_________________________________________________________________________ 23

8.3 Design and Development of Products and Services ____________________________________________________________________________ 24

8.3.1 General ___________________________________________________________________________________________________________ 24

8.3.2 Design and Development Planning ______________________________________________________________________________________ 24

8.3.3 Design and Development Inputs ________________________________________________________________________________________ 25

8.3.4 Design and Development Controls ______________________________________________________________________________________ 26

8.3.5 Design and Development Outputs ______________________________________________________________________________________ 26

8.3.6 Design and Development Changes _____________________________________________________________________________________ 27

8.4 Control of Externally Provided Processes, Products and Services _________________________________________________________________ 27

8.4.1 General ___________________________________________________________________________________________________________ 27

8.4.2 Type and Extent of Control ____________________________________________________________________________________________ 28

8.4.3 Information for External Providers_______________________________________________________________________________________ 29

8.5 Production and Service Provision __________________________________________________________________________________________ 30

8.5.1 Control of Production and Service Provision ______________________________________________________________________________ 30

8.5.2 Identification and Traceability __________________________________________________________________________________________ 31

8.5.3 Property Belonging to Customers or External Providers _____________________________________________________________________ 32

8.5.4 Preservation _______________________________________________________________________________________________________ 33

8.5.5 Post-delivery Activities _______________________________________________________________________________________________ 34

8.5.6 Control of Changes __________________________________________________________________________________________________ 34

8.6 Release of Products and Services __________________________________________________________________________________________ 35

8.7 Control of Nonconforming Outputs _________________________________________________________________________________________ 36

Clause 9 - Performance Evaluation ____________________________________________________________________________________________ 38

9.1 Monitoring, Measurement, Analysis and Evaluation ____________________________________________________________________________ 38

9.1.1 General ___________________________________________________________________________________________________________ 38

9.1.2 Customer Satisfaction ________________________________________________________________________________________________ 39

Gap Analysis Checklist

ISO 9001:2015 Self-assessment

www.iso-9001-checklist.co.uk Page 3 of 49

9.1.3 Analysis and Evaluation ______________________________________________________________________________________________ 39

9.2 Internal Audit __________________________________________________________________________________________________________ 40

9.3 Management Review ____________________________________________________________________________________________________ 41

9.3.1 General ___________________________________________________________________________________________________________ 41

9.3.2 Management Review Inputs ___________________________________________________________________________________________ 41

9.3.3 Management Review Outputs __________________________________________________________________________________________ 42

Clause 10 - Improvement ____________________________________________________________________________________________________ 43

10.1 General _____________________________________________________________________________________________________________ 43

10.2 Nonconformity and Corrective Action ______________________________________________________________________________________ 43

10.3 Continual Improvement _________________________________________________________________________________________________ 44

Gap Analysis Findings List Part B _____________________________________________________________________________________________ 46

Action Plan ________________________________________________________________________________________________________________ 46

Clause 4 - Context of the Organization _________________________________________________________________________________________ 46

Clause 5 - Leadership ______________________________________________________________________________________________________ 46

Clause 6 - Planning ________________________________________________________________________________________________________ 47

Clause 7 - Support _________________________________________________________________________________________________________ 47

Clause 8 - Operation _______________________________________________________________________________________________________ 48

Clause 9 - Performance Evaluation ____________________________________________________________________________________________ 49

Clause 10 - Improvement ___________________________________________________________________________________________________ 49

Gap Analysis Checklist

ISO 9001:2015 Self-assessment

www.iso-9001-checklist.co.uk Page 4 of 49

Gap Analysis Checklist Part A

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