Table of Contents Page

0.1 Forward ............................................................................................... 5

1.1 Scope .................................................................................................................................. 6

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2 Approval & Assignment .................................................................... 7

2.1 Approval ............................................................................................................................ 7

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2.2 Assignment ....................................................................................................................... 7
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3 Terms & Definitions ........................................................................... 8

3.1 Terms & 8

Definitions ........................................................................................................................
4.0 Context of the Organization .............................................................. 9

4.1 Understanding the Organization and its 9

Context .........................................................................
4.2 Understanding the Needs and Expectations of Interested Parties 9

4.3 Determining the Scope of the Quality Management System 10

4.3.1 Boundaries and Applicability ..................................................... 10

4.3.2 Scope ..................................................... 10

4.3.3 Not Applicable ..................................................... 10

4.4 Quality Management System and its 10

Processes ..........................................................................
4.4.1 Quality Management System and its 10
Processes .......................................................................
4.4.2 Quality Management System Process Flow.......... 13

5 Leadership ......................................................................................... 14

5.1 Leadership and Commitment 14

5.1.1 General ..................................................... 14

5.1.2 Customer Focus 15

5.2 Policy 16
5.2.1 Establishing a Quality 16
Policy ...................................................................................................
5.2.2 Communicating the Quality 16
Policy ..........................................................................................
5.3 Organizational Roles, Responsibilities and 16
Authorities .............................................................
5.3.1 Organizational Roles, Responsibilities, and 18
Authorities .........................................................
 5.3.2 Responsibility and Authority for Product Requirements and Corrective 18
Actions
6 Planning ............................................................................................. 19

6.1 Actions to Address Risks and 19

Opportunities ...............................................................................
6.2 Quality Objectives and Planning to Achieve 21
Them ....................................................................
6.3 Planning of 21
Changes ......................................................................................................................
7 Support .............................................................................................. 22

7.1 Resources .......................................................................................................................... 22

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7.1.1 General ..................................................... 22

7.1.2 People................................................................................... 22

7.1.3 Infrastructure ..................................................... 22

7.1.4 Environment for the Operation of 23
Processes ...........................................................................
7.1.5 Monitoring and Measuring of 23
Resources .................................................................................
7.1.6 Organizational Knowledge ..................................................... 26

7.2 Competence ...................................................................................................................... 26

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7.2.1 Competence ..................................................... 26
7.2.2 Competence – On the Job Training 27
(OJT) ...............................................................................
7.2.3 Internal Auditor Competency ..................................................... 27

7.2.4 Second-party Auditor Competency ..................................................... 28

7.3 Awareness ......................................................................................................................... 28

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7.3.1 28
Awareness ................................................................................................................................
7.3.2 Employee Motivation and 28
Empowerment ...............................................................................
7.4 Communication 29

7.5 Documented Information 29

7.5.1 General 29

7.5.2 Creating and Updating 30

7.5.3 Control of Documented Information 30

8 Operation ........................................................................................... 32
8.1 Operational Planning and Control 32

8.1.1 Operational Planning and Control 32

8.1.2 Confidentiality 32

8.2 Requirement for Product and Services 32

8.2.1 Customer Communication 32

8.2.2 Determining the Requirements for Products and Services 33

8.2.3 Review of Requirements for Products and Services 33

8.2.4 Changes to Requirements for Products and Services 34

8.3 Design and Development of Products and Services 35

8.3.1 General 35

8.3.2 Design and Development Planning 35

8.3.3 Design and Development Inputs 36

8.3.4 Design and Development Controls 38

8.3.5 Design and Development Outputs (Output) 39

8.3.6 Design and Development Changes 41

8.4 Control of Externally Provided Processes, Products, and Services 41

8.4.1 General 41

8.4.2 Type and Extent of Control 42

8.4.3 Information for External Providers 45

8.4.3.1 Information for External Providers 45

8.5 Production and Service Provision 46

8.5.1 Control of Production and Service Provision 46

8.5.2 Identification and Traceability 49

8.5.3 Property Belonging to Customers or External Providers 50

8.5.4 Preservation 50

8.5.5 Post Delivery Activities 50

8.5.6 Control of Changes 51

 8.6 Release of Products and Services ...................... 52

8.6.1 Release of Products and Services 52

8.6.2 Layout Inspection and Functional Testing 52

8.6.3 Appearance Items (Not Applicable) 52

8.6.4 Verification and Acceptance of Conformity of Externally Provided .. 53
Products and Services
8.6.5 Statutory and Regulatory (Legal) Conformity 53

8.6.6 Acceptance Criteria 53

8.7 Control of Nonconforming Outputs 53

9 Performance Evaluation 56

9.1 Monitoring, Measurement, Analysis and Evaluation 56

9.1.1 General 56

9.1.2 Customer Satisfaction 57

9.1.3 Analysis and Evaluation 57

9.2 Internal Audit 58

9.3 Management Review 60

9.3.1 General 60

9.3.2 Management Review Inputs 60

9.3.3 Management Review Outputs 61

10.0 Improvement 62

10.1 General ...... 62

10.2 Nonconformity and Corrective Action.................. 62

10.2.3 Problem Solving 63

10.2.4 Error-Proofing 63

10.2.5 Warranty Management Systems 63

10.2.6 Customer Complaints and Customer Returns Test Analysis 63

10.3 Continual Improvement 64

10.3.1 Continual improvement 64