1. Scope

1

1.1 General

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1.2 Application

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2. Normative Reference

2

3. Terms and Definitions

3

4. Quality Management System

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4.1 General Requirements

4.2.1

4.2 Documentation Requirements

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4.2.1 General

4.2.2

4.2.2 Quality Manual

4.2.1

4.2.3 Control of Documents

4.5.1, 4.5.2, 4.5.3

4.2.4 Control of Records

4.16

5. Management Responsibility

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5.1 Management Commitment

4.1.1

5.2 Customer Focus

4.3.2

5.3 Quality Policy

4.1.1

5.4 Planning

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5.4.1 Quality Objectives

4.1.1

5.4.2 Quality Management System Planning

4.2.3

5.5 Responsibility, Authority, and Communication

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5.5.1 Responsibility and Authority

4.1.2.1

5.5.2 Management Representative

4.1.2.3

5.5.3 Internal Communications

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5.6 Management Review

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5.6.1 General

4.1.3

5.6.2 Review Input

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5.6.3 Review Output

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6. Resource Management

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6.1 Provision of Resources

4.1.2.2

6.2 Human Resources

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6.2.1 General

4.1.2.2

6.2.2 Competence, Awareness, and Training

4.18

6.3 Infrastructure

4.9

6.4 Work Environment

4.9

7. Product Realization

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7.1 Planning of Product Realization

4.2.3, 4.10.1

7.2 Customer-Related Processes

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7.2.1 Determination of Requirements Related to the Product

4.3.2, 4.4.4

7.2.2 Review of Requirements Related to the Product

4.3.2, 4.3.3, 4.3.4

7.2.3 Customer Communication

4.3.2

7.3 Design and Development

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7.3.1 Design and Development Planning

4.4.2, 4.4.3

7.3.2 Design and Development Inputs

4.4.4

7.3.3 Design and Development Outputs

4.4.5

7.3.4 Design and Development Review

4.4.6

7.3.5 Design and Development Verification

4.4.7

7.3.6 Design and Development Validation

4.4.8

7.3.7 Control of Design and Development Changes

4.4.9

7.4 Purchasing

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7.4.1 Purchasing Process

4.6.2

7.4.2 Purchasing Information

4.6.3

7.4.3 Verification of Purchased Products

4.6.4, 4.10.2

7.5 Production and Service Provision

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7.5.1 Control of Production and Service Provision

4.9, 4.15.6, 4.19

7.5.2 Validation of Processes for Production and Service Provision

4.9

7.5.3 Identification and Traceability

4.8, 4.10.5, 4.12

7.5.4 Customer Property

4.7

7.5.5 Preservation of Product

4.15.2, 4.15.3, 4.15.4, 4.15.5

7.6 Control of Monitoring and Measuring Devices

4.11.1, 4.11.2

8. Measurement, Analysis, and Improvement

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8.1 General

4.10.1, 4.20.1, 4.20.2

8.2 Monitoring and Measurement

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8.2.1 Customer Satisfaction

-

8.2.2 Internal Audit

4.17

8.2.3 Monitoring and Measurement of Processes

4.17, 4.20.1, 4.20.2

8.2.4 Monitoring and Measurement of Product

4.10.2, 4.10.3, 4.10.4, 4.10.5, 4.20.1, 4.20.2

8.3 Control of Nonconforming Product

4.13.1, 4.13.2

8.4 Analysis of Data

4.20.1, 4.20.2

8.5 Improvement

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8.5.1 Continual Improvement

4.1.3

8.5.2 Corrective Action

4.14.1, 4.14.2

8.5.3 Preventive Action

4.14.1, 4.14.3