Foreword

Introduction

0.1 General

0.2 Content of ISO 10018

0.3 Using ISO 10018

1 Scope

2 Normative reference

3 Terms and definitions

3.1 quality (3.1.1 in ISO 9000)

3.2 management (3.2.6 in ISO 9000)

3.3 top management (3.2.7 in ISO 9000)

3.4 continual improvement (3.2.13 in ISO 9000)

3.5 process (3.4.1 in ISO 9000)

3.6 competence (3.1.6 in ISO 9000)

3.7 leadership

3.8 involvement

3.9 data

3.10 information (3.7.1 in ISO 9000)

3.11 knowledge

4 Quality management principles from a human perspective

4.1 Principle 1 – Customer focus

4.2 Principle 2 – Leadership

4.3 Principle 3 – Involvement of people

4.4 Principle 4 – Process approach

4.5 Principle 5 – System approach to management

4.6 Principle 6 – Continual improvement

4.7 Principle 7 – Factual approach to decision making

4.8 Principle 8 – Mutually beneficial supplier relationships

5 Human factors

5.1 Leadership factors

5.1.1 Leadership

5.1.2 Organizational culture

5.1.3 Change management

5.1.4 Knowledge management

5.2 Competence factors

5.2.1 Recruitment

5.2.2 Education and learning

5.2.3 Competence

5.2.4 Creativity and innovation

5.3 People involvement factors

5.3.1 Communication

5.3.2 Networking and collaboration

5.3.3 Teamwork

5.3.4 Discipline

5.3.5 Empowerment and responsibility;

5.3.6 Recognition and rewards

6 Management of people involvement and competence .

6.1 General

6.2 Managing the competence acquisition process

6.2.1 Analysis

6.2.2 Planning

6.2.3 Realization

6.2.4 Evaluation

6.3 Management of people involvement

6.3.1 Individual Involvement versus group involvement

6.3.2 Process approach

6.4 The people involvement process

7 Guidance for effective people involvement and competence

7.1 General requirements (4.1. in ISO 9001)

7.2 Documentation requirements (4.2 in ISO 9001)

7.2.1 General (4.2.1 in ISO 9001)

7.2.2 Quality manual (4.2.2 in ISO 9001)

7.2.3 Control of documents (4.2.3 in ISO 9001)

7.2.4 Control of records (4.2.4 in ISO 9001)

7.3 Management commitment (5.1 in ISO 9001)

7.4 Customer focus (5.2 in ISO 9001)

7.5 Quality policy (5.3 in ISO 9001)

7.6 Planning (5.4 in ISO 9001).

7.7 Responsibility, authority and communication (5.5 in ISO 9001)

7.7.1 Responsibility and authority (5.5.1 in ISO 9001)

7.7.2 Management representative (5.5.2 in ISO 9001)

7.7.3 Communication (5.5.3 in ISO 9001)

7.8 Management review (5.6 in ISO 9001)

7.8.1 General (5.6.1 in ISO 9001)

7.8.2 Review input (5.6.2 in ISO 9001)

7.8.3 Review Output (5.6.3 in ISO 9001)

7.9 Provision of resources (6.1 in ISO 9001).

7.10 Human Resources (6.2 in ISO 9001) .

7.10.1 General (6.2.1 in ISO 9001).

7.10.2 Competence, awareness and training (6.2.2 in ISO 9001) .

7.11 Infrastructure (6.3 in ISO 9001)

7.12 Work environment (6.4 in ISO 9001)

7.13 Planning of product realization (7.1 in ISO 9001)

7.14 Customer-related processes (7.2 in ISO 9001)

7.14.1 Determination of requirements related to the product (7.2.1 in ISO 9001)

7.14.2 Review of requirements related to the product (7.2.2 in ISO 9001)

7.14.3 Customer communication (7.2.3 in ISO 9001) .

7.15 Design and development (7.3 in ISO 9001) .

7.15.1 Design and development planning (7.3.1 in ISO 9001) .

7.15.2 Design and development inputs (7.3.2 in ISO 9001) .

7.15.3 Design and development outputs (7.3.3 in ISO 9001).

7.15.4 Design and development review (7.3.4 in ISO 9001)

7.15.5 Design and development verification (7.3.5. in ISO 9001)

7.15.6 Design and development validation (7.3.6 in ISO 9001)

7.15.7 Control of design and development changes (7.3.7 in ISO 9001)

7.16 Purchasing (7.4 in ISO 9001)

7.16.1 Purchasing process (7.4.1 in ISO 9001)

7.16.2 Purchasing information (7.4.2 in ISO 9001)

7.16.3 Verification of purchased product (7.4.3 in ISO 9001)

7.17 Production and service provision (7.5 in ISO 9001)

7.17.1 Control of production and service provision (7.5.1 in ISO 9001)

7.17.2 Validation of processes for production and service provision (7.5.2 in ISO 9001)

7.17.3 Identification and traceability (7.5.3 in ISO 9001)

7.17.4 Customer property (7.5.4 in ISO 9001)

7.17.5 Preservation of product (7.5.5 in ISO 9001)

7.18 Control of monitoring and measuring devices (7.6 in ISO 9001)

7.19 Measurement, analysis and improvement - General (8.1 in ISO 9001)

7.20 Monitoring and measurement (8.2 in ISO 9001)

7.20.1 Customer satisfaction (8.2.1 in ISO 9001)

7.20.2 Internal audit (8.2.2 in ISO 9001)

7.20.3 Monitoring and measurement of processes (8.2.3 in ISO 9001)

7.20.4 Monitoring and measurement of product (8.2.4 in ISO 9001)

7.21 Control of nonconforming product (8.3 in ISO 9001)

7.22 Analysis of data (8.4 in ISO 9001)

7.23 Improvement (8.5 in ISO 9001)

7.23.1 Continual improvement (8.5.1 in ISO 9001)

7.23.2 Corrective action (8.5.2 in ISO 9001)

7.23.3 Preventive action (8.5.3 in ISO 9001)

Annex A

A.1 General

A.2 Change management

A.3 Communication

A.4 Competence

A.5 Creativity and innovation

A.6 Organizational culture.

A.7 Networking and Collaboration

A.8 Education and learning.

A.9 Empowerment

A.10 Exploration – experimentation – failure acknowledgement

A.11 Recognition and rewards

A.12 Recruitment

A.13 Self discipline

A.14 Teamwork.

A.15 Knowledge management .

A.16 Empowerment, responsibility and authority

A.17 Leadership ..