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Quality Manual

Template

ISO 9001:2015 Quality Management System

Quality Manual Template

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ISO 9001:2015 Quality Management System

Table of Contents

1

INTRODUCTION ............................................................................................................................................... 5

2

QUALITY MANAGEMENT PRINCIPLES ......................................................................................................... 6

3

REFERENCES & DEFINITIONS......................................................................................................................... 6

4

CONTEXT OF THE ORGANIZATION .............................................................................................................. 8

5

4.1

ORGANIZATIONAL CONTEXT........................................................................................................................................................ 8

4.2

RELEVANT INTERESTED PARTIES................................................................................................................................................... 9

4.3

QUALITY MANAGEMENT SYSTEM SCOPE ................................................................................................................................... 9

4.4

QUALITY MANAGEMENT SYSTEM PROCESSES ......................................................................................................................... 10

LEADERSHIP ...................................................................................................................................................12

5.1

LEADERSHIP & COMMITMENT ................................................................................................................................................... 12

General.............................................................................................................................................................................. 12

Customer Focus ............................................................................................................................................................. 13

5.2

QUALITY POLICY .......................................................................................................................................................................... 13

Establishing the Quality Policy ................................................................................................................................ 13

Communicating the Quality Policy ........................................................................................................................ 14

Quality Policy Statement ........................................................................................................................................... 14

5.3

ROLE, RESPONSIBILITIES AND AUTHORITIES ............................................................................................................................. 15

Top Management ......................................................................................................................................................... 15

Quality Manager ........................................................................................................................................................... 15

Quality Coordinators ................................................................................................................................................... 16

Managers & Supervisors ........................................................................................................................................... 16

Employees & Contractors ......................................................................................................................................... 16

6

MANAGEMENT SYSTEM PLANNING ..........................................................................................................17

6.1

ADDRESSING RISKS & OPPORTUNITIES .................................................................................................................................... 17

6.2

QUALITY OBJECTIVES & PLANNING TO ACHIEVE THEM ......................................................................................................... 18

Establishing Quality Objectives ............................................................................................................................... 18

Plans to Achieve Quality Objectives ...................................................................................................................... 19

6.3

7

PLANNING FOR CHANGE ............................................................................................................................................................ 19

SUPPORT .........................................................................................................................................................21

7.1

RESOURCES .................................................................................................................................................................................. 21

General.............................................................................................................................................................................. 21

People ............................................................................................................................................................................... 21

Infrastructure .................................................................................................................................................................. 21

Operational Environment .......................................................................................................................................... 22

Monitoring & Measurement Tools ........................................................................................................................ 22

Organizational Knowledge ....................................................................................................................................... 23

7.2

COMPETENCE ............................................................................................................................................................................... 24

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ISO 9001:2015 Quality Management System

7.3

AWARENESS ................................................................................................................................................................................. 24

7.4

COMMUNICATION ....................................................................................................................................................................... 25

7.5

DOCUMENTED INFORMATION ................................................................................................................................................... 26

Management System Documents .......................................................................................................................... 26

Creating & Updating ................................................................................................................................................... 27

Controlling Documented Information.................................................................................................................. 27

8

OPERATION ....................................................................................................................................................28

8.1

OPERATIONAL PLANNING & CONTROL.................................................................................................................................... 28

8.2

CUSTOMER REQUIREMENTS ....................................................................................................................................................... 28

Customer Communication ........................................................................................................................................ 28

Determining Requirements ...................................................................................................................................... 29

Review of Requirements ............................................................................................................................................ 29

Changes in Requirements ......................................................................................................................................... 29

8.3

DESIGN & DEVELOPMENT.......................................................................................................................................................... 30

General.............................................................................................................................................................................. 30

Planning............................................................................................................................................................................ 30

Inputs................................................................................................................................................................................. 31

Controls ............................................................................................................................................................................ 31

Outputs ............................................................................................................................................................................. 32

Changes ............................................................................................................................................................................ 32

8.4

CONTROL OF SUPPLIERS & EXTERNAL PROCESSES ................................................................................................................. 32

General.............................................................................................................................................................................. 32

Purchasing Controls .................................................................................................................................................... 33

Purchasing Information .............................................................................................................................................. 34

8.5

PRODUCTION & SERVICE PROVISION ....................................................................................................................................... 34

Control of Production & Service Provision ........................................................................................................ 34

Identification & Traceability ..................................................................................................................................... 35

3rd Party Property.......................................................................................................................................................... 35

Preservation .................................................................................................................................................................... 36

Post-delivery Activities ............................................................................................................................................... 36

Control of Changes ...................................................................................................................................................... 37

9

8.6

RELEASE OF PRODUCTS & SERVICES ......................................................................................................................................... 37

8.7

CONTROL OF NON-CONFORMING OUTPUTS .......................................................................................................................... 38

PERFORMANCE EVALUATION .....................................................................................................................39

9.1

MONITORING, MEASUREMENT, ANALYSIS & EVALUATION ................................................................................................... 39

General.............................................................................................................................................................................. 39

Customer Satisfaction ................................................................................................................................................. 39

Analysis and Evaluation .............................................................................................................................................. 40

9.2

INTERNAL AUDIT.......................................................................................................................................................................... 41

General.............................................................................................................................................................................. 41

Internal Audit Programme ........................................................................................................................................ 41

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ISO 9001:2015 Quality Management System

9.3

MANAGEMENT REVIEW .............................................................................................................................................................. 42

General.............................................................................................................................................................................. 42

Inputs................................................................................................................................................................................. 42

Outputs ............................................................................................................................................................................. 42

10

IMPROVEMENT ..........................................................................................................................................43

10.1

GENERAL....................................................................................................................................................................................... 43

10.2

NON-CONFORMITY & CORRECTIVE ACTION ........................................................................................................................... 43

10.3

IMPROVEMENT ............................................................................................................................................................................. 44

APPENDICES ...........................................................................................................................................................45

A.1

CORRELATION MATRIX ............................................................................................................................................................... 45

A.2

QMS PROCESSES INTERACTION................................................................................................................................................ 48

A.3

ORGANIZATION CHART .............................................................................................................................................................. 49

A.4

QUALITY MANAGEMENT SYSTEM DOCUMENT INDEX ............................................................................................................ 50

A.4.1

Schedule of Procedures ............................................................................................................................................. 50

A.4.2

Schedule of Report & Forms.................................................................................................................................... 50

A.4.3

Schedule of Audit Documents ................................................................................................................................ 50

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ISO 9001:2015 Quality Management System

4 Context of the Organization

4.1 Organizational Context

Your organization is committed to defining our position in the marketplace and understanding how relevant

factors arising from legal, political, economic, social and technological issues influence our strategic direction

and our organizational context.

To ensure that our quality management system is aligned with our strategy, whilst taking account of relevant

internal and external factors; we collate and analyze pertinent information in order to determine the potential

impact on our context and subsequent business strategy.

Figure 2: Examples of Internal & External Influences

Your organization identifies, analyzes, monitors and

reviews factors that may affect our ability to satisfy

Types of

external

influence

? Regulations

? Competition

? Innovation

? Technology

? Environment

? Globalization

our customers and stakeholders, as well as; factors

that may adversely affect the stability of our

processes and the integrity of the management

system. Broadly, these issues are defined as:

Internal issues are conditions related to our

organizational

Types of

internal

influence

? Values

? Strategy

? Competence

? Culture

? Knowledge

? Performance

activities,

products,

services,

strategic direction, culture, people, size, complexity,

knowledge, performance, processes and systems.

Using SWOT analysis provides our organization

Organizational

Context

with framework for reviewing and evaluating our

strategies, and the position and direction of our

organization, business propositions and other

ideas.

External issues are factors that exist outside of our

organization that are related to statutory and

regulatory requirements, industry requirements and agreements, competition, globalization, innovations,

technology and natural environment. Using PESTLE analysis provides our organization with framework for

measuring our market and growth potential according to external political, economic, social, technological,

legal and environmental factors.

Your organization monitors and reviews this information to ensure that a continual understanding of each

party¡¯s requirements is derived and maintained. To facilitate the understanding of our context, we regularly

consider issues that influence our context during management review meetings using the Context & Interested

Party Analysis template.

The results of which are conveyed via minutes and business planning documents. We maintain and retain; in

addition to this document, the following documented information to describe our organizational context and

decisions relating to it:

1.

Analysis of business plans, strategies, and statutory and regulatory commitments;

2.

Analysis of technology, competitors, economic reports from relevant business sectors or from

technical experts and consultants;

Document Ref.

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