Quality Management System Manual - ISO 9001 Help
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Quality Manual
Template
ISO 9001:2015 Quality Management System
Quality Manual Template
iso9001help.co.uk
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
Document Ref.
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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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