Quality Manual Template Example

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uk
Insert your company’s name or logo, and address.
ISO 9001:2015
Quality Manual Template
This quality manual is the property of Your Company. It must not be reproduced in whole or in part or otherwise
disclosed without prior written consent.
The official controlled copy of this quality manual is the digitally signed PDF document held within our network
server and visible to all authorised users. All printed copies, and all electronic copies and versions, except the ones
described above, are considered uncontrolled copies which should be used for reference only.
Insert your company’s name or logo.
ISO 9001:2015
Contents
1 Introduction _______________________________________________________________________________________________ 5
2 References _________________________________________________________________________________________________ 5
3 Definitions _________________________________________________________________________________________________ 5
4 About Our Organisation __________________________________________________________________________________ 6
4.1 Organizational Context ______________________________________________________________________________ 6
4.2 Relevant Interested Parties __________________________________________________________________________ 7
4.3 Quality Management System________________________________________________________________________ 7

4.3.1 Management System Scope ______________________________________________________________________ 7
4.3.2 Management System Processes __________________________________________________________________ 7
4.3.3 Outsourced Processes ____________________________________________________________________________ 8
4.3.4 Documented Information_________________________________________________________________________ 8
5 Leadership & Governance ______________________________________________________________________________ 10
5.1 Leadership & Commitment ________________________________________________________________________ 10

5.1.1 Quality Management ____________________________________________________________________________ 10
5.1.2 Customer Focus _________________________________________________________________________________ 11
5.1.3 Quality Policy ____________________________________________________________________________________ 11
5.2 Role, Responsibilities & Authorities ______________________________________________________________ 12
5.3 Communication ____________________________________________________________________________________ 13

5.3.1 Internal Communication _________________________________________________________________________ 13
5.3.2 External Communication_________________________________________________________________________ 14
6 Management System Planning_________________________________________________________________________ 15
6.1 Addressing Risks & Opportunities ________________________________________________________________ 15
6.2 Quality Objectives __________________________________________________________________________________ 16
6.3 Planning for Change _______________________________________________________________________________ 16
7 Support __________________________________________________________________________________________________ 18
7.1 Resources ___________________________________________________________________________________________ 18

7.1.1 General __________________________________________________________________________________________ 18
7.1.2 People ___________________________________________________________________________________________ 18
7.1.3 Infrastructure ____________________________________________________________________________________ 19
7.1.4 Operational Environment ________________________________________________________________________ 19
7.1.5 Monitoring & Measurement Tools ______________________________________________________________ 19
7.1.6 Organisational Knowledge ______________________________________________________________________ 20
8 Product & Service Development _______________________________________________________________________ 21
8.1 Operational Planning & Control __________________________________________________________________ 21
www.iso-9001-checklist.co.uk Page 2 of 37
ISO 9001:2015
8.2 Customer Requirements ___________________________________________________________________________ 21

8.2.1 Customer Communication _______________________________________________________________________ 21
8.2.2 Determining Requirements ______________________________________________________________________ 21
8.2.3 Review of Requirements _________________________________________________________________________ 22
8.2.4 Changes in Requirements _______________________________________________________________________ 22
8.3 Design & Development ____________________________________________________________________________ 22

8.3.1 General __________________________________________________________________________________________ 22
8.3.2 Planning _________________________________________________________________________________________ 23
8.3.3 Inputs ____________________________________________________________________________________________ 23
8.3.4 Controls__________________________________________________________________________________________ 23
8.3.5 Outputs __________________________________________________________________________________________ 24
8.3.6 Changes _________________________________________________________________________________________ 24
8.4 Control of Suppliers & External Processes _______________________________________________________ 24

8.4.1 General __________________________________________________________________________________________ 24
8.4.2 Purchasing Controls _____________________________________________________________________________ 25
8.4.3 Purchasing Information __________________________________________________________________________ 25
8.5 Production & Service Provision ___________________________________________________________________ 26

8.5.1 Control of Production & Service Provision ______________________________________________________ 26
8.5.2 Identification & Traceability _____________________________________________________________________ 26
8.5.3 3rd Party Property ________________________________________________________________________________ 26
8.5.4 Preservation _____________________________________________________________________________________ 26
8.5.5 Post-delivery Activities __________________________________________________________________________ 27
8.5.6 Control of Changes ______________________________________________________________________________ 27
8.6 Release of Products & Services ___________________________________________________________________ 27
8.7 Control of Non-conforming Outputs _____________________________________________________________ 28
9 Performance Evaluation ________________________________________________________________________________ 29
9.1 Monitoring, Measurement, Analysis & Evaluation_______________________________________________ 29

9.1.1 General __________________________________________________________________________________________ 29
9.1.2 Customer Satisfaction ___________________________________________________________________________ 29
9.1.3 Analysis and Evaluation __________________________________________________________________________ 30
9.2 Internal Audit_______________________________________________________________________________________ 30
9.3 Management Review ______________________________________________________________________________ 31

9.3.1 General __________________________________________________________________________________________ 31
9.3.2 Inputs ____________________________________________________________________________________________ 31
9.3.3 Outputs __________________________________________________________________________________________ 31
10 Improvement _________________________________________________________________________________________ 32
10.1 General ___________________________________________________________________________________________ 32
10.2 Non-conformity & Corrective Action __________________________________________________________ 32
ISO 9001:2015
10.3 Improvement ____________________________________________________________________________________ 33
Appendices ___________________________________________________________________________________________________ 34
A.1 Correlation Matrix _________________________________________________________________________________ 34
A.2 Sequence & Interaction of Processes _____________________________________________________________ 36
A.3 Organization Chart _________________________________________________________________________________ 37
ISO 9001:2015
1 Introduction
Your organization has developed and implemented a quality management system (QMS), which uses ISO
9001:2015 as a framework that allows our organization to document and improve our practices in order to
better satisfy the needs and expectations of our customers, stakeholders and interested parties.
This manual describes the quality management system, delineates authorities, inter relationships and
responsibilities of personnel operating within the management system. The manual also provides references
to procedures and activities that also comprise our quality management system.
The manual is used to familiarise customers and other external organizations or individuals with the controls
that have been implemented and to assure them that the integrity of our quality management system is
maintained and is focused on customer satisfaction and continual improvement.
Our quality management system meets the requirements of ISO 9001:2015 and uses the Plan, Do, Check and
Act approach to process planning. Our QMS addresses and supports our strategies for the <design,
development, manufacturing, installation and servicing of our products>. <insert your scope statement here.
This should succinctly summarize your products and/or services. A single sentence is all that is required, as
this will be shown your ISO 9001:2015 certificate>.
<Also insert the registered address of your organization here>
The following table identifies any ISO 9001:2015 requirements, from Section 8.0, that are not applicable to
our organization as well as providing a brief narrative to justify their omission from the scope of our QMS:
Clause Justification for Exclusion

8.3 We exclude design and development from our QMS, as we do not design or modify components
2 References
In addition to ISO 9001:2015 we also make reference to other relevant British and/or international standards
as well as customer specifications appropriate to our products and market.
Standard Title Description

BS EN ISO 9000:2015 Quality management systems Fundamentals and vocabulary
BS EN ISO 9004:2000 Quality management systems Guidelines for performance improvements
BS EN ISO 19011:2011 Auditing management systems Guidelines for auditing
3 Definitions
This document does not introduce any new definitions but rather relies on the following:
1. Definitions typically used by our customers, stakeholders or marketplace;

2. Terms typically used in standards and regulations as they relate to our QMS or products;
3. Standard business terminology;
4. Terms and vocabulary commonly used in quality and <engineering> practices.
ISO 9001:2015
4 About Our Organisation

4.1 Organizational Context
Your organization is committed to defining Figure 1: Typical QMS Input Hierarchy
our position in the marketplace and
understanding how relevant factors arising Local Factors Macro Environment
from legal, political, economic, social and Internal External Interested

technological issues influence our strategic Issues Issues Parties
direction and our organizational context.

SWOT Analysis PESTLE Analysis
Your organization identifies, analyzes,
monitors and reviews factors that may Organizational Strategy
affect our ability to satisfy our customers
and stakeholders, as well as; factors that
may adversely affect the stability of our Business Planning
process, or our management system’s Resources Budgets
integrity.
To ensure that our QMS is aligned with our Quality Policy Managment System
strategy, whilst taking account of relevant KPIs/
Objectives Context Scope
internal and external factors; we initially Metrics
collate and analyze pertinent information in

order to determine potential impact on our
context and subsequent business strategy.
Your organization then monitors and reviews this information to ensure that a continual understanding of
each group’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 and are conveyed
via minutes and business planning documents.
Internal Issues External Issues The output from this activity is evident as an input to
Market share Customers & suppliers the consideration of risks and opportunities, and the
Employees Markets & competition actions that we take to address them. Refer to Section
Performance Regulatory & statutory 6.1 for more information about our risk and
Values & culture Technological opportunity management framework.
Innovation & knowledge Cultural & social
Although we acknowledge that ISO 9001:2015 does
not require our organizational context to be maintained as documented information, we maintain and retain;
in addition to this document, the following documented information to describe our organizational context:
1. Analysis of business plans, strategies, and statutory and regulatory commitments;

2. Analysis of technology and competitors;
3. Economic reports from relevant business sectors;
4. Technical reports from technical experts and consultants;
5. SWOT analysis reports or schedules for internal issues;
6. PESTLE analysis reports or schedules for external issues;
ISO 9001:2015
7. Minutes of meetings (Management and design review minutes), process maps and reports, etc.
SWOT analysis provides our organization with a framework for reviewing and evaluating our strategies, and
the position and direction of our organization, business propositions and other ideas. Similarly 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.
4.2 Relevant Interested Parties

Your organization recognizes that we have a unique set of interested parties whose needs and expectations
change and develop over time, and furthermore; that only a limited set of their respective needs and
expectations are applicable to our operations or to our quality management system. Such needs and
expectations broadly include those shown in the table below.
Interested Parties Needs & Expectations To ensure that our products and processes continue
Customers Price, reliability & value to meet all relevant requirements, we identify and
Distributors & retailers Quality, price & logistics assess the potential impact of any relevant needs and
Owners/shareholders Profitability & growth expectations that may be elicited from the interested
Employees Shared values & security parties. Where appropriate, to ensure that our
Suppliers Beneficial relationships processes are aligned to deliver the requirements of
Regulatory & statutory Compliance & reporting our interested parties; we convert relevant needs and
expectations into requirements which become inputs to our QMS and to our product and service designs.
4.3 Quality Management System

4.3.1 Management System Scope
Based on the analysis of the issues and requirements identified in Sections 4.1 and 4.2, your organization has
established the scope of our quality management system in order the implement our objectives and our
policies that are relevant to our context, products and any interested parties.
This document describes our quality management system, delineates authorities, inter-relationships and
responsibilities of process owners and personnel that operate within the system. Although we recognize that
ISO 9001:2015 does not require a quality manual, we have decided to retain and update our quality manual,
as our employees, customers, suppliers and other stakeholders perceive it to add value to our operations.
This document also demonstrates the relationship between our quality management system and the
sequence and interaction of our key processes. Conformance to ISO 9001:2015 has been verified utilizing a
formal assessment and review process by <insert name of Registrar>.
4.3.2 Management System Processes

Your organization has implemented a quality management system that exists as part of a larger strategy that
has established, documented and implemented our processes, quality policies and objectives, whilst
satisfying the requirements of ISO 9001:2015.
To achieve this, your organization has adopted the process approach advocated by ISO 9001:2015. Top
management has determined the processes required for achieving the intended outputs. By defining four key
process-groups and by managing their inputs, activities, controls, outputs and interfaces; we ensure that
system effectiveness is established maintained. These key process groups include;
ISO 9001:2015
1. Leadership and planning processes;

2. Customer and stakeholder processes;
3. Product/service development processes;
4. Evaluation and improvement processes.
These process groups are described using tools such as Figure 2 : Key Process Groups
documented procedures, process maps, flow diagrams,
matrices, schedules, and charts, etc. Refer to the Sequence &
Leadership &
Interaction of Processes in Appendix A.2 which shows the Governance
sequence and interaction of the process groups within our Processes
management system. Product

Development
It is recognized that defining, implementing and documenting Processes
our quality management system is only the first step towards
fully implementing its requirements. The effectiveness of the
Our Quality
Management
each process and its subsequent output is measured and
System
evaluated through regular internal audits, quality inspections
Customer &
and data analysis. Stakeholder
Processes
We use key performance indicators (KPIs) that are linked to our
objectives to control and monitor our processes, as well as Evaluation &
assessments to determine the risks and opportunities inherent Improvement
Processes
to each process. We use trends and indicators relating to
nonconformities, objectives and corrective action, as well as,
monitoring and measurement results, audit results and customer satisfaction data, process performance and
the conformity of our products.
4.3.3 Outsourced Processes

Where your organization identifies the requirement to outsource any process, or part thereof, which affects
conformity with the stated requirements; your organization identifies control criteria such as; the competence
of personnel, inspection regimes, the provision of product conformity certificates, adherence to specifications
and specific job files, etc. Refer to Section 8.4.
The controls identified do not absolve us of the responsibility to conform to client, statutory and regulatory
requirements but instead they enhance our capacity to effectively manage our supply chain. The controls
adopted are influenced by the potential impact of outsourcing on meeting customer or stakeholder
requirements and the degree to which control of the process is shared. Outsourced processes are controlled
via purchasing and contractual agreements. Refer to Section 8.4. They may also be assessed by 2nd party
audits and performance data reviews where appropriate,
4.3.4 Documented Information

4.3.4.1 Management System Documents
Your organization ensures that our QMS includes the documented information that is required to be
maintained and retained by ISO 9001:2015, and additionally, any documented information identified by our
organization that demonstrates the effective operation of our QMS. Refer to the Register of Documented
Information.
ISO 9001:2015
Appendices
A.1 Correlation Matrix
This section provides a matrix to correlate the requirements of ISO 9001:2015 against the relevant sections in
this document and should be used to determine where the new and amended clauses are located.
ISO 9001:2015 This Document

4.0 Context of the Organization 4.0 About our Organization
4.1 Understanding the Organization and its Context 4.1 Organizational Context
4.2 Needs and Expectations of Interested Parties 4.2 Relevant Interested Parties
4.3 Scope of the Quality Management System 4.3.1 Management System Scope
4.4 Quality Management System and its Processes 4.3.2 Management System Processes
5.0 Leadership 5.0 Leadership & Governance
5.1 Leadership and Commitment 5.1 Leadership & Commitment
5.1.1 Quality Management System 5.1.1 Quality Management System
5.1.2 Customer Focus 5.1.2 Customer Focus
5.2 Quality Policy 5.1.3 Quality Policy
5.2.1 Establishing the Quality Policy 5.1.3.1 Establishing the Quality Policy
5.2.2 Communicating the Quality Policy 5.1.3.2 Communicating the Quality Policy
5.3 Roles, Responsibilities and Authorities 5.2 Roles, Responsibilities & Authorities
6.0 Planning for the Quality Management System 6.0 Management System Planning
6.1 Actions To Address Risks and Opportunities 6.1 Addressing Risk & Opportunities
6.2 Quality Objectives & Planning To Achieve Them 6.2 Quality Objectives
6.3 Planning of Changes 6.3 Planning for Change
7.0 Support 7 Support
7.1 Resources 7.1 Resources
7.1.1 General 7.1.1 General
7.1.2 People 7.1.2 People
7.1.3 Infrastructure 7.1.3 Infrastructure
7.1.4 Environment for the Operation Of Processes 7.1.4 Operational Environment
7.1.5 Monitoring and Measuring Resources 7.1.5 Monitoring and Measuring Tools
7.1.6 Organizational Knowledge 7.1.6 Organizational Knowledge
7.2 Competence 7.1.2.1 Competence
7.3 Awareness 7.1.2.2 Awareness
7.4 Communication 5.3 Communication
7.5 Documented Information 4.3.4 Documented Information
7.5.1 General 4.3.4.1 Management System Documents
7.5.2 Creating and Updating 4.3.4.2 Creating and Updating
7.5.3 Control of Documented Information 4.3.4.3 Controlling Documented Information
8.0 Operation 8.0 Product & Service Development
8.1 Operational Planning and Control 8.1 Operational Planning and Control
8.2 Requirements for Products and Services 8.2 Customer Requirements
8.2.1 Customer Communication 8.2.1 Customer Communication
8.2.2 Determining Requirements Related to Products 8.2.2 Determining Requirements
ISO 9001:2015
A.2 Sequence & Interaction of Processes
MANAGEMENT
SUPPORT PROCESSES
PROCESSES Customer Related Prcesses
Quality Management
System Communication
Set Objectives &

Customer, Market, Stakeholder Competence &
Targets & Legal Requirements Awareness
Provide Resources & Maintain Facilities

Infrastructure & Equipment
Identify Risks & Calibrate

Quote Order
Opportunities Equipment
Identify Legal & Mitigate Risks &

Other Requirements Impacts
Product & Process

Determine Roles & Contract Review Document & Data
Planning
Responsibilties Control
Domain
Quality Planning
Knowledge
Design & Supplier Selection &
Development Evaluation
ASSESSMENT ASSESSMENT
PROCESSES PROCESSES
Incoming Continual
Evaluation of Production
Inpsection, Handling Improvement
Compliance Processes
& Storage
Internal Auditing Corrective Action
Storage, Dispatch & Evaluate Risks &

Non-conformities Delivery
& Corrective Action Opportunities
Customer Management
Feedback & Review
Satisfaction
Customer, Market &
Product & Process
Analyze QMS Stakeholder Feedback Monitoring
Process Data

Quality Manual Template Example

Uploaded by

Quality Manual Template Example

Uploaded by

www.iso-9001-checklist.co.

Insert your company’s name or logo, and address.

4 About Our Organisation __________________________________________________________________________________ 6

4.1 Organizational Context ______________________________________________________________________________ 6

4.2 Relevant Interested Parties __________________________________________________________________________ 7

4.3 Quality Management System________________________________________________________________________ 7

5 Leadership & Governance ______________________________________________________________________________ 10

5.1 Leadership & Commitment ________________________________________________________________________ 10

5.2 Role, Responsibilities & Authorities ______________________________________________________________ 12

5.3 Communication ____________________________________________________________________________________ 13

6 Management System Planning_________________________________________________________________________ 15

6.1 Addressing Risks & Opportunities ________________________________________________________________ 15

6.2 Quality Objectives __________________________________________________________________________________ 16

6.3 Planning for Change _______________________________________________________________________________ 16

7.1 Resources ___________________________________________________________________________________________ 18

8 Product & Service Development _______________________________________________________________________ 21

8.1 Operational Planning & Control __________________________________________________________________ 21

8.2 Customer Requirements ___________________________________________________________________________ 21

8.3 Design & Development ____________________________________________________________________________ 22

8.4 Control of Suppliers & External Processes _______________________________________________________ 24

8.5 Production & Service Provision ___________________________________________________________________ 26

8.6 Release of Products & Services ___________________________________________________________________ 27

8.7 Control of Non-conforming Outputs _____________________________________________________________ 28

9 Performance Evaluation ________________________________________________________________________________ 29

9.1 Monitoring, Measurement, Analysis & Evaluation_______________________________________________ 29

9.2 Internal Audit_______________________________________________________________________________________ 30

9.3 Management Review ______________________________________________________________________________ 31

10.1 General ___________________________________________________________________________________________ 32

10.2 Non-conformity & Corrective Action __________________________________________________________ 32

10.3 Improvement ____________________________________________________________________________________ 33

A.1 Correlation Matrix _________________________________________________________________________________ 34

A.2 Sequence & Interaction of Processes _____________________________________________________________ 36

A.3 Organization Chart _________________________________________________________________________________ 37

<Also insert the registered address of your organization here>

Clause Justification for Exclusion

Standard Title Description

1. Definitions typically used by our customers, stakeholders or marketplace;

4 About Our Organisation

from legal, political, economic, social and Internal External Interested

direction and our organizational context.

collate and analyze pertinent information in

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

4.2 Relevant Interested Parties

4.3 Quality Management System

4.3.2 Management System Processes

1. Leadership and planning processes;

management system. Product

4.3.3 Outsourced Processes

4.3.4 Documented Information

ISO 9001:2015 This Document

A.2 Sequence & Interaction of Processes

Set Objectives &

Provide Resources & Maintain Facilities

Identify Risks & Calibrate

Identify Legal & Mitigate Risks &

Product & Process

Internal Auditing Corrective Action

Storage, Dispatch & Evaluate Risks &

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