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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
ISO 9001:2015
logo. Quality Manual Template
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
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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
rd
8.5.3 3 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
10.3 Improvement 33
Appendices 34
A.1 Correlation Matrix 34
A.2 Sequence & Interaction of Processes 36
A.3 Organization Chart 37
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.
4 About Our Organisation
4.1 Organizational Context
Your organization is committed to
Figure 1: Typical QMS Input Hierarchy
defining our position in the
marketplace and understanding how Local Factors Macro Environment
relevant factors arising from legal, Internal Issues External Issues Interested Parties
political, economic, social and
technological issues influence our strategic
direction and our organizational context. SWOT AnalysisPESTLE Analysis
Your organization identifies, analyzes, Organizational Strategy
monitors and reviews factors that may
affect our ability to satisfy our customers
and stakeholders, as well as; factors that Business Planning
may adversely affect the stability of ResourcesBudgets
our process, or our management
system’s integrity.
Quality Policy Managment System
To ensure that our QMS is aligned with
KPIs/ Metrics
our strategy, whilst taking account of Objectives Context Scope
relevant internal and external factors; we
initially 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.
TheInternal
output Issues
from this activityExternal
is evident as an input to the consideration of risks and opportunities, and
Issues
the Market
actions share Customers
that we take to address them.&Refer
suppliers
to Section
6.1 Employees Markets
for more information about & competition
our risk and opportunity management framework.
Performance Regulatory & statutory
Values & culture Technological Although we acknowledge that ISO 9001:2015
does not require
Innovation our organizational
& knowledge Cultural & context
social 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;
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.
To ensure thatParties
Interested our products and processes
Needs continue to meet all relevant requirements, we identify and
& Expectations
assess
Customers
the potential impactPrice,
of any
reliability
relevant
& value
needs and expectations that may be elicited from the
Distributors
interested & retailers
parties. Where Quality, price &to
appropriate, logistics
ensure that our processes are aligned to deliver the
Owners/shareholders
requirements Profitability
of our interested parties; we& growth
convert relevant needs and
Employees Shared values &
expectations into requirements which become inputs to our QMS and to our product and service designs.
security
Suppliers Beneficial relationships
4.3 Quality Management System
Regulatory & statutory Compliance & reporting
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;
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 Leadership & Governance Processes
Sequence & Interaction of Processes in Appendix A.2
which shows the sequence and interaction of the
process groups within our management system. Product Development Processes
It is recognized that defining, implementing and
documenting our quality management system is only the
Our Quality Management System
first step towards fully implementing its requirements. The
effectiveness of the each process and its subsequent
output is measured and evaluated through regular internal
Customer & Stakeholder Processes
audits, quality inspections and data analysis.
We use key performance indicators (KPIs) that are linked to
our objectives to control and monitor our processes, as Evaluation & Improvement Processes
well as assessments to determine the risks and opportunities
inherent 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.
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ISO 9001:2015
logo. Quality Manual Template
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 6.0 Management System Planning
System
6.1 Actions To Address Risks and Opportunities 6.1 Addressing Risk & Opportunities
6.2 Quality Objectives & Planning To Achieve 6.2 Quality Objectives
Them
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
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A.2 Sequence & Interaction of Processes
MANAGEMENT PROCESSES
Customer Related Prcesses SUPPORT PROCESSES
Quality Management System
Communication
Customer, Market, Stakeholder & Legal Requirements
Set Objectives & Targets Competence & Awareness
Provide Resources & Infrastructure Maintain Facilities & Equipment
Identify Risks & Opportunities Quote Order Calibrate Equipment
Identify Legal & Other Requirements Mitigate Risks & Impacts
Contract Review Product & Process Planning
Determine Roles & Responsibilties Document & Data Control
Domain Knowledge
Quality Planning
Design & Development Supplier Selection & Evaluation
ASSESSMENT PROCESSES ASSESSMENT PROCESSES
Evaluation of Compliance Continual Improvement
Incoming Inpsection, Handling & StorageProduction Processes
Internal Auditing Corrective Action
Storage, Dispatch & Delivery
Non-conformities & Corrective Action Evaluate Risks & Opportunities
Customer Feedback & Satisfaction Management Review
Analyze QMS Process Data Product & Process Monitoring
Customer, Market &
Stakeholder Feedback
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