Sample of the first 8-9 pages of the manual. The manual is available online at https://www.complianceresourcelibrary.co.uk/product-category/certified-business-resources/qms-iso-9001_2015/

1. Your organisation name & Logo
Quality Management
System Manual
ISO 9001:2015
Revision No.: 001
Date: DD – MM – YYYY
Prepared by: _____________
(QMR)
Approved by: _________________
(Top Management)
Revision Date Description
Sections
Affected
Revised By Approved By

2. Manual Contents
1 General
1.1 Company Profile
1.2 Purpose
1.3 Scope of the QMS
2 Normative references
3 Terms and conditions
4 Context of the organisation
4.1 Understanding the organisation and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the Quality management system
4.4 Quality management system and its processes
5 Leadership
5.1 Leadership and commitment
5.1.1 General
5.1.2 Customer focus
5.2 Quality policy
5.2.1 Establishing the quality policy
5.2.2 Communicating the quality policy
5.3 Organisational roles, responsibilties and authorities
6 Planning
6.1 Actions to address risks and opportuunities
6.1.1 General
6.1.2 Planning
6.2 Quality objectives and planning to achieve them
6.2.1 Establishing Quality objectives
6.2.2 Planing actions to achieve Quality objectives
6.3 Planning of changes
7 Support
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrasructure
7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
7.1.5.1 General
7.1.5.2 Measurement traceability
7.1.6 Organizational knowledge
7.2 Competence
7.3 Awareness
7.4 Comminication
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented records
7.5.3.1 Documents

3. 7.5.3.2 Controls
8 Operation
8.1 Operational planning and control
8.2 Requirements for products and services
8.2.1 Customer communication
8.2.2 Determining the requirements for products and services
8.2.3 Review of requiremenst for products and services
8.2.3.1 Specifications
8.2.3.2 Retained documentation
8.2.4 Changes to producst and services
8.3 Design and development of products and services
8.4 Control of externally provided processes, products and services
8.4.1 General
8.4.2 Type and extent of control
8.4.3 Information for external providers
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes
8.6 Release of products and services.
8.7 Control of nonconforming outputs
9 Performance evaluation
9.1 Monitoring measurement analysis and evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
9.2 Internal audit
9.2.1 Audit schedule and plans
9.2.2 Audit Strategy
9.3 Management review
9.3.1 General
9.3.2 Management review inputs
9.3.3 Management review outputs
10 Improvement
10.1 General
10.2 Nonconformity and corrective action
10.2.1 Nonconformity strategy
10.2.2 Retention of records
10.3 Continual improvement

4. Appendix ‘A’ Cross Reference of ISO 9001:2015 Requirements and Sections in the QMS Manual and
Quality Procedures.
Appendix ‘B’ Controlled Document List

5. 1.0-General
1.1 General
(Provide general background information on your organisation (ORGANISATION NAME). Describe the nature and
products / services of ORGANISATION business). These details should provide details on the spatial and geographical
locations of each site if applicable and the related boundaries of all activities. In addition to this we have included
the extent of its suppliers and the extent of the distribution of its products and services
1.2-Scope of the Quality management system
The scope of the QMS applies to the (BUSINESS ACTIVITIES) related to the (PRODUCTS / SERVICES) provided /
undertaken by ORGANISATION NAME including all locations and areas to be covered in the QMS. ORGANISATION
NAME shall endeavour to pursue a strategy that not only encompasses all our activities but also that of our suppliers
and customers and stakeholders. In doing this we aim to influence the quality of our goods and services not only of
our business but of all businesses people and organisations that we use or interact with.
1.3-Purpose of this manual
Although not explicitly mandated within the standard this Manual defines the Quality Management System (QMS)
of ORGANISATION NAME’s its processes activities and contains:
1. Understanding our business and its potential impact on our products and services
2. The context of the organisation
3. Leadership and commitment
4. The Quality Policy
5. Statements of responsibility and authority
6. An overview of the company’s Quality procedures and controls
7. The identification of the resources and training allocated to management, performance of work and verification
activities including internal audit
8. The appointment of the Quality Management Representative (QMR)
9. The arrangement for periodic management reviews
The purpose of this manual is to demonstrate that this QMS meets all ISO 9001:2015 requirements and provide
guidance and direction for the implementation and operation of the QMS to all personnel including all relevant
documents.

6. Section 2.0 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 9001:2015
Enter additional normative references here
Section 3.0 Terms and definitions
Key management system criteria and terminology
Quality Policy Describes the intention and principles to be adopted in relation to
Quality performance, including but not limited to legal compliance,
continual improvements, pollution prevention, interested parties
and other stakeholders.
Context of the organisation Describes the extent, leadership and commitment of the
organisation as well as the hierarchy of control and influence
Quality Management System
Manual (QMS Manual)
Describes the Quality management system and outlines how the
requirements of the International Standard (ISO 9001:2015) are
achieved. A cross-reference of the ISO 9001:2015 clauses to the
sections of this manual is listed in Appendix A.
Objective(s) The overall Quality goals that ORGANISATION NAME set to achieve
its Quality strategy
Target(s) The set of measurable performance requirements that
ORGANISATION NAME establishes to achieve the objectives.
Programme(s) The programme and schedule which ORGANISATION NAME
implements to achieve the objectives and targets.

7. Quality Procedures (EPs) Define the roles, responsibilities and actions to be taken to ensure
that activities are performed in a manner that minimises its impact
and ensure the QMS is implemented in accordance with the Quality
policy and that the requirements of ISO 9001: 2015.are effectively
implemented and managed A cross-reference of the ISO 9001:2015
clauses to the EPs is listed in Appendix A.
Register of Risks and opportunities Consists of the significant risks to ongoing quality that are derived
from the activities and services of ORGANISATION NAME. The
register also denotes the significance of these risks and the
respective obligations and operational controls for all significant
Quality issues including impacts from 3rd
party’s suppliers and
customers.
Quality Instructions (QIs) Describes how and which activities should be performed to manage
significant Quality strategy and to achieve the conformity
requirements documented in ISO 9001:2015.
Quality Forms/Records Records and documented information to enable the effective
management and the assessment of Quality conditions and
performance.
Internal audits Annual system audit of all elements of the Quality management
system to ensure ongoing conformity with the requirements of ISO
9001:2015
4.0: Context of the organisation
4.1 Understanding the context of the organisation
We ORGANISATION NAME will determine both internal and external issues that are relevant to
the organisation and that have both a direct influence on the effectiveness of the Quality
management system and the impact on Quality strategy and performance. In doing so
ORGANISATION NAME will consider the following Quality issues when developing and
implementing its business strategy:
• Suppliers and strategy of contingency programmes
• Employees resources and competence
• Raw materials
• Retail of products and services
• Web resources and financial risk
• Product or service conformity
• Distribution and third parties
• Customers and customer feedback complaints

8. In addition to these core values ORGANISATION NAME will also consider the implications and risks
to our business in respect of:
• Cultural and social responsibility
• Legal and regulatory issues, consumer groups, bodies and key guidance
• Financial implications
• Use best available technologies where financially practical and feasible
• Ethical business strategies where feasible
In applying the above criteria and techniques ORGANISATION NAME will actively manage and
implement programs, procedures and its business strategy to ensure the consistent excellence of
its products and services. These issues will form the core strategy of ORGANISATION NAME when
managing both its risks and opportunities to ensure the continued excellence of its products and
services. These key strategies and management programs will form the core values of
ORGANISATION NAME when implementing and managing its Quality management system.
Document how this will be realised and include how Quality management objectives will be achieved at a
strategic level.
4.2 Understanding the needs and expectations of interested parties
ORGANISATION NAME will carry out regular reviews with regards to all interested parties whether internal
or external. In doing so ORGANISATION NAME will consider the needs and expectations of interested
parties in terms of its overarching Quality strategy and performance.
4.3 Determining the scope of the Quality management system
ORGANISATION NAME will undertake a full review and apply all relevant strategy of its operations within
the scope of this Quality management system. The applied scope will document the spatial extent of all
ORGANISATION NAME activities that are relevant to the successful and effective management of its
Quality management system. The physical and spatial boundaries will also consider those issues that the
organisation can influence, such as customers and suppliers.
ORGANISATION NAME will ensure that the spatial extent and physical attributes of the scope of its
operations are made available to any interested parties and shall include as a minimum any regulatory
controls, consumer groups and industry best practice.
4.4 Quality management system
ORGANISATION NAME will design, implement and continually improve all of its processes to ensure that
Quality issues remain at the forefront of its business strategies and that all potential impacts are duly
mitigated against in accordance with ISO 9001:2015. This will include but is not limited to:
• Suppliers

9. • Regulators
• Risks and opportunities
• Business strategy
• Evaluation and improvements
• Performance indicators
• Responsibilities and authorities
• Customers
• Product specifications