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Quality Management
System Manual
ISO 9001:2015

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Quality Management System Manual
ISO 9001:2015

Contents
1 Approvals & Revision History _____________________________________________________________________________ 4
1.1 Approvals _______________________________________________________________________________________________ 4
1.2 Revision History _________________________________________________________________________________________ 4
1.3 Proprietary Information _________________________________________________________________________________ 4

2 Introduction ________________________________________________________________________________________________ 5
2.1 Process Activity Map ____________________________________________________________________________________ 5
2.2 Purpose _________________________________________________________________________________________________ 5
2.3 Applicability _____________________________________________________________________________________________ 6
2.4 Process Approach _______________________________________________________________________________________ 6
2.5 Plan-Do-Check-Act Cycle _______________________________________________________________________________ 6
2.6 Management System Principles ________________________________________________________________________ 6

3 Terms & Definitions ________________________________________________________________________________________ 7

4 About Our Organization ___________________________________________________________________________________ 8

4.1 Organizational Context _________________________________________________________________________________ 8
4.2 Relevant Interested Parties _____________________________________________________________________________ 9
4.3 Management System Scope ___________________________________________________________________________ 10
4.4 Management System Processes _______________________________________________________________________ 11

5 Leadership ________________________________________________________________________________________________ 13

5.1 Leadership & Commitment _________________________________________________________________________ 13

5.1.1 General ____________________________________________________________________________________________ 13
5.1.2 Customer Focus ___________________________________________________________________________________ 14

5.2 Management System Policy ________________________________________________________________________ 14

5.2.1 Establishing the Policy ____________________________________________________________________________ 14
5.2.2 Communicating the Policy ________________________________________________________________________ 15

5.3 Roles, Responsibilities & Authorities ______________________________________________________________ 15

5.3.1 Top Management _________________________________________________________________________________ 16
5.3.2 Quality Manager __________________________________________________________________________________ 16
5.3.3 Quality Coordinators ______________________________________________________________________________ 16
5.3.4 Managers & Supervisors __________________________________________________________________________ 17
5.3.5 Employees & Contractors _________________________________________________________________________ 17

6 Planning ___________________________________________________________________________________________________ 18

6.1 Actions to Address Risks & Opportunities ________________________________________________________ 18

6.1.1 Risks & Opportunities ____________________________________________________________________________ 18
6.1.2 Planning Action ___________________________________________________________________________________ 19

6.2 Objectives & Planning to Achieve Them __________________________________________________________ 20

6.2.1 Quality Objectives ________________________________________________________________________________ 20
6.2.2 Planning to Achieve Objectives ___________________________________________________________________ 21

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Quality Management System Manual
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6.3 Planning for Change ________________________________________________________________________________ 22

7 Support____________________________________________________________________________________________________ 24

7.1 Resources ____________________________________________________________________________________________ 24

7.1.1 General ____________________________________________________________________________________________ 24
7.1.2 People _____________________________________________________________________________________________ 24
7.1.3 Infrastructure & Natural Resources _______________________________________________________________ 24
7.1.4 Operational Environment _________________________________________________________________________ 25
7.1.5 Monitoring & Measurement Tools _______________________________________________________________ 25
7.1.6 Organizational Knowledge _______________________________________________________________________ 26

7.2 Competence __________________________________________________________________________________________ 27

7.3 Awareness ____________________________________________________________________________________________ 27

7.4 Communication ______________________________________________________________________________________ 28

7.4.1 General ____________________________________________________________________________________________ 28
7.4.2 Internal Communication __________________________________________________________________________ 28
7.4.3 External Communication __________________________________________________________________________ 29

7.5 Documented Information ___________________________________________________________________________ 30

7.5.1 Management System Documents ________________________________________________________________ 30
7.5.2 Creating, Updating & Issuing _____________________________________________________________________ 30
7.5.3 Controlling Documented Information ____________________________________________________________ 30

8 Operations ________________________________________________________________________________________________ 32

8.1 Operational Planning & Control ___________________________________________________________________ 32

8.2 Determining Requirements for Products __________________________________________________________ 32

8.2.1 Customer Communication ________________________________________________________________________ 32
8.2.2 Determining Requirements _______________________________________________________________________ 33
8.2.3 Review of Requirements __________________________________________________________________________ 33
8.2.4 Changes in Requirements ________________________________________________________________________ 33

8.3 Design & Development _____________________________________________________________________________ 34

8.3.1 General ____________________________________________________________________________________________ 34
8.3.2 Planning ___________________________________________________________________________________________ 34
8.3.3 Inputs _____________________________________________________________________________________________ 35
8.3.4 Controls ___________________________________________________________________________________________ 35
8.3.5 Outputs ___________________________________________________________________________________________ 36
8.3.6 Changes ___________________________________________________________________________________________ 36

8.4 Suppliers & Purchasing _____________________________________________________________________________ 36

8.4.1 General ____________________________________________________________________________________________ 36
8.4.2 Purchasing Controls ______________________________________________________________________________ 37
8.4.3 Purchasing Information ___________________________________________________________________________ 38

8.5 Production & Service Provision ____________________________________________________________________ 39

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Quality Management System Manual
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8.5.1 Control of Production & Service Provision _______________________________________________________ 39

8.5.2 Identification & Traceability ______________________________________________________________________ 39
8.5.3 3rd Party Property _________________________________________________________________________________ 40
8.5.4 Preservation _______________________________________________________________________________________ 40
8.5.5 Post-delivery Activities ____________________________________________________________________________ 41
8.5.6 Control of Changes _______________________________________________________________________________ 41

8.6 Release of Products & Services _____________________________________________________________________ 41

8.7 Nonconforming Outputs____________________________________________________________________________ 42

9 Performance Evaluation _________________________________________________________________________________ 44

9.1 Monitoring, Measurement, Analysis & Evaluation _______________________________________________ 44

9.1.1 General ____________________________________________________________________________________________ 44
9.1.2 Customer Satisfaction_____________________________________________________________________________ 44
9.1.3 Analysis & Evaluation _____________________________________________________________________________ 45

9.2 Internal Audit ________________________________________________________________________________________ 46

9.2.1 General ____________________________________________________________________________________________ 46
9.2.2 Internal Audit Programme ________________________________________________________________________ 47

9.3 Management Review ________________________________________________________________________________ 48

9.3.1 General ____________________________________________________________________________________________ 48
9.3.2 Inputs _____________________________________________________________________________________________ 49
9.3.3 Outputs ___________________________________________________________________________________________ 49

10 Improvement ___________________________________________________________________________________________ 50

10.1 General _____________________________________________________________________________________________ 50

10.2 Nonconformity & Corrective Action ____________________________________________________________ 50

10.2.1 Corrective Action _________________________________________________________________________________ 50
10.2.2 Supplier Corrective Action ________________________________________________________________________ 52

10.3 Improvement ______________________________________________________________________________________ 52

Appendices ____________________________________________________________________________________________________ 54
A.1 Interaction of Processes _______________________________________________________________________________ 54
A.2 Organization Chart ____________________________________________________________________________________ 55
A.3 Correlation Matrix _____________________________________________________________________________________ 56

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Quality Management System Manual
ISO 9001:2015

2 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 to better satisfy
the needs and expectations of our customers, stakeholders, and other interested parties.

2.1 Process Activity Map

The process overview (turtle diagram) provides stakeholders, process owners, and participants with an overview
of the interactions of the management system.

The figure below illustrates our methodology for developing our quality management system, using the plan,
do, check, and act process approach to implement and deliver management system objectives and stakeholder
requirements to achieve compliance.

Figure 1: Overview of the Quality Management System

Certification to ISO 9001 will help achieve these intended outcomes and demonstrate that the quality
management system effectively provides value for our organization and its interested parties.

2.2 Purpose
This document describes our quality management system and delineates authorities, interrelationships, and
the responsibilities of personnel within the system. The quality manual also references the procedures and
activities comprising our management system.

The document is used to familiarise customers and other external organizations or individuals with the quality
controls that your organization has implemented. The controls defined herein demonstrate to all interested
parties that our management system is focused on implementing processes that deliver customer satisfaction
and process efficiency.

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Quality Management System Manual
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The output from this activity is evident as an input to consider risks and opportunities and the actions we take
to address them. For more information about our risk and opportunity management framework, refer to
Section 6.1.
Although we acknowledge that ISO 9001 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 that describes our organizational context:
1. Analysis of business plans, strategies, and statutory and regulatory commitments;
2. Analysis of technology and competitors;
3. Technical reports from experts and consultants;
4. SWOT analysis reports or schedules for internal issues;
5. PESTLE analysis reports or schedules for external issues;
6. 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, the
position and direction of our organization, business propositions, and other ideas.

Similarly, PESTLE analysis provides our organization with a 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,
some of which relate to climate change, will develop over time and that only a limited set of their respective
needs and expectations apply to our operations, or the quality management system. Such needs and
expectations broadly include those shown in the figure below.

Figure 3: Interested Parties and Their Needs and Expectations

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Quality Management System Manual
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4.4 Management System Processes

Your organization has implemented the quality management system in a broader management landscape. It
has established, documented, and implemented our processes, policies, and objectives while satisfying the
requirements of ISO 9001.

To achieve this, your organization has adopted the process approach advocated by ISO 9001:2015 and ISO
9000:2015. Using the PDCA cycle to manage processes and stimulate improvement, we have incorporated the
‘process approach’ into our daily operations.

Risk-based thinking is applied when developing, implementing, and improving the effectiveness of our quality
management system.
Figure 4: Process Approach

We establish and maintain system effectiveness by defining key process groups and managing their inputs,
activities, controls, outputs, and interfaces. Refer to Appendix A.1, which shows the interaction of the process
groups within our quality management system.

Monitoring key performance indicators (KPIs) linked to our objectives is used to measure, monitor, and
communicate process performance. This approach allows top management to regularly review quality
management system performance and ensure its ongoing integration with business processes.

As part of the decision-making process, we use trends and statistical data and trends related to
nonconformities, customer feedback, targets, objectives, and corrective actions, as well as monitoring and
measurement results, audit results, levels of customer satisfaction, process performance data and compliance
data, to ensure that objective management decisions can be made.

By managing the inputs, activities, controls, outputs, and interfaces, our organization ensures that management
system effectiveness is established, monitored, maintained, and improved. The process landscape is described

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Quality Management System Manual
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6 Planning
6.1 Actions to Address Risks & Opportunities
To have a successful quality management system, we consider and manage the risks and opportunities relating
to our stakeholders and our organization’s external and internal contexts. This process uses the information
collected during our context and strategy evaluations (via SWOT & PESTLE analysis) and stakeholder and
interested party analysis.
Figure 6 Risk & Opportunity Process

Top management then considers the risks and opportunities we manage to ensure that our quality
management system meets its intended outcomes, manages external environmental conditions, and achieves
continual improvement.

Once the significant or material risks and opportunities are identified, our organization plans actions to mitigate
perceived risks or take advantage of opportunities. Action is taken in various ways using our quality
management system processes via setting objectives, targets, and policies, developing operational controls,
and undertaking supplier evaluations.

6.1.1 Risks & Opportunities

Risk and opportunity management within your organization aims to ensure that organizational capabilities and
resources are employed efficiently and effectively to take advantage of opportunities and mitigate risks.

Top management is responsible for incorporating risk-based thinking into our organization's culture. This
includes the establishment of risk management policies and targets to ensure the effective implementation of
risk and opportunity management principles throughout the lifecycle of our products, activities, or services by:

1. Providing sufficient resources to carry out risk and opportunity management activities;
2. Assigning responsibilities and authorities for risk and opportunity management activities;

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Quality Management System Manual
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and reporting this data to top management. Our identified quality risks and opportunities are used to prioritize
which objectives and plans to implement.

Top management is responsible for agreeing on objectives and targets relating to activities under their control
and for approving and endorsing objectives and targets for the organization. Planning for action to mitigate
adverse risk and the leveraging of opportunities is implemented via:
1. Quality objectives;
2. Monitoring, measuring, and analysis;
3. Operational controls;
4. Others, as appropriate.
The programme acts as our management action plan that identifies individual objectives, the means by which
the objectives are to be achieved, and the timeframe in which the actions are to be achieved. Actions are
assigned to suitably authorized and responsible members of the management team, who are responsible for
ensuring that the actions are completed within the terms specified by the programme.

Regular and documented management reviews make recommendations to ensure that those risks and
opportunities that could affect the intended outcomes of the quality management system are considered and
planned for via the most appropriate business processes.

6.3 Planning for Change

Our management system is planned and implemented to meet our corporate objectives and the requirements
of ISO 9001. Planning involves establishing and communicating our corporate policies, objectives, and
associated operational procedures.

Figure 7: Change Management Process

This document constitutes our overall plan for establishing, maintaining, and improving our management
system. For each instance of management system planning, the output is documented and retained
accordingly.

Any changes are controlled to ensure that no unintended threats affect the quality management system, and
they are documented and assessed using the Risk & Opportunity Register.

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The type and extent of control applied to our suppliers and the purchased product depend on the effect the
outsourced product or service may have on our final product or service. The following considerations are taken
into account:

1. Ensuring that we understand the capabilities and competencies of potential outsourcing suppliers;
2. Ensuring that we communicate the roles and responsibilities of the outsourcing supplier;
3. Defining the quality requirements for the outsourced process, activity, or product;
4. Establishing upfront the criteria for and review of deliverables, frequency of inspections and audits;
5. Selecting and qualifying appropriate outsourcing suppliers;
6. Ensuring usage requirements, precautions, and protective measures are communicated and available.
After successful review and evaluation, suppliers are evaluated and added to the Approved Supplier Index. It is
the responsibility of the Purchasing Manager to evaluate and select suppliers based on their ability to supply
products or services in accordance with specified QMS requirements to ensure that our operations remain
compliant with our:

1. Corporate QMS policies and objectives;

2. Sustainable development procurement policy;
3. Legal and other requirements.
Additionally, other internal resources may be called on to assist as required. The selection, evaluation, and re-
evaluation criteria are defined and communicated in the Suppliers & Purchasing Procedure. Records of the
results of evaluations and any necessary actions arising from the evaluation are maintained.

8.4.2 Purchasing Controls

Your organization ensures that externally provided processes, products, and services do not adversely affect
our ability to consistently deliver conforming products and services to our customers. Quality control measures
are applied to outsourced processes and purchased products where appropriate. These controls are
documented within the purchasing information and communicated to the supplier.

A SCAR Form is issued to Suppliers and vendors for repetitive, ongoing problems and issues that significantly
impact end-product delivery. A SCAR may be requested due to the supplier's poor performance for more than
three consecutive months or any three months in 12 months based on data analysis.

Supplier performance and capability are monitored and assessed through periodic, 2nd party audits,
performance data analysis, and inspection and/or verification of the purchased product or outsourced process.
Suppliers who demonstrate inadequate audit and delivery performance must implement corrective actions.

Personnel with authority to take action on the remediation are identified in the report. The Supplier’s approval
status will be determined based on the table below:

Score New Supplier Currently Approved Supplier

Systems are effective; start doing business with No change in status, systems are effective, continue
>86%
this supplier business with this supplier

Conditionally approve the supplier and Request improvement, encourage them to improve their
85%
encourage them to improve their processes processes, and monitor and continue using the supplier

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Quality Management System Manual
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2. First-article inspection and testing – Typically, the first produced unit that both the customer or
supplier agrees to use as the required base-line standard for all following units;
3. In-process inspection and testing - Products are withheld from further processing until there is
objective evidence that the required inspection and test have been performed;
4. Final inspection and testing - Evidence that all inspections and tests that were required during
previous stages of manufacturing were performed and documented as meeting the requirements.
Measurement and acceptance criteria that are necessary for product acceptance are retained as documented
information; subsequent acceptance records form the production documentation evidence, which includes the
following information:
1. Criteria for acceptance and rejection;
2. Locations in the process sequence where measurement and testing operations were performed;
3. Types of measurement instruments used, including any instructions associated with their use;
4. Test records showing actual test results where required by the specification or acceptance test plan.
Documented information is retained to indicate the person authorizing the release of the product. Product
release and service delivery do not proceed until all the planned arrangements have been satisfactorily
completed unless otherwise approved by a relevant authority and, where applicable, by the customer.
Supporting documentation:
Doc No. Title & Description
P0860-01 Testing & Inspection Procedure

8.7 Nonconforming Outputs

Your organization ensures that provisions are made for identifying and controlling all nonconforming outputs
and materials, including nonconforming product returns by a customer, to prevent the inadvertent use or
shipment of nonconforming products and the unnecessary costs associated with the processing of
nonconforming products.

Figure 8: Nonconforming Outputs Process

The Nonconforming Outputs Procedures define the responsibilities, authorities, and methods used for the
identification, segregation, review, and disposition of nonconforming products, as well as the implementation
of corrective action to prevent the recurrence of the nonconformance and action appropriate to the effect, or

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Internal auditors are selected to ensure objectivity and impartiality of the audit process. This is achieved by
selecting a team of auditors from cross-functional departments who have received the appropriate training in
the auditing process. The following qualitative scoring criteria are used to identify the level of compliance and
effectiveness during internal audits:

Finding Criteria Description

Audit findings indicate conformity (3.6.11). See ISO 9000:2015. Conforms [+100]. Criteria: All performance
indicators, metrics, objectives, audit results, etc., show stability and consistently achieve targets. The
Conforms
process is fully documented and implemented and demonstrates compliance and effectiveness. Continue
to monitor trends and indicators to determine ongoing stability.
Audit findings indicate a nonconformity (3.6.9). See ISO 9000:2015. Minor [-25]. Criteria: Poor
performance, adverse trends, expected results not achieved. Current practices conform but are not
Minor NC documented. Deviation from practice is unlikely to result in the failure of the QMS or process or will not
result in the delivery of nonconforming products. Investigate root cause (s) and implement corrective
action by the next reporting period or next audit.
Audit findings indicate a nonconformity (3.6.9). See ISO 9000:2015. Major [-75]. Criteria: Practices are
nonconforming and likely to cause compliance issues. Likely to have a significant adverse effect on
Major NC customer satisfaction, product quality, delivery, or profitability. Process not implemented or documented.
Implement immediate containment action, investigate root cause (s), and apply corrective action. Re-
audit in 4 weeks.
Opportunities for improvement (3.3.1) See ISO 9000:2015 or recording good practices. (3.10) Note 2 ISO
19011:2018. Minor problems exist, with weaknesses, bottlenecks, or potential deficiencies, which, if not
OFI
improved, may lead to nonconformity in the future. The auditor noted negative or positive situations but
did not relate to a requirement in the standard.

The Quality Manager coordinates all external audits; the relevant findings will be input for the improvement
phase. External audits such as statutory fire inspections, reviews, evaluations, and compliance audits may be
carried out by external bodies, such as the Health and Safety Executive (HSE) or Notified Body. When such
external audits occur, whether planned or unannounced, the Quality Manager will accompany external auditors.

9.2.2 Internal Audit Programme

The internal audit programme, coordinated by the Quality Manager, details the frequency and general focus
of each internal audit and is recorded and communicated within the Internal Audit Programme. Your
organization’s internal audit programme is based upon a strategy that considers the status and importance of
each process comprising the quality management system.

The audit frequency is also based on process performance trends, results from previous audits, levels of
customer satisfaction, rates of nonconformity and corrective action, etc., to ensure that our organization
focuses on the aspects that affect product and process conformity the most.

The internal audit reports define each audit's criteria, scope, frequency, and methods. The selection of trained
auditors and their subsequent impartial conduct ensures objectivity throughout the audit process and that:

1. The results of each are reported to the Quality Manager;

2. That timely, appropriate corrective action is undertaken where required;
3. They retain documented information such as audit checklists and audit reports as evidence of the
effective implementation of the audit programme with respect to each audit.

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