PL

M
SA
[Your Company]

E
PL
M
Quality Management

SA
System Manual

E
PL
Meeting BS EN ISO 9001:2008 Requirements
M
SA
E
PL
M
SA
E
PL
M
SA
E
PL
M
SA
 [Your Company] Quality Management System Manual
BS EN ISO 9001:2008

Table of Contents

PL
INTRODUCTION ......................................................................................................................................... 7

1. SCOPE .................................................................................................................................................... 8

M
2. REFERENCES ........................................................................................................................................ 8

SA
3. TERMS & DEFINITIONS ......................................................................................................................... 8

4. QUALITY MANAGEMENT SYSTEM....................................................................................................... 9

E
4.1 INTRODUCTION ..................................................................................................................................... 9

PL
4.2 DOCUMENTATION REQUIREMENTS.......................................................................................................... 9

M
4.2.1 General ................................................................................................................................ 9

SA
4.2.2 Quality Manual ................................................................................................................... 10
4.2.3 Document Control .............................................................................................................. 11
4.2.4 Control of Records ............................................................................................................. 13

E
5. MANAGEMENT RESPONSIBILITIES................................................................................................... 15

PL
5.1 MANAGEMENT COMMITMENT ............................................................................................................... 15
5.2 CUSTOMER FOCUS ............................................................................................................................. 16
M
5.3 QUALITY POLICY ................................................................................................................................ 17
SA

5.4 PLANNING.......................................................................................................................................... 18
5.4.1 Quality Objectives .............................................................................................................. 18
5.4.2 Quality Management System Planning .............................................................................. 19
E

5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION............................................................................... 19

PL

5.5.1 Responsibility and Authority ............................................................................................... 19

5.5.2 Management representative............................................................................................... 20
M

5.5.3 Internal Communication ..................................................................................................... 21

SA

5.6 MANAGEMENT REVIEW ....................................................................................................................... 21

5.6.1 General .............................................................................................................................. 21
5.6.2 Review Input ...................................................................................................................... 22
E

5.6.3 Review Output.................................................................................................................... 22

PL

6. RESOURCE MANAGEMENT................................................................................................................ 23
M

6.1 PROVISION OF RESOURCES ................................................................................................................. 23

SA

6.2 HUMAN RESOURCES ........................................................................................................................... 24

6.2.1 General .............................................................................................................................. 24
6.2.2 Competence, Awareness & Training .................................................................................. 24
E

6.3 INFRASTRUCTURE ............................................................................................................................... 25

PL

6.4 WORK ENVIRONMENT ......................................................................................................................... 25

7. PRODUCT REALISATION .................................................................................................................... 26

M
SA

7.1 PLANNING.......................................................................................................................................... 26
7.2 CUSTOMER RELATED PROCESSES ....................................................................................................... 26
7.2.1 Determination of Requirements Related to Product ........................................................... 26

[Insert document No. here] Page 5 of 46

 [Your Company] Quality Management System Manual
BS EN ISO 9001:2008

7.2.2 Review of Requirements Related to Product...................................................................... 27

7.2.3 Customer Communication.................................................................................................. 27

PL
7.3 DESIGN & DEVELOPMENT .................................................................................................................... 28
7.3.1 Planning ............................................................................................................................. 28

M
7.3.2 Input ................................................................................................................................... 28

SA
7.3.3 Output ................................................................................................................................ 28
7.3.4 Review ............................................................................................................................... 28
7.3.5 Verification ......................................................................................................................... 28

E
7.3.6 Validation ........................................................................................................................... 28

PL
7.3.7 Change Control .................................................................................................................. 29
7.4 PURCHASING ..................................................................................................................................... 29

M
7.4.1 Purchase Orders ................................................................................................................ 29

SA
7.4.2 Purchasing Information ...................................................................................................... 29
7.4.3 Verification of Purchased Product ...................................................................................... 29
7.5 PRODUCTION & SERVICE PROVISION .................................................................................................... 30

E
7.5.1 Control of Production & Service Provision.......................................................................... 30
7.5.2
7.5.3
PL
Validation of Processes for Production & Service Provision............................................... 30
Identification & Traceability ................................................................................................ 30
M
7.5.4 Customer Property ............................................................................................................. 30
SA

7.5.5 Preservation of Product...................................................................................................... 31

7.6 CALIBRATION ..................................................................................................................................... 31

8. MEASUREMENT, ANALYSIS & IMPROVEMENT................................................................................ 32

E

8.1 GENERAL .......................................................................................................................................... 32

PL

8.2 MONITORING & MEASUREMENT ........................................................................................................... 33

M

8.2.1 Customer Satisfaction ........................................................................................................ 33

SA

8.2.2 Internal Audit ...................................................................................................................... 33

8.2.3 Process Monitoring & Measurement .................................................................................. 35
8.2.4 Product Monitoring & Measurement................................................................................... 35
8.3 CONTROL OF NON-CONFORMING PRODUCTS ......................................................................................... 35
E

8.4 ANALYSIS OF DATA ............................................................................................................................. 37

PL

8.5 IMPROVEMENT ................................................................................................................................... 38

M

8.5.1 Continual Improvement ...................................................................................................... 38

SA

8.5.2 Corrective Action................................................................................................................ 38

8.5.3 Preventative Action ............................................................................................................ 40

APPENDICES............................................................................................................................................ 41
E

A.1 LIST OF KEY QMS DOCUMENTS .......................................................................................................... 41

PL

A.2 QUALITY MANAGEMENT SYSTEM, PROCESSES & INTERACTIONS ............................................................. 42

A.3 QUALITY GLOSSARY ........................................................................................................................... 43
M

A.4 ABBREVIATIONS, TERMS & DEFINITIONS ............................................................................................... 46

SA

[Insert document No. here] Page 6 of 46

 [Your Company] Quality Management System Manual
BS EN ISO 9001:2008

5. Management Responsibilities

PL
Top Management has the responsibility and authority for supporting development and implementation of
the Quality Management System, for ensuring that it remains relevant to the company’s objectives and the

M
needs and expectations of customers, and that it promotes a continual improvement environment.

SA
Top Management and their direct reports are responsible for communicating the Quality Policy and the
importance of meeting customer as well as statutory and regulatory requirements to employees within

E
their respective organizations. They shall ensure that it is understood and applied to the daily work of the

PL
organization through the establishment of goals and quality objectives.

M
Top Management is responsible for ensuring that the Quality Policy is appropriate for the goals of the

SA
business, that it promotes the continuing improvement of the effectiveness of the Quality Management
System and that it is reviewed for continuing suitability.

All managers are responsible for communication of business plans and organizational goals within their

E
respective sectors and reporting back to the organization on the performance and effectiveness of the
Quality Management System. PL
M
GUIDANCE: 5 Management Responsibilities
SA

Top management must communicate to the organization that it is of the utmost

importance that the company meet customer requirements, as well as any applicable
government regulatory requirements.
E

Top management must ensure the quality objectives are created, and that quality
PL

measurements are taken and recorded and compared against those objectives. One of
M

the driving goals of ISO 9001:2008 is “continual improvement”. You must be able to
SA

demonstrate continual improvement. This is done by establishing quality objectives (or

goals) that are just slightly above where you are at now. A year from now, after a year’s
worth of measurements, you should have evidence of improvement. If you don’t, you’re
doing something wrong. Having your quality measurements (records) compared against
E

where you were, and where you want to be, is a really good place to start figuring out how
PL

to improve your system.

M

Top management must conduct periodic management reviews. That is, management
SA

must review the quality system and make changes if necessary. And, of course, you have
to be able to show evidence of your management reviews, so records are necessary.
E

5.1 Management Commitment

PL

The Directors of Your Company are committed to implementing and developing the Quality Management
M

System and this commitment is defined by the Quality Policy located in Section 5.3.
SA

We ensure that our quality policy is understood, implemented, and maintained at all levels of the
organization through printed distribution of our quality policy statement, and through periodic management

[Insert document No. here] Page 15 of 46

 [Your Company] Quality Management System Manual
BS EN ISO 9001:2008

review of the quality policy statement and corporate level improvement objectives. In addition, our quality
policy and objectives are communicated and deployed throughout the business via individual performance

PL
objectives established and reviewed during employee performance reviews.

M
All managers demonstrate their commitment to the development and improvement of the quality

SA
management system through the provision of necessary resources Section 6.1, through their involvement
in the internal audit process Section 8.2.2, and through their proactive involvement in our continual
improvement activities Section 8.5 where emphasis is placed on improving both effectiveness and

E
efficiency of key quality management system processes.

PL
GUIDANCE: 5.1 Management Commitment

M
It’s clear that without solid management commitment, you will not have a successful

SA
quality management system. This is not a commitment in words; it is the continuous and
active demonstration to everyone in the organization that the need to meet customers'
expectations is vital. The actions required of top management under Section 5 must:

E
Support quality and promote the importance of quality:

ƒ
PL
Promote the need to meet customer, regulatory, statutory requirements (5.5.3)
M
ƒ Develop and support a quality management system
SA

ƒ Formulate the organization's quality policy (5.3)

ƒ Set organizational quality objectives (5.4.1)
ƒ Provide appropriate resources (6.0)
ƒ Implement your quality management system (4.1)
ƒ Provide resources to implement your quality system (6.0)
E

ƒ Encourage personnel to meet quality system requirements (5.5.3)

PL

ƒ Improve your quality management system (8.5)

ƒ Perform quality management reviews (5.6)
ƒ Provide resources to improve the quality system (6.0)
M
SA

5.2 Customer Focus

Your Company strives to identify current and future customer needs to meet customer requirements, and
E

exceed customer expectations. Executive management ensures that the focus on improving customer
PL

satisfaction is maintained by setting and reviewing objectives related to customer satisfaction at

Management Review Meetings.
M

Top management ensures that customer requirements are understood and met. Customer requirements
SA

are understood, converted into internal requirements, and communicated to the appropriate personnel in
our organization.
E

Customer complaints and other customer input/feedback are continually monitored and measured to
PL

identify opportunities for improvement. We continually look for other ways to interact directly with individual
customers to ensure a proper focus to their unique needs/expectations is established and maintained.
M
SA

[Insert document No. here] Page 16 of 46

 [Your Company] Quality Management System Manual
BS EN ISO 9001:2008

GUIDANCE: 5.2 Focus on your Customers

ISO 9001:2008 defines customer focus as a top management responsibility. Customer

PL
focus involves determining customer requirements and meeting the requirements so as
to achieve customer satisfaction.

M
SA
Enhance customer satisfaction by ensuring that customer requirements are identified.
The principal message is that management must convey is that the objective of the
business is to keep the customer happy.

E
ƒ Satisfy your customers

PL
ƒ Identify customer requirements
ƒ Meet your customers' requirements
ƒ

M
Enhance customer satisfaction

SA
5.3 Quality Policy

Top management ensures that the quality policy is communicated to all employees. It is included in new
employee training and training on the quality management system. Management reviews the quality policy

E
during management review meetings to determine the policy’s continuing suitability for our organization.
PL
M
We will achieve customer satisfaction by continually improving
SA

processes, products and services to ensure they consistently meet

or exceed customer requirements
E

Your Company’s quality policy statement indicates our commitment and focuses on what is important to
PL

us as an organization; achieving customer satisfaction and it prescribes the method by which we

accomplish this; by continually improving processes, products, and services to ensure they consistently
M

meet or exceed requirements. Moreover, our quality policy statement acts as a compass in providing the
SA

direction and a framework for establishing key corporate level performance measures and related
improvement objectives Section 5.4.1.
E

We ensure that our quality policy is communicated and understood at all levels of the organization through
PL

documented training, regular communication, and reinforcement during annual employee performance
reviews.
M
SA

Our quality policy statement is controlled by inclusion in this manual, and along with all policies contained
in this manual, is reviewed for continuing suitability during management review meetings Section 5.6.
E
PL

Signed
M

Dated
SA

[Insert document No. here] Page 17 of 46

 [Your Company] Quality Management System Manual
BS EN ISO 9001:2008

GUIDANCE: 5.3 Quality Policy

The quality policy is the only true definition of quality that counts in your organization.

PL
Provided that you take into account the few important items the standard asks for, you
can define and measure quality any way you choose.

M
SA
ƒ Make sure the policy builds on current corporate objectives and values
ƒ It must be fully integrated with those concepts

Part of the reason why you need a well written quality policy is to make your employees
understand that their job affects product quality, and therefore the success of the

E
PL
company. Employees must be made aware that their individual contribution is important
to the company’s overall success.

M
If the quality policy is simply written to satisfy the requirements of ISO 9001:2008 then it

SA
might be worthless. You should keep it simple and keep it relevant to your organization.
Make it meaningful to the people in your organization.

E
ƒ Define and establish your organization's quality policy
ƒ
ƒ
ƒ
PL
Ensure that it serves your organization's purpose
Ensure that it emphasizes the need to meet requirements
Ensure that it facilitates the development of quality objectives
M
ƒ Ensure that it makes a commitment to continuous improvement
ƒ
SA

Manage your organization's quality policy

ƒ Communicate your policy to your organization
ƒ Review your policy to ensure that it is still suitable

The quality policy should act as a driver for continual improvement. You will be required
E

to ensure that you continually improve the degree to which the organization’s products
PL

and services meet customer requirements and to measure effectiveness of the

processes responsible. To this end the continual improvement principle implies that you
M

should adopt the attitude that improvement is always possible and that organizations
SA

should develop the skills and tools necessary to drive improvement.

5.4 Planning
E

5.4.1 Quality Objectives

PL

Quality objectives are established to support our organization’s efforts in achieving our quality
M

policy and reviewed annually for suitability. Quality objectives are measurable, and reviewed
SA

against performance goals during management review and scheduled Management Meetings.

1. Achievement of ZERO DEFECTS and 100% on time delivery (Section 7.5.1.) performance.
E

2. Manage and control facilities, processes, quality systems and personnel to consistently and
PL

cost effectively produce products and furnish services that meet customer needs (Section
7.5.1).
3. Be committed to continuous process improvement (Section 8.5) by emphasising reduction of
M

part-to-part variation and the elimination of all waste.

SA

4. Conduct operations in conformance with, or to exceed, all applicable environmental laws and
regulations of the jurisdictions in which we do business (Section 6.4).

[Insert document No. here] Page 18 of 46

 [Your Company] Quality Management System Manual
BS EN ISO 9001:2008

GUIDANCE: 5.4.1 Quality Objectives

Quality objectives are a clear requirement in their own right as opposed to being just a

PL
part of quality policy. They must be established in support of the policy and must focus
on meeting product requirements and achieving continual improvement.

M
SA
The translation of the quality policy into practice is made by defining the supporting
quality objectives. ISO 9001 does not specify how the quality objectives should be
documented; they may be documented in business plans, management review output or
annual budgets, etc. Formulate your quality objectives:

E
PL
ƒ Ensure that objectives are set for functional areas
ƒ Ensure that objectives are set at organizational levels

M
ƒ Ensure that objectives facilitate product realization
ƒ

SA
Ensure that objectives support the quality policy
ƒ Ensure that objectives are measurable

Incorporate the quality objectives into the reporting process. When your quality objectives
are defined they must reflect the quality policy, be coherent, and align with the overall

E
corporate objectives and customer expectations. Clearly defined quality objectives
PL
should also be closely linked to your key performance indicators or other pre-existing
M
indicators; otherwise they can become meaningless. They must be set by Top
Management and be incorporated into reporting.
SA

5.4.2 Quality Management System Planning

E

The quality system has been planned and implemented to meet our quality objectives and the
PL

requirements of 4.1 of the ISO 9001:2008 standard.

M

The quality management system planning process involves the establishing and communicating
SA

our quality policy Section 5.3 and objectives Section 5.4.1 through issuance of this manual and
its associated procedures, and through the provision of resources needed for its effective
implementation Section 6.1. Accordingly, this manual constitutes our overall plan for establishing,
E

maintaining and improving an effective quality management system. Our management review
PL

process Section 5.6 and internal audit process Section 8.2.2 ensure the integrity of our quality
management system is maintained when significant changes are planned and implemented that
M

affect our key quality management system processes.

SA

5.5 Responsibility, Authority and Communication

5.5.1 Responsibility and Authority

E
PL

An organizational structure has been established to show the interrelation of personnel in the
organization. Job descriptions define the responsibilities and authorities of each of the positions.
M

Job descriptions and the organizational structure are reviewed and approved by top management
SA

for adequacy.

[Insert document No. here] Page 19 of 46

 [Your Company] Quality Management System Manual
BS EN ISO 9001:2008

Members of Top Management are ultimately responsible for the quality of Your Company’s
products and services since they control the systems and processes by which work is

PL
accomplished.

M
Top Management is responsible for business planning, development and communication of our

SA
quality policy Section 5.3, quality management system planning Section 5.4.2 including the
establishment and deployment of objectives Section 5.4.1, the provision of resources needed to
implement and improve the quality management system Section 6.1 and management reviews

E
Section 5.6.

PL
All managers are responsible for execution of the business plan and implementation of the policy,

M
processes and systems described in this manual. All managers are responsible for planning and

SA
controlling quality management system processes within their area(s) of responsibility, including
the establishment and deployment of operational level objectives and the provision of resources
needed to implement and improve these processes.

E
All employees are responsible for the quality of their work and implementation of the policy and

PL
procedures applicable to processes they perform Section 8.2.3. Personnel responsible for
product quality have the authority to stop production to correct quality problems Section 8.3.
M
Employees are motivated and empowered to identify and report any known or potential problems
SA

and recommend related solutions through internal audits Section 8.2.2 and/or the continual
improvement and corrective/preventive action processes Section 8.5.
E

GUIDANCE: 5.5.1 Responsibility & Authority

PL

Develop and insert a management hierarchy/organization chart and define job

descriptions:
M

ƒ Clearly define roles, responsibilities and authorities

SA

ƒ Communicate responsibilities and authorities

5.5.2 Management representative

E

Your Company’s Management Representative [insert job title of your management representative
PL

here] is appointed as management representative with delegated responsibilities for ensuring

that a compliant quality management system is established, implemented, and maintained; for
M

promoting awareness of customer requirements throughout the organization Section 5.5.3; and
SA

for ensuring that the performance of the quality management system is reviewed by Top
Management for effectiveness, continuing suitability and the need for improvement Section 5.6.
The Management Representative has the following responsibilities:
E

ƒ Ensure that processes needed for the QMS are established and implemented
PL

ƒ Report to top management on the performance of the QMS system

M

ƒ Suggest areas for performance improvement

SA

ƒ Promote awareness of customer requirements throughout the organization

ƒ Act as a liaison with customers and external auditors on matters relating to the QMS

[Insert document No. here] Page 20 of 46

 [Your Company] Quality Management System Manual
BS EN ISO 9001:2008

GUIDANCE: 5.5.2 Management Representative

PL
Assign a Quality Management Representative who will be responsible for:

ƒ Overseeing the quality management system

M
ƒ Reporting the status of your quality management system
ƒ

SA
Supporting the improvement of your quality management system

5.5.3 Internal Communication

Your Company communicates information regarding quality management system processes and

E
PL
their effectiveness through documented training Section 6.2.2, the internal audit process Section
8.2.2, continual improvement and corrective/preventive action processes Section 8.5.

M
SA
All managers and supervisors are responsible for establishing regular formal and informal
communications as needed to convey to their employees the relevance and importance of their
activities; typically this information is conveyed through team meetings and cross-functional
improvement projects.

E
PL
Communications regarding how employees contribute to the achievement of objectives is also
M
conveyed and reinforced during employee performance reviews.
SA

GUIDANCE: 5.5.3 Internal Communication

Support internal communications by ensuring:

ƒ Internal communication processes are established

E

ƒ Ensure that communication occurs throughout the organization

PL

5.6 Management Review

M

5.6.1 General
SA

Top Management conducts a management review meeting at least once annually to ensure the
continuing suitability, adequacy, and effectiveness of our quality management system. The
E

primary inputs reviewed include data that measures the conformance and performance of our
PL

quality management system and recommendations based on analysis of such data.

M

Conformance is primarily assured through internal audits Section 8.2.2 and demonstrated
SA

through a review of internal audit results and our demonstrated ability to correct/prevent
problems.
E

Performance is primarily assured through the deployment of corporate/operational level

PL

objectives Section 5.4.1 and demonstrated through a review of our demonstrated ability to
achieve desired results. The primary outputs of management review meetings are management
M

actions taken Section 8.5 to make changes or improvements to our quality management system
SA

and the provision of resources needed to implement these actions.

[Insert document No. here] Page 21 of 46

 [Your Company] Quality Management System Manual
BS EN ISO 9001:2008

GUIDANCE: 5.6.1 General

The management review must:

PL
ƒ Review the quality management system
ƒ Evaluate the performance of your quality system

M
ƒ Evaluate whether the quality management system should be improved

SA
5.6.2 Review Input

Assessment of the Quality Management System is based on a review of information inputs to

E
management review. These inputs include the following:

PL
ƒ Audit results

M
ƒ Product conformity data
ƒ

SA
Opportunities to improve
ƒ Feedback from customers
ƒ Process performance information
ƒ Corrective and preventive actions

E
ƒ
ƒ
Changes that might affect the system
Previous quality management reviews
PL
M
SA

5.6.3 Review Output

During these review meetings, management will identify appropriate actions to be taken
regarding the following issues:
E

ƒ
PL

Actions to improve your quality system

ƒ Actions to improve your products
M

ƒ Actions to address resource needs

SA

ƒ Management meeting minutes

The primary outputs of management review meetings are management actions taken to make
changes or improvements to our Quality Management System and the provision of resources
E

needed to implement these actions.

PL
M

Responsibilities for required actions are assigned to members of the management review team.
SA

Any decisions made during the meeting, assigned actions, and their due dates are recorded on
the management review presentation.
E
PL
M
SA

[Insert document No. here] Page 22 of 46