Implementation Guidance

(The header page and this section must be removed from final version of the document)

Purpose of this document

The Quality Manual is a document which acts as the root definition of the Quality
Management System (QMS).

Areas of the standard addressed

The following areas of the ISO9001 standard are addressed by this document:

5 Leadership

General Guidance

The quality manual should be approved by Top Management (normally defined as

the “person or group of people who direct and control the organization at the highest
level”) as evidence of their commitment.

This manual refers in places to other documents which provide more detail; the
exact structure of documentation is not mandated by the ISO9001 standard and so
you could choose to add some of the contents of other documents into this manual
to reduce the total number of documents in your QMS.

We would also recommend that this document is made available via the intranet if
you have one or via any other appropriate means.

Review Frequency

We would recommend that this document is reviewed as part of an annual exercise

which also covers key documents such as the risk assessment and training plan.
This exercise should include significant business involvement to ensure that
changed requirements are captured and customer feedback obtained.
 Quality Manual

Quality Manual

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Revision History

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Contents

1 INTRODUCTION........................................................................................................................................4
2 QUALITY MANUAL...................................................................................................................................5
2.1 TOP MANAGEMENT LEADERSHIP AND COMMITMENT...............................................................................5
2.2 FRAMEWORK FOR SETTING OBJECTIVES....................................................................................................5
2.3 ROLES AND RESPONSIBILITIES...................................................................................................................5
2.4 CONTINUAL IMPROVEMENT OF THE QMS..................................................................................................6
2.5 APPROACH TO MANAGING RISKS AND OPPORTUNITIES............................................................................6
2.6 HUMAN RESOURCES...................................................................................................................................6
2.7 AUDITING AND REVIEW.............................................................................................................................7
2.8 DOCUMENTATION STRUCTURE AND POLICY..............................................................................................7
2.9 CONTROL OF RECORDS..............................................................................................................................7

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1 Introduction

This manual defines how a Quality Management System (QMS) will be set up,
managed, measured, reported on and developed within MASEL Tech.

Whist it doesn’t give any absolute guarantees of quality, a QMS can contribute
significantly towards delivering many of the following benefits to MASEL Tech:

 Significantly reduced risk of reputational damage, legal penalties or business

revenue due to quality issues
 Peace of mind assurance to our customers, staff, board members, suppliers
and other interested parties that our products and services are of defined
quality
 An ability to bid for and respond to tenders for business where ISO9001
certification is a requirement
 A public demonstration that MASEL Tech takes quality management seriously
 Internal and external recognition of the quality controls in place
 Year-on-year improvement in the quality of our products and services as a
result of the continuous improvement aspects of the standard
 A strong move away from reactive fire-fighting towards proactive quality
management
 Better alignment of quality management with the needs of the business and
our customers through regular review meetings with interested parties
 Better perception and awareness of quality issues within the business, our
customers and other stakeholders
 An improved ability to manage quality issues if they do occur, so reducing
reputational damage and limiting business impact to us and our customers

The International Standard for Quality Management Systems, ISO9001:2015

(referred to in this document as ISO9001), is a development of the earlier British
Standard, BS 5750 and was first published in 1987. This standard defines the
requirements for a QMS based on internationally-recognized best practice.

MASEL Tech has decided to pursue full certification to ISO9001 in order that the
effective adoption of quality management best practice may be validated by an
independent third party, a Registered Certification Body (RCB).

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2 Quality Manual

2.1 Top Management Leadership and Commitment

Commitment to quality management extends to senior levels of the organization and

will be demonstrated through this Quality Manual and the provision of appropriate
resources to provide and develop the QMS and associated procedures and controls.

Top management will also ensure that a systematic review of performance of the
programme is conducted on a regular basis to ensure that quality objectives are
being met and relevant issues are identified through the audit programme and
management processes. Management review can take several forms including
departmental and other management meetings.

The [Quality Manager] shall have overall authority and responsibility for the
implementation and management of the Quality Management System, specifically:

 The identification, documentation and fulfilment of quality requirements

 Implementation, management and improvement of risk and opportunity
management processes
 Integration of operational processes, procedures and controls
 Compliance with statutory, regulatory and contractual requirements
 Reporting to top management on performance and improvement

2.2 Framework for Setting Objectives

A regular cycle will be used for the setting of objectives for quality, to coincide with
the budget planning cycle. This framework is documented in the Quality Policy.

2.3 Roles and Responsibilities

Within the field of quality management, there are a number of roles that correspond
to the areas defined within the scope set out above. In a larger organization, these
roles will often be filled by an individual in each area. In a smaller organization these
roles and responsibilities must be allocated between the members of the team.

Full details of the responsibilities associated with each of the roles and how they are
allocated within MASEL Tech are given in a separate document QMS Roles,
Responsibilities and Authorities.

It is the responsibility of the [Quality Manager] to ensure that employees and

contractors understand the roles they are fulfilling and that they have appropriate
skills and competence to do so.

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2.4 Continual Improvement of the QMS

MASEL Tech policy with regard to continual improvement of the QMS is described in
the Quality Policy.

2.5 Approach to Managing Risks and Opportunities

Risk and opportunity management will take place at several levels within the QMS,
including:

 Management planning – risks to the achievement of quality objectives will be

assessed and reviewed on a regular basis
 Organization-wide risk and opportunity assessments
 Assessment of the risk of changes via the change management process
 As part of major projects to achieve business change e.g. new computer
systems and services

High level risk and opportunity assessments will be reviewed on an annual basis or
upon significant change to the business or service provision.

A risk and opportunity assessment process will be used which is line with the
requirements and recommendations of ISO9001, the International Standard for
Quality Management Systems. This is documented in Risk and Opportunity
Assessment Process.

From this analysis, a risk and opportunity assessment report will be generated
followed by a plan in which appropriate actions will be identified to address these
risks and opportunities.

2.6 Human Resources

MASEL Tech will ensure that all staff involved in quality management are competent
on the basis of appropriate education, training, skills and experience.

The skills required will be determined and reviewed on a regular basis together with
an assessment of existing skill levels within MASEL Tech. Training needs will be
identified and a plan maintained to ensure that the necessary competencies are in
place.

Training, education and other relevant records will be kept by the HR Department to
document individual skill levels attained.

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2.7 Auditing and Review

Once in place, it is vital that regular reviews take place of how well quality
management processes and procedures are being adhered to. This will happen at
three levels:

1. Structured regular management review of conformity to policies and

procedures

2. Internal audit reviews against the ISO9001 standard (and accompanying

codes of practice) by the MASEL Tech Internal Audit Team

3. External audit against the standard by a Registered Certification Body (RCB)

in order to gain and maintain certification

Details of how internal audits will be carried out can be found in Procedure for
Internal Audits.

2.8 Documentation Structure and Policy

All quality management policies and plans must be documented. Details of

documentation conventions and standards are given in the Procedure for the Control
of Documented Information.

A number of core documents will be maintained as part of the QMS. They are
uniquely numbered and the current versions are tracked in the QMS Documentation
Log.

2.9 Control of Records

The keeping of records is a fundamental part of the QMS. Records are key
information resources and represent evidence that processes are being carried out
effectively.

The controls in place to manage records are defined in the document Procedure for
the Control of Documented Information.

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