QUALITY MANUAL

The Quality Manual is at the very heart of an organisation’s QMS and describes the interrelationships between:

 A process – an outline of its objective, scope and key performance indicators;

 Quality procedures (QPs) – an enlargement of the process explaining how it is controlled;

 Work instructions (WIs) – the ‘fine print’ required to perform a specific activity.

It is the main policy document that establishes the QMS and how it meets the requirements of ISO 9001:2008 – particularly the mandatory requirements for:

 Document control;

 Control of records;

 Internal auditing;

 Control of non-conforming product;

 Corrective action;

 Preventative action.

It provides general information on the system (i.e. objectives, goals, roles, organisation and responsibilities).

The Quality Manual (see example in Chapter 6) is the formal record of that organisation’s QMS (Fig. 4.7).

It:

 Is a rule book by which an organisation functions;

 Is a source of information from which the client may derive confidence;

 Provides consistent information, both internally and externally, about the organisation’s QMS;

TABLE 4.1 QMS Documentation Level 1 Quality

Manual

The main policy document that establishes the QMS and how it meets the requirements of ISO 9001:2008.

Level 2 Processes The Core Business Process plus Supporting Processes that describe the activities required to implement the QMS and to meet the policy requirements made in the Quality Manual.

Level 3 Quality procedures

A description of the method by which quality system activities are managed.

Level 4 Work instructions

A description of how a specific task is carried out.

 Is a means of defining the responsibilities and interrelated activities of every member of the organisation;

 Is a vehicle for auditing, reviewing and evaluating the organisation’s QMS.

The Quality Manual will identify the organisation’s business-critical processes and their associated QPs and WIs. The Quality Manual will also provide examples of the various forms and documentation used by the organisation – such as production control forms, inspection sheets and documents used to purchase components, systems and software from subcontractors.

For a complete description and guidance on how to develop a Quality Manual, the reader is referred to PD ISO/TR 10013:2001 ‘Guidelines for Developing Quality Management System Documentation’.

4.6 PROCESSES

Processes describe the activities required to implement the QMS and to meet the policy requirements set out in the Quality Manual.

Typically, the organisational processes making up a company’s QMS will normally comprise a Core Business Process supplemented by a number of supporting processes which describe the infrastructure required to produce the contract deliverable (or market opportunity) on time and within budget. The interaction of these processes are shown inTable 4.2.

Note: A process owner with full responsibility and authority for managing the process and achieving process objectives should be nominated. In many small businesses, one person might be responsible for a number of processes or even

Policy statement

Organisational structure

Quality Processes

Quality Procedures Work Instructions Quality Manual

FIGURE 4.7 Quality Manual

all of them (i.e. in the case of an extremely small business or a ‘one-man-band’

sort of organisation).

For each process, there will be an organisation document detailing:

 Objective – what the process aims to achieve;

 Scope – what the process covers;

 Responsible owner – who is ultimately responsible for implementing the process;

TABLE 4.2 Core Business and Supporting Processes

Core Business Process Which describes the end-to-end activities involved in producing a contract deliverable or marketing opportunity.

It commences with the definition of corporate policy and ends when the product is manufactured and marketed.

The Core Business Process is then supplemented by a number of supporting processes that describe the infrastructure required to manufacture (or supply) the product on time.

Note: All businesses revolve around taking inputs and putting them through a series of activities that turn them into useful outputs, be that a product or service.

These activities are the supporting processes.

Primary supporting processes

The basic set of activities which when combined into a logical sequence takes you from receipt of an order (or marketing opportunity) through to the realisation of the finished product or service.

Secondary supporting processes

The purpose of secondary supporting processes is to docu-ment those activities that are essential for supporting and achieving the primary supporting processes.

Secondary supporting processes will have an identical struc-ture to the primary supporting processes and will also have their own associated supporting documentation [e.g. Quality Procedures (QPs) and Work Instructions (WIs)].

Secondary supporting processes may include such things as:

 Identification and provision of suitable staff;

 Management and support of staff;

 Identification and provision of information;

 Identification and provision of materials;

 Identification and provision of equipment and facilities;

 Management of the QMS;

 Continual improvement.

 Policy – what the organisation intends to do to ensure that quality is controlled;

 Key performance indicators – those items of objective evidence that can be used as a way of monitoring performance of the process;

 Cross-reference to supporting system documentation (QPs and WIs).

All processes should be documented to give a complete picture of how to perform the activity to a consistent level of quality. The level of detail varies from:

 Process – an outline of its objective, scope and key performance indicators;

 QPs – an enlargement of the process explaining how it is controlled;

 WIs – the ‘fine print’ required to perform a specific activity.