QUALITY MANAGEMENT SYSTEMS

Introduction
An organisation will benefit from establishing an effective quality management system (QMS). The
cornerstone of a quality organisation is the concept of the customer and supplier working together for their mutual benefit. For this to become effective, the customer-supplier interfaces must extend into, and
outside of, the organisation, beyond the immediate customers and suppliers.

A QMS can be defined as:
“A set of co-ordinated activities to direct and control an organisation in order to continually improve the effectiveness and efficiency of its performance.”

These activities interact and are affected by being in the system, so the isolation and study of each one in detail will not necessarily lead to an understanding of the system as a whole. The main thrust of a QMS is in defining the processes, which will result in the production of quality products and services, rather than in detecting defective products or services after they have been produced.

The benefits of a QMS

A fully documented QMS will ensure that two important requirements are met:

•  The customers’ requirements - confidence in the ability of the organisation to deliver the desired
     product and service consistently meeting their needs and expectations.
•  The organisation’s requirements - both internally and externally, and at an optimum cost with efficient
     use of the available resources - materials, human, technology and information.

These requirements can only be truly met if objective evidence is provided, in the form of information and data, to support the system activities, from the ultimate supplier to the ultimate customer.

A QMS enables an organisation to achieve the goals and objectives set out in its policy and strategy. It
provides consistency and satisfaction in terms of methods, materials, equipment, etc, and interacts with all activities of the organisation, beginning with the identification of customer requirements and ending with their satisfaction, at every transaction interface.

It can be envisaged as a “wedge” that both holds the gains achieved along the quality journey, and prevents good practices from slipping:

Management systems are needed in all areas of activity, whether large or small businesses, manufacturing, service or public sector. A good QMS will:

•  Set direction and meet customers’ expectations
•  Improve process control
•  Reduce wastage
•  Lower costs
•  Increase market share
•  Facilitate training
•  Involve staff
•  Raise morale

In a survey conducted by the Defence Evaluation Research Agency (DERA), ca.96% of respondents said they believed their system contributed to meeting the business goals. However, ca.72% responded that their organisation did not measure this contribution.

International Organization for Standardization (ISO)
ISO is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing
International Standards is carried out through ISO technical committees, in liaison with international
organisations, governmental and non-governmental bodies. ISO’s most recent family of standards for quality management systems are currently in their final draft (FDIS) form, and comprises:

•   ISO/FDIS 9000:2000 - Quality management systems - Fundamentals   and vocabulary
•   ISO/FDIS 9001:2000 - Quality management systems - Requirements
•   ISO/FDIS 9004:2000 - Guidelines for performance improvement

It is expected that they will be issued as an ISO in December 2000 or January 2001. If these vary from the FDIS version, changes will be made to this website.

They are built around business processes, with a strong emphasis on improvement and a focus on meeting the needs of customers. The new standards originated from a regular six year review and are intended to be generic and adaptable to all kinds of organisations.

The ISO 9002 and ISO 9003 are to be discontinued (but can still be used by those organisations certified against them during the three year transition period), and ISO 9001and ISO 9004 are designed to be used together, but can be used independently.

The ISO Series can form the means by which a holistic management system can be implemented, into
which quality, health and safety and environmental responsibility can be integrated, with the audits carried out either separately or in combination.

The ISO Standard is also now more closely aligned with the requirements of the EFQM Excellence Model®.

ISO 9001
ISO 9001 specifies the requirements for a QMS that may be used by organisations for internal application, certification or contractual purposes.

The process approach is shown in the conceptual model from the ISO 9001 Standard, recognising that
customers play a significant role in defining requirements as inputs, and monitoring of customer
satisfaction is necessary to evaluate and validate whether customer requirements have been met.

The major clauses and sub-clause are:

•   Scope
•   Normative reference
•   Terms and definitions
•   Quality management system
General requirements
Documentation requirements
•   Management responsibility
Management commitment
Customer focus
Quality policy
Planning
Responsibility, authority and communication
Management review
•   Resource management
Provision of resources
Human resources
Infrastructure
Work environment

•   Product realisation
Planning of product realisation
Customer-related processes
Design and/or development
Purchasing
Production and service operations
Control of measuring and monitoring devices

•   Measurement, analysis and improvement
General
Planning
Monitoring and measurement
Control of non-conforming product
Analysis of data
Improvement

The management system requirements under these clauses are specified in more detail in the ISO 9001 Standard.