On completion of this session, you must:

Understand the concept of qualityUnderstand the importance of satisfying customer requirements

Be familiar with the documentation required to support a Quality Management System (QMS)Be able to develop documentation relevant to QMS

Quality Management Systems (QMS)

10- 2

Strategic Quality PlanningThe Tools of Quality Improving the System

Quality System

Model

QMS

Quality Manual

Policy

Procedures

Work Instructions

Documentation

Quality Manual

• A document specifying the quality management system of an organization (ISO Standards)

• Rule book for organization to function by source of information

• Means of definition responsibility and interrelated activities

• Defines level of quality

• Vehicle for auditing, reviewing and evaluating QMS

• Include statement of organization policy toward quality control

• Contain details of a management structure, organization,jobdescription and responsibilities

• Requirements, training programme

• Procedures, work instructions

• Copies of all documents eg inspection sheets, purchase forms etc

Quality Policy

• The overall intentions and directions of an organization related to quality as formally expressed by top management (ISO 9000)

• Clear statement of intent for each activity.

• Must be:

• The appropriate

• Involve everybody

• Out line organizational goals and objectives

• Communicated and implemented

• Understood by all

Quality Policy cont……

• The basic documentation used for the overall planning and administration of activities which impact on quality

• What has to be carried out?

• Clear concise• Must include:

• basic documents – plan and control all activities

• details how policy is to be implemented

• cover all elements of ISO and detail special aspects of organization

• relatively constant

• easily accessible

• must be able to be tracked back to the quality policy

• not include technical info

• filed in separated manual

• layout must be consistent

Quality Procedures Include:

• Document data

• Distribution list

• Amendments

• Contents

• List of annexures

• List of tables/illustrations

• Abbreviations 2 acronyms

• Terminology – explanation

• References

• Scope and objective

• Procedure overview and procedure

• Responsibilities

• Relevant forms

•

Work Instruction

• Provides details to carry out specific job in an exact manner to a predetermined standard• Tells you:

• What has to be done

• Who should do it

• When it should be done

• What supplies and services and equipment

• What criteria need to be satisfied

• Regularly reviewed for

• continuing acceptability

• Validity

• Effectiveness

What goes into a Work Instruction?

• Document data sheet - who wrote. When approved etc.

• Distribution list

• Amendments

• Contents list

• List of annexures

• List of illustrations, tables

• Abbreviations and acronyms

• Terminology

• References

• Scope and objectives

• Procedure – safety, production, installation

• Responsibility – who can carry out process

• Relevant forms

Latest ISO Standards