1. Quality Management Systems (QMS)
On completion of this session, you must:   Understand the concept of quality Understand 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  

2. Strategic Quality Planning The Tools of Quality Improving the System
Quality System Model

3. QMS
Quality Manual
Policy
Procedures
Work Instructions
Documentation

4. 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

5. Include statement of organization policy toward quality control
Contain details of a management structure, organization,job description and responsibilities
Requirements, training programme
Procedures, work instructions
Copies of all documents eg inspection sheets, purchase forms etc

6. 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

7. 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

8. 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

9. 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

10. 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

11. Latest ISO Standards