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  

Strategic Quality Planning The 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,job description 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