The first four clauses (clause 0. Introduction to - clause 3. Terms and Definitions) do not provide any requirements for a QMS. They provide background information as to the purpose; concepts and principles used in the standard (e.g. process approach; PDCA); guidance on the QMS scope; reference to related documents; and key terms and definitions used. These clauses will all be explained in more detail as we go through each section.
The remaining five clauses numbering 4 through 8 provide the control requirements that a QMS must implement. The following is a summary explanation of these 5 major clauses or elements of the ISO 9001:20000 standard. Each major clause has several sub-clauses. Collectively, these 5 clauses set out the requirements for your QMS.
Clause 4- Quality Management System - sets requirements to identify, plan, document, operate and control QMS processes and to continually improve QMS effectiveness.
Clause 5- Management Responsibility - sets requirements for top management to demonstrate its leadership and commitment to develop, implement and continually improve the QMS.
Clause 6- Resource Management - sets requirements to determine, provide and control the various resources needed to operate and manage QMS processes; to continually improve QMS effectiveness; and to enhance customer satisfaction by meeting customer requirements.
Clause 7- Product Realization - sets requirements to plan, operate and control the specific QMS processes that determine, design, produce and deliver an organization’s product and services.
Clause 8- Measurement, Analysis and Improvement - sets requirements to plan, measure, analyze and improve processes that demonstrate product and QMS conformity and continually improve QMS effectiveness.
The overall objective of your QMS must be to enhance customer satisfaction by meeting their requirements. This objective can be achieved by using the ISO 9001 requirements to control your QMS processes and by continually improving QMS effectiveness.
No comments:
Post a Comment