Quality management systems - Requirements
ISO 9001:2008 Quality management systems — Requirements is a document of approximately 30 pages which is available from the national standards organization in each country. It is supplemented by two other standards, ISO 9000:2005 Quality management systems — Fundamentals and vocabulary and ISO 9004:2009 Managing for the sustained success of an organization — A quality management approach, which do not contain specific requirements and are not used directly in certification. Outline contents for ISO 9001 are as follows:
* Page iv: Foreword
* Pages v to vii: Section 0 Intro
* Pages 1 to 14: Requirements
o Section 1: Scope
o Section 2: Normative Reference
o Section 3: Terms and definitions (specific to ISO 9001, not specified in ISO 9000)
* Pages 2 to 14 132 1
o Section 4: Quality Management System
o Section 5: Management Responsibility
o Section 6: Resource Management
o Section 7: Product Realization o Section 8: Measurement, analysis and improvement
In effect, users need to address all sections 1 to 8, but only 4 to 8 need implementing within a QMS.
* Pages 15 to 22: Tables of Correspondence between ISO 9001 and other standards
* Page 23: Bibliography
The standard specifies six compulsory documents:
* Control of Documents (4.2.3)
* Control of Records (4.2.4)
* Internal Audits (8.2.2)
* Control of Nonconforming Product / Service (8.3)
* Corrective Action (8.5.2)
* Preventive Action (8.5.3)
In addition to these, ISO 9001:2008 requires a quality policy and Quality Manual (which may or may not include the above documents).
Summary of ISO 9001:2008 in informal language
* The quality policy is a formal statement from management, closely linked to the business and marketing plan and to customer needs.
* The quality policy is understood and followed at all levels and by all employees. Each employee works towards measurable objectives.
* The business makes decisions about the quality system based on recorded data.
* The quality system is regularly audited and evaluated for conformance and effectiveness.
* Records show how and where raw materials and products were processed to allow products and problems to be traced to the source.
* The business determines customer requirements.
* The business has created systems for communicating with customers about product information, inquiries, contracts, orders, feedback, and complaints.
* When developing new products, the business plans the stages of development, with appropriate testing at each stage. It tests and documents whether the product meets design requirements, regulatory requirements, and user needs.
* The business regularly reviews performance through internal audits and meetings. The business determines whether the quality system is working and what improvements can be made. It has a documented procedure for internal audits.
* The business deals with past problems and potential problems. It keeps records of these activities and the resulting decisions, and monitors their effectiveness.
* The business has documented procedures for dealing with actual and potential nonconformances (problems involving suppliers, customers, or internal problems).
* The business (1) makes sure no one uses bad product, (2) determines what to do with bad product, (3) deals with the root cause of problems, and (4) keeps records to use as a tool to improve the system.