ISO 9001:2008 Quality Management Systems - Contents of ISO 9001

Xmultiple has ISO 9001:2008 in all of our manufacturing plants in China and Taiwan. The ISO 9000 family of standards relate to quality management systems and are designed to help organizations ensure they meet the needs of customers. The standards are published by ISO, the International Organization for Standardization and available through National standards bodieS Contents fo ISO 9001:2008 Level I: The pyramid is topped by the single, overarching Quality Manual and Quality Policy that guides the organization in all decisions. Level II: The Quality Manual defines general guidelines for completing particular tasks and Documented Procedures. Level III: Work Instructions define precisely how to complete a specific task. Level IV: Records and forms are the base of the Quality Management System showing compliance to the International standard and Customer specification. 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. Outline contents are as follows:. Page IV: Foreword Pages V to VII: Section 0- Intro Pages 1 to 14: Requirements Section 1: Scope Section 2: Normative Reference Section 3: Terms and definitions (specific to ISO 9001, not specified in ISO 9000) Section 4: Quality Management System, The general requirements for a quality management system are defined in clause 4.1 of ISO9001:2008. Section 5: Management Responsibility Section 6: Resource Management Section 7: Product Realization 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). Auditing Two types of auditing are required to become registered to the standard: auditing by an external certification body (external audit) and audits by internal staff trained for this process (internal audits). The aim is a continual process of review and assessment, to verify that the system is working as it's supposed to, find out where it can improve and to correct or prevent problems identified.