Diferencias entre iso 13485 y 9001

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Summary of Unique ISO/TS 16949:2009 Requirements
This document summarizes the additional ISO/TS 16949:2009 requirements, beyond those included from ISO 9001:2008. ISO 9001:2008 clauses and titles are boxed to set them off from the ISO/TS 16949:2009 requirements. The ISO 9001:2008 requirements are not included in this summary. 4. Quality Management System 4.1 General Requirements 4.1.1 GeneralRequirements – Supplemental Ensure the control over outsourced processes does not absolve the organization of its responsibility to conform to all customer requirements. Note: See also 7.4.1 and 4.2 Documentation Requirements 4.2.1 General 4.2.2 Quality Manual 4.2.3 Control of Documents Engineering Specifications The organization must have a process to assure the timely review,distribution, and implementation of all customer standards, specifications, and changes based on the customer-required schedule. A “timely review” is as soon as possible and must not exceed two work weeks. The organization must keep a record of the date on which each change was implemented in production. Implementation must include updated documents. Note: A change requires an updated record ofcustomer production part approval when the specifications are referenced in the design record, or if they affect PPAP documents. 4.2.4 Control of Records Note 1: The disposition of records includes their disposal. Note 2: Records to be controlled include customer-specified records. Records Retention Control of records must satisfy statutory, regulatory, and customer requirements.

© 2009Whittington & Associates

Page 1 of 22

July 2009

Summary of Unique ISO/TS 16949:2009 Requirements
5. Management Responsibility 5.1 Management Commitment 5.1.1 Process Efficiency Top management must review the product realization and support processes to assure their effectiveness and efficiency. 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning 5.4.1 Quality Objectives QualityObjectives – Supplemental Top management must define the quality objectives and measurements to be included in the business plan and used to deploy the quality policy. Note: Quality objectives should address customer expectations and be achievable within a defined timeframe. 5.4.2 Quality Management System Planning 5.5 Responsibility, Authority, and Communication 5.5.1 Responsibility and Authority5.5.1.1 Responsibility for Quality Managers with responsibility and authority for corrective action must be promptly informed of products or processes that do not conform to requirements. Personnel responsible for conformity to product requirements must have the authority to stop production to correct quality problems. Production operations across all shifts must be staffed with personnel in charge of,or delegated responsibility for, ensuring conformity to product requirements.

© 2009 Whittington & Associates

Page 2 of 22

July 2009

Summary of Unique ISO/TS 16949:2009 Requirements
5.5.2 Management Representative Customer Representative Top management must designate personnel with responsibility and authority to ensure customer requirements are addressed. This includesselection of special characteristics, setting quality objectives, and related training, corrective and preventive actions, and product design and development. 5.5.3 Internal Communication 5.6 Management Review 5.6.1 General Quality Management System Performance These reviews must include all the requirements of the quality management system and its performance trends as an essential part ofthe continual improvement process. Part of the management review must be the monitoring of quality objectives, and the regular reporting and evaluation of the cost of poor quality (see 8.4.1 and 8.5.1). These results must be recorded to provide, at a minimum, evidence of achievement of the quality objectives in the business plan and customer satisfaction with supplied products. 5.6.2 Review Input...
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