Quality management system, requirements

The International Standard, ISO 9001 2000, Quality Management Systems -Requirements, is a general standard that applies to all types of organizations,... 

Quality Management Systems - Requirements , ISO 9001 2000, International Organization for Standardization (ISO), Geneva, Switzerland, 2000. 

The laboratoiy quality manual is a document addressing the quality management system requirements and shall... 

The monitoring of the laboratory performance is required to demonstrate that the laboratory product conforms to the specified requirements and that the laboratory activity conforms to the quality management system requirements. Moreover, there is a need and it is a requirement that the laboratory continually improves the effectiveness of the quality management system. 

The management system requirements In ISO/IEC 17025 2005 (Section 4) are written in language relevant to laboratory operations and meet the principles of ISO 9001 2000 Quality management systems -Requirements and are aligned with its pertinent requirements . 

American National Standards Institute (ANSI) (2000), Quality management system— Requirements, ANSI/ISO/ASQ Q9001-2000, ANSI, New York. 

ISO (2000), Quality management systems—Requirements, 9001 3rd ed. (Geneva International Organization for Standardization). 

Fraser CG, Kallner A, Kenny D, Peterson PH (1999) Strategies to set global analytical quality applications in laboratory medicine. Scand J Clin Lab Invest 59 477-478 IS09001 2000 Quality management systems - Requirements. International Organization for Standardization (ISO), 1, Rue de Varentie, Case Postals 56, CH-2111 Geneva 20, Switzerland... 

Requirements for the qualification of personnel and quality management system requirements... 

Conforms to the planned arrangements (see 7.1), the requirements of the international standards, and the quality management system requirements established by the organization... 

ISO 9001 1994, Quality System — Model for Quality Assurance in Design, Development, Production, Installation, and Servicing ISO 9001 2000, Quality Management System Requirements. Design, Manufacture, and Final Product Inspection and Testing. 

Documentation plays an important role in the effective control and implementation of quality management system requirements. The quality policy, objective, and applicable procedures ensure to meet ... 

The quality-related material requisitions are raised with material specification, describing code number, and subjective and quantitative details. Purchasing information describes the product to be purchased, including, where appropriate, requirements for approval of product, procedures, processes and equipment, requirements for qualification of personnel, and quality management system requirements. 

The pharmaceutical manufacturer s quality management system requirements are met at all stages of the project. 

Quality Management Systems Requirements (ISO 9001 2000) European Committee for Standardization Brussels, Belgium, 2000. 

International Standards Organization, ISO 9001 2008, Quality Management Systems—Requirements, Geneva, 2008. 

ISO 9000 2000, Quality Management Systems—Fundamentals and Vocabulary ISO 9001 2000, Quality Management Systems—Requirements... 

ANSI/ISO/ASQ Q9001-2000, American National Standard, Quality management systems—Requirements. Milwaukee American Society for Quality, 2000. 

International Organization for Standardization. ISO 13485 2003. Medical devices - quality management systems - requirements for regulatory purposes. 2003. 

Consequently, BBS misses the mark (much like quality programs did in the 1970s). A quality management system requires that management act on the system, not the workers, in order to solve quality problems. Quality management theory recognizes that output problems are built into the system. The same is true of safety. Most quality and safety problems are not created by individual employees [p. 39]. 

Duffuaa, S., Raouf, A. Dixon Campbell, J. 2000. Sistemas de mantenimiento. Planeacidny control. Mexico Limusa. EN 9001 2008 Quality management systems. Requirements. European Standard. CEN (European Committee for Standardization), Bmssels. 

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