ISO9001-interpretations.pdf
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1、TUV Rheinland of North America ISO9001:2000 Interpretations Element Standard/Section/Interpretation/Comments January 1,2002 Page 1 of 18 0.1 0.2 Introduction This document sets forth the formal TUV Rheinland of North America,Inc.interpretations of the ISO9001:2000 quality management system standard.
2、In addition,comments and references are included to provide information that may be of use to organizations seeking to implement a quality management system that meets the requirements of ISO9001:2000.Formal interpretations of ISO9001:2000 are identified as(I).TUV Rheinland will audit against the fo
3、rmal interpretations.Comments are identified as(C).All clauses and sub clauses of ISO9001:2000 are included for consistency.ISO9001:2000 Introduction General (C)The benefits of ISO9001:2000 are most effectively realized through the development of a comprehensive quality management system that addres
4、ses the activities of the entire organization,while emphasizing the eight quality management principles.However,there is no single best way to comply with the requirements of the ISO9001:2000 standard.Organizations are encouraged to find the approach that works best for them.Process Approach (C)The
5、document“Guidance on the Process Approach to Quality Management Systems”provides an introduction and description of the process approach to management.(C)The dynamic nature of the system represented by the diagram in Figure 1 should be carefully considered.The diagram is intended to represent a cust
6、omer focused,continually improving organization that routinely reviews and improves all aspects of its activities and processes on an ongoing basis,as a matter of routine business.TUV Rheinland of North America ISO9001:2000 Interpretations Element Standard/Section/Interpretation/Comments January 1,2
7、002 Page 2 of 18 0.3 0.4 1 1.1 1.2 Relationship with ISO9004 (C)The concepts and principles defined in ISO9004:2000 should be reviewed for opportunities for improvement in all aspects of the organization.Compatibility with other management systems (C)Where other management systems are implemented in
8、 addition to ISO9001:2000,TUV Rheinland recommends integration of all management system requirements into a single set of requirements.This approach will reduce or eliminate duplication of effort and reflect a more consistent approach on the part of management.Quality Management Systems Requirements
9、 Scope General (C)Note that the intent of the ISO9001:2000 now addresses internal benefits,as well as the need to demonstrate ability to meet requirements(as compared to ISO9001:1994).Application (C)The document“Guidance on ISO9001:2000 clause 1.2 Application”provides guidance on the consideration a
10、nd justification of exclusions.Exclusions are claims and their justifications that certain clauses of the ISO9001:2000 standard cannot be applied due to the nature of the organization and its product.(C)As a practical matter,it is likely that only parts or all of the following clauses and sub clause
11、s can be excluded:1.7.3 2.7.4.3 3.7.5.3 4.7.5.4 TUV Rheinland of North America ISO9001:2000 Interpretations Element Standard/Section/Interpretation/Comments January 1,2002 Page 3 of 18 2 5.7.5.5 6.7.6 However,the organization should not hesitate to claim and justify a valid exclusion.(I)TUV Rheinlan
12、d will review exclusions claimed by the organization at the document review stage,and at subsequent visits to ensure that the justifications remains valid.(I)Organizations previously registered to ISO9002:1994 should not assume that clause 7.3 can be excluded.There are subtle distinctions to be made
13、 between the design of a product and the development of a product.This point is made in ISO9001:1994 at clause 4.9(e),but the qualification“As appropriate”reduces the emphasis.The point is more forcefully made in ISO9001:2000.The development of a product may involve changes to the process that creat
14、ed the accepted design.The requirement in 7.5.2 to validate a process may require application of the requirements of clause 7.3 to ensure that the product resulting from the changed process is still acceptable to the customer.For example,a new chemical product created in a laboratory may require sca
15、le up in the production area to ensure commercial feasibility.In this or similar circumstances,exclusion of clause 7.3 is not justified.Normative Reference (C)TUV Rheinland strongly recommends the customer review and familiarize themselves with ISO9000:2000 in order to gain a more complete understan
16、ding of the intent and principles of the year 2000 revisions of the ISO9000 series of standards.The document“Guidance on the Terminology Used in ISO9001:2000 and ISO9004:2000”may be useful in this regard.TUV Rheinland of North America ISO9001:2000 Interpretations Element Standard/Section/Interpretat
17、ion/Comments January 1,2002 Page 4 of 18 3 4 4.1 Terms and Definitions (I)It is important that the meaning of the term“product”be properly understood.The term“product”as used in the ISO9000:2000 series of quality management system standards,refers to the deliverable prepared by the organization for
18、the customer,as defined or agreed by the customer.Where the term“product”is used,it can mean a physical product,a service,a piece of software,information,etc.Quality Management System General Requirements (I)Process Management(4.1 a-f)TUV Rheinland recognizes that there may be many different ways to
19、 meet the requirements of this clause.This clause does NOT require a formal,comprehensive exercise in process mapping,although such an approach can be very useful.Other more traditional ways of meeting the requirements of this clause could include the use of organization charts,job descriptions,and
20、documented procedures and work instructions,either alone or in combination.However the organization chooses to address this clause,the following elements must be explicitly documented:1.the quality management system processes,including:a)inputs;b)outputs;c)activities;d)responsibilities;e)authorities
21、;f)records;2.the sequence and interaction of these processes(see 4.2.2 c);3.the quality objectives that indicate whether or not the processes are meeting their requirements(see 5.4.1);TUV Rheinland of North America ISO9001:2000 Interpretations Element Standard/Section/Interpretation/Comments January
22、 1,2002 Page 5 of 18 4.2 4.2.1 4.evidence of review and,where necessary,corrective action to ensure effective operation of the process.(I)Outsource There is an important distinction between an excluded clause and an outsourced clause of ISO9001:2000.A clause that does not apply to the organization a
23、nd its products can be excluded under 1.2.A clause that is performed by an external party on behalf of the organization,and whose activities affect the organizations ability or responsibility to provide product that meets customer requirements is outsourced,and must be addressed by the quality manag
24、ement system.Under these circumstances,the quality management system must identify the controls that ensure that the requirements of the standard that are achieved by the activities of the external party are met.Documentation Requirements (C)The document“Guidance on the Documentation Requirements of
25、 ISO9001:2000”may prove useful in developing documentation.General (C)Much has been said about the reduced documentation requirements of the ISO9001:2000 standard.TUV Rheinland agrees that there will likely be less documentation.There are only 6 places where the phrase“documented procedure”is found.
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