ISO9001-interpretations.pdf

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.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 formal 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 addresses 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 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 customer 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 1,2002 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 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 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 and 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 clauses 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 Rheinland 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 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 created 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 scale 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 understanding 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/Interpretation/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 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 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 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;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 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 and 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 management 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 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.In addition,the Quality Manual must be documented.However,clause 4.2.1(d)requires“documents needed by the organization to ensure the effective planning,operation,and control of its processes”.The organization may choose to include documentation as one means of assuring effective planning,operation,and control of its quality management system processes.In addition,documents required by statutory and regulatory requirements will also be required.(C)The organization should consider Note 1 in 4.2.1.The phrase“documented procedure”means the procedure is established,documented,implemented,and maintained.TUV Rheinland of North America ISO9001:2000 Interpretations Element Standard/Section/Interpretation/Comments January 1,2002 Page 6 of 18 4.2.2 4.2.3 4.2.4 Quality Manual (I)Exclusions and justifications claimed under clause 1.2 must be documented in the quality manual.(C)The document“Guidelines for Developing Quality Manuals”may prove useful in developing a quality manual.Control of Documents (I)The ISO9001:2000 standard specifically requires the following documents:1.Quality Manual(4.2.1 b)2.Procedure for Control of Documents(4.2.3)3.Procedure for Control of Records(4.2.4)4.Procedure for Internal Audits(8.2.2)5.Procedure for Control of Nonconforming Product(8.3)6.Procedure for Corrective Action(8.5.2)7.Procedure for Preventive Action(8.5.3)(I)Other than the reduced number of required documents,there is no substantive difference in document control requirements between ISO9001:1994 and ISO9001:2000.(I)The ISO9001:2000 standard specifically requires the following records:1.Records of management review(5.6.1)2.Records of education,training,skills,and experience(6.2.2 e)3.Records of product realization processes and product(7.1 d)4.Records of product requirements review and actions(7.2.2)5.Records of product requirements inputs(7.3.2)6.Records of design reviews and actions(7.3.4)7.Records of design verification and actions(7.3.5)8.Records of design validation and actions(7.3.6)9.Records of design changes(7.3.7)10.Records of design change reviews(7.3.7)11.Records of supplier evaluation and actions(7.4.1)12.Records of process validation(7.5.2)TUV Rheinland of North America ISO9001:2000 Interpretations Element Standard/Section/Interpretation/Comments January 1,2002 Page 7 of 18 5 5.1 5.2 13.Records of traceability(7.5.3)14.Records of customer notification regarding damage to customer property(7.5.4)15.Records of production or service delivery,as determined to be necessary for special processes(7.5.2)16.Records of calibration or verification where no national or international standards exist(7.6 a)17.Records of review of previous measuring results when measuring equipment is found not to conform to requirements(7.6)18.Records of calibration or verification(7.6)19.Records of internal audits(8.2.2)20.Records of product release authorization(8.2.4)21.Records of nonconformities and actions taken(8.3)22.Records of corrective actions taken(8.5.2 e)23.Records of preventive action taken(8.5.3 d)(C)Note that this list only identifies the records specifically required by ISO9001:2000.H owever,clause 4.2.4 states“Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system”.The organization will have to carefully consider how it will demonstrate the effective operation of those elements(for example,7.3.1)of the quality management system where there is no stated requirement for records.Management Responsibility Management Commitment (I)Note that clause 5.1,is inclusive.The evidence of management commitment is the collective weight of all listed items.Customer Focus (I)Note that the language of this clause emphasizes the goal of enhancing customer satisfaction.A quality management system that includes all required elements,documentation,and records,yet fails to demonstrate customer satisfaction does not comply with the TUV Rheinland of North America ISO9001:2000 Interpretations Element Standard/Section/Interpretation/Comments January 1,2002 Page 8 of 18 5.3 5.4 5.4.1 5.4.2 requirements of ISO9001:2000.Quality Policy (I)The requirement to review the quality policy for continuing suitability is new.The ISO9001:1994 standard required review of the quality management system for its continuing suitability and effectiveness in achieving the requirements of the standard,the policy,and the objectives.In the ISO9001:2000 standard,these requirements are retained,and the requirement to include a review of the policy statement itself to ensure its continuing suitability for the organization is added.In clause 5.6.1,this requirement is restated to include this review as part of the management review process.Planning Quality Objectives (I)Regarding the requirement that“quality objectives are established at all relevant functions and levels within the organization”,a quality objective must be understood in all organizational units that contribute to the achievement of that objective.All personnel in an organization must be aware of the overall organizational quality objectives to which their work contributes,and,per 6.2.2 d,how their work contributes to the achievement of those objectives.Quality Management System Planning (I)The requirement to maintain the integrity of the quality management system during the planning and implementation of changes means that quality management system activities must continue during such changes,including changes of personnel.(C)TUV Rheinland recommends the appointment of deputies for all key positions,including that of management representative.TUV Rheinland of North America ISO9001:2000 Interpretations Element Standard/Section/Interpretation/Comments January 1,2002 Page 9 of 18 5.5 5.5.1 5.5.2 5.5.3 5.6 5.6.1 5.6.2 5.6.3 Responsibility,Authority,and Communication Responsibility and Authority (I)The responsibilities assigned to top management cannot be delegated.Management Representative (I)The ISO9001:2000 standard adds the requirement that the management representative“ensure the promotion of awareness of customer requirements throughout the organization”.Per ISO9000:2000 3.3.5,and 3.4.2,this will mean that all personnel in an organization must be aware of not only their immediate customer,typically internal,but also the end customer.Internal Communication Management Review General (I)Other than specifying particular inputs and outputs,and adding the requirement to review the quality policy statement for continuing suitability(5.3),the management review process required by the ISO9001:2000 standard is not fundamentally different from the ISO9001:1994 standard.Review Input Review Output (C)TUV Rheinland recommends that the record of management review include an explicit concluding statement regarding the effectiveness of the quality management system.TUV Rheinland of North America ISO9001:2000 Interpretations Element Standard/Section/Interpretation/Comments January 1,2002 Page 10 of 18 6 6.1 6.2 6.2.1 6.2.2 6.3 Resource management Provision of Resources (I)This clause of the standard does not require that management necessarily provide all requested resources.Management may choose to revise the requirements of the quality management system to be more in line with the practical realities of the business.However,in all events,the quality management system must demonstrate the effective maintenance and continual improvement of the quality management system,and enhancement