TRANSITION PLANNING GUIDANCE for ISO/FDIS 9001:2000

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1 CONTENTS 1.0 INTRODUCTION 2.0 EXPLANATION OF TRANSITION PERIOD 2.1 Pre-publication period Phase One 2.2 Co-existence period Phase Two Duration of Phase ISO/TC 176 IAF ISO/CASCO 2.3 Definitions of User Groups affected by the Transition Periods Current Users Users Users of Industry Sector Schemes and Awards Schemes Transitional / Intermediate Users New Users 3.0 TRANSITION GUIDELINES FOR USER GROUPS 3.1 Current Users Organizations Industry Sector Schemes and Quality Awards National Standards Bodies Accreditation Bodies Certification/Registration Bodies Training Bodies and Consultants 3.2 Transitional / Intermediate Users 3.3 New Users 4.0 AUTHENTICITY OF INFORMATION REGARDING ISO 9001: SUMMARISED COMPARISON OF KEY ENHANCEMENTS BETWEEN ISO 9001:1994 / ISO 9001: Requirements correlation table 6.2 Applicability 6.3 Correspondence between ISO/FDIS 9001:2000 and ISO 9001: Summarised analysis of key enhancements 2

2 1.0 INTRODUCTION Several of the key standards within the current ISO 9000 family of Quality Management and Quality Assurance standards are being revised to form the core of the future year 2000 ISO 9000 family of standards. These revisions will include: The merging of ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994 into a single ISO 9001:2000 standard. The merging of ISO 8402 and part of the content of ISO into a new ISO 9000:2000 standard. The revision of ISO into a new ISO 9004:2000 standard. The merger of ISO (Parts 1, 2 and 3) with ISO 14010, ISO and ISO into a new guidelines standard for quality and environmental management system auditing (to be numbered ISO 19011). The other 20 or so documents within the current ISO 9000 family of standards are also being formally reviewed by ISO Technical Committee ISO/TC 176, to determine whether they should be revised, amended, or withdrawn from the ISO 9000 family etc., in light of the above revisions. Following extensive consultation with users of the current ISO 9000 standards, a number of significant changes have been incorporated in the new drafts, particularly concerning their underlying concepts and structures. In summary, these changes will require users to approach quality management systems as a series of processes, and not merely follow, for example, the 20 element discrete quality management system structure given in ISO 9001:1994. This process management approach is widely used in today s business world, and has led to the development of a process-based structure for the future standards. This new process-based structure is compatible with the Plan-Do-Check-Act improvement cycle used in the ISO family of standards on environmental management systems. This Transition Planning Guidance has been developed to assist users in understanding the issues that need to be considered during the transition from using ISO 9001:1994, ISO 9002:1994, or ISO 9003:1994 to ISO 9001:2000. In detailing the Transition Planning Guidance it has been found useful to provide specific guidance to distinct User Groups, as follows: Current Users Transitional / Intermediate Users New Users 3

3 2.0 EXPLANATION OF TRANSITION PERIOD The Transition Period has two distinct phases: a) Phase One This relates to the period when ISO 9001:2000 is being developed, until the issue of the approved International Standard. The following development stages are included in Phase one: CD1 (completed): The First Committee Draft (released for comment) CD2 (completed): The Second Committee Draft (released for comment / ballot) DIS (completed): Draft International Standard (released for comment / ballot) FDIS (started Sep 00): Final Draft International Standard (for ballot) Although the approved International Standard is not expected to be published until December 2000, some user groups have already commenced, or will commence, implementation of ISO 9001:2000 based on the CD1, CD2, DIS or FDIS drafts. b) Phase Two This is the period after ISO 9001:2000 has been published, and during which accredited certification/registration to the 1994 editions of ISO 9001, ISO 9002, or ISO 9003 continues to be available, in addition to accredited certification/registration to ISO 9001:2000. The above phases and their relationship with various user groups are illustrated in the Transition Process Model (see Figure 1). 2.1 Pre-publication period - Phase One This phase has a direct impact on user groups that have already implemented ISO 9001:1994, ISO 9002:1994, ISO 9003:1994 or ISO 9004:1994 regardless of whether they have sought certification/registration (see annex A, items 1 and 3). It is expected that the following user groups will be affected during this phase: Individual organizations using ISO 9001/9002/9003 (including industry associations) Industry Sector Schemes and Award Schemes National Standards Bodies (NSBs) Accreditation Bodies(ABs) Certification/Registration Bodies(CB/RBs) Trainers and Consultants 4

4 2.2 Co-existence period - Phase Two Duration of Phase 2 This phase concerns the co-existence of the availability of accredited certification to the1994 editions of ISO 9001, ISO 9002, or ISO 9003 and to ISO 9001:2000. The same user groups identified in 2.1 will be affected. This phase will only last for a specific period, during which users will have to upgrade their quality management systems to meet the requirements of ISO 9001:2000. In acknowledgement of Certification/Registration Body interests and the contractual issues relevant to certification/registration in various countries, it is highly recommended that users contact their Certification/Registration Body, or relevant Accreditation Body, for advice regarding the details or time frame for implementing ISO 9001:2000. This is particularly important when their certificate is subject to expiration based on a periodic audit ISO/TC 176 IAF ISO/CASCO In September 1999 a joint meeting was held between the International Accreditation Forum (IAF), ISO/TC176 and ISO/CASCO (ISO Committee for conformity assessment), to establish common and consistent messages to ensure a smooth transition to the new standards. As a result of this meeting, a joint communiqué was issued detailing five specific points concerning the transition to ISO 9001:2000. A copy of this communiqué is given in Annex A. Further guidance will be made available regarding the Application (Clause 1.2 of ISO 9001:2000), and the implications for Scope Statements for certification purposes, from web site One of the five points specifies a maximum period of three years for the co-existence of accredited certification to the 1994 and year 2000 editions of ISO 9001(see Annex A, items 1 to 3). The IAF will co-ordinate enforcement of this policy by the Accreditation Bodies. ISO/CASCO has also been requested to determine how the current guidelines (ISO/IEC Guide 61 and ISO/IEC Guide 62) that are followed by Certification/Registration and Accreditation Bodies are affected by the new ISO 9001:2000. ISO/CASCO will liaise with ISO/TC176 and the IAF during revisions of these Guides. 5

5 National Standardisation Bodies Accreditation Bodies Certification Bodies Trainers ISO 9001: 1994 to ISO 9001: 2000 Transition Model ISO co-existence End of 1999 CD2 DIS FDIS New Standard Transition Accreditation Update Transition End of 2000 End of 2001 End of 2003 Translation International Standard Adoption National Standards Released ISO 9001: 2000 Certification Auditor upgrade Certified Organisations Certification Update Transition Sector Schemes October 2000 Figure Definition of User Groups affected by the Transition Periods Current Users Users of ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994 This user group category is defined as having completed the implementation of ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994, regardless of whether or not they are certified. User groups that are in the process of implementing ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994 are addressed as Transitional / Intermediate Users (see 2.3.2) Users of Industry Sector Schemes, based on ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994 and Awards Schemes This user group can be divided into two categories: The first group is defined as those using quality management system programmes based on ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994 that include additional quality management system requirements. These form a set of criteria that can either be certified or accredited under the guidelines of a particular Industry Sector Scheme (e.g. 6

6 ISO/TS Quality systems Automotive suppliers Particular requirements for the application of ISO 9001:1994). The second group is defined as those using business excellence models incorporating part of ISO 9001: 1994 This category of user may be certified or may have no intention to pursue third party certification Transitional / Intermediate Users This user category has been defined as those who are in the process of implementing ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994 and have not yet reached full implementation of the standards' requirements. This category also includes users of Industry Sector Schemes and Award Schemes. It is recognized that this category may also include users who have started to implement quality management systems based on a draft version of the ISO 9001:2000 standard. This category of user may either be in the process of seeking certification/registration, intending to pursue certification/registration in the near future, or have no intention of becoming certified/registered New Users A New User is defined as an organisation that is either: a) Beginning to use ISO 9001:2000 for the first time; b) Beginning to implement ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994 for the first time; c) Is a potential user. 7

7 3.0 TRANSITION GUIDELINES FOR USER GROUPS 3.1 Current Users Organizations using ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994 Organisations certified to ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994 are recommended to contact their specific Certification / Registration Body to discuss the time frame for re-certification or upgrade of current certificates. To facilitate a smooth transition from ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994 to the ISO 9001:2000 revision (refer figure 2), the following key areas have been identified as important to this user group: Internal Auditor training (focusing on the changes between the current and the new standards) Management awareness (focusing on the benefits that can be added to business as a result of the new approach in the new standard, the structure of the new standard and the proactive top management role) General staff awareness programs (to encourage total involvement and understanding) An understanding of process management If all the requirements of ISO 9001:2000 cannot be applied in an organisation, a clear understanding of the concept and criteria for the justification of any exclusions will be necessary (see 6.2) Industry Sector Schemes and Quality Awards In general, Industry Sector Schemes are based on a relevant 1994 edition of an ISO 9000 standard and are supplemented with additional requirements and/or a higher level of compliance criteria. In consideration of ISO 9001:2000 s introduction of a process management approach, it is recommended that these user groups commence a strategic plan to assess the continuing suitability or need for supplemental requirements as soon as possible. At this stage, the evaluation of supplemental requirements should be based on the Final Draft International Standard (FDIS) version of ISO 9001:2000. However, it should be undertaken with full awareness that the International Standard, when published, may differ slightly from the Final Draft International Standard (FDIS). 8

8 Note Box numbers are not in sequencial logic, they are linked to "Key Consult the Certification / Registration Body to discuss timing issues related to the coexistence period Consider the timing/release of the various drafts of ISO 9001:2000 and their potential impact on the organisations implementation plans Identify the changes in ISO 9001:2000 (The comparison table may be of assistance, refer clause ***** of the Transition Planning Guidance) (1) (2) KEY CONSIDERATIONS Ref. Box 1 Use of Final Draft International Standard or International Standard (final published version) of ISO 9001:2000 Scope of upgraded certificate, taking in account the application of the standard (Clause 1.2) Access to ISO Web Site Access to SC2 Web Site Ref. Box 2 (text is self explanatory) Revise procedures to incorporate ISO 9001:2000 requirements Implement procedures to provide evidence of conformity Undertake self audit / evaluation (4) (7) (9) No Are the requirements of ISO 9001:2000 being met (5) Yes Evaluate the current QMS structure to determine the level of enhancement that may be necessary in meeting the Process Mgt focus of ISO 9001:2000 Yes Does the QMS have a Process Mgt focus No Is the user committed to establishing a Process Mgt focused system (8) Yes (6) (3) Ref. Box 3 Continuing suitability of current 20 element system structure Expert guidance with respect to Process Management approach Determine applicability of ISO 9001:2000 to meet the specific operational functions of the organisation Ref. Box 4 Process Management orientation of the system Ref. Box 5 Internal system review Initial preliminary evaluation by Certification Body Ref. Box 6 (text is self explanatory) Apply for Certification / Registration upgrade (10) Re-design current system to adopt Process Mgt focus Establish & deploy Process Mgt focused training program (11) (12) NO Ref. Box 7 Training needs Ref. Box 8 Management training/awareness of Process Management approach Assistance in awareness may be sought from the Frequently Asked Questions accessible on the ISO Web Site Re-examine the organizations objectives Ref. Box 9 Enhancement of internal auditor process Enhancement of internal training & qualifications Ref. Box 11 Use of ISO 9004:2000 as a further information source for improvement of quality performance Expertise of persons involved in the redesign process Ref. Box 12 (text is self explanatory) Figure 2 9

9 While developing supplemental requirements to ISO 9001:2000, it is recommended that the relevant user groups seek: to ensure consistent interpretation of the ISO 9001:2000 requirements to establish close relationships with the National Standards Bodies to establish close relationships with relevant Certification / Registration Bodies or Accreditation Bodies A consideration for Quality Award related Schemes, or similar programmes, is the role of ISO 9004:2000 in providing guidance for performance improvement and in assisting organizations to move toward TQM. Although ISO 9004:2000 will be a guideline document, Quality Award Schemes etc. may find it prudent to consider this document in their processes, as ISO 9004:2000 will now include an annex on organizational self-assessment National Standards Bodies (NSBs) a) Information Focal Point NSBs will be one of the primary information sources for organizations needing assistance during the transition period. It is recommended that NSBs establish a focal information point where assistance can be obtained on problems that may be encountered during the initial application of ISO 9001:2000 and related transition issues. These may include, for example, questions relating to transition period timing, statutory issues, withdrawal of ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994, interpretation, exclusions, etc. This will also provide a solid base for consistent communication with all interested parties / user groups. b) Information output to Users and Interested Parties In an effort to provide a smooth transition for users and interested parties, information regarding the ISO 9001:2000 revision of the standard should be communicated in a timely manner. It is recommended that NSBs synchronise their information programmes with the information flows from ISO and ISO/TC 176 (ref. the web site) and reuse as much first hand information as considered relevant. The information provided should also advise on the relationship and use of other standards (or documents) in the new ISO 9000:2000 series, especially ISO 9004:2000 and ISO 9000:

10 c) Translation Issues If a requirement for translation of the new standards exists, the translation process should be started as early as possible, using the FDIS versions of the standards. This may be of particular importance, given the significance of the changes that have been incorporated into ISO 9001:2000 compared with the previous content of ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994. (ISO/TC176 will soon be issuing a document Translation tips to provide guidance on this subject.) Accreditation Bodies Accreditation Bodies should consider the need for reassessment of the accreditation of individual Certification / Registration Bodies. Auditor competence is expected to play a major role during the transition period. Consideration should be given to the criteria that will be used to assess auditor competency in performing audits that verify compliance to ISO 9001:2000. The recent IAF, ISO/TC 176, ISO/CASCO communiqué has established a policy for consistent accreditation assessment of the competency of Certification/Registration Body personnel with respect to the new standards (see annex A, item 4), in an effort to ensure that all accreditation bodies use uniform criteria Certification/Registration Bodies The changes in the standards are expected to place a relatively heavy burden on the Certification/ Registration Bodies. Not only will they have to plan to meet the changes for their customer organizations, but they will have to plan to address the changes within their own organizations. Many of the items of direct concern to the Certification/ Registration Bodies during the transition period have been addressed by the IAF, ISO/TC 176, ISO/CASCO agreement (see annex A). The following are some of the aspects that should be considered by Certification/ Registration Bodies during the transition process: Timing of assessment and certification activities based on ISO9001:2000 Arrangement of assessment schedules for existing customer organizations Training of auditors Protocols for encouraging users to implement ISO 9001:2000 Timely administration of upgraded certificates The Certification/Registration Bodies will be one of the primary information sources for organizations seeking assistance during the transition period. 11

11 It is important that the information they provide is well co-ordinated and consistent with other Certification / Registration Bodies. To facilitate this process, it is recommended that the Accreditation Bodies or NSBs participate in this co-ordination task. Most importantly, Certification / Registration Bodies will have the task of informing their existing customer base of certified/registered organisations of the new developments concerning ISO 9001:2000. This should be followed-up by regular communication on the implementation of expected changes in the standard, renewals of certification, individual transition arrangements etc., to avoid any unnecessary confusion. The competence of their auditors to assess to ISO 9001:2000 should be a major item for consideration by Certification/Registration Bodies during the transition period. It will be necessary to ensure that auditors receive appropriate training to achieve the required levels of competence. It is recommended that Certification/ Registration Bodies start their auditor training programmes as soon as possible. It is expected that a considerable number of current users will request upgrade audits as soon as possible, to enable them to utilise their audit reports to facilitate their own transition processes. Certification/Registration Bodies should therefore schedule formal assessments to start against the revised ISO 9001 standard at the FDIS stage. However, following the IAF, ISO/TC 176, ISO/CASCO agreement, accredited certificates may not be granted until the ISO 9001:2000 standard is published and compliance ensured (see annex A, items 1 3). Note: Due to the process management approach of ISO 9001:2000, current users who are considering "integrated" management systems may wish to accelerate the implementation of such integrated systems. This in turn will require Certification/ Registration Bodies to respond accordingly and adopt an integrated audit approach Training Bodies and Consultants Training Bodies and consultants have an important role to play in the transition process and are paramount to the success of a smooth transition from ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994 to ISO 9001:2000. With respect to auditor training, consideration should be given to the currency of existing auditor certification and the protocol to upgrade these auditors in readiness for the release of ISO 9001:2000. In the past, the 1994 revisions of these standards did not pose the same level of transition complication, due to the low extent of changes that were introduced when compared to the earlier 1987 editions. The ISO 9001:2000 revision however, does provide a number of significant changes that will require sound interpretation of its requirements. 12

12 All trainers and consultants should be aware that the issue of a process management approach is the key to the application of ISO 9001:2000, and should also be knowledgeable of the revised requirements. It is recommended that training bodies start to meet the need for competent auditors and other personnel, by preparing suitable courses based on the available drafts of ISO 9001:2000. The training should be divided into different user applications and be based on factual interpretations and not opinions (see annex A, item 4). 3.2 Transitional / Intermediate Users Transitional / Intermediate users are those who either have implemented, or are currently in the process of implementing, ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994. Due to the change from the current 20 system element structure of the 1994 family of ISO 9000 standards to that of a process management approach, it is strongly recommended that this user group review their systems, or the development of their systems, against the requirements of ISO 9001:2000. Users with established systems should not just discard them, as parts will continue to be required under ISO 9001:2000. However, some system documentation may need to be revised or enhanced to meet the requirements of ISO 9001:2000. Transitional / Intermediate users should consult with their Certification/Registration Bodies or National Standards Bodies, in order to ensure that their information on the transition of the standards is kept up-to-date. 3.3 New Users While new users may be currently considering the implementation of ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994, it is recommended that they also evaluate their quality system objectives with a view to implementing ISO 9001:2000. Consideration should be given the fact that the 1994 editions of ISO 9001, ISO 9002 and ISO 9003 will be consolidated into the future ISO 9001:2000. Care should be taken when sourcing training or professional assistance during the implementation of ISO 9001:2000, due to its new structure and process management approach. New users should commence implementation using the most recent draft available at the time of committing to the implementation of ISO 9001:

13 4.0 AUTHENTICITY OF INFORMATION REGARDING ISO 9001:2000 It is of utmost importance to ensure the most uniform application of the standard possible, given the inevitable variations caused by linguistic differences. The first contact for information regarding the requirements of ISO 9001:2000 should be limited to National Standards Bodies. It is however, anticipated that organizations that have already established a working relationship with Certification / Registration Bodies, may feel more comfortable discussing ISO 9001:2000 requirements with them. 14

14 5.0 SUMMARISED COMPARISON OF KEY ENHANCEMENTS BETWEEN ISO 9001:1994 / ISO 9001:2000 A comparison between ISO 9001:1994 and ISO 9001:2000 related to key enhancements is given in chapter 5.4 to assist the user in identifying the scope of revisions to ISO 9001:2000. It is important to note that this comparison is not done word by word, it only contains a summary of salient issues relevant to ISO 9001:2000 in consideration of current ISO 9001:1994 requirements. It is strongly recommended that the user obtain a copy of latest draft of ISO 9001:2000 from their respective ISO member body. 5.1 REQUIREMENTS CORRELATION TABLE BETWEEN ISO 9001:2000 AND ISO 9001:1994 In the following table, the numbers in brackets show briefly how the quality system requirements of ISO 9001:1994 fit into the new ISO 9001:2000, clauses 5 to 8. It should be noted that although some clauses in ISO 9001:2000 have the same title as in ISO 9001:1994, the contents may not be exactly the same and the requirements may have been enhanced. 5 Management Responsibility 5.1 Management commitment (4.1/ /4.2.1) 5.2 Customer focus 5.3 Quality policy (4.1.1) 5.4 Planning (4.1.1/ 4.2.1/4.2.3) 5.5 Responsibility, authority and communication (4.1.2/ / /4.2.1/4.5/4.16) 5.6 Management review (4.1.3) 6 Resource management 6.1 Provision of resources ( ) 6.2 Human resources ( /4.18) 6.3 Infrastructure(4.9) 6.4 Work enviroment (4.9) 8 Measurement, Analysis & Improvement 8.1 General (4.10/4.20) 8.2 Monitoring and measurement (4.10/4.17/4.20) 8.3 Control of nonconforming product (4.13) 8.4 Analysis of data (4.14/4.20) 8.5 Improvement (4.1.3/4.9/4.14) 15 7 Product realization 7.1 Planning of product realization (4.2.3/4.9/4.10/ 4.15/4.19) 7.2 Customer-related processes (4.3/4.7) 7.3 Design and development (4.4) 7.4 Purchasing (4.6) 7.5 Production & service provision (4.7/4.8/4.9/4.15/4.19) 7.6 Control of monitoring and measuring devices (4.11)

15 5.2 APPLICATION OF ISO 9001:2000 Currently an organization is able to seek certification against either ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994 dependent on the scope of their business operations. The publication of ISO 9001:2000 will result in ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994 becoming obsolete. This will require that organizations upgrade their existing certification if already certified, or that they seek certification to ISO 9001:2000. However, it is recognized that owing to: a) the nature of an organization's product; b) customer requirements; c) applicable regulatory requirements; not all the requirements of ISO 9001:2000 may be appropriate to every organization. Therefore ISO 9001:2000 will permit organizations to exclude compliance with specific quality management system requirements that neither affect their ability, nor absolve them from their responsibility, to provide product that meets customer and applicable regulatory requirements, yet still allow those organizations to claim conformity to the standard. Exclusions will be restricted to clause 7 Product realization of ISO 9001:2000 and will not apply to any other clauses of the standard. Details of justification for any exclusions will have to be documented in the organisation s Quality Manual. It is recommended that users discuss any intention to exclude certain clauses of ISO 9001:2000 with their selected Certification/Registration Body (see annex A, item 5), and refer to the Guidance on this topic that is available from the ISO/TC176/SC2 Website (see Section 4.0). 16

16 5.3 Correspondence between ISO 9001:1994 and ISO/FDIS 9001:2000 ISO 9001:1994 ISO/FDIS 9001: Scope 1 2 Normative reference 2 3 Definitions 3 4 Quality system requirements [title only] 4.1 Management responsibility [title only] Quality policy Organization [title only] Responsibility and authority Resources Management representative Management review Quality system [title only] General Quality system procedures Quality planning Contract review [title only] General Review Amendment to a contract Records Design control [title only] General Design and development planning Organizational and technical interfaces Design input Design output Design review Design verification Design validation Design changes Document and data control [title only] General Document and data approval and issue Document and data changes Purchasing [title only] General Evaluation of subcontractors Purchasing data Verification of purchased product

17 Correspondence between ISO 9001:1994 and ISO/FDIS 9001:2000 (continued) ISO 9001:1994 ISO/FDIS 9001: Control of customer-supplied product Product identification and traceability Process control Inspection and testing [title only] General Receiving inspection and testing In-process inspection and testing Final inspection and testing Inspection and test records Control of inspection, measuring and test equipment [title only] General Control procedure Inspection and test status Control of nonconforming product [title only] General Review and disposition of nonconforming product Corrective and preventive action [title only] General Corrective action Preventive action Handling, storage, packaging, preservation & delivery [title only] General Handling Storage Packaging Preservation Delivery Control of quality records Internal quality audits Training Servicing Statistical techniques [title only] Identification of need Procedures 18

18 Correspondence between ISO/FDIS 9001:2000 and ISO 9001:1994 ISO/FDIS 9001:2000 ISO 9001: Scope General 1.2 Application 2 Normative references 2 3 Terms and definitions 3 4 Quality management system [title only] 4.1 General requirements Documentation requirements [title only] General Quality manual Control of documents Control of quality records Management responsibility [title only] 5.1 Management commitment Customer focus Quality policy Planning [title only] Quality objectives Quality management system planning Responsibility, authority and communication [title only] Responsibility and authority Management representative Internal communication 5.6 Management review [title only] General Review input Review output Resource management [title only] 6.1 Provision of resources Human resources [title only] General Competence, awareness and training Infrastructure Work environment Product realization [title only] 7.1 Planning of product realization Customer-related processes [title only] Determination of requirements related to the product Review of requirements related to the product Customer communication

19 Correspondence between ISO/FDIS 9001:2000 and ISO 9001:1994 (continued) ISO/FDIS 9001:2000 ISO 9001: Design and development [title only] Design and development planning Design and development inputs Design and development outputs Design and development review Design and development verification Design and development validation Control of design and development changes Purchasing [title only] Purchasing process Purchasing information Verification of purchased product Production and service provision [title only] Control of production and service provision Validation of processes for production and service provision Identification and traceability Customer property Preservation of product Control of monitoring and measuring devices Measurement, analysis and improvement [title only] 8.1 General Monitoring and measurement [title only] Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of product Control of nonconforming product Analysis of data Improvement [title only] Continual improvement Corrective action Preventive action

20 5.4 SUMMARISED ANALYSIS OF KEY ENHANCEMENTS BETWEEN ISO 9001:1994 / ISO 9001:2000 SCOPE ISO 9001: Clause 1.1 General The Scope has been enhanced, including also the requirements to address customer satisfaction through the effective application of the system, including processes for continual improvement and the prevention of nonconformity ISO 9001: Clause 1 corresponds The requirements specified are aimed primarily at achieving customer satisfaction by preventing nonconformity ISO 9001: Clause 1.2 Application This clause is new and is a general description of the application of the standard. Where any requirement(s) of this International Standard cannot be applied due to the nature of the organization and its product, this can be considered for exclusion Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization s ability, or responsibility, to provide product that fulfils customer and applicable regulatory requirements. There is no corresponding ISO 9001:1994 clause TERMS AND DEFINITIONS ISO 9001: Clause 3 Terms and Definitions This clause states that the terms and definitions given in ISO 9000:2000 Quality management systems Fundamentals and vocabulary, apply to ISO 9001:2000. The term organization replaces the term supplier, used in ISO 9001:1994, and refers to the unit to which this International Standard applies. Also, the term supplier now replaces the term subcontractor Throughout the text of this International Standard, wherever the term product occurs, it can also mean service ISO 9001: Clause 3 corresponds The definitions that are given in ISO 8402 apply. 21

21 QUALITY MANAGEMENT SYSTEM REQUIREMENTS ISO 9001: Clause 4.1 General Requirements Under this clause more emphasis has been added on the need for continuous improvement. Clarification of the necessary steps to implement a quality management system is given: a) identify the processes needed for the quality management system, and its application throughout the organization b) determine the sequence and interaction of these processes, c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes e) measure, monitor and analyse these processes, and f) implement actions necessary to achieve planned results and continual improvement of these processes. ISO 9001:1994 Clause corresponds ISO 9001: Clause General Under this clause, an indication is given about the quality management system documentation required. The quality management system documentation shall include: a) documented statements of a quality policy and quality objectives b) quality manual c) documented procedures required by this International Standard d) documents required by the organization to ensure the effective planning, operation and control of its processes e) quality records required by this International Standard ISO 9001:1994 Clause corresponds ISO 9001: Clause Quality manual This clause has been enhanced to include the requirement for an organization to specify and justify any exclusion in the quality manual (refer to clause 1.2 of ISO 9001:2000). The quality manual shall also have a description of the sequence and interaction of the processes included in the quality management system ISO 9001: Clause corresponds 22

22 MANAGEMENT RESPONSIBILITY ISO 9001: Clause 5.1 Management commitment More emphasis is placed on Top management commitment. Particular attention should be given to subclauses (a), (b), (c) and (e). The latter refers to resources and has a direct link to clause 6 Resource Management. a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements; b) establishing the quality policy; c) ensuring that quality objectives are established e) ensuring the availability of resources ISO 9001:1994 Clauses 4.1; and correspond ISO 9001: Clause 5.2 Customer focus This clause reinforces the involvement of top management with customer requirements. It states that Top management shall ensure that customer requirements are determined and fulfilled with the aim of enhancing customer satisfaction There is no corresponding ISO 9001:1994 clause ISO 9001: Clause 5.3 Quality Policy This clause has been enhanced to ensure that Top management establishes its policy for quality. Particular attention should be given to subclause (b) which includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system, and subclause (c) which provides a framework for establishing and reviewing quality objectives; ISO 9001: Clause corresponds ISO 9001: Clause Quality objectives Under this clause, the requirement for quality objectives, at relevant functions and levels within the organization has been enhanced. It also states that the quality objectives shall be measurable and consistent with the quality policy. ISO 9001: Clause and correspond 23

23 ISO 9001: Clause Quality management system planning This clause has been revised for clarity and to ensure that managing change is included in planning. Top management shall ensure that a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1 as well as the quality objectives and b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented ISO 9001: Clause corresponds ISO 9001: Clause Management Representative This clause now further clarifies that Top management shall appoint a member(s) of the management who, irrespective of other responsibilities, shall have defined authority that includes: (c) ensuring the promotion of awareness of customer requirements throughout the organization ISO 9001: Clause corresponds ISO 9001: Clause Internal Communication This is a new clause that requires the Tp management to ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system There is no corresponding ISO 9001:1994 clause ISO 9001: Clause 5.6 Management Review Further text has been included to address key input and output requirements of a Management review. Attention should be given to input related subclauses: (b) customer feedback; (c) process performance and product conformity; and (d) status of preventive and corrective actions (f) planned changes that could affect the quality management system. And output related subclauses: 24

24 (a) improvement of the effectiveness of the quality management system and its processes and (b) improvement of product related to customer requirements ISO 9001: Clause corresponds RESOURCE MANAGEMENT ISO 9001: Clause 6.1 Provision of resources This clause further clarifies the requirement for an organization to determine and provide the resources needed to implement and maintain the quality management system and continually improve its effectiveness, and to enhance customer satisfaction. ISO 9001: Clause corresponds ISO 9001: Clause Competence, awareness and training The scope of this clause has been enhanced to include not only training needs but competence and awareness. The organization shall: a) determine the necessary competence for personnel performing work affecting product quality, b) provide training or take other actions to satisfy these needs evaluate the effectiveness of the actions taken d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives; d) maintain appropriate records of education, training, skills and experience. ISO 9001: Clause 4.18 corresponds ISO 9001: Clause 6.3 Infrastructure The organization shall determine, provide and maintain the infrastructure needed to achieve the conformity to product requirements This includes, for example: a) building, workspace and associated utilities b) process equipment, both hardware and software c) supporting services such as transport and communication ISO 9001: Clause 4.9 corresponds Under this clause the primary requirement is to ensure processes are carried out under controlled conditions. 25

25 ISO 9001: Clause 6.4 Work Environment The organization shall determine and manage the work environment needed to achieve conformity to product requirements. ISO 9001: Clause 4.9 corresponds PRODUCT REALIZATION Note: The title of Process Control as traditionally referred to in ISO 9001:1994 has been replaced with the title Product Realization. ISO 9001: Clause 7.1 Planing of product realization Special attention shall be put on subclauses (a) to (d) that further clarify requirements that shall be met to ensure product realization processes are under control. ISO 9001: Clause 4.2.3; 4.9; 4.10; 4.15 and 4.19 correspond ISO 9001: Clause Determination of requirements related to the product Under this clause, three new requirements have been added in the process of determining customers needs. They are: b) requirements not stated by the customer but necessary for specified or known intended use; c) statutory and regulatory requirements related to the product d) any additional requirements determined by the organization There is no corresponding ISO 9001:1994 clause ISO 9001: Clause Customer communication This clause is essentially a new requirement. The organization is required to determine and implement effective arrangements for communicating with customers. In defining its communication requirements the organization is required to meet a number of subclause requirements from (a) to (c) There is no corresponding SO 9001:1994 clause 26

26 ISO 9001: Clause Design and development Inputs This clause has been enhanced to include clarification of the design input requirements that are to be met. Particular attention should be given to the following subclause: a) functional and performance requirements ISO 9001: Clause corresponds ISO 9001: Clause Design and development Review This clause has been enhanced to clarify that design and development reviews must be systematic in ensuring conformance with input requirements. If during the review process a problem is identified, the organization shall propose necessary actions. In addition to recording reviews, the results of any necessary actions SHALL be recorded. ISO 9001: Clause corresponds ISO 9001: Clause Control of design and development changes This clause now includes a requirement for the organization to determine the effect of change on constituent parts and delivered product. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. ISO 9001: Clause corresponds ISO 9001: Clause Validation of processes for production and service operation This clause now includes a requirement for the organization to carry out process validation. The organization shall establish arrangements for these processes, including, as applicable: a) defined criteria for review and approval of the processes b) approval of equipment and qualification of personnel c) use of specified methods and procedures d) requirements for records e) re-validation ISO 9001: Clause 4.9 corresponds 27

27 MEASUREMENT, ANALYSIS AND IMPROVEMENT ISO 9001: Clause 8.1 General This clause requires that monitoring, measurement, analysis and improvement processes needed to demonstrate conformity of the product, ensure conformity of the quality management system and continually improve the effectiveness of the quality management system shall be planned and implemented. This shall include the determination of applicable methods, including statistical techniques, and the extent of their use. ISO 9001: Clause 4.10 and 4.20 correspond ISO 9001: Clause Customer satisfaction This clause is new and emphasizes that the organization shall monitor information relating to customer perception as to whether the organisation has fulfilled customer requirements. There is no corresponding ISO 9001:1994 clause ISO 9001: Clause Internal audit This clause has been enhanced by: Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audits ISO 9001:1994 Clause 4.17 corresponds ISO 9001: Clause Monitoring and measuring of processes This clause has been enhanced by: These methods shall demonstrate the ability of the processes to achieve planned results. ISO 9001:1994 Clause 4.20 corresponds 28

28 ISO 9001: Clause 8.4 Analysis of data In addition to the traditional statistical technique requirement of the 1994 version, this clause focuses on the Analysis of applicable data as one means of determining where continual improvement of the quality management system can be made. The organization SHALL analyze this data to provide information on: a) customer satisfaction b) conformance to product requirements c) characteristics and trends of processes and products, including opportunities for preventive actions; d) suppliers ISO 9001:1994 Clauses 4.14 and 4.20 correspond ISO 9001: Clause Continual improvement The organization shall continually improve the of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review ISO 9001: Clauses and 4.9 correspond 29

29 September 27, 1999 ANNEX A IAF ISO/TC 176 ISO/CASCO Joint Working Group COMMUNIQUE Results of the IAF ISO/TC 176 ISO/CASCO joint session on Transition Planning for the Year 2000 ISO 9000 Standards Background Industry expects that the introduction of the new ISO 9000 Family of standards will be a coordinated effort between the developers of the standards, certification / registration bodies and accreditation bodies. An International Accreditation Forum (IAF) ISO/TC 176 ISO/CASCO joint session was held on September 26, 1999 in Vienna, Austria to establish common and consistent messages to ensure a smooth transition to the new standards. Scope of the work To develop consistent implementation guidance for the new ISO 9000 standards for such audiences as: organizations already certified / registered to ISO 9001, ISO 9002 or ISO 9003 :1994 organizations presently not certified / registered to ISO 9001, ISO 9002 or ISO 9003 :1994 certification / registration bodies accreditation bodies the general public Agreements Reached 1. Accredited Certificates to the new ISO 9001 shall not be granted until the publication of ISO 9001:2000 as an International Standard (IS) For information - ISO 9001:2000 will replace the 1994 editions of ISO 9001, ISO 9002 and ISO A Draft International Standard (DIS) of ISO 9001 is due to be released in November Current plans are to circulate a Final Draft International Standard (FDIS) in the third quarter of 2000 and to publish the new ISO 9001 as an International Standard (IS) in the fourth quarter of Certification/Registration body assessments to the latest draft of the new standard may begin prior to publication of the ISO 9001:2000 International Standard (IS) Certification / Registration Bodies may begin to assess conformity to the latest draft of ISO 9001:2000 (ie, DIS or FDIS) prior to publication of the IS, so that organizations may prepare and take any necessary actions. To minimize costs, currently certified / registered organizations may consider taking advantage of the opportunity for assessment to the latest draft of the new ISO 30

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