ISO 9001: 2008 Boosting quality to differentiate yourself from the competition. xxxx November 2008

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1 ISO 9001: 2008 Boosting quality to differentiate yourself from the competition xxxx November 2008

2 ISO Periodic Review

3 ISO 9001:2008 Periodic Review ISO 9001, like all standards is subject to periodic review to determine whether it is still relevant, whether it needs to be updated or whether it should be discarded The review period is around 5-6 years and for ISO 9001 it is designed such that whenever there are significant changes to be done (major revision) the next revision will be less significant (minor) Since the revisions issued in 2000 (implemented in 2003) were major, the next one will be minor; changes are more based on the clarification of the existing requirements rather than including new ones New version released on the 15th of November

4 ISO 9001 Principles & Challenges

5 ISO 9000:2000 Family Annexes A & B for information only ISO 9000 Measurement Audits ISO ISO ISO Guidelines Quality management systems - Guidelines for performance improvement ISO 9004 ISO 9001 Quality management systems - Requirements Technical Reports 5

6 ISO 9001:2000 Process Approach CONTROLS PROCESS EFFECTIVENESS Extent to which planned activities are realised and planned results achieved INPUT PROCESS set of interrelated or interacting activities which transforms inputs into outputs OUTPUT PRODUCT PROCESS EFFICIENCY RESOURCES Relationship between the result achieved and the resources used A desired result is achieved more efficiently when activities and related resources are managed as a process 6

7 ISO 9001:2000 System approach to management Identifying, understanding and managing interrelated processes as a system contributes to the organisation s effectiveness and efficiency in achieving its objectives I R Process A I C I = INPUT O = OUTPUT R = RESOURCES C = CONTROLS O I Process C C I R O R Process B C I I O R Process D C O 7

8 Concept of integration ISO 9001:2008, ISO 14001:2004 & OHSAS 18001:2007 standards based on PDCA concept, therefore having similar structure: Policy Planning Implementation and operation Performance assessment Improvement Management review 8

9 ISO 9001: 2008 Main changes and transition

10 ISO 9001:2008 In 2000, major changes were put in place and continue to remain important and valid The current changes are more a clarification of points already in the standard rather than the inclusion of new requirements. Changes have also been made to be consistent with the current ISO revision (2004) in order to make the combination easier and more efficient. 10

11 ISO 9001:2008 main changes Reinforcement of Control over outsourced processes that affect product conformity to requirements Management representative has to be a member of the organisation management and not an external individual Competence of all personnel affecting conformity to product requirement must be controlled by the organisation Additional guidance to explain the different methods on measuring and monitoring customer satisfaction For internal audits, the management of the audited unit must ensure that necessary corrections and corrective actions are taken Clarification that information systems are included as part of the company infrastructure, and therefore the management system New requirement to review the effectiveness of corrective and preventive actions 11

12 IAF and ISO policy for transition IAF and ISO have approved a transition policy Certification to new revision granted only after a surveillance or a recertification audit New certificates can t mention a standard which is not published (for example a country version not yet translated) No 9001:2000 certificates issued after Nov All 9001:2000 to be transitioned and withdrawn before Nov

13 Bureau Veritas Certification policy for transition Process The transition to this new revision will be performed either during your next surveillance audit or your next recertification and no later than 15th of November 2010 No additional auditing time, no change in your auditing cycle A new certificate will be issued replacing your current certificate (including multi-sites). The expiration date of a new certificate issued after a surveillance audit remains the same as the previous one. 13

14 Annex 1 Changes in the detail

15 Foreword 2000: International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. International Standard ISO 9001 was prepared by Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee SC 2, Quality systems. This third edition of ISO 9001 cancels and replaces the second edition (ISO 9001:1994) together with ISO 9002:1994 and ISO 9003:1994. It constitutes a technical revision of these documents. Those organizations which have used ISO 9002:1994 and ISO 9003:1994 in the past may use this International Standard by excluding certain requirements in accordance with 1.2. The title of ISO 9001 has been revised in this edition and no longer includes the term Quality assurance. This reflects the fact that the quality management system requirements specified in this edition of ISO 9001, in addition to quality assurance of product, also aim to enhance customer satisfaction. Annexes A and B of this International Standard are for information only. : International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 9001 was prepared by Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee SC 2, Quality systems. This fourth edition cancels and replaces the third edition which has been technically revised. Annex A of this International Standard is for information only 15

16 Introduction General ISO 9001: 2000 The design and implementation of an organization's quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the organization ISO 9001: 2008 The design and implementation of an organization s quality management system is influenced by: its business environment, changes in that environment, or risks associated with that environment; its varying needs; its particular objectives; the products it provides; the processes it employs; its size and organizational structure... This International Standard can be used by internal and external parties, including certification bodies, to assess the organization s ability to meet customer, statutory and regulatory requirements applicable to the product, and the organization s own requirements. For the 1st time the word risk appears in ISO

17 Introduction Process approach 2000: The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management, can be referred to as the process approach. : The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the process approach. IAF and ISO have published a document on Desired out come of 9001 From the customer s perspective A certified organization, for the defined scope, consistently provides products that meet customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction. 17

18 Introduction Relationship with ISO : : The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair of quality management system standards which have been designed to complement each other, but can also be used independently. Although the two International Standards have different scopes, they have similar structures in order to assist their application as a consistent pair. ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organization's overall performance and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. The present edition of ISO 9004 has been developed to maintain consistency with ISO Both standards complement each other, but can also be used independently. ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, or for certification, or for contractual purposes. It focuses on the effectiveness of the quality management system in meeting customer and applicable statutory and regulatory requirements. ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly in managing for the sustainable success of an organization. ISO 9004 is recommended as a guide for organizations whose top management wishes to extend the benefits of ISO 9001 in pursuit of systematic and continual improvement of the organization s overall performance and 9004 are a consistent pair that should be used together but 9004 revision will be published only in

19 Introduction Compatibility with other management systems 2000: This International Standard has been aligned with ISO 14001:1996 in order to enhance the compatibility of the two standards for the benefit of the user community. 2008: During the development of this International Standard, due consideration has been taken of the provisions of ISO 14001:2004 to enhance the compatibility of the two standards for the benefit of the user community. Important for the compatibility with ISO this should increase efficiency of combined audits 19

20 1 - Scope 1.1 General - ISO 9001:2008 a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. NOTE 1 In this International Standard, the term product applies to the product intended for, or required by, a customer or the product realization processes. This applies to any intended output resulting from product realization processes, including purchasing. NOTE 2 Statutory and regulatory requirements may be expressed as legal requirements. Clarification as to what is a product 1.2 Application ISO 9001:2008 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 organizations ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements. 20

21 2 - Normative reference 2000 The following normative document contains provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 9000:2000, Quality management systems Fundamentals and vocabulary. The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9000:2005 Quality management systems Fundamentals and vocabulary. 21

22 3 - Terms and definitions 2000 The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used: supplier organization customer 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. 22

23 4 - QMS General requirements 2000 Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system. e) monitor, measure (where applicable), and analyse these processes, and f) implement actions necessary to achieve planned results and continual improvement of these processes. Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system. NOTE 1 Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization and measurement, analysis and improvement. NOTE 2 An outsourced process is the process that the organization needs for its quality management system and which the organization chooses to have performed by an external party NOTE 3 Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. a) the potential impact of the outsourced process on the organization s capability to provide product that conforms to requirements; b) the extent to which the control for the process is shared; c) the capability of achieving the necessary control through the application of clause

24 4 - QMS Documentation requirements General 2000 d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and e) records required by this International Standard (see 4.2.4). c) documented procedures and records required by this International Standard, and d) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes. NOTE 1 Where the term documented procedure appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. A single document may include the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document. 24

25 4 - QMS Documentation requirements Control of documents f) to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled, and 25

26 4 - QMS Documentation requirements Control of records 2000 Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled. The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records. Records shall remain legible, readily identifiable and retrievable. 26

27 5 - Management responsibility Management representative 2000 Top management shall appoint a member of the management who, irrespective of other responsibilities.. Top management shall appoint a member of the organisation s management who, irrespective of other responsibilities.. The management representative must be a member of the organisation management team 27

28 6 - Resource management Human resources - General Personnel performing work affecting conformity to product quality requirements shall be competent on the basis of appropriate education, training, skills and experience NOTE Conformity to product requirements may be affected directly or indirectly by personnel performing any task within the quality management system. 28

29 6 - Resource management Human resources Competence, training and awareness 2000 a) determine the necessary competence for personnel performing work affecting product quality, b) provide training or take other actions to satisfy these needs, c) evaluate the effectiveness of the actions taken a) determine the necessary competence for personnel performing work affecting conformity to product requirements, b) where applicable, provide training or take other actions to achieve the necessary competence, c) ensure that the necessary competence has been achieved, Competence for personnel that affect the conformity to product requirements must be defined 29

30 6 - Resource management 6.3 Infrastructure c) supporting services (such as transport, communication or information systems). Information systems are explicitly part of the infrastructure 6.4 Work environment NOTE The term "work environment" relates to conditions under which work is performed including physical, environmental and other factors (such as noise, temperature, humidity, lighting, or weather). 30

31 7 - Product realisation Planning of product realization 2000 b) the need to establish processes, documents, and provide resources specific to the product; b) the need to establish processes and documents, and to provide resources specific to the product; c) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance; 31

32 7 - Product realisation 7.2. Customer related processes Determination of requirements related to the product 2000 c) statutory and regulatory requirements related to the product, and d) any additional requirements determined by the organization. c) statutory and regulatory requirements applicable to the product, and d) any additional requirements considered necessary by the organization. NOTE Post delivery activities include, for example, actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal. 32

33 7 - Product realisation 7.3. Design and development Design and development planning NOTE Design and development review, verification and validation have distinct purposes. They may be conducted and recorded separately or in any combination as suitable for the product and the organization. 33

34 7 - Product realisation 7.3. Design and development Design and development outputs 2000 The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release. The outputs of design and development shall be in a form suitable for verification against the design and development input and shall be approved prior to release. Design and development outputs shall a) meet the input requirements for design and development, b) provide appropriate information for purchasing, production and for service provision, c) contain or reference product acceptance criteria, and d) specify the characteristics of the product that are essential for its safe and proper use. NOTE Information for production and service provision may include details for the preservation of product. 34

35 7 - Product realisation 7.5 Production and service provision Control of production and service provision 2000 d) the availability and use of monitoring and measuring devices, d) the availability and use of monitoring and measuring equipment, e) the implementation of monitoring and measurement, and f) the implementation of product release, delivery and post-delivery activities. 35

36 7 - Product realisation 7.5 Production and service provision Validation of processes for production and service provision 2000 The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered. 36

37 7 - Product realisation 7.5 Production and service provision Identification and traceability 2000 Where traceability is a requirement, the organization shall control and record the unique identification of the product (see 4.2.4). The organization shall identify the product status with respect to monitoring and measurement requirements throughout product realization. Where traceability is a requirement, the organization shall control the unique identification of the product and maintain records (see 4.2.4). 37

38 7 - Product realisation 7.5 Production and service provision Customer property 2000 The organization shall exercise care with customer property while it is under the organization's control or being used by the organization. The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see 4.2.4). NOTE Customer property can include intellectual property. The organization shall exercise care with customer property while it is under the organization s control or being used by the organization. The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer and maintain records (see 4.2.4). NOTE Customer property can include intellectual property and personal data. 38

39 7 - Product realisation 7.5 Production and service provision Preservation of product 2000 The organization shall preserve the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product. The organization shall preserve the product during internal processing and delivery to the intended destination in order to maintain conformity to requirements. As applicable, preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product. 39

40 7 - Product realisation Control of monitoring and measuring equipment Control of monitoring and measuring devices The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 7.2.1). c) be identified to enable the calibration status to be determined; NOTE See ISO and ISO for guidance. 7.6 Control of monitoring and measuring equipment The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements. a) be calibrated and/or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded (see 4.2.4); c) have identification in order to determine its calibration status; NOTE Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use. 40

41 8 - Measurement analysis and improvement General 2000 a) to demonstrate conformity of the product, a) to demonstrate conformity to product requirements, 41

42 8 - Measurement analysis and improvement Monitoring and measurement Customer satisfaction NOTE Monitoring customer perception may include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims, dealer reports. 42

43 8 - Measurement analysis and improvement Monitoring and measurement Internal audit 2000 The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure. NOTE See ISO , ISO and ISO for guidance. A documented procedure shall be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results. The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of verification results (see 8.5.2). NOTE See ISO for guidance. 43

44 8 - Measurement analysis and improvement Monitoring and measurement Monitoring and measurement of processes 2000 The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure conformity of the product. NOTE When determining suitable methods, the organization should consider the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system. 44

45 8 - Measurement analysis and improvement Monitoring and measurement Monitoring and measurement of product 2000 Product release and service delivery shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer. Evidence of conformity with acceptance criteria shall be maintained The release of product and delivery of service to the customer shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer. 45

46 8 - Measurement analysis and improvement Control of nonconforming product 2000 The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure. When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity. The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. A documented procedure shall be established to define the controls and related responsibilities and authorities for dealing with nonconforming product. Where practicable, the organization shall deal with nonconforming product by one or more of the following ways: d) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started. 46

47 8 - Measurement analysis and improvement Improvement Corrective action 2000 f) reviewing corrective action taken e) reviewing the effectiveness of the corrective action taken Preventive action 2000 f) reviewing preventive action taken e) reviewing the effectiveness of the preventive action taken 47

48 48

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