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Bureau Veritas SA — Technical Presentation (November 2008)
48 slides from Bureau Veritas SA's technical presentation, November 2008
Slide 1: ISO 9001: 2008 Boosting quality to differentiate yourself from the competition
ISO 9001: 2008 Boosting quality to differentiate yourself from the competition xxxx November 2008
Slide 2: ISO 9001 - Periodic Review
ISO 9001 - Periodic Review
Slide 3: ISO 9001:2008 – Periodic Review
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 ar
Slide 4: ISO 9001 – Principles & Challenges
ISO 9001 – Principles & Challenges
Slide 5: ISO 9000:2000 Family
ISO 9000:2000 Family ISO ISO Annexes A & B for information only 10012 Measurement 10012 ISO ISO 9000 Audits 19011 Guidelines Quality management ISO ISO Quality management systems - systems - Guidelines for 9004 9001 Requirements performance improvement Technical Reports ISO 9001:2008 - NOV 2008 5
Slide 6: ISO 9001:2000 Process Approach
ISO 9001:2000 Process Approach PROCESS EFFECTIVENESS Extent to which planned CONTROLS activities are realised and planned results achieved PROCESS “set of interrelated or INPUT interacting activities OUTPUT PRODUCT which transforms inputs into outputs PROCESS EFFICIENCY Relationship between the RESO
Slide 7: ISO 9001:2000 System approach to management
ISO 9001:2000 System approach to management Identifying, understanding and R R managing interrelated processes as a I Process O I Process O system contributes to A R B R I the organisation’s I C C effectiveness and I Process Process O C D efficiency in I = INPUT O I achieving its O = OUTPUT R = RESO
Slide 8: Concept of integration
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 ISO 9001:2008 - NOV 2008 8
Slide 9: ISO 9001: 2008 Main changes and transition
ISO 9001: 2008 Main changes and transition
Slide 10: ISO 9001:2008
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 1400
Slide 11: ISO 9001:2008 main changes
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 re
Slide 12: IAF and ISO policy for transition
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 90
Slide 13: Bureau Veritas Certification policy for transition
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
Slide 14: Annex – Changes in the detail
Annex 1 – Changes in the detail
Slide 15: Foreword
Foreword New in ISO 9001:2008 Does not appear in ISO 9001:2008 anymore Text slightly changed in ISO 9001:2008 ► 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/
Slide 16: Introduction - General
Introduction - 01 - 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 de
Slide 17: Introduction - Process approach
Introduction - 02 - 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”. ► 2008: The application of a system of processes
Slide 18: Introduction - Relationship with ISO 9004
Introduction - 03 - Relationship with ISO 9004 ► 2000: 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
Slide 19: Introduction - Compatibility with other management systems
Introduction - 04 - 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, du
Slide 20: 1 - Scope
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
Slide 21: 2 - Normative reference
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
Slide 22: 3 - Terms and definitions
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
Slide 23: 4 - QMS - 4.1 General requirements
4 - QMS - 4.1 General requirements New in ISO 9001:2008 Does not appear in ISO 9001:2008 anymore Text slightly changed in ISO 9001:2008 ► 2000 Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such p
Slide 24: 4 - QMS - 4.2 Documentation requirements
4 - QMS - 4.2. Documentation requirements ► 4.2.1 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). ► 2008 c) documented procedures and records req
Slide 25: 4 - QMS - 4.2 Documentation requirements
4 - QMS - 4.2. Documentation requirements ► 4.2.3 Control of documents ► 2008 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 New in I
Slide 26: 4 - QMS - 4.2 Documentation requirements
4 - QMS - 4.2. Documentation requirements ► 4.2.4 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 retrieva
Slide 27: 5 - Management responsibility
5 - Management responsibility ► 5.5.2 Management representative ► 2000 Top management shall appoint a member of the management who, irrespective of other responsibilities ….. ► 2008 Top management shall appoint a member of the organisation’s management who, irrespective of other responsibilities
Slide 28: 6 - Resource management
6 - Resource management ► 6.2.1 Human resources - General ► 2008 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 direct
Slide 29: 6 - Resource management
6 - Resource management ► 6.2.2 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 acti
Slide 30: 6 - Resource management
6 - Resource management ► 6.3 Infrastructure ► 2008 c) supporting services (such as transport, communication or information systems). ► Information systems are explicitly part of the infrastructure ► 6.4 Work environment ► 2008 NOTE The term "work environment" relates to conditions under which w
Slide 31: 7 - Product realisation - 7.1 Planning of product realization
7 - Product realisation - 7.1 Planning of product realization ► 2000 b) the need to establish processes, documents, and provide resources specific to the product; ► 2008 b) the need to establish processes and documents, and to provide resources specific to the product; c) required verification
Slide 32: 7 - Product realisation – 7.2 Customer related processes
7 - Product realisation – 7.2. Customer related processes ► 7.2.1 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. ► 2008 c) statutory and regulatory r
Slide 33: 7 - Product realisation – 7.3 Design and development
7 - Product realisation – 7.3. Design and development ► 7.3.1 Design and development planning ► 2008 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 organ
Slide 34: 7 - Product realisation – 7.3 Design and development
7 - Product realisation – 7.3. Design and development ► 7.3.3 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. ► 2008 The outputs of d
Slide 35: 7 - Product realisation – 7.5 Production and service provision
7 - Product realisation – 7.5 Production and service provision ► 7.5.1 Control of production and service provision ► 2000 d) the availability and use of monitoring and measuring devices, ► 2008 d) the availability and use of monitoring and measuring equipment, e) the implementation of monitori
Slide 36: 7 - Product realisation – 7.5 Production and service provision
7 - Product realisation – 7.5 Production and service provision ► 7.5.2 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 me
Slide 37: 7 - Product realisation – 7.5 Production and service provision
7 - Product realisation – 7.5 Production and service provision 7.5.3 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). ► 2008 The organization shall identify the product stat
Slide 38: 7 - Product realisation – 7.5 Production and service provision
7 - Product realisation – 7.5 Production and service provision ► 7.5.4 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
Slide 39: 7 - Product realisation – 7.5 Production and service provision
7 - Product realisation – 7.5 Production and service provision 7.5.5 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, st
Slide 40: 7 - Product realisation - 7.6 Control of monitoring and measuring equipment
7 - Product realisation - 7.6 Control of monitoring and measuring equipment New in ISO 9001:2008 ► 2000 Does not appear in ISO 9001:2008 anymore Text slightly changed in ISO 9001:2008 7.6 Control of monitoring and measuring devices The organization shall determine the monitoring and measurement
Slide 41: 8 - Measurement analysis and improvement - 8.1 General
8 - Measurement analysis and improvement - 8.1 General ► 2000 a) to demonstrate conformity of the product, ► 2008 a) to demonstrate conformity to product requirements, New in ISO 9001:2008 Does not appear in ISO 9001:2008 anymore Text slightly changed in ISO 9001:2008 ISO 9001:2008 - NOV 2008 41
Slide 42: 8 - Measurement analysis and improvement - 8.2.1 Customer satisfaction
8 - Measurement analysis and improvement - 8.2 Monitoring and measurement 8.2.1 Customer satisfaction ► 2008 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 bu
Slide 43: 8 - Measurement analysis and improvement - 8.2.2 Internal audit
8 - Measurement analysis and improvement - 8.2 Monitoring and measurement 8.2.2 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 1
Slide 44: 8 - Measurement analysis and improvement - 8.2.3 Monitoring of processes
8 - Measurement analysis and improvement - 8.2 Monitoring and measurement 8.2.3 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
Slide 45: 8 - Measurement analysis and improvement - 8.2.4 Monitoring of product
8 - Measurement analysis and improvement - 8.2 Monitoring and measurement 8.2.4 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 a
Slide 46: 8 - Measurement analysis and improvement - 8.3 Nonconforming product
8 - Measurement analysis and improvement - 8.3 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 aut
Slide 47: 8 - Measurement analysis and improvement - 8.5 Improvement
8 - Measurement analysis and improvement - 8.5 Improvement 8.5.2 Corrective action ► 2000 f) reviewing corrective action taken ► 2008 e) reviewing the effectiveness of the corrective action taken 8.5.3 Preventive action ► 2000 f) reviewing preventive action taken ► 2008 e) reviewing the effe
Slide 48: Bureau Veritas - Move Forward with Confidence
BUREAU VERITAS Move Forward with Confidence ISO 9001:2008 - NOV 2008 48
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