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BSI Canada
 ... making excellence a habit™
 With ISO 9001 Training and Certification




    Quality Management ISO 9001 –
    The Nuts and Bolts of ISO Certification
    P art 3: Com m on non-conform ities
                                              1


Copyright © 2012 BSI. All rights reserved.
The Nuts and Bolts of ISO Certification
                           Canada.                     Part 3: Common non-conformities
... making excellence a habit™


   ISO 9001 – Minor non-conformities




Copyright © 2012 BSI. All rights reserved.
The Nuts and Bolts of ISO Certification
                           Canada.                     Part 3: Common non-conformities
... making excellence a habit™


   ISO 9001 – Clause 7.6
   • 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 determine requirements.

   • The organization shall establish processes to ensure that monitoring and
   measurements can be carried out and are carried out in a manner that is
   consistent with monitoring and measurement requirements.




Copyright © 2012 BSI. All rights reserved.
The Nuts and Bolts of ISO Certification
                           Canada.                     Part 3: Common non-conformities
... making excellence a habit™


   ISO 9001 – Clause 4.2.3 and 4.2.4
   • Documents required by the quality management system shall be
   controlled…

   • A documented procedure shall be established to define the controls needed
       • Approve documents for adequacy prior to issue
       • Review and update as necessary and re-approve documents




Copyright © 2012 BSI. All rights reserved.
The Nuts and Bolts of ISO Certification
                           Canada.                     Part 3: Common non-conformities
... making excellence a habit™


   ISO 9001 – Clause 4.2.3 and 4.2.4 (continued)
   A documented procedure shall be established to define the controls needed

   • Ensure that changes and the current revision status of documents are
   identified
   • Relevant versions of applicable documents are available at point of use
   • Document remain legible and readily identifiable
   • 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
   • To prevent the unintended use of obsolete documents and to apply suitable
   identification to them if they are retained for any purpose




Copyright © 2012 BSI. All rights reserved.
The Nuts and Bolts of ISO Certification
                           Canada.                     Part 3: Common non-conformities
... making excellence a habit™


   ISO 9001 – Clause 4.2.3 and 4.2.4 (continued)
   • 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 disposal of records

   • Records shall remain legible, readily identifiable and retrievable




Copyright © 2012 BSI. All rights reserved.
The Nuts and Bolts of ISO Certification
                           Canada.                     Part 3: Common non-conformities
... making excellence a habit™


   ISO 9001 – Clause 5.6
   Management Review

   • Top management shall review the organization’s quality management
   system, at planned intervals, to ensure its continuing suitability, adequacy
   and effectiveness.

   • This review shall include assessing opportunities for improvement and the
   need for changes to the quality management system, including the quality
   policy and quality objectives.




Copyright © 2012 BSI. All rights reserved.
The Nuts and Bolts of ISO Certification
                           Canada.                     Part 3: Common non-conformities
... making excellence a habit™


   ISO 9001 – Clause 6.3
   Infrastructure

   • The organization shall determine, provide and maintain the infrastructure
   needed to achieve conformity to product requirements, infrastructure
   includes, as applicable
       • Buildings, workspace and associated utilities
       • Process equipment (both hardware and software), and
       • Supporting service (such as transport, communications or information
       systems)




Copyright © 2012 BSI. All rights reserved.
The Nuts and Bolts of ISO Certification
                           Canada.                     Part 3: Common non-conformities
... making excellence a habit™


   ISO 9001 – Major non-conformities




Copyright © 2012 BSI. All rights reserved.
The Nuts and Bolts of ISO Certification
                           Canada.                     Part 3: Common non-conformities
... making excellence a habit™


   ISO 9001 – Clause 8.2.2
   Conduct internal audits at planned intervals to determine if QMS:

   • Conforms to:
      • Planned arrangements (see 7.1)
      • ISO 9001 requirements
      • Organization requirements

   • Is effectively implemented

   • Is maintained




Copyright © 2012 BSI. All rights reserved.
The Nuts and Bolts of ISO Certification
                           Canada.                     Part 3: Common non-conformities
... making excellence a habit™


   ISO 9001 – Clause 8.2.2 (continued)
   • Plan the audit program taking into consideration:
       • Status and importance of processes and areas
       • Results of previous audits

   • Define audit criteria, scope, frequency, and methods

   • Select auditors and conduct audits to ensure:
      • Objectivity
      • Impartiality

   • Ensure auditors do not audit their own work




Copyright © 2012 BSI. All rights reserved.
The Nuts and Bolts of ISO Certification
                           Canada.                     Part 3: Common non-conformities
... making excellence a habit™


   ISO 9001 – Clause 8.2.2 (continued)
   • Prepare a documented procedure to address responsibilities and
   requirements for:
       • Planning audits and conducting audits
       • Recording results and maintaining records

   • Ensure actions taken without undue delay
   (management responsible for audited area)

   • Verify actions taken and report the results
   (also refer to clause 8.5.2)




Copyright © 2012 BSI. All rights reserved.
The Nuts and Bolts of ISO Certification
                           Canada.                     Part 3: Common non-conformities
... making excellence a habit™


   ISO 9001 – Clause 8.5.2
   • Take action to eliminate cause of nonconformities to prevent their
   recurrence

   • Take action appropriate to the effects of problem

   • Define requirements in documented procedure to:
      • Review nonconformities (including complaints)
      • Determine the causes of nonconformities
      • Evaluate need for actions to prevent recurrence
      • Determine and implement corrective action
      • Record results and review action taken)




Copyright © 2012 BSI. All rights reserved.
The Nuts and Bolts of ISO Certification
                           Canada.                     Part 3: Common non-conformities
... making excellence a habit™


   ISO 9001 – Clause 4.1
   General Requirements

   • The organization shall establish, document, implement and maintain a
   quality management system and continually improve its effectiveness in
   accordance with the requirements of this international standard
      • Determine the processes
         • Determine the sequence and interaction of these processes
         • Determine criteria and methods needed to ensure that both operation
         and monitoring of these processes/availability of resources and information
         • Monitor, measure where applicable, and analyse these processes
         • Implement actions necessary to achieve planned results




Copyright © 2012 BSI. All rights reserved.
The Nuts and Bolts of ISO Certification
                           Canada.                     Part 3: Common non-conformities
... making excellence a habit™


   Contact Us

   1-800-862-6752
   www.bsigroup.ca

   Anne-Marie Pizzitelli, Marketing Manager
   Anne-marie.pizzitelli@bsigroup.com

   iso 9001 Courses & Auditor Training

   iso 9001 Standards


Copyright © 2012 BSI. All rights reserved.

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BSI Canada | Part 3: Nuts and bolts of iso 9001 certification Halifax

  • 1. BSI Canada ... making excellence a habit™ With ISO 9001 Training and Certification Quality Management ISO 9001 – The Nuts and Bolts of ISO Certification P art 3: Com m on non-conform ities 1 Copyright © 2012 BSI. All rights reserved.
  • 2. The Nuts and Bolts of ISO Certification Canada. Part 3: Common non-conformities ... making excellence a habit™ ISO 9001 – Minor non-conformities Copyright © 2012 BSI. All rights reserved.
  • 3. The Nuts and Bolts of ISO Certification Canada. Part 3: Common non-conformities ... making excellence a habit™ ISO 9001 – Clause 7.6 • 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 determine requirements. • The organization shall establish processes to ensure that monitoring and measurements can be carried out and are carried out in a manner that is consistent with monitoring and measurement requirements. Copyright © 2012 BSI. All rights reserved.
  • 4. The Nuts and Bolts of ISO Certification Canada. Part 3: Common non-conformities ... making excellence a habit™ ISO 9001 – Clause 4.2.3 and 4.2.4 • Documents required by the quality management system shall be controlled… • A documented procedure shall be established to define the controls needed • Approve documents for adequacy prior to issue • Review and update as necessary and re-approve documents Copyright © 2012 BSI. All rights reserved.
  • 5. The Nuts and Bolts of ISO Certification Canada. Part 3: Common non-conformities ... making excellence a habit™ ISO 9001 – Clause 4.2.3 and 4.2.4 (continued) A documented procedure shall be established to define the controls needed • Ensure that changes and the current revision status of documents are identified • Relevant versions of applicable documents are available at point of use • Document remain legible and readily identifiable • 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 • To prevent the unintended use of obsolete documents and to apply suitable identification to them if they are retained for any purpose Copyright © 2012 BSI. All rights reserved.
  • 6. The Nuts and Bolts of ISO Certification Canada. Part 3: Common non-conformities ... making excellence a habit™ ISO 9001 – Clause 4.2.3 and 4.2.4 (continued) • 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 disposal of records • Records shall remain legible, readily identifiable and retrievable Copyright © 2012 BSI. All rights reserved.
  • 7. The Nuts and Bolts of ISO Certification Canada. Part 3: Common non-conformities ... making excellence a habit™ ISO 9001 – Clause 5.6 Management Review • Top management shall review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. • This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Copyright © 2012 BSI. All rights reserved.
  • 8. The Nuts and Bolts of ISO Certification Canada. Part 3: Common non-conformities ... making excellence a habit™ ISO 9001 – Clause 6.3 Infrastructure • The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements, infrastructure includes, as applicable • Buildings, workspace and associated utilities • Process equipment (both hardware and software), and • Supporting service (such as transport, communications or information systems) Copyright © 2012 BSI. All rights reserved.
  • 9. The Nuts and Bolts of ISO Certification Canada. Part 3: Common non-conformities ... making excellence a habit™ ISO 9001 – Major non-conformities Copyright © 2012 BSI. All rights reserved.
  • 10. The Nuts and Bolts of ISO Certification Canada. Part 3: Common non-conformities ... making excellence a habit™ ISO 9001 – Clause 8.2.2 Conduct internal audits at planned intervals to determine if QMS: • Conforms to: • Planned arrangements (see 7.1) • ISO 9001 requirements • Organization requirements • Is effectively implemented • Is maintained Copyright © 2012 BSI. All rights reserved.
  • 11. The Nuts and Bolts of ISO Certification Canada. Part 3: Common non-conformities ... making excellence a habit™ ISO 9001 – Clause 8.2.2 (continued) • Plan the audit program taking into consideration: • Status and importance of processes and areas • Results of previous audits • Define audit criteria, scope, frequency, and methods • Select auditors and conduct audits to ensure: • Objectivity • Impartiality • Ensure auditors do not audit their own work Copyright © 2012 BSI. All rights reserved.
  • 12. The Nuts and Bolts of ISO Certification Canada. Part 3: Common non-conformities ... making excellence a habit™ ISO 9001 – Clause 8.2.2 (continued) • Prepare a documented procedure to address responsibilities and requirements for: • Planning audits and conducting audits • Recording results and maintaining records • Ensure actions taken without undue delay (management responsible for audited area) • Verify actions taken and report the results (also refer to clause 8.5.2) Copyright © 2012 BSI. All rights reserved.
  • 13. The Nuts and Bolts of ISO Certification Canada. Part 3: Common non-conformities ... making excellence a habit™ ISO 9001 – Clause 8.5.2 • Take action to eliminate cause of nonconformities to prevent their recurrence • Take action appropriate to the effects of problem • Define requirements in documented procedure to: • Review nonconformities (including complaints) • Determine the causes of nonconformities • Evaluate need for actions to prevent recurrence • Determine and implement corrective action • Record results and review action taken) Copyright © 2012 BSI. All rights reserved.
  • 14. The Nuts and Bolts of ISO Certification Canada. Part 3: Common non-conformities ... making excellence a habit™ ISO 9001 – Clause 4.1 General Requirements • The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this international standard • Determine the processes • Determine the sequence and interaction of these processes • Determine criteria and methods needed to ensure that both operation and monitoring of these processes/availability of resources and information • Monitor, measure where applicable, and analyse these processes • Implement actions necessary to achieve planned results Copyright © 2012 BSI. All rights reserved.
  • 15. The Nuts and Bolts of ISO Certification Canada. Part 3: Common non-conformities ... making excellence a habit™ Contact Us 1-800-862-6752 www.bsigroup.ca Anne-Marie Pizzitelli, Marketing Manager Anne-marie.pizzitelli@bsigroup.com iso 9001 Courses & Auditor Training iso 9001 Standards Copyright © 2012 BSI. All rights reserved.