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New 9100 Series Standard is ready for rollout.

The new standard of the EN 9100 series is based on the ISO 9001-2015 release. The standardization champagne over the last years was successful and a full harmonization over all “Management Systems” standards has been achieved. This makes life a lot easier and more effective. A few open issues still need to be addressed:

  1. the certification bodies working hard on their internal processes
  2. the Auditor face a equally complex challenge. They must go though an comprehensive training and exam. Only 25% have passed up to now.
  3. IAQG OASIS must release the online tool for the audit management. This will greatly improve the quality of planning, communication and documentation of the audit, when operational.
  4. the organization must adopt their processes and management scheme to the new requirements of the standard. Significant changes are:
    • implementation of the risk based thinking
    • implementation of knowledge management
    • implementation of human factor management
    • controlling product safety including counterfeit parts
    • design and development is also applicable when manufacturing processes need to be developed and validated

Keep up-to-date and monitor the information at IAQG-OASIS…

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Excellent EN 9100-2016 Information Event by Bureau Veritas

The transition to the new standard ist well on the way. Plenty quality representatives have taken the chance. . Bureau Veritas (BVC) offers a series of information events to inform their customers about the changes. The move towards an risk based management concept and culture is for the most of the companies fairly significant. The BVC  lead auditor gave an excellent inside to the new requirements.

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What are the significant changes to be addressed while impementing the AS/EN 9100-2016 Series?

Finally, all known standards related to Management Systems are hamonized with the ISO 9001-2015 version. This are good news!

The new structure and content is far better than the previos version. It is more logic and practice based and follows thrictly the PCDA approach. One important stap is made to clarify and emphasize on the risk based thinkung and management.

Other significant changes are:

  • High level structure (HLS) & Terminology
  • Risk-based thinking – Concept of preventive action
  • identification and mitigation
  • Process approach strengthened with integration of the
  • QMS into organization’s business processes
  • Emphasis on change management
  • Introduction of knowledge management
  •  Clearer understanding of the organization’s context
  • Aligning QMS policy and objectives with the strategy of the organization
  • Explicit performance evaluation requirements
  • Greater flexibility with documentation
  • More compatible with services

For more – go to……

See the changes…

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AS/EN/JISQ 9100 Auditor Transition Training has started

The EN/AS/JISQ 9100 transition training consists of:

  1. ISO 9001:2015 Pre-Assessment (2-hour assessment, 80% pass requirement)
  2. 9100:2016 Delta Training
  3. 9100:2016 Comprehensive Review (30-minute assessment, feedback-only)
  4. 9101:2016 Delta Training
  5. 9100:2016 Forms and Audit Reporting Training
  6. Trial Assessment (15-minute trial assessment, for training purposes only)
  7. Trial Assessment Review
  8. 9100:2016 Forms and Audit Reporting Assessment (2-hour assessment, 80% pass requirement)

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