Heads-up - ISO 9001:2015 Transition Nonconformance’s

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ISO 9001 registrar about Compliance and audit in wordsRand E. Winters - Senior ASR Auditor

As ASR clients begin their surveillance or recertification audit to the 2015 version of ISO 9001, top management and quality leaders may find it helpful to know what 2015 NC's have been written by ASR auditors during May and June 2017.

What is interesting - of the NC's found, only 1% were written against risk – a new topic for 2015. Remaining NC's were old issues including training, document control, management review, and internal audits.

Below is a list of NC findings. Highlighted findings are requirements that organizations that did not include in their revised 2015 quality management system.

Risk (New for 2015)

  • no plan to address risk and opportunities in the QMS
  • quoting and contract review process did not address risk and opportunities
  • method of addressing risk and opportunities not effective

Training

  • training process did not include training that addressed organizational knowledge of the ISO 9001:2015 changes to the QMS
  • documented information is not being developed for all annual required training received
  • process to determine and document competency not effective

Document control

  • control of documented information not effective
  • documents of external origin (blueprints, specifications) not identified and not under control
  • approval of product drawings provided by customers failed
  • process that controls changes to work instructions not entirely effective

Management review

  • company conducts management review quarterly, however, format used does not reflect ISO 9001:2015 changes
  • process of conducting management review is not effective
  • management review does not address all inputs/outputs as required by ISO 9001:2015

Internal audits

  • internal auditing not entirely effective
  • planning and scheduling of internal audit not effective
  • internal audit procedure and process does not address requirements of ISO 9001:2015
These four segments of the 2015 version of ISO 9001 address approximately one half of the findings written by ASR auditors. Hopefully, this short feedback on findings will be beneficial to clients planning to upgrade in the next few months.

Request a quote for a review or an ISO standards auditBeginning September 15, 2018 only an ISO 9001:2015 certificate will be valid for ISO 9001 organizations.

Check out ASR's monthly newsletter for continuing feedback on 2015 findings that may help your organization to complete a smooth transition to ISO 9001:2015.

Contact Dave or Tom at ASR (888-891-9002) if you need answers regarding the transition to the 2015 version of ISO 9001.


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Automotive

  • IATF 16949
  • Intl. Automotive Task Force
  • BS 25999
  • OHSAS 18001

Medical Devices

  • ISO 13485
  • Product Safety
  • Device Recalls
  • Emergency Situations

Aerospace

  • AS9100
  • AS9110
  • AS9120
  • SAE Technical Standards

Environmental

  • ISO 14001
  • EPA Regulations
  • EMS Tools
  • Emergency Preparedness