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Number and type of nonconformities being written up against ISO 9001:2015

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Sidney Vianna, Feb 4, 2016.

  1. Sidney Vianna

    Sidney Vianna Well-Known Member

    Jul 30, 2015
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    In private and in public we hear of organizations undergoing transition audits to ISO 9001:2015 which end up with zero nonconformities.
    I suspect that, under ISO 9001:2015 we will see even fewer nonconformities issued by 3rd party auditors, all around. Why? Any valid nonconformity has to have a requirement being violated. As ISO 9001:2015 distanced itself from a requirement-centric standard towards performance-based QMS and auditors feel extremely uncomfortable auditing "performance", I suspect that auditors will struggle with the new audit reality for a while.

    So, it would be very interesting to identify the type and number of nonconformities being written up by 3rd party auditors against ISO 9001:2015, obviously information duly sanitized so there are no concerns over confidentiality breaches. I have a suspicion that a significant percentage of audits being performed against ISO 9001:2015 end up with zero nonconformities
    tony s, Somashekar and hogheavenfarm like this.
  2. Leonid

    Leonid Well-Known Member

    Jan 4, 2016
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    I expect to see nonconformities to:
    9.1.1 The organization shall evaluate the performance and the effectiveness of the quality management system. The organization shall retain appropriate documented information as evidence of the results.
    LY Note: criteria for and outputs of evaluation are not quite clear.
    9.1.3 The organization shall evaluate e) the effectiveness of actions taken to address risks and opportunities.
    9.3.2 The management review shall be planned and carried out taking into consideration:
    e) the effectiveness of actions taken to address risks and opportunities.
    LY Note: What time should pass after implementing 6.1 in order to provide evidence of conformity to 9.1.3 and 9.3.2?
  3. Somashekar

    Somashekar Well-Known Member

    Jul 30, 2015
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    What does the training to Lead Auditors about this tells...
    I guess that this three situations are required to write up a NC
    1. A audit situation explained by the responsible officer or detailed in the documented information.
    2. The gaps or disjoints agreed upon by the auditee as well as the responsible manager in the audit process towards both performance and effectiveness
    3. If the impact has happened in the product or service as evidenced in the audit process, then this is related to the specific functional clause and major., and if the impact could potentially occur then this is related to the QMS planning clause, touching upon risk based thinking., and as minor.
    This now all falls under the effective auditing skills imparted to the leads based on the new standard. There is big scope to hit upon many NC, if we are fair to third party auditing.