ISO 9001:2015 – Common Nonconformance’s

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ASR ISO 9001 compliance reportASR continues its update of common nonconformance's being experienced by ASR's ISO 9001 clients as they transition to the 2015 version of this international standard.

Following is a highlight of the common issues recently written by ASR's ISO 9001 auditors in the following sections:

Section 4 – clients are not addressing the new requirement to identify and define interested parties. Also, monitoring and measuring of processes is an issue. This is another new requirement.

Section 6 - one of the sub-sections is defining change management. Auditors are finding that this is not effectively implemented. Another problem is the evaluation of risk. ISO 9001:2015 requires a risk evaluation throughout an organization. Several findings noted warehousing, internal and external issues missing from the risk evaluation.


Section 7 - auditors found some measurement devices inaccurate for the measurement being conducted. Example might be using a ruler rather than calipers. Auditors also wrote findings for failed internal calibration systems. 2015 didn't change the intent of calibration, but did change some language.

New to ISO 9001 is the organization's need to improve their knowledge. This can be through the capture of best practices and lessons learned. Auditors cited several organizations with quality systems that did not effectively capture knowledge. On-going findings include document control and records retention not effective. An example is training records not effectively retained.

Section 8 - Common findings were first piece inspection not always effective and not documented. Receiving inspection was also cited as not always effective and the process for approving vendors and disqualifying vendors not defined. Additional common findings included non-conforming material areas not clearly defined or material not identified. These types of findings can be found by internal auditors.

Section 9 - 2015 language has changed regarding an organization's internal audit program, however, requirements for carrying out the internal audit remain the same. An example regarding language is no document procedure is required, however, records must show a fully documented internal audit system. As a result, ASR auditors found audit systems ineffective and auditors not adequately trained to ISO 9001:2015. Auditors also found management review records that did not address the mitigation of risk or actions taken. Findings also included management reviews that used the 2008 agenda. Again, internal auditors could have caught this.

Section 10 – this new section pulls together two old subjects - non-conforming material and corrective action. Organizations have had to address non-conforming material and corrective action for years. What is new in the 2015 version of ISO 9001 is the addition
of customer complaint language.

Auditors found customer complaint logs maintained, but decisions regarding disposition or corrective action not defined or documented. Additionally, corrective action follow-ups were not documented all the time. These findings could have been caught by internal auditors.

Hopefully, awareness of these common nonconformance's will aid ISO 9001:2015 organizations to make improvements that can help to effectively drive their business for results.


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