This is the second part of a series of articles about the “Good Practices: Experience in the Market Surveillance of ISO 9001 Quality Management Systems” report, which was published in October 2016 by the United Nations Industrial Development Organization. Read the first part of the series here.
According to the report, the weakest areas of ISO 9001 implementation identified during the market surveillance visits were:
- A lack of understanding and effective implementation of the process approach throughout the organization.
- A general lack of focus on preventing nonconformities.
- A poor culture of continual improvement.
- Poor use of the Plan-Do-Check-Act approach to manage quality management system processes.
- Lack of adequate cause analysis and effective corrective action for process, product, and system nonconformities.
- Inadequate internal communication and employee understanding of their roles in the quality management system.
The traditional methodology used for accreditation of management system certification bodies is based on ISO/IEC 17011 and typically involves office assessments in conjunction with witnessing a sample of the certification bodies’ audits.
Office audits necessarily focus on the administrative aspects of a certification bodies’ activities and include extensive documentation review. While witnessed audits are more operational in nature, in the past they have been shown to alter the behaviour of a certification body auditor in the presence of the accreditation body’s assessor and may not be representative of the reality of audits under normal conditions.
In recent years there have been growing concerns about the effectiveness of this methodology in ensuring that expected outcomes from management system certification are being achieved consistently across accredited certification bodies globally.
The report outlines that IAF informative document ID4:2012 provides suggestions about how short market surveillance visits might be used by accreditation bodies to complement traditional oversight techniques.
In the context of accreditation, this is consistent with Clause 7.11.2 of ISO/IEC 10711:2014 which states “The accreditation body shall establish procedures and plans for carrying out periodic surveillance onsite assessments, other surveillance activities and reassessments at sufficiently close intervals to monitor the continued fulfilment by the accredited CAB of the requirements for accreditation.”
While some accreditation bodies already conduct such visits to certified organizations, and while the objective of IAF ID4 is not to make such visits mandatory, it is intended to provide a common platform and methodology for such visits if and when they are deemed appropriate.
Certification bodies whose certified clients demonstrate a high level of confidence in the effectiveness of their management systems during market surveillance visits may benefit from a less onerous program of office assessments and witness audits by the accreditation body. At the other end of the spectrum, certification bodies whose certified clients do not provide an acceptable level of confidence could be subject to a more intense and targeted program of traditional oversight.
Continue to read The Auditor Online in the coming weeks for more findings from the “Good Practices: Experience in the Market Surveillance of ISO 9001 Quality Management Systems” report.