Section 6.3 of ISO9001: 2015 requires the organisation to consider changes in a broader sense. In previous iterations of the 9001 series, changes would traditionally have been thought of as document and version control.
In this clause the Standard requires the organisation to consider changes in both a broad and operational manner. The author would advocate examination of the high-level interaction of processes diagram by the management team, during change reviews.
When considering change it is wise to examine what dependent processes may be affected.
Changes might occur when new objectives are set, or the business finds it should offer conceptual design. Additionally, new services may result in changes to other processes with regards inputs, monitors and measures and outputs.
Changes to the operating environment could alter the risks that the business faces. Processes might need to be tightened or greater verification activities deployed during processing to meet new contractual requirements.
When changes are made the Standard requires that the purpose of the change should be identified. Consideration of the quality system is required. The availability of resources and an assessment of roles and responsibilities is necessitated.
The author advocates that that this process should be recorded and evaluated with appropriate approval. This provides a suitable audit trail for future evaluations of the effectiveness of changes made.
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Marcus has twenty years’ experience in delivering Governance, Risk and Compliance solutions to over two hundred organisations within the UK. Including over one hundred ISO9001 programmes.
Marcus holds a BSI ISO9001 lead auditor qualification and is registered on the BSI Associate Consultant Programme.
Marcus holds the respected Diploma in Governance, Risk and Compliance from the International Compliance Association and holds a master’s degree in Management Learning & Change from the University of Bristol. Marcus is a Fellow of the Institute of Consultants and Fellow of the Chartered Management Institute.