Scope creation can be more complex with ISO9001: 2015 as organisation’s consider what is needed and what activities should be included. In simple terms the boundary definition needs establishing.
The first issue for the management team to consider are the external and internal factors and their needs and expectations, as the quality system should be created to satisfy these requirements.
In addition, feedback from interested parties should also be considered and aligned with the framework of the quality programme. If all parties require high quality products with sureties and product certifications, then the processes developed need to ensure such outcomes can be achieved.
The operational structure of the business should be considered and align with key processes.
Ideally all key activities should fall under the ISO9001: 2015 programme, exclusions can cause quality related issues.
Infrastructure needs, and the various operational sites of the organisation should be considered. If there is significant site working this might require inclusion.
It is important to remember that all parts of the Standard are deemed applicable unless after careful review an organisation can satisfy itself and its selected certification body that such a clause is not appropriate.
The organisation should document the scope. Often a short statement and a diagram will suffice. The author suggests that this is done early with consultation of the selected certification body.
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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.