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ISO 9001:2015 Why its relevant and what are the changes

ISO 9001 is the world’s most used management system standard, and all eyes are on this revision.

The impact it has had in shaping how organizations manage the issue of quality correctly, is huge. No organization can afford to let their standards slip and the new ISO 9001 encompasses the changing needs of businesses. In this article we’ll look at how ISO 9001 has evolved over the years and the changes related to the Final Draft International Standard (FDIS).

ISO 9001 started life in 1992 as BS 5750, driven by the Ministry of Defense which specified how manufacturing processes should be managed, instead of looking at what was manufactured. In 1987, ISO adopted BS 5750 and it became ISO 9001. The 1994 version of the standard particular emphasis on product assurance using preventive actions, instead of just checking the final product and also required documented procedures.

The radical change came in the 2000 version when it placed quality and process management at its core. It aimed to first understand the client’s requirements before designing processes that would help deliver these. It also looked at how to continuously improve processes and track customer satisfaction. Where previous versions focused on quality control, ISO 9001 2000 was built on quality management. ISO 9001 2008 only made the existing requirements clearer.

So why the need for change now?

Since 2000 the way we do business has changed enormously. We all have instant access to information and higher expectations of organizations we work with, whilst having to deal with more complex supply chains and a globally competitive economy. ISO 9001 2015 has been revised to take this into account and the key changes are.

  • Greater emphasis on building a management system suited to each organization’s particular needs
  • A requirement that those at the top of an organization be involved and accountable, aligning quality with wider business strategy
  • Risk-based thinking throughout the standard makes the whole management system a preventive tool and encourages continuous improvement
  • Less prescriptive requirements for documentation
  • Alignment with other key management system standards through the use of a common structure and core text

ISO 9001 2015 brings quality management and continual improvement into the heart of an organization. The new standard is an opportunity for organizations to align their strategic direction with their quality management system and means that it can be used to help enhance and monitor the performance of an organization.

So what has changed specifically?

ISO 9001 2015 is based on Annex SL – the new high level structure. This is a common framework for all ISO management systems and helps to keep consistency, align different management system standards, offer matching sub-clauses and apply common language across all standards. There are 10 clauses within the standard and these are the changes:

Clause 1 is very similar to the 2008 version covering the scope of the standard and there has been very little change to this clause.

Clauses 2 and 3 cover normative references and term and definitions, both these clauses reference ISO 9000, Quality Management System – Fundamental and vocabulary which provides valuable guidance.

The remainder of the clauses include some new key elements which need to be considered when implementing the new standard.



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