Changes In The New ISO 9001:2015 Revision

The ISO 9001:2015 has been officially published by ISO on 23rd September 2015. Let's look at the changes as compared to the ISO 9001:2008 version, as follows:
  1. The format of the standard has changed dramatically with the adoption of Annex SL's high level structure. This facilitates easy integration of ISO 14001:2015 and other standards as they get revised in the very near future.
  2. The introduction of risk-based thinking in planning for the quality management system. This implies that the organization must consider all risks and opportunities that it can identify within its external and internal environments, and gaps in meeting the needs and expectations of interested parties. See 3, 4 and 5 below.
  3. Understanding the external context of the organization in terms of risks and opportunities.
  4. Understanding the internal context of the organization in terms of risks and opportunities.
  5. Identifying and determining the needs and expectations of interested parties. It used to be just customers and regulatory bodies with regards to the organization's products and services.
  6. The deletion of the requirement for the appointment for a management representative.
  7. The deletion of the requirement for preventive actions. This is replaced by the risk-based thinking as explicitly stated in Clauses 4.1, 4.2 and 6.1.
  8. Deletion of the requirements for the six mandatory documented procedures for the control of documents, records, internal audit, nonconforming product, corrective action and preventive action.
  9. Introduction of the term documented information to represent documents and records.
  10. Introduction of the terms risk and opportunity. Risk is defined as the effect of uncertainty and the decision to adopt a risk represents taking advantage of an opportunity to gain from the risk. The control strategies for managing risks include avoiding them, reducing the negative impacts and / or the likelihood of their occurrences, or accepting them in order to gain beneficial outcomes.
If you are transitioning from the ISO 9001:2008 to the ISO 9001:2015 version, what should you do? Read this transition guidance. And do this:
  1. Revise your Quality Manual to reflect the ISO 9001:2015 Standard. This is to ensure that you don't leave out anything from the standard and it also facilitates effective audits of your quality management in terms of the audit criteria.
  2. Maintain all existing documented procedures but reference them in the Quality Manual.
  3. Carry out a SWOT analysis of your organization.
  4. Introduce a risk assessment procedure with the scope covering your organization's external context, internal context and needs and expectations of interested parties.
Read more on ISO 9001:2015 Revision.

Ismail Latiff  helps his corporate clients implement the ISO 9001, ISO 14001 and OHSAS 18001 International Standards via training, documentation development, audit and advisory services. Check out his presentations on Slideshare.