Certified ISO 9001 systems account for over 75% of all ISO certifications with over 1 million systems operating in 187 countries.
The revised ISO 9001:2015 standard was published in September 2015 and all organization’s that are currently certified to ISO 9001:2008 have up to 3 years to transition to the new standard and achieve re-certification.
The transition from ISO 9001:2008 to ISO 9001:2015 will, of course, require some work to ensure the system meets the new requirements of the standard but it is also a unique opportunity to review the existing system (i.e. policy, procedures, forms, etc.) for relevancy and also to consider what opportunities are presented by the adoption of the new standard.
The steps we take are typically aligned to the classic Plan-Do-Check-Act cycle, see below, but we always start with a gap analysis and management review:
1. Structured gap analysis against the requirements of the new standard
2. Review with top management (leadership) to discuss the outcome of the gap analysis and explore the impacts, implications and opportunities associated with the transition.
e.g. review of business context, interested parties, system objectives and consider integration with other management systems.
e.g. establish policies, create new procedures, allocate roles & responsibilities, communicate
e.g. review system performance, check alignment of system objectives against strategic business objectives
e.g. actions arising from improvement activity
The diagram below illustrates how the 10 clauses of ISO 9001:2015 can be applied to the traditional PDCA model.