ISO 9001:2015 Is Published: What Changed from the 2008 Edition
The 2015 edition of ISO 9001 was published in September 2015. It keeps the purpose of the standard and changes how organisations are expected to think about context, risk and leadership.
Key points
- ISO 9001:2015 was published on 15 September 2015 with a three-year transition period.
- The standard now follows the common structure used by all new ISO management system standards.
- Risk-based thinking replaces preventive action, and top management carries more direct responsibility.
A new structure
ISO 9001:2015 has ten clauses and follows the high-level structure that ISO now uses for all management system standards. The practical benefit is that quality, environmental and other systems can be integrated more easily, because they share the same clause titles and core text.
The main changes
- Context and interested parties: the organisation must understand the issues and the parties that affect its ability to deliver.
- Risk-based thinking: risks and opportunities are addressed when planning the system; the separate clause on preventive action has gone.
- Leadership: top management is accountable for the effectiveness of the system; a management representative is no longer required.
- Documented information: the terms “documents” and “records” are replaced, and a quality manual is no longer mandatory.
- Organisational knowledge: the knowledge needed to run the processes must be identified and maintained.
What certified organisations should do
Certificates issued against ISO 9001:2008 remain valid during the transition period, which ends in September 2018. Start with a gap analysis, train your internal auditors on the new edition, and agree a transition date with your certification body well before the deadline.