The Five Key Changes in ISO9001:2015 are:
- The use of ISO Annex SL document structure changes the ISO9001:2008 five certifiable clauses (4 to 8) into seven certifiable clauses (4 to 10). Thus, making it easier for organizations to comply with multiple management system standards that use Annex SL document structure.
- The term “Document Information” replaces the terms “Documents”, “Records” and “Procedures”. This provides flexibility on how organizations maintain their quality knowledge and data. There is also no mandatory requirement to have a Quality Manual.
- The introduction of “Risk Management” that modifies the requirement of “Preventive Action” of ISO9001:2008. Risk Management encompasses a wider scope of preventive methods when compared with Preventive Action. Risk Management requires the organization to identify risk impacts to the product and business and have mitigation plans available to reduce those risks AND to continue to take action to eliminate causes of a potential nonconformity that could occur in products and processes.
- The Management Representative (MR) requirement has been removed. The responsibilities of the QMS is placed on the organizational “Leadership” and not just on a person within the Leadership.
- Management Review includes additional requirements for review which are “internal and external organizational changes impacting quality”, “performance of external providers” and “assessing business risks and opportunities”.