Changes to ISO 9001:2015
Changes to ISO 9001:2015
As we help organization transition into the new ISO 9001:2015 standard through transition projects, transition classes and transition Lunch and Lean’s we have noticed several of the same questions being asked regarding the changes. Below is some information that might help answer some of those questions and help other organizations on their transition journey. This information can also be very helpful to those organizations initially implementing the standard.
One of the most notable changes to ISO 14001:2015 and ISO 9001:2015 is the introduction and use of Annex SL (previously known as ISO Guide 83). Annex SL forms the basis of a generic management system. It is designed to help streamline the creation of new standards and make implementing/ integrating multiple ISO standards within one organization much simpler.
Annex SL has 10 high level clauses:
Clause 1- SCOPE
Clause 2- NORMATIVE REFERENCES
Clause 3- TERM AND DEFINITIONS
Clause 4- CONTEXT OF THE ORGANIZATION
Clause 5- LEADERSHIP
Clause 6- PLANNING
Clause 7- SUPPORT
Clause 8- OPERATION
Clause 9- PERFORMANCE EVALUATION
Clause 10- IMPROVEMENT
A significant change that can be observed in the new 2015 standard is that where requirements were previously implied now the wording has been changed to make the requirement explicit. The use of a process approach and risk-based thinking along with understanding the organization and its context are the most significant examples.
Clauses 4.1 and 4.2 are new clauses in the standard
4.1 Understanding the organization and its context
To understand the organization and its context the organization must identify any relevant external and internal issues that may (or have) impact(ed) the quality management system.
4.2 Understanding the needs and expectations of interested parties
The organization must identify those individuals and organizations that can affect, be affected by, or perceive themselves to be affected by a decision or activity of the organization. The organization must then determine the needs and expectations for these interested parties.
4.3 Determining the scope of the organization
Exclusions have been removed from the standard. The scope must contain justification for any requirements deemed “non applicable” in the QMS
In the previous standard (ISO 9001:2008) clause 5 addressed Management Responsibility and the management representative. There is no longer a requirement for a management representative. Clause 5 has been renamed “Leadership” and top management are required to demonstrate that they engage in key quality management system activities as compared to ensuring that the activities occur. This change requires the QMS to be part of everyday business operations instead of an independent management system within the organization.
What does this mean?
Top management is accountable for the effectiveness of the QMS. Top management must ensure that someone else is doing it “correctly” or they must do it themselves. This does NOT mean that the organization must eliminate the role but some of the responsibilities must be undertaken directly by top management.
The new standard has removed the references to requirements for a documented quality manual, documented procedures and to quality records. Does this mean you don’t have to keep any documents for your quality management system? No, organizations still have to keep documents. Some requirements are explicit such as the scope and quality policy. To the extent necessary, the organization shall maintain documentation (SOP, WI) to support the operation of its processes. Sufficient documents (records) must be retained to have confidence that processes are being carried out as planned. There is no need or requirement to through away your existing quality manual and documented procedures. If it’s working for you then keep using it.
For any questions regarding ISO 9001:2015 transition courses and implementation assistance please contact Esteban Pedraza at Esteban.firstname.lastname@example.org