BACKGROUND:

All businesses operate with multiple processes that must function correctly individually and work seamlessly as a whole in order to efficiently and effectively meet customer requirements. The “process approach” was introduced in the ISO9001:2000 standard as a means of showing the importance of interactions of standard processes in the business and their impact on results, including customer satisfaction. No individual or process has sole impact on the overall output of the business. No one can take sole blame when things go wrong and no one can take sole credit when things go right. The emphasis is on the interactions in the Quality Management System (QMS) and that “the whole is greater than the sum of its parts”.

ISO 9001:2015 will maintain that focus and expand and/or clarify how processes are to be managed within the QMS. This is not a departure from the current process approach, but merely an enhancement.

SUMMARY OF ISO 9001:2015 NEW REQUIREMENTS:

1. Inputs required and outputs expected from each process must be defined and their interactions must be managed. This goes beyond the ISO 9001:2008 requirement to “determine the sequence and interaction of these processes” (4.1 b).

2. Performance indicators must be established to measure the performance of the QMS processes. This is implied in the ISO 9001:2008 standard, but now made explicit.

3. Responsibilities and authorities for processes must be assigned. This the first time “authorities” have been used in an ISO 9001 standard, to my knowledge.

4. Risks and opportunities associated with each process must be determined along with planning and implementing appropriate actions to address them. I believe this simply clarifies how continual improvement (which has always been required) should be addressed.

5. Maintain documented information needed to support the processes and retain documented information to the as needed to have confidence that the processes are being carried out as planned.