Friday, August 14, 2015

ISO 9001: Two Important Changes Coming to a QMS System Near You

ISO 9001 is the world’s most utilized management system standard, and currently, all eyes are on its
revision. The anticipated release date later this year of the revised version, ISO 9001:2015, has many companies asking how the revision will affect them. Specifically, what are the key changes required for existing ISO 9001-compliant quality management systems to achieve compliance with the revised standard? Michigan Manufacturing Technology Center (MMTC) has some of the answers. Follow along below for two changes you should expect to see in the upcoming, revised standard.

No More Management Representative?
The Management Representative has been a mainstay with ISO 9001 since its inception in 1987. Since then, it has created frustration and even confusion amongst some smaller companies who tried to select a member of management to fulfill the role. Since many of these small companies often have only one person in management, an artificial management position was created on the organizational chart to check a box and meet the standard.

Well, good, bad or indifferent, ISO 9001:2015 will be eliminating the Management Representative position. LET'S BE CLEAR: ISO 9001:2015 will only be eliminating the position, not the responsibilities. Just as it is outlined in the current version of ISO 14001, there is an option of having more than one management representative with ISO 9001:2015. The following is an excerpt from the Final Draft International Standard (FDIS):

“Top management shall assign the responsibility and authority for:
a) ensuring that the quality management system conforms to the requirements of this International Standard;
b) ensuring that the processes are delivering their intended outputs;
c) reporting on the performance of the quality management system and on opportunities for improvement (see 10.1), in particular to top management;
d) ensuring the promotion of customer focus throughout the organization;
e) ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.”

The removal of a mandated management representative greatly increases the flexibility for smaller organizations. As a manufacturer, start thinking about how you will meet the modified requirements. Share your opinions and ideas with us in the comments of this blog!

No More Documents?
While one of the largest ISO 9001:2015 change for most people will be the new structure (going from eight to 10 clauses), another significant change is the removal of any mandatory procedures or documents. So, for those who thought the system was paperwork heavy before, you will now be able to justify less documentation – at least to an extent.

Before you start rejoicing in a less paper and process filled world, you need to understand the meaning of a new term in the ISO 9001:2015: Documented Information. While there are no documented procedures mandated by the new standard, it does state that various items shall be maintained as “documented information”.

For instance, the quality policy:

“…shall be maintained as documented information”. 

Another portion states,

“The organization’s quality management system shall include: 

  • Documented information required by this International Standard; 
  • Documented information determined by the organization as being necessary for the effectiveness of the quality management system.”

The intention of the standard is to focus on the organization and process, not just a documented system. Yet, documentation is still required where needed. Don’t throw away your current documentation until you review it against the new ISO requirements. During transition, you will be able to streamline your system, but documented procedures, work instructions, forms and records may still be needed. With ISO 9001:2015 you will have the flexibility as an organization to determine which ones you do and don’t need.

ISO 9001:2015 is on the minds of many Michigan manufacturers. Stay on top of ISO 9001:2015 by joining MMTC quality experts at the 2015 Proud to Manufacture in Michigan Conference September 23-24. Hear more information about to what to expect with the revised standard in the months to come.

Since 1991, MMTC has assisted Michigan’s small and medium-sized businesses compete and grow. Through personalized services fitted to meet the needs of clients, we develop more effective business leaders, drive product and process innovation, promote company-wide operational excellence and foster creative strategies for business growth and greater profitability. Find us at

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