By Kathy on Sep. 20, 2017
(Modified Feb. 7, 2018)

Thriving companies know that producing a quality product is the only reliable path to success. Most are well-versed in the International Organization for Standardization’s detailed program for incorporating quality throughout the business.

After three years of diligent work, experts around the world created a revised version of the ISO 9001:2008 requirements: ISO 9001:2015. Certified companies were permitted three years to upgrade their certificates, and by September 2018, all businesses will be operating at a new level of excellence.

Since they were first published in 1987, the ISO standards have given companies in every industry a blueprint for streamlining processes, improving efficiency and producing high-quality products. The most recent revision was specifically focused on taking the impact of increased globalization into consideration. While ISO 9001:2015 is still based on the same seven quality principles, there is increased attention given to the transformation of business methods over the past decade.

The 3 Changes That Will Affect Your Manufacturing Company the Most

“The revised standards are less of a revolution than an evolution,” according to Nigel Croft, Chair of the ISO subcommittee that worked on the changes. While they are intended to “bring ISO 9001 firmly into the 21st century,” you will not be required to completely overhaul your current processes to upgrade your certification. Instead, ISO 9001:2015 changes the focus from documentation to managing processes with risk-based thinking. Three of the biggest changes to be aware of include the following:

  • Formal Risk Analysis – The new standards place heightened emphasis on the importance of formal risk analysis — and this change makes the preventative measures section of ISO 9001:2008 obsolete. As an organization, your goals have changed, and you are now tasked with using risk analysis to identify management challenges in your business processes.
  • Context of the Organization – Instead of creating generic quality management systems that apply to all certified companies, ISO 9001:2015 takes a new approach. Organizations are required to design their quality management systems based on the context in which they operate. This means asking new types of strategic questions that apply to the particulars of the company’s internal and external environment and take into consideration all interested parties.
  • Interested Parties – Finally, the definition of interested parties has changed. While the ISO 9001:2008 standards emphasized customer needs, ISO 9001:2015 has changed the scope of which groups warrant consideration as you develop your products and services. Examples of additional interested parties listed in the new standards include employees, suppliers, legislators, and shareholders.

Next week we will discuss the application of the new ISO 9001:2015 standard to the automotive manufacturing sector more specifically, as well as how the new standard impacts DECC’s services.

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