Understanding Your Quality Management System

Companies Have 3 Years to Become Compliant for ISO 9001:2015
Release Date: 
Tuesday, January 26, 2016
Release Number: 
16-0126KY
Contact: 
michael.ashcraft@sba.gov

First, some background. All companies should be cognizant of the quality of their products. Bad quality tends to kill future relationships and is bad for business. How often do you frequent a restaurant that consistently gives you undercooked food, dirty silverware and has generally ill-mannered staff? Those types of establishments normally go out of business fairly quickly. The same goes for manufacturers. Inconsistent quality, bad customer service, undeveloped strategies, and undocumented problems is a strong sign of a lack of a Quality Management System.

According to Wikipedia, “The ISO 9000 family of quality management systems standards is designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product.” In other words, its helps document and support a structured reliable quality program ensuring the product is consistent with the standards that were decided on in advance. With a documented quality program, your customers simply have more faith in your products.

Regardless if you have a Certified ISO System or not and there are many legitimate reasons to only be “compliant”, the playing field just changed. On September 15th of 2015 the ISO TC 176 released both ISO 9001:2015 and ISO 14001:2015 Standards. This means the clock is ticking and you have 3 years to convert your current documented quality system (QMS) to the new standard and be re-registered.

Below is a short list of tidbits about the new ISO 9001:2015 Standard.

  1. ISO TC 176 has allowed three years for the conversion;

  2. The new standard does not require a quality manual;

  3. No requirement for a management representative;

  4. Difficult for internal auditors to audit;

  5. Record retention has been refined;

  6. No requirement for a preventive action procedure;

  7. Compliance sections are now 4 through 10;

  8. Requires documented information covering the context of the organization;

  9. Framework for documented information is very similar to the environmental standard ISO 14001;

  10. The QMS is focused on the strategic direction of the organization, interested parties, process controls and their interactions with other processes;

  11. Risk-based thinking needs to become the culture of the organization;

  12. Knowledge necessary for the operation of processes;

  13. The term process is mentioned 62 times in compliance sections 4, 5, 6, 8, 9, and 10;

  14. Outputs and inputs are required 21 times in compliance sections 4 – 10;

  15. Reviews are recommended or required 31 times in compliance sections 4 – 10.

Issues companies are facing are (1) fully understanding what has changed and (2) not knowing where to turn for assistance, as most ISO initiatives take an average 12 months to complete.

For more information regarding the ISO 9001:2015 Program, please go to AKA’s website at www.AdvantageKY.org or click here.

About AKA: Advantage Kentucky Alliance (AKA) specializes in helping manufacturers uncover their problems, create solutions for those problems, and implement change so those problems go away or at least are minimized. For more information about the Advantage Kentucky Alliance, the ISO 9001:2015 Program, ISO 9001/14001 assistance in general, or AKA’s various manufacturers “Best Practices” programs, contact Scott Broughton, Center Director at scott.broughton@wku.edu , at 814-505-3786 or visit www.AdvantageKY.org.