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--- articles:qms_vs_iso9001_cert_mgmnt_system [2023/03/21 20:52] – [How a QMS is different from a "Certified Management System"?] rrandall
+++ articles:qms_vs_iso9001_cert_mgmnt_system [2023/12/08 08:09] (current) – [But our customers demand we hold a QMS Certification...] rrandall
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-====== How a QMS is different from a "Certified Management System"? ======
+====== How a QMS is different from a "Certified Management System" ======
-Upon being asked this question, most 3rd Party QMS Auditors would say that there is no difference.
+EVERY company in a free market economy has a QMS (Quality Management System). Whether formal or informal and regardless of the degree to which it is documented, it exists because management views it as adding value. This QMS likely existed prior to the company ever becoming aware of ISO 9001 (or AS9100). We know this because if the company didn’t have any sort of QMS, customers would take their business to competitors and it would (eventually) cease to exist! I'll refer to this QMS as the "__actual__" QMS.
-However, 3rd Party QMS Auditors typically visit companies wearing "blinders". Their primary job is to verify the company's compliance with a QMS standard (e.g., ISO 9001, AS9100, AS9120). And if a company develops procedures beyond those specified by the standard, the Auditor will often verify compliance with those as well. The Auditors "think" that they're auditing the company's Quality Management System (QMS). And while this is partially true, they're also auditing a QMS Certification accessory!
-EVERY company in a free market economy has a QMS (Quality Management System). Whether formal or informal and regardless of the degree to which it is documented, it exists because management views it as adding value. This QMS likely existed prior to the company ever becoming aware of ISO 9001. We know this because if the business didn’t have any sort of QMS, it would not have customers and would cease to exist! I'll refer to this QMS as the "__actual__" QMS.
 A "Certification Management System" (usually maintained by one or two key people) is developed, implemented, and maintained for the sole purpose of obtaining and retaining QMS Certification from an accredited Certification Body (CB). The value in obtaining a QMS Certification is to:
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   * Market to customers who perceive value in the "QMS Certification".
-While there is a significant overlap between these two systems, the "actual" QMS operates independently of any "QMS Certification" status.
+While these two systems overlap, the "actual" QMS operates independently of any "QMS Certification" status. The primary difference between these systems is that the "__actual__" QMS is "Customer Focused" while the "Quality Certification Management System" is "Auditor Focused".
+{{ :articles:qms_vs_qcms_venn_diagram-transp.png?direct&400|}}
 Here are some indicators that this dual system is in place:
-  * Rather than referring to its Quality Management System as simply a "QMS", the company will literally attach the identification of the standard for which it is being "certified" as a prefix. For example, its "ISO 9001 Quality Management System" or "AS9100 Quality Management System" (tacitly acknowledging the dual system in place).
+  * Rather than referring to its documented Quality Management System as simply a "QMS", the company will literally attach the identification of the standard for which it is being "certified" as a prefix. For example, it's "ISO 9001 Quality Management System" or "AS9100 Quality Management System" (tacitly acknowledging the dual systems in place).
-  * If a key person managing the "QMS Certification System" leaves the company, the business will struggle during its next external audit because there is no one managing the "QMS Certification System". However, the outgoing quality usually remains unchanged because the "actual" QMS is still functioning.
+  * If a key person managing the "QMS Certification System" leaves the company, the business will struggle during its next external audit because there is no one managing the "QMS Certification System". However, the outgoing quality usually remains unchanged because the "actual" QMS is still functioning as usual.
   * In some cases, the person managing the "QMS Certification System" has the identification of the standard embedded in their title (e.g., ISO 9000 Manager, ISO 9000 Systems Director, ISO 9000 Administrator).
   * [[ :articles:why_companies_dont_promote_their_qms_certifications|Not promoting (or poorly promoting) their registration]] (e.g., on their website)
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 [[https://deming.org/|{{ :articles:every-system-is-perfectly-10141-1.png?&400|}}]]
 ==== Doesn't ISO 9001 / AS91xx improve Quality? ====
-Whether ISO 9001, AS9100, or any other QMS Standard improves your "actual" QMS depends on the level of maturity and sophistication of your "actual" QMS. Remember, ISO 9001 is an "entry-level" QMS Standard intended to improve companies with an extremely basic, immature QMS producing poor or inconsistent results.
+Whether ISO 9001, AS91xx, or any other QMS Standard improves your "actual" QMS depends on the level of maturity and sophistication of your "actual" QMS. Remember, ISO 9001 is an "entry-level" QMS Standard intended to improve companies with an extremely basic, immature QMS producing poor or inconsistent results.
-Companies with very mature and sophisticated quality management systems (e.g., using Lean Six Sigma & TRIZ) would not benefit at all from implementing ISO 9001 or AS9100. In fact, ISO 9001, AS9100, and many other QMS Standards actually promote some [[how_iso_perpetuates_flawed_concepts|flawed, antiquated concepts]]. Consequently, compliance with these standards could actually have an adverse effect on a sophisticated QMS! This is why some major companies do not seek QMS Certification.
+Companies with very mature and sophisticated quality management systems (e.g., using Lean Six Sigma & TRIZ) would not benefit at all from implementing ISO 9001 or AS9100. In fact, ISO 9001, AS9100, and many other QMS Standards actually promote //some// [[how_iso_perpetuates_flawed_concepts|flawed, antiquated concepts]].
 ==== But our customers demand we hold a QMS Certification... ====
-When companies have a sophisticated QMS, and customers demand that they also hold a QMS Certification, this presents interesting challenges. For companies with mature, sophisticated Quality Management Systems, seeking QMS Certification "could" actually be detrimental to their finely tuned QMS. In fact, some Quality professionals have stated: "//A company can have an excellent QMS, or it can have a certified QMS, but it can't have both//". While this may be a binary oversimplification of the challenges that having both presents, it should highlight that there are indeed significant challenges to having both.
+When companies have a sophisticated QMS, and customers demand that they also hold a QMS Certification, this presents some interesting challenges. For example, the company must have personnel who are able to:
-The company must have personnel who are able to:
   - Effectively defend & justify its interpretation and application of the standard; and
   - Educate the external auditor(s) as to "how" the more modern tools satisfy the requirements of the standard.
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 === Auditor Competence ===
-Since ISO 9001:2015 is outdated (by decades), many of the ISO 9001 auditors still rely on outdated information for the purpose of interpreting the standard. While these ISO 9001 Auditors may have been extremely competent 30 or 40 years ago, they are often ill-equipped to interpret and apply the requirements of ISO 9001 to a company that has implemented more modern concepts... such as Lean Six Sigma. And the vast majority of these Auditors have never even heard of TRIZ.
+ISO 9001:2015 was designed to be both simple (entry-level) and generic. However, many of the ISO 9001 & AS91xx auditors still rely on outdated information to interpret the standard. While these ISO 9001 & AS91xx Auditors may have been extremely competent 30 or 40 years ago, they are often ill-equipped to interpret and apply the requirements of ISO 9001 & AS91xx to a company that has implemented more modern concepts... such as Lean Six Sigma. And the vast majority of these Auditors have never even heard of [[https://www.amazon.com/Apollo-Root-Cause-Analysis-Thinking-dp-1883677114/dp/1883677114/|Apollo Root Causes Analysis]] or [[https://triz.org/|TRIZ]].
-Case-in-point, I heard one experienced Aerospace Auditor state: "//I don't care how much Lean Six Sigma a company has, it's not going to make them a better company.//" This is an appalling level of Auditor incompetence in the quality profession.
+Case-in-point, I heard one experienced Aerospace Auditor state: "//I don't care how much Lean Six Sigma a company has, it's not going to make them a better company.//" This is an appalling level of Auditor knowledge in current quality tools and techniques.
-I've witnessed multiple Auditors complain and even issue nonconformities simply because they did not understand the logic of how the company had interpreted and applied the standard. While these invalid nonconformities should be appealed, far too many companies lack the personnel with the knowledge, skills, and ability to submit a proper appeal to the CB. This has resulted in companies experiencing their QMS being "held back" by ISO 9001!
+I've witnessed multiple Auditors complain, and even issue nonconformities, simply because they did not understand the logic of how the company had interpreted and applied the standard. While these invalid nonconformities should be appealed, far too many companies lack personnel with the knowledge, skills, and ability to submit a proper [[articles:how_to_appeal_nonconformance|appeal]] to the CB.
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