New Trend of not seeking Official ISO 9001 Registration

QMMike

Involved In Discussions
#1
I was curious, it seems more and more companies that I've been talking to - as long as having a 3rd party registered quality system is not an official customer requirement - people are starting to let their certification lapse and just state that they have an "ISO (or insert standard here) Compliant Quality System".

This got me thinking --- if it is not a customer requirement, it is basically a sales tool, and if new customers (as well as current customers) still insist on coming in for an audit; a weak sales tool at best, no?

Does it make more business sense to seek registration, obtain it - then if it isn't a customer requirement let it lapse so you aren't wasting money on something that isn't required? From a COQ standpoint, I would think its a no-brainer.

Are these companies on to something? What are your thoughts?
 
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Re: New trend of not seeking official registration

I have often seen the statement "Compliant to ISO 9001:xxxx" and am not sure how many people notice the difference between compliant and certified. Certainly very few are aware of the nonaccredited registrars and the fake accrediting body issuing certificates.
 

QMMike

Involved In Discussions
#3
Re: New trend of not seeking official registration

I see it as well. Maybe I am just noticing it more and more now? Not sure, but thinking about it more it makes sense.
 
#4
Re: New trend of not seeking official registration

We voluntarily de-certified, and called our QMS Compliant. In today's global market, quite a few countries demand it. For those of us in the 9001:2015 world, the certificate just makes things a bit easier...:)
 

howste

Thaumaturge
Super Moderator
#5
Re: New trend of not seeking official registration

I've seen "ISO 9001 compliant" advertised where it means they read the standard once and may have a few things implemented that slightly resemble parts of a QMS. I've audited quite a few suppliers that said compliant on their website but they didn't even have basic things like management review or internal audits. As a 3rd party auditor for many years I can spot the difference quickly, but many people can't.

Certification (or not) is a strategic decision made by the organization. If their important customers require it, they will do it. If their customers don't require it, and it doesn't affect business being awarded to them, they may not. I was a QMS consultant for 10 years. Only one company during that time asked me to help them to implement a QMS for their own benefit (with the possibility of certification later) instead of customer requests for their certification.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#6
Re: New trend of not seeking official registration

I see it as well. Maybe I am just noticing it more and more now? Not sure, but thinking about it more it makes sense.
I think you're just noticing it more, ad it may also be that fewer companies are requiring it of their suppliers. I haven't been following the registration stats, but I've been seeing "self declaration" and "self certification", as well as "compliant" for quite a few years now.

I used to do ISO 9001 implementations and my experience goes back to early 1990's. All were for sales or customer requirement, much like howste's experience. That is not to say companies didn't want to see improvements, but that was never the what caused them to seek certification/registration.
 

dwperron

Trusted Information Resource
#7
Re: New trend of not seeking official registration

BLASPHEMY!!!

Now that I have that out of my system...

I've been fortunate to have worked at organizations that at least took the process of certification and accreditation seriously. They saw the value, and sometimes necessity, that certification can bring to customer and regulatory relationships. However, I have not worked for an organization that utilized these programs as a method of improving their performance. It was all just window dressing. Get through the audits and publish the certificates.

On the other hand, I have also seen that many successful organizations already have an informal program in place that approximates the goals of ISO 9001. They document their processes, have document control, perform corrective action activities, training, etc. They generate performance metrics, gauge customer satisfaction, deal with nonconforming product. They do it because they know these are the right things to do to grow their business. They need to constantly improve to survive!

It still galls me to see "Compliant" statements. I wonder why a customer who determines that ISO registration is important doesn't back that up by requiring the real thing. Whatever happened to "Accept no substitute"?

Today we are far too willing to accept imitations - as long as they are cheaper.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#8
Customers don't care about system certificates in the supply chain. Customers want confidence (assurance if possible) in a reliable, high performing supply chain. Customers want their orders fulfilled as per their expectations. Customers want suppliers to be more of an asset/opportunity and less of a liability/risk.

Management system standards and the associated certification processes are components of an effort to improve supply chain performance. Unfortunately, a high percentage of the interested parties in the global supply chain seek, attain, maintain and/or deliver certificates which are undeserving and dissociated from the confidence they should bring. Let's face it: certification that does not result in higher levels of confidence is useless. So, for almost 30 years now, the management system certification business space is fielded by the whole range of people; in one end, we have the fraudsters, the scam artists, the bozos; in the opposing end, we have the competent, professional, value-adding practitioners; and everything in between. So, to paint certification with a wide brush is to negate the obvious. Not all certificates can be trusted and, unfortunately, that's a fact.

In between a (highly questionable) self declaration of compliance and a 3[sup]rd[/sup] party accredited certification, there is a very sensible logical and confidence-providing solution. Details of such solution may be provided privately.
 
Last edited:

Edward Reesor

Trusted Information Resource
#9
I haven't noticed this trend but I will start paying attention to it now.

Unfortunately I see this as a result of the ever increasing layers of certification and the associated costs that go along with it. As new standards are being released and others are updated, costs to maintain certification keep escalating. With the MDSAP system, now two auditors will be in attendance plus the submission of the files beforehand. Throw in the unannounced audits both upstream and downstream and you can see how the small companies will be squeezed out. The FDA is supposed to be weaned off the public purse and should become financially self-sufficient through increased fees (according to some national leader whose name escapes me at the moment).

The release of the MDR in Europe may (or will depending on your view) cause the smaller companies to abandon the European market or find strategic partnerships to enter. Razor thin margins cannot sustain such business practices. A good contact of mine has already suggested that the one or two person design shop will be forced out because of the cost and resource commitment.

When I was a licensed healthcare professional, I helped initiate our regional regulatory body. A member of the council mentioned that the licensing fees could be $10,000 annually and those who wish to practice would have to pay it as a necessary cost. What they didn't realize is that the market for these essential but few professionals would collapse as the average practitioner wouldn't pay it.

Sorry for the rant but I'm in training to become a curmudgeon...
 

Crusader

Trusted Information Resource
#10
After having gone through the first ISO 9001:2015 audit and passing, I now feel that the new revision is annoying and if we did not have a hard requirement for it, I would have discussed with management to let the cert lapse.

The 2008 revision was fine for our organization and these new Top Mgmt responsibilities are a bit much. IP's and Context of the Org, etc. that is private stuff that should be let alone and not audited at all.

Just my :2cents:
 
Last edited:
Thread starter Similar threads Forum Replies Date
T Trend Reporting under the EU MDR EU Medical Device Regulations 7
Ed Panek Requirement to track and trend positive feedback from customers ISO 13485:2016 - Medical Device Quality Management Systems 12
S Track Cpk trend Statistical Analysis Tools, Techniques and SPC 5
J TS 16949 - The Rules performance trend for 12 months IATF 16949 - Automotive Quality Systems Standard 7
D Best Minitab Tool to determine a Statistically Significant Trend Using Minitab Software 5
D Vigilance Trend reporting requirements of Meddev 2.12/ver 7 in the EU Document Control Systems, Procedures, Forms and Templates 1
L GB15980-2003 Bioburden Count Trend on Operator Hands Other ISO and International Standards and European Regulations 1
R Out of Trend (OOT) investigation Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 8
A Aircraft Maintenance Quality & Safety KPIs - Industry Trend or Database EASA and JAA Aviation Standards and Requirements 3
A Aircraft Maintenance Quality & Safety KPIs - Industry Trend or Database Quality Manager and Management Related Issues 2
K Customer Satisfaction - Would you advise to investigate the trend or the incidence? Customer Complaints 9
S Trend Review and Process Improvement help needed Capability, Accuracy and Stability - Processes, Machines, etc. 6
C Trend Analysis - Evaluating Quality of Pricing - ANVOA or Std Dev? Statistical Analysis Tools, Techniques and SPC 25
Marc Definition Significant Trend Trigger Level - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
R Trend Chart Clarification - Is it necessary to include targets? Misc. Quality Assurance and Business Systems Related Topics 2
Marc Enraged Customers fuel a disturbing trend Customer and Company Specific Requirements 9
F Trend Analysis of Kanban System for our Finished Goods Statistical Analysis Tools, Techniques and SPC 6
K Supplier Performance - Recording Supplier Performance for long term trend reporting ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Crusader Registrar CAR (Corrective Action Request) Trend Analysis Benchmarking 6
T Control Chart on Paper vs. Software where trend cannot be seen (Alarm only) Statistical Analysis Tools, Techniques and SPC 8
B Statistical Analysis SPC Trend explanation needed Statistical Analysis Tools, Techniques and SPC 4
P Trend analysis - Common Mistakes of Sales Process Mapping Software Quality Assurance 2
S How to Calculate Out-of-Trend Results Statistical Analysis Tools, Techniques and SPC 16
Q Root Cause Analize or Trend Project Audit Findings Problem Solving, Root Cause Fault and Failure Analysis 2
D How do we interpret the following XmR Trend Chart data? Statistical Analysis Tools, Techniques and SPC 3
D When to use an XmR Trend Chart Statistical Analysis Tools, Techniques and SPC 5
ScottK Is using a 3rd party auditor for supplier audits a big trend? Supplier Quality Assurance and other Supplier Issues 14
Crusader Customer Concerns Trend Database to Share .xls Excel file Customer Complaints 17
D Is there a process shift and/or trend in the attached control chart? Statistical Analysis Tools, Techniques and SPC 33
M Toyota Approach to Root Cause Analysis - Operator Error trend Problem Solving, Root Cause Fault and Failure Analysis 9
Marc Bye-Bye, Pension! The trend in the US to reduce middle class worker wages World News 17
G Control charts where the center line is a trend or slope? Statistical Analysis Tools, Techniques and SPC 26
C The Life Cycle of a Trend The Reading Room 3
L Effective Meetings for trend analysis - Corrective and preventive action Nonconformance and Corrective Action 8
Q Pole Data Trend Analysis Help - Monitoring the % of poles that we have to straighten Quality Tools, Improvement and Analysis 34
W TREND Identification - Good (and simple) procedure or process to identify and track Other ISO and International Standards and European Regulations 4
Steve Prevette Life Cycle of a Trend - An SPC Overview Registered Visitor Articles Archive 7
B Searching for software to track and trend customer complaints Customer Complaints 11
D Control charts to trend data for multiple dependent variables? Hotelling's T^2 stat Statistical Analysis Tools, Techniques and SPC 3
Y Control Chart Rules - Trend and Statistics Explainations Statistical Analysis Tools, Techniques and SPC 13
A Internal Audit - Negative Trend Identified - What Clause to Cite? Internal Auditing 3
A Positive Trend - Rejections and Customer Complaints - What to do? Customer Complaints 6
W Seeking Guidance Verification Test Strategy for Class B Medical Devices IEC 62304 - Medical Device Software Life Cycle Processes 1
M Seeking advice regarding use of off-the-shelf (OTS) batteries Other Medical Device and Orthopedic Related Topics 4
A ISMS - Seeking VAPT Consultant Food Safety - ISO 22000, HACCP (21 CFR 120) 1
M Medical Device Directive - Seeking common nonconformance write up scenarios CE Marking (Conformité Européene) / CB Scheme 2
S Seeking efficient method to manage install base data Manufacturing and Related Processes 0
K Seeking ISO 13485 Registrar Recommendations Registrars and Notified Bodies 15
R Tapping problems - 3/8" hot roll pickled & oiled steel - seeking expertise Manufacturing and Related Processes 15
S Responsibilities between government owner and private subcontractor of a power plant seeking ISO 9001 certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9

Similar threads

Top Bottom