ISO only audits whether you are doing what you documented (And recevied ISO Certification for) that you were going to do, not whehter it is a good and effecient process. The questions that need to be answered are:

1. Can your company pass an ISO process certiifcation or audit and still have an inefficent process? Yes

2. Can your company fail an ISO audit but have effecient work processes? Yes and No

3. Can your company be effecient and not ISO certified? Yes

So here are the bigger questions....

Should a company be ISO Certified with processes that are not effective? NO  Are they? Yes

Does ISO have the ability and accountability to make that happen? Not sure but should

Dear Sir,

One thing we have to remmember that ISO is only a tool for Quality, if company has a poor quality it doen't mean it is ISO system fault, most of the time and I seen poor quality comes from bag management  from the top, these days management they do not want to learn nes systems " You can not teach old dog new tricks" this is the management respond, what a WRONG idad. Sorry,

Regards

When I buy a product that is stamped certified to meet certain standards that is indication to me that the product meets criteria to be usablle for the intended purpose. If it does not do what I bought it for and was certified for, then I wasted my money and it was a lie.

So what does ISO Certified supposed to indicate? It is supposed to indicate that this is a solid process that went through a rigorous certification process and can meet its goal of service. If it goes through through the process, gets certified and passed audits but still cannot meet the needs of the customer, shame on all invloved (ISO and the company)

Here is where the so called quality gurus heads will literally explode.    However. why would I make such a bold statement?   With 35 years experience in manufacturing, I have lived through all of the tricks of the trade related to the Quality movement...  And after studying these systematic pontifications of shining excellence, I have come to the realization they are all mostly rotten eggs, especially ISO management system standards.   Think about this statistic for just a moment.... Over 1/2 of the ISO registrations for Quality Management exist in China, and of those registrations, the majority are window dressing....  Certificates handed out through corrupt instutions and officials. 

But lets get to the heart of the mater shall we.... 

ISO 9001 or Quality Management System Standard, was invented for supplier management only.   Its intent, was to replace manufacturing driven supplier management programs.  The reasoning was related to the conflict imposed upon suppliers attempting to adhere to the supplier requirements of the manufacturers they served (usually several),  Taking a wheel manufacturer as an example, they might serve several OE manufacturers, each with its own set of supplier requirements. ISO 9001 was designed with the intent of leveling out those manufacturers supplier requirements... ..... However today its strayed completely off course from that original intent. 

TC 176 made a few gross errors. 

• It assumed its scope exceeded its original intent in the manufacturing area of supplier management and the leveling of supplier requirements
• It attempted to force its way into government as the global standards bearer, who presumed to know more than the experts in manufacturing 
• It became political, adopting the ideology of the UNs Global Socialists and Communists (Specifically Agenda 21 and Climate Change or Biospheric Rift) 
• Through politics, it lost its connection with the major manufacturing experts of the world, assuming its self to be the expert through its alliance with the elite global socialists and communists who are construct of thermotical understanding only. 
• ISO presented in its latest menagerie the idea that government regulators and street anarchists are somehow equal with customers. Tossing them all into one basket called “Interested Parties”….. The very definition of Interested Party within ISO 9000. Legally includes everyone on the planet.   This was written into the ISO Annex SL, by lawyers who wanted a policy which they could successfully use to sue corporations.  It has absolutely nothing to do with meeting the expectations of customers.  A hand grenade is a killing device.  If an manufacturer makes such a device for its customers, should they be legally liable for anyone who is subject to its use? However the legal terminology of “Interested Party” allows that liability to exist for any organization registered to the 2015 version of ISO 9001.
• ISO auditing is not based on the financial audit standard. Most registered organizations could not pass an audit should financial auditors be employed.  The methodologies of 19011, are far to inept to meet the successful requirements of financial auditing... and yes I audit both 
• There must be a pressure point, else the entire system of ISO 9001 collapses.  Something of authority over an organizations efforts to meet customer and specifically relative interested party requirements must be in place, else upper management will always choose to ignore ISO requirements which stand in the way to its assumed success. 
• Finally the construct, the ideal that documents are a methodology of control is simply and wholly absurd. 

So how do I blame ISO management for causing poor quality?   That one is very easy....   Any organization who has as its focal point, maintaining registration to some ISO management system standard, and commits its resources to such nonsense, has already taken its focus off of its Customer(s).  An organization which spends one second of its precious time not completely and specifically focused upon its Customer(s), is an organization doomed to fail.  Secondly, the Annex SL based versions of ISO MSS’s focuses the organization on the minutia of interested parties.   Its correct to state that TC 176 added the term relevance to its interested party requirements, however that is a term which can be stretched to indicate anyone especially when coupled with the defined term “Interested Party” found in ISO 9000.  Therefore, an organization focused upon meeting ISO requirements is an organization which is not focused upon the expectations of its Customers.  Without Customers an organization need not be worried about interested parties as they will not exist. An organization which allows its employees to focus on the touchy feely Marxist anti-corporate street thug, is an organization doomed... People who hate corporations in antithesis, have been ideologically subverted and therfore will hate all corporations. An organization should never waste one second of its time acnowledgeing them or giving creedence to their failed ideology.  An organization should simply state it holds value in its customers and not the twisted ideologies of subverted individuals. 

Its always been a failure for one to assume that documents in an of themselves, represent effective process control. Especially work instructions. Many organizations which I have been involved with, make the mistake of thinking due to the texts of ISO MSSs that work instructions are required for every function within that organization. Worse, registrar auditors support that ideal and indicate such to the client.  I cant state how many times I have observed failure to meet a specific written work instruction step which is no longer valid, or which was never valid in the first place, especially with repetitive tasks under continual improvement.  Work instructions are only valid for operations which are infrequent and the successful steps easily forgotten.   Even if a task is infrequent, where the process is visually inherent, there is simply no need for a work instruction to exist.   A case in point would be escape from an aircraft.  How often do non-flight personnel open aircraft hatchways in an emergency?    However, do they need to read a work instruction on how to accomplish that task?  No! the assembly is inherent and visual. Organizations need to be smart and the existence of work instructions always made with a minimalistic approach.  

This latest approach to ISO MSS for quality, the 2015 version, is without doubt the most absurd version ever constructed by TC 176.   It was an attempt to get at the problem with any implementation of ISO MSS which is not bound on a pressure point.  It attempts to state that Interested parties are the dictate and everyone within the organization are subject to those interested parties.  It’s a completely absurd idea, which is impossible to manage, especially when considering the definition of Interested parties found in ISO 9000.  This is where the lawyers and Marxist based anti-corporation thugs, mucked up Annex SL by putting their thumb on the scale.  There is an old saying (adage) which goes thus…. You can please some of the people some of the time but not all of the people all of the time.. The abject meaning of Context and Interested Parties within ISOs latest Quality MSS, assumes the former not the later to be true in that adage.

Therefore, is ISO 9001 responsible for poor quality… Most certainly as identified in the points given above… Of course, I expect the quality gurus to circle their wagons and defend their abomination known as ISO 9001:2015 to the end…  after all it makes them all very wealthy….. However, for you CEOs and CFOs … you hold the reigns … if you don’t need ISO 9001 because its not a Customer requirement… then boot it out the door …. Tomorrow would not be soon enough… Instead focus your organization of Deming’s (Actually Toyotas) PDCA, Lean, 5S (the real thing no cleaning only version) and Monozukuri.  Further focus on having a solid ERP and PLM solution which interacts together and provides workflow capability.   Build the business around meeting the expectations of your Customers and only specifically relevant interested parties.   I could express brashness for those who adhere to the construct of ISO MSS, but I won’t.  All I will state is that Without the headache and abject failure of ISO MSSs … life will improve… immediately.

A well sesoned Auditors Perspective