In all the years I did implementations, every one was to the standard, as evidenced by my QMS Implementation presentation. An elemental approach. Not one failed first audit registration. Not one had a "bad" experience.
I don't know how old you are, and I don't know how many implementations you have done. My bet is you are young and I also bet you haven't worked with both major corporations and "Mom and Pop shops of < 10 people.
I think if you want to show any credibility you should come up with some facts and figures rather than theories and anecdotal "evidence" for what you assert. You have already been shot down in the "process approach" threads.
My point here is that we're back to beating a dead horse. As I reviewed your posts recently, all I can see is your hyping "the process approach". I see no posts dealing with interpretations or requirements of the standard. It's like a one track mind/one trick pony. From your posts I can not even tell if you actually know and understand ISO 9001 (much less other, more "demanding" standards).
You registered here as "ISO 9001 Guy". So tell us. What was the first implementation you did - What year? What major corporations and companies have you guided through the implementation process? What facts do you have that show that implementation "to the standard" is any less successful than "the process approach" and please define the "process approach" in a manner that approaches my QMS Implementation presentation. Show us something that lends some credibility to your assertions. Show us an example implementation project plan.
My reason for jumping in here is I am really tired of your derailing threads to spout nonsense. The thread title is: "Reasons for the Decline of ISO 9001 Registrations in North America". Other than you there is not one other person who has posted in this thread in which it is posited that the decline of ISO 9001 registrations is in any way linked to a failure of companies to implement ISO 9001 according to a "process approach".
This is not to mention, even implementations "by the elements of the standard" necessarily require a company to evaluate and be able to show evidence of the the interactions of processes and their effectiveness. So - By default, every implementation requires a company to use what I know to be a "process approach", and always has.
The closest I can come to understanding what your "process approach" is, is that there were (and are still) some consultants and companies which implement ISO 9001 using canned procedures without regard to existing company processes. That is, companies and consultants who do not evaluate and show evidence of the the interactions of processes and their effectiveness. I believe this is rare, especially these days.
That said, I'm not at all a fan of ISO 9001. This is not because it is in any way "bad". It is because it is so basic. Over the years I did have many clients who would tell me a couple of years or so afterward that ISO 9001 did not effect any discernible, measurable difference with the sole exception in that because so many companies were requiring suppliers to be ISO 9001 registered (certified if you like) they probably got some business than they might have otherwise because of their certification. Or, that they did not lose business from their current customers due to their not having the certificate on their wall.
Also of note is that in my years of doing implementations I never had a client that could honestly say they were doing it solely to improve their business processes. When digging deeper, the few that did say that did admit that their reason for actually proceeding with the process was because their customer(s) were requiring them to be registered.
I did thoroughly enjoy doing implementations. The reason why had nothing to do with ISO 9001. It had to do with seeing a company take the time and spend the money to thoroughly evaluate their systems/processes, and as they did so they found places where they were failing and/or could significantly improve. Yes - Compliance with the standard was part of each implementation, but the "meat" was in their stepping back, so to speak, and looking at what they were doing, how they were doing it, and identifying their strengths and weaknesses. The important part was the value of their "self assessment" with respect to their processes/systems, and what they did to improve their existing systems.
In fact, about the only thing I consistently found in companies I worked with that ISO 9001 requires was not having an Internal Audit system. They all had some type of document control system, for example. I come back to ISO 9001 being "basics" of a business every time.
One of the things that I remember most was after the registration audit almost every one of them said how easy it was compared to their expectations, and it was always because they were already doing most if not all of what ISO 9001 required before getting involved in ISO 9001. The other comment that always came up was they were glad they did it because they took the time to evaluate their systems/processes and found places they could (and did) improve.
A few comments on my take as a by-stander today: Assuming ISO 9001 registrations are in fact declining, it is because it is becoming more obvious, as the years pass, that ISO 9001 *is* just basic, "good business practices". If a company learns anything from ISO 9001 it is they have to continually monitor their systems and improve and they don't need ISO 9001 registration to do so. ISO 9001 often serves as a "wake up" call, and I associate it with a student taking a class. One takes a course, one learns from it, but one doesn't need to take it again (assuming they learned from it in the first place). This is the problem registrars face in trying to convince companies that third party audits are value added. If a company has a robust (I hate to use that word, but...) internal audit system third party audits become unnecessary.
This is not to say that third party audits can not be very valuable, but in my opinion they are most valuable in companies with what I call "bad" personalities. That is to say if there isn't a third party "watching" they will fall back into old bad habits. In those cases, and there are many, third party audits are value added, but only because of bad management. "Good personality" companies don't need a nanny. Upper management in "good personality" companies is effective.
I also believe that, looking back to the late 1980's, technology has played a significant part in companies being better able to monitor their systems/processes, including internal audits. There is better data and better use of data. Instead of document control being a manual, expensive proposition, we now have computers, specialized software and other aids that have eliminated a lot of the expense and (unfortunately) personnel that was once needed to maintain them. Internal communications have improved in ways that were unimaginable to most people back then.
I don't see ISO 9001 going away, but it's value (in the US, at least) has diminished. If there is anything that shows how basic and "old hat" ISO 9001 is, it is their releasing a revision in 2008 which for all intents and purposes had no changes from ISO 9001:2000. When one reaches a point where, over a period of 8 years, the best they can do is change a few words around it says something, and I think that something is there is only so far one can go in defining basic, "good business practices" for commercial businesses.
I don't know how old you are, and I don't know how many implementations you have done. My bet is you are young and I also bet you haven't worked with both major corporations and "Mom and Pop shops of < 10 people.
I think if you want to show any credibility you should come up with some facts and figures rather than theories and anecdotal "evidence" for what you assert. You have already been shot down in the "process approach" threads.
My point here is that we're back to beating a dead horse. As I reviewed your posts recently, all I can see is your hyping "the process approach". I see no posts dealing with interpretations or requirements of the standard. It's like a one track mind/one trick pony. From your posts I can not even tell if you actually know and understand ISO 9001 (much less other, more "demanding" standards).
You registered here as "ISO 9001 Guy". So tell us. What was the first implementation you did - What year? What major corporations and companies have you guided through the implementation process? What facts do you have that show that implementation "to the standard" is any less successful than "the process approach" and please define the "process approach" in a manner that approaches my QMS Implementation presentation. Show us something that lends some credibility to your assertions. Show us an example implementation project plan.
My reason for jumping in here is I am really tired of your derailing threads to spout nonsense. The thread title is: "Reasons for the Decline of ISO 9001 Registrations in North America". Other than you there is not one other person who has posted in this thread in which it is posited that the decline of ISO 9001 registrations is in any way linked to a failure of companies to implement ISO 9001 according to a "process approach".
This is not to mention, even implementations "by the elements of the standard" necessarily require a company to evaluate and be able to show evidence of the the interactions of processes and their effectiveness. So - By default, every implementation requires a company to use what I know to be a "process approach", and always has.
The closest I can come to understanding what your "process approach" is, is that there were (and are still) some consultants and companies which implement ISO 9001 using canned procedures without regard to existing company processes. That is, companies and consultants who do not evaluate and show evidence of the the interactions of processes and their effectiveness. I believe this is rare, especially these days.
That said, I'm not at all a fan of ISO 9001. This is not because it is in any way "bad". It is because it is so basic. Over the years I did have many clients who would tell me a couple of years or so afterward that ISO 9001 did not effect any discernible, measurable difference with the sole exception in that because so many companies were requiring suppliers to be ISO 9001 registered (certified if you like) they probably got some business than they might have otherwise because of their certification. Or, that they did not lose business from their current customers due to their not having the certificate on their wall.
Also of note is that in my years of doing implementations I never had a client that could honestly say they were doing it solely to improve their business processes. When digging deeper, the few that did say that did admit that their reason for actually proceeding with the process was because their customer(s) were requiring them to be registered.
I did thoroughly enjoy doing implementations. The reason why had nothing to do with ISO 9001. It had to do with seeing a company take the time and spend the money to thoroughly evaluate their systems/processes, and as they did so they found places where they were failing and/or could significantly improve. Yes - Compliance with the standard was part of each implementation, but the "meat" was in their stepping back, so to speak, and looking at what they were doing, how they were doing it, and identifying their strengths and weaknesses. The important part was the value of their "self assessment" with respect to their processes/systems, and what they did to improve their existing systems.
In fact, about the only thing I consistently found in companies I worked with that ISO 9001 requires was not having an Internal Audit system. They all had some type of document control system, for example. I come back to ISO 9001 being "basics" of a business every time.
One of the things that I remember most was after the registration audit almost every one of them said how easy it was compared to their expectations, and it was always because they were already doing most if not all of what ISO 9001 required before getting involved in ISO 9001. The other comment that always came up was they were glad they did it because they took the time to evaluate their systems/processes and found places they could (and did) improve.
A few comments on my take as a by-stander today: Assuming ISO 9001 registrations are in fact declining, it is because it is becoming more obvious, as the years pass, that ISO 9001 *is* just basic, "good business practices". If a company learns anything from ISO 9001 it is they have to continually monitor their systems and improve and they don't need ISO 9001 registration to do so. ISO 9001 often serves as a "wake up" call, and I associate it with a student taking a class. One takes a course, one learns from it, but one doesn't need to take it again (assuming they learned from it in the first place). This is the problem registrars face in trying to convince companies that third party audits are value added. If a company has a robust (I hate to use that word, but...) internal audit system third party audits become unnecessary.
This is not to say that third party audits can not be very valuable, but in my opinion they are most valuable in companies with what I call "bad" personalities. That is to say if there isn't a third party "watching" they will fall back into old bad habits. In those cases, and there are many, third party audits are value added, but only because of bad management. "Good personality" companies don't need a nanny. Upper management in "good personality" companies is effective.
I also believe that, looking back to the late 1980's, technology has played a significant part in companies being better able to monitor their systems/processes, including internal audits. There is better data and better use of data. Instead of document control being a manual, expensive proposition, we now have computers, specialized software and other aids that have eliminated a lot of the expense and (unfortunately) personnel that was once needed to maintain them. Internal communications have improved in ways that were unimaginable to most people back then.
I don't see ISO 9001 going away, but it's value (in the US, at least) has diminished. If there is anything that shows how basic and "old hat" ISO 9001 is, it is their releasing a revision in 2008 which for all intents and purposes had no changes from ISO 9001:2000. When one reaches a point where, over a period of 8 years, the best they can do is change a few words around it says something, and I think that something is there is only so far one can go in defining basic, "good business practices" for commercial businesses.
And, more, they have 151 employees. Sales of Standards represent only 45% of ISO's revenue stream according to 
