Is it possible to get ISO 9001 certification in 90 days?

[Chris Ford]

Wow, 90 days, huh? Ridiculous timetable (in any industry) from whoever sold you that.
My advice would be to avoid using any "Consultant". I've found that no matter how much customer satisfaction they claim to have, Consultants have a vested interest.....in themselves. Perhaps some spoil it for all, but I calls 'em like I sees 'em.
For a much better value...invest in yourself by taking the time to learn ISO9001 and apply what you learn.
There's multitudes of training available for anyone who cares to take the time.
Start with the basics and progress from there. Don't complicate things by using outsiders. Keep it simple.
In the long run, it serves you best. Sure, it takes time, but the return on investment is infinately better.
Best of luck.

So... let's see. They have 90 days to implement and demonstrate effectiveness of a quality management system that conforms to a standard they have little or no experience with.

Somehow it's better to take the time to source training courses, then finally find one, as the 90 day clock continues to tick. Attend the training - maybe a week long course if they're lucky... but it's probably 2000 miles away so there will be air fare and accommodations involved, as well as that person's time away from the office - which apparently is pretty small to begin with.

Once that's all said and done... probably now nearly 60 days into the 90 day timetable, they're ready to begin. Maybe they really go full board and buy one of those quality systems in a box, since they're so short on time. But not to worry, someone attended an ISO 9001 class, so that person is far more qualified than a consultant.

Meanwhile, consultant like me and the many other professionals here, are implementing quality systems and educating clients just like this company.

I indeed do have a vested interest in myself, and I certainly am NOT shy about saying that. Consequently, you SHOULD have a vested interest in yourself. The only difference is the companies I work for pay me on a 1099 and yours pays you on a W-2. If you don't have a vested interest in yourself, you should probably have that looked at by a qualified psychologist, but then again that would probably be equivalent to hiring a consultant, so maybe there's a training class you can take on that and figure it out for yourself. Because, if you really are one of the last few remaining people in this country who actually do put the needs of a company they work for before their own needs or the needs of their families, you're in the greatest need of a consultant.

It's difficult for me to grasp how you can take a leap from a tax status to someone's qualifications or his motives. I'm currently working for one client on a 49 page contract. They've specified every detail including qualifications, education, etc. The entire project schedule is outlined in detail - hundreds of line items. I created the plan for this contract. I've met every requirement to date, submitted every deliverable - INCLUDING my invoices! Just as you'd expect to receive your check every other week or on the first and fifteenth or whatever it is, I'd expect to submit an invoice to my client for the work performed and items delivered.

Sure, there are stipulations in our agreement that address the unlikely event that I will actually miss a deliverable date. Just as there are stipulations in the agreement that hold their feet to the fire when it comes time to review and accept those deliverables.

Working as a consultant is not a humanitarian effort. This isn't the peace corps. I don't work for free.

So yes, absolutely.... I'm completely driven in my work to receive a paycheck. It's nicer that way. My landlord seems to like me better. My cats appreciate the fresh litter in the litter box and a full bowl of food. It's certainly a lot easier accessing the internet if you've paid your fees. Golly, what a concept - people in the US wanting to work and earn a living!

Is it that you're of that mindset - you think that consultants fees are highway robbery? Put your tax dollars back into your paycheck, pay for your own health insurance, fund your own disability account, establish your own retirement investment fund, then pay your own taxes at the end of the year, and tell me if you think that consultants - even at $200 / hour are paid too much.

I've hired and fired consultants countless times over the years. I've been working as a consultant now since 2004, and it's much more difficult in many ways. But, it's far more gratifying in the end for me, and that's why I do it. And guess what... I STILL hire consultants! I've got three part-time consultants on two projects. Their education and work experience speaks for itself. They're experts in their fields, they're reliable, and they're easy to work with. That's all I need.

And by the way, I'd be more than happy to share my CV that demonstrates my own experience and qualifications. But, according to you, regardless of the long list of testimonials, customer satisfaction rating, and demonstrated experience on a CV, consultants can't be trusted because they're only interested in being paid. Try saying that out loud and see if it still makes any sense at all. I don't know about you, but I've worked with more unqualified, lazy, undedicated underachievers who were just there to collect their bi-weekly pay check, do their eight hours and go home, than I could ever compare with the consultants I've hired.

 

[Chris Ford]

And by the way... the client with the 49 page contract... I'm implementing an entire quality system compliant with the FDA QSR which is generally equivalent to ISO 9001 with some added requirements, which is generally equivalent to ISO 13485. We're working on a similar time line, but without the certification part. I'm implementing the quality system, and writing their premarket approval application. FDA will perform an inspection of the quality system, but won't expect to see a great deal of evidence because it's a new company. They'll schedule a follow up inspection to come back to verify the system is effective, but it won't delay their product approval. At any rate, it's a very similar situation, because they have absolutely no knowledge of the requirements of these regulations or any standards, they've documented nothing at all, and they've never even signed anything. Everything is done electronically. They all work all over the country... remote employees. As I implement portions of the quality system, I walk them through the change review process, then provide training on the systems. The training explains the regulatory requirement and how the procedures meet the requirements, and gives them opportunities to ask question or clarify procedures. What they're getting is a quality system implemented by someone with 15 years of experience in their industry and who's worked directly with the regulatory bodies for the past 10 years They're also receiving regulatory requirements training (so they'll understand the requirements), job-specific training on the procedures, and an introduction to other applicable standards (e.g. ISO 14971 Risk Management for medical devices). The quality system needs to be implemented and functional by the third week of June. We'll start writing the application in a couple of weeks. That'll take the consultant I hired about 80 hours. I'm going back to conduct a quality system audit in July. By then, most of the systems will have generated some records. There won't be much to audit in terms of effectiveness, but I will be able to see if the company is adopting the new system. At any rate, there is absolutely no comparison between what this company could accomplish if it followed this silly advice to "keep it inside" and what I'm providing to them. I think it's absurd to suggest that an internal employee with no experience or knowledge in an area could provide a higher ROI and higher degree of confidence than competent and experienced consultant who specializes in the area by education, training and experience, and fully understands the requirements and how they are interpreted. If CV's alone were compared, the absurdity would stick out like a sore thumb!

 

[Polly Pure Bread]

Thank you Mr Wes Bucey for your private message. Unfortunately, I am no longer connected with the company whose management was seeking a consultant that could help them get ISO certification in 90 days. I have learned from a friend who is working for that company that they got an ISO consultant already. I wasn’t able to ask whether the consultant took the risk of accepting the 90 days timeline or was able to negotiate a longer timeline. As far as I know, the consultant comes from a reputable consultancy firm here in the Philippines. I think when the projects kicks off the management will realize that it’s pretty not reasonable to impose short timetable but the value of taking time to ensure effectiveness of the system that matters.

If I know a company that needs assistance on the development of their management system that conform to ISO 9001 (or other services that you are offering), I will recommend you highly.

 

[Wes Bucey]

Moderator note

From the foregoing message, we can see the issue of the original post - finding a consultant to get a job done in 90 days is now moot.

However, I am intrigued by the turn the thread has taken to a discussion about the general idea of hiring experts (consultants) versus trying to do something oneself. Therefore, instead of closing the tread to further comment, I am inclined to let the thread run with this topic, reminding everyone there is no longer any sense to praise or lambaste the company originally proposing a consultant contract with time tables and penalties, but to deal in generic terms about the relative merits of consultant versus "do-it-yourself."

ONE FINAL CAVEAT!
Let's keep it civil! We attack or defend IDEAS, not PERSONS.

 

[RSEGRIGGY]

Well, in general terms:

I'd look at hiring a consultant (in this instance) as a form of do-it-yourself. You need to learn how to do anything, no one is born ISO certified. You could hire a consultant for every problem that came up, or you could hire one initially, try to study and learn their techniques, and then apply what you've learned to new problems.

I'm sure there are some consultants (in any industry/profession) who would make you dependant on them to ensure their income stream, never explaining anything. "Just call me every time that happens, I'll fix it."

Basically, I don't see hiring a consultant (or doctor, welder, botanist, etc) as a lazy way out when it is a topic that you have limitied knowledge and need to learn. Although I think you should always try to learn no matter what the situation is....

 

[Stijloor]

Re: Moderator note

From the foregoing message, we can see the issue of the original post - finding a consultant to get a job done in 90 days is now moot.

However, I am intrigued by the turn the thread has taken to a discussion about the general idea of hiring experts (consultants) versus trying to do something oneself. Therefore, instead of closing the tread to further comment, I am inclined to let the thread run with this topic, reminding everyone there is no longer any sense to praise or lambaste the company originally proposing a consultant contract with time tables and penalties, but to deal in generic terms about the relative merits of consultant versus "do-it-yourself."

ONE FINAL CAVEAT!
Let's keep it civil! We attack or defend IDEAS, not PERSONS.

This has been a very civil discussion. May I point out that we consultants deserve the right to make a case for defend ourselves when our professionalism and integrity is questioned.

Stijloor.

 

[AndyN]

Well, in general terms:


Basically, I don't see hiring a consultant (or doctor, welder, botanist, etc) as a lazy way out when it is a topic that you have limitied knowledge and need to learn. Although I think you should always try to learn no matter what the situation is....

Yeah, I'd hate to get a colonoscopy without using a consultant.......:mg:

 

[Stijloor]

Yeah, I'd hate to get a colonoscopy without using a consultant.......:mg:

Well Andy, your post sums it all up.
I underwent quite a few myself and I was happy that I had a very competent consultant.
(That's how you call a medical specialist in the UK right?).

Stijloor.

 

[Wes Bucey]

Re: Moderator note

From the foregoing message, we can see the issue of the original post - finding a consultant to get a job done in 90 days is now moot.

However, I am intrigued by the turn the thread has taken to a discussion about the general idea of hiring experts (consultants) versus trying to do something oneself. Therefore, instead of closing the tread to further comment, I am inclined to let the thread run with this topic, reminding everyone there is no longer any sense to praise or lambaste the company originally proposing a consultant contract with time tables and penalties, but to deal in generic terms about the relative merits of consultant versus "do-it-yourself."

ONE FINAL CAVEAT!
Let's keep it civil! We attack or defend IDEAS, not PERSONS.

This has been a very civil discussion. May I point out that we consultants deserve the right to make a case for defend ourselves when our professionalism and integrity is questioned.

Stijloor.

Sure. Don't jump to conclusions. Note I used the word "keep." However, one person's passion easily can be interpreted by another as an attack. Don't forget - I've been in the consulting business a LONG time. I'm acutely aware of a broad spectrum of both consultants and clients and could easily give examples from anywhere along the spectrum. I'm also experienced enough to be aware even my extensive experience does not represent a fair sample because I continually refine my criteria for accepting or rejecting clients and haven't contracted with a "client from hell" in years because they usually get knocked out of consideration before we even reach Contract Review.

I have had my credentials called into question on one or two occasions, but no one I respect has ever challenged my professionalism. The simple fact is a lot of emotion enters into any choice of a consultant when an organization is in a crisis mode because of outside pressure from customers or regulators. If the client does not respect the consultant, it is a real uphill battle for the consultant to persuade the client to accept recommendations.
What is the root cause?

1. Did the client pretend he was happy with the consultant (perhaps feeling he could "control" the consultant?)
2. Did the client hire the first guy to come down the road, just to appease the pressure point from outside? (this happens a lot with a client under regulatory pressure - very tough for a consultant focused on the regulatory issues to recognize the fit between client and consultant is not good due to inexperience.)
3. Did something arise during the engagement?
4. Did the consultant misread the client?
5. Did the consultant take a bad contract because he was desperate for money? (suppliers do this ALL the time)
6. Was the REAL decision maker at the client left out and decided to come back in and show his power? (at the expense of an innocent consultant?)
7. etc.
8. etc.

I can think of dozens of scenarios where a consultant assignment goes south which have absolutely nothing to do with the consultant's expertise in the subject topic, but everything to do with the consultant's ability to deal with the in-house political considerations at the client.

When an assignment goes south, it's difficult to analyze why in hindsight by either of the participants. I've listened to dozens of sob stories from both sides of the equation where the one telling the tale, even through the telescope of time, is so emotionally invested he can't see the tell-tale signals readily apparent to an outsider which should have alerted either party to reassess the situation before getting more embroiled.

Quality consultants and business consultants are not the only consultants who have assignments go south - think about all the malpractice suits filed against doctors and attorneys and accountants and stockbrokers, many of which are ultimately adjudicated as "simple misunderstandings." The cause may be a simple misunderstanding, but that doesn't affect whether either or both parties sustained damage.

 

[Stijloor]

Wes,

Excellent points.

Stijloor.