HI,

I am brand new to a small(less than 20 employee machine shop). This company has been in business for 7 years. We have approx. 500 part numbers. We want to be ISO 9001 certified and currently all I have is a quality manual template.

Please tell me the BARE MINIMUM and provide me with any templates that you may have. I have been given an unrealistic goal regarding timing also so the sooner the better.

Thanks,

Kris:truce:

HI,

I am brand new to a small(less than 20 employee machine shop). This company has been in business for 7 years. We have approx. 500 part numbers. We want to be ISO 9001 certified and currently all I have is a quality manual template.

Please tell me the BARE MINIMUM and provide me with any templates that you may have. I have been given an unrealistic goal regarding timing also so the sooner the better.

Thanks,

Kris:truce:

Kris:

First off, welcome to the Cove and the wonderful world of Management Systems! :bigwave: The Cove is full of information and templates, so here are some hints to finding what you are looking for.

Having a general request for the bare minimum will result in probably few value-added responses and potentially some sarcastic comments about implementing a "bare minimum" management system. I'm sure that the latter is not your intent. :D
Towards the top, you'll see links to our attachments section - lots of useful templates there for you to sift through - and the free files section - there's a link to information on implementing a quality management system in there.
Towards the top right (below the Welcome box) is the Search function. Please use it! Type in ISO 9001 Implementation and I'm certain you'll receive lots of links.


Why do I suggest this? Other than the fact that Moderators are here to help you and point you in the right direction, it can be frustrating for Cove members to see the same general questions repeatedly. If, on one of the linked-to threads, you wish to add on, please do so! :D Or, if after reading a linked-to thread, you have a more specific question, please post it.

A rule of thumb in the Cove is "A general question will receive a general answer."

First - Welcome to the cove - there's no better place for free consulting.

Have you tried the search function? There are loads of sample quality manuals as attachments for the picking.

But I have to ask -
Why are you seeking certification?

Honestly - if you (or your management) want just bare bones to meet the requirements and get a piece of paper on the wall you're in for a big surprise.

What's your time frame?

Thanks Roxanne,
I guess I was a little vague in my yell for help. My main dilemma is what is the minimum that I need as far as procedures, work instructions, do I have to have control plans for every part, remember I have over 500 part numbers, do I need work instructions for every part #. :mg:

I am just overwhelmed right now and am just looking for some direction, I have always worked in a structured automotive environment and now I am in a job shop mnon automotive machine shop.

Thanks,

Kris
:tg:

Have you taken a course on Implementing ISO 9001? I highly recommend it. Yes, we can tell you that there is a requirement for a quality manual and 6 procedures and even what those 6 procedures are, however, a course will help you to understand WHY and HOW there are all of those requirements in the Standard.

FYI, though, the 6 required procedures are:

Document Control
Records Control
Internal Audits
Control of Nonconforming Product
Corrective Action
Preventive Action


The caveat is that you will also have documentation where the absence of the document may adversely impact the organization's ability to meet requirements.

Of course, if you have read the standard, you might be scratching your head and asking yourself "Hey, do I really need six procedures or can I merge some of them?" Guess what? We've already discussed this in the Cove!

Maybe you're wondering if you need actual procedures or if everything can go into the manual. Guess what? We've already discussed this in the Cove!

You might be looking at the requirements for the Quality Manual and wondering what the heck it's supposed to cover and what it means by "...sequence and interaction of these processes." Guess what? We've already discussed this in the Cove!

Many of us in the Cove have been in - and are still in - the same position you currently find yourself. You are not alone! :bighug: I've been in the management systems world for over 10 years and continue to learn things almost every time I visit the Cove.

One advantage to taking a course on Implementing ISO 9001 is that you will learn the "bare minimum" requirments that may help you to find some structure within the chaos.

You're in Michigan, right? There are bound to be plenty of courses in the area on this very subject. If you're company is unwilling to pay for you to take the course, I would question management's committment to this venture. One of the requirements of ISO 9001 is that top management is to provide the necessary resources to ensuring requirements are met - this includes competent people, training, and $$$.

That being said, please take a look at the Free Files link near the top of the screen. There is a link to QMS Implementation that might help you organize your thoughts and prompt more specific questions.

Taking a class in ISO is good advice. :agree:

This is not a time for learn-as-you-implement. The subject of QMS is too big for a novice to succeed with in a short time frame. Nor do I recommend hiring a consultant to "make you certified". You can do it, but your process will run more efficiently if you first take a week to take a class in this subject. The expense would be offset by avoiding the frustrations and wasted time in making mistakes and wrong turns.

We can answer questions and are happy to do so, but you need an educational basis for understanding the answers and selecting the variety of choices we will present you with. We're a very diverse crowd here.

When you go to class (I hope this is the one piece of my advice you take, if you take only one) bring with you a list of types of products you make, categorized by their similarities. Also come armed with a list of your types of customers (names aren't needed). This would help you imagine how to apply the lessons to suit your needs, and it would help you to ask meaningful question in the class sessions.

If you don't have a laptop to take with you, I would select a hotel that has free computer access in the lobby for guests. This is so you can log in to The Cove after each day's class and ask about subjects that confuse you, or you have trouble applying to your needs, or how you would get it done. This way we can send you to threads and tools that are most pertinent and timely.

I hope this helps!

Thanks Roxanne,
I guess I was a little vague in my yell for help. My main dilemma is what is the minimum that I need as far as procedures, work instructions, do I have to have control plans for every part, remember I have over 500 part numbers, do I need work instructions for every part #. :mg:

I am just overwhelmed right now and am just looking for some direction, I have always worked in a structured automotive environment and now I am in a job shop mnon automotive machine shop.

Thanks,

Kris
:tg:

Hello, Kris!

First you will probably want to buy the standard. As you read the standard, observe the different sections, and begin to think about addressing the different sections.

Next, look at your current process and see how you do things. Do you do pretty well? Saying, maybe a large part of the work will be documenting what you are already doing.

Hopefully, your general strategy will be something like this: 1) See what we do well, and the areas that need improvement. 2) Document the core strengths, and spend more time on the areas that need improvement. 3) communicate from start to finish with upper management, getting constant feedback from them on the Quality Policy, the objective of the QMS, and aligning the QMS with the Strategies of the shop.

I think the advice given previously about ISO training is a really good one. First, you need to understand the standard. Too, it demonstrates management commitment, as it costs money. If management won't pay for training, that is a good indicator there will be problems creep up on you in a short time frame.

As much time as you can dedicate, read through the threads here. There is so much information you can learn from. And.... keep the questions coming!

As to your question above... it will depend on your process and what you want to do. You might can group your parts into similar processes and cover them with a handful of instructions. You may can get by with 1 instruction; it might take 500. Talk to your management about it, but more importantly, talk to the floor folks who make the parts; they'll probably know best.

Good post, Jennifer.

If you don't have a laptop to take with you, I would select a hotel that has free computer access in the lobby for guests. This is so you can log in to The Cove after each day's class and ask about subjects that confuse you, or you have trouble applying to your needs, or how you would get it done. This way we can send you to threads and tools that are most pertinent and timely.

I hope this helps!

I might suggest that management get you a laptop. I bet after everything is said and done, it will save enough money to pay for itself.

I am unsure from the posts if you are aware of 9001's finer points and just need advice on implementing them or if you are (as I was 4 months ago) completely new to quality management.

If you are running to a fine deadline you may need to be honest with management and tell them to think twice. If that doesnt sound too hopefuly then all the information you need about 9001 is...in the Standard :read:.

If you read through it a few times (it isnt that difficult a read after the 2nd time) then you can identify what is needed at your company, and what is already in existence (albeit under a different name maybe). There are plenty of examples here of Quality Manuals, procedures, audit forms, records for training, documentation management etc etc. Just make sure that you produce final documents that relate to your company and the way it works, and not a copy of a document you find online unless it fits with your system (it will be clear to an external auditor if the QMS is disjointed).

Nearly anything you could possibly conceive needing (to become 9001 certified) will be online here. The people on the Cove are more of an asset then any other info service I have experienced.

HI,

I am brand new to a small(less than 20 employee machine shop). This company has been in business for 7 years. We have approx. 500 part numbers. We want to be ISO 9001 certified and currently all I have is a quality manual template.


Thanks,

Kris:truce:



Hi Kris,

You are describing exactly my situation. The 500 part numbers, less than 20 employee machine shop, wanting to be ISO900 certified, and coming from the structured auto industry. Only difference is my place has been in business since 1945 and I don't feel as pressured as you sound.

Maybe we can talk some via PM.

Thanks,
Bill S.

hi Kris & Bill'

I'm the Quality Manager of a 65 person Job Shop Machine Shop. We have been ISO certified for about 9 years and are in the process of upgrading to AS9100 Aerospace.

Go ahead and sift thru the massive amounts of Cove material and if you need any help feel free to contact me.

Briz

Thanks, Briz,

I see you just made post #100 - Congrats!

I have already spent hours and hours reading through the Cove. It has helped immensely. I pretty much know what needs to be done although I may have some technical questions later.

My biggest challenge right now is to get people out of their long entrenched comfort zones and become more organized. Get rid of what I call clutter and redundancy. The written procedures and instructions will follow much more easily afterwards.

Thanks again,

Bill S.:)

What would you need the template for. Quality system is suppose to work base on your needs, not based on the template or format from otehr organization. Here is my 2 cent recom.:
Identify your process.
Integrate the process description in your manual, of course, dont forget to include the primaries of a manual, like policy, management commitment...etc.
Identify the ISO elements that directly impact your process, this will be a guide to auditors to which chapter of ISO 9001 you will be audited against.
Once elements of ISO has been identified, act on the requirements specified by those elements. As a clue, anything that shows the word shall or will are considered as requirement and should be evidently being implemented.

thanks

Some basics: Implementing an ISO 9001 Quality System (http://elsmar.com/Imp/).

Some other related implementation discussion threads you should read through: Implementing ISO 9001 (http://Elsmar.com/Forums/search.php?do=process&titleonly=1&query=9001+implementation).

Thank you so much Marc. I just needed some dir. I have maintained QMS before just never created one from the ground up. Yours and everyone else's insight is proving invaluable.

Thank you so much Marc. I just needed some dir. I have maintained QMS before just never created one from the ground up. Yours and everyone else's insight is proving invaluable.Now this is important to know.

In light of that I instead recommend a lead auditor's class - You'd need to set up or perform auditing anyway. In this class you can get some really valuable insight from a registrar (who teaches the class) on what is needed, what is acceptable and what is overkill.

Could anyone please let me know the the ANSI manuals that I should initially purchase, I have the AIAG but since I am not going for QS I would like the right books.

Could anyone please let me know the the ANSI manuals that I should initially purchase, I have the AIAG but since I am not going for QS I would like the right books.

The standards that you want are: ISO9000:200x, ISO9001:200x and ISO9004:200x.

That is where you want to start. After you get those and read and understand them, you will want to get: ISO19011:200x and ISO17021:200x

You may also want to purchase this book, by Craig Cochran: Craig's Book (http://elsmar.com/Forums/showthread.php?t=27836)

Thanks Coury,

The list of manuals is very large and I just need the basics.

Thanks,

Kris

Thanks Coury,

The list of manuals is very large and I just need the basics.

Thanks,

Kris

Than ISO9001:200x is the one you want.

The other ones (except maybe ISO9000:200x) would be the minimum you need. ISO9000:200x is vocabulary.

Okay, bare bones stuff

First, as was mentioned earlier, get a copy of the standard.
Second, your organization has to do different "things" to meet your customer requirements. Make a flowchart of these things (you can call them activities, or processes if you like). Some folks call these your Core Processes, or your Customer Oriented Processes.
Third, read through the standard. Each time you see the word "shall", stop. Shalls are mandatory requirements. Some of these shalls will line up with your flowchart of things. Note that. Others will not. Some of those that do not will line up with the activities you have to do to fulfill your Core Processes. Often, they are referred to as Support Processes.
The standard requires you to identify your processes (Core and Support) and determine their sequence (the flowchart) and their interaction (lots of ways to do that).
Fourth, as you go through figure out how you are going to meet each shall. If you get stumped, then come back here and do a search on the requirements for that individual shall.

Bear in mind….. This is not going to be a quick sit down one afternoon and hammer this out. Be prepared to spend hours, days and even weeks on this. There is no simple one size fits all solution. What you come up with has to reflect your organization, and your business.

And I agree, a class could help. Even an internal auditor class, as they often teach the interpretations of the standard, and you can often bounce questions off the instructor during breaks, lunch and after class.

And I agree, a class could help. Even an internal auditor class, as they often teach the interpretations of the standard, and you can often bounce questions off the instructor during breaks, lunch and after class.Thank you for this in addition to your excellent post.

I hate to nag (okay, maybe not! :lol:) but you will be expected to somehow show you are competent to do yoru internal assessments, among other things. The ability of classes to "make" one competent has been tirelessly argued, but most of us agree a class is a good part of it.

A class will also provide you with a copy of the standard, and maybe a bunch of other goodies too, like definitions as were included in Coury's list. Why pay for something twice?

Thank you for this in addition to your excellent post.

I hate to nag (okay, maybe not! :lol:) but you will be expected to somehow show you are competent to do yoru internal assessments, among other things. The ability of classes to "make" one competent has been tirelessly argued, but most of us agree a class is a good part of it.

A class will also provide you with a copy of the standard, and maybe a bunch of other goodies too, like definitions as were included in Coury's list. Why pay for something twice?

If I may jump on the "take a class" bandwagon for a moment, I'd like to add that if you do take a class, there will probably be others in attendance who may be in the same boat you're in or maybe have just gone through the experience, and you may be able to share ideas and get some tips from those who have gone through it and are willing to share. :yes: Networking like this can sometimes give you a different point of view, especially if you've spent so much time focusing on your company's situation and issues. It's always good to have a fresh set of eyes to look at your problem, IMO... And who knows? You may be able to offer help to someone else with a different problem!

Just a thought...

Now this is important to know.

In light of that I instead recommend a lead auditor's class - You'd need to set up or perform auditing anyway. In this class you can get some really valuable insight from a registrar (who teaches the class) on what is needed, what is acceptable and what is overkill.

For help with implementation, the lead auditor course is useless, IMHO. It's for second or third party auditors! For 15 years I've seen people come to class, "deer in the headlights", because they have to 'get the company registered". I can't figure why, but it's almost definitively the wrong course to attend! Yes, I know many have gone this route, but what did it do for you when it came to planning and implementation? Just the bit at the end - the certification audit!

Sure it's a great class, everyone bonds and we all have fun, but what practical use is it for implementors? None, except you get to know the third party process - so go to an internal auditor course, not only are they run by a Certification Body, and ask the instructor (who should, by rights, be very experienced in implementation) and ask what's different about the IA course to what the CB will do! That way the course is only 2/3 days (instead of 4/5) and you still get the CB process.......

Better still, find a good consultant to support you. It doesn't have to be done all 'on-site'. And can be far more focused on your specific implementation than going to a publicly held course, where you have to 'share' your time with a bunch of others with different issues - not very cost effective, really!

Thanks Roxanne,
I guess I was a little vague in my yell for help. My main dilemma is what is the minimum that I need as far as procedures, work instructions, do I have to have control plans for every part, remember I have over 500 part numbers, do I need work instructions for every part #. :mg:
Thanks,Kris
:tg:

Forget control plans, FMEAs, etc. Those are TS requirements.

If your job order (routing, shop order, etc.) contains sufficient information and is accompanied by a product drawing, and the people running the equipment are properly trained, you will find very little need for work instructions.

And you can handle document control and record retention with simple tables. A good chance you can include these and other procedures in your quality manual, and really minimize documentation.

Thanks Duke,

It is not as if I don't have any knowledge, I just wasn't aware of the differences between ISO and TS and did not know exactly what I needed. I did order a standard yesterday so that along with the help of the Cove I am hoping this process will be relatively pain free.

Forget control plans, FMEAs, etc. Those are TS requirements.

Duke,

Control plans are not necessarily "ISO/TS 16949:2002 requirements."
Any organization can benefit from them....;)

Stijloor.

Thanks Duke,

It is not as if I don't have any knowledge, I just wasn't aware of the differences between ISO and TS and did not know exactly what I needed. I did order a standard yesterday so that along with the help of the Cove I am hoping this process will be relatively pain free.

Kris,

Pain free? You know what they say: "No Pain, No Gain." :tg:

Good luck Kris. Please come back often.

Stijloor.