ISO 9001 Implementation and Certification - 6 Years of Advice

[Stijloor]

Re: Taking my company to ISO 9001 certification - Some advice for me?

And one more question regardin work instructions. Do we have to have written work instructions? They are verbal and well known by the personel. If we wrote them down, it would just be useless, because the employees wouldn't read them at all. All new personel is trained about what they have to do, and that is recorded in HR docs.

Given the fact that each product is almost unique and manufactured at order, can the form for each order be considered a work instruction? I cold attach such a form, but it's in Romanian and it takes some time to translate...

Hello driaadi,

Wecome to The Cove!

Work instructions are not required. ISO 9001:2000 Clause 7.5.1 b) states: "the availability of work instructions, as necessary." So, if the work order provides all the necessary information and your people are competent, then you should be OK. The outcome of the manufacturing process will demonstrate if you're right or not.

Stijloor.

 

[driaadi]

Re: Taking my company to ISO 9001 certification - Some advice for me?

Hello driaadi,

Wecome to The Cove!

Work instructions are not required. ISO 9001:2000 Clause 7.5.1 b) states: "the availability of work instructions, as necessary." So, if the work order provides all the necessary information and your people are competent, then you should be OK. The outcome of the manufacturing process will demonstrate if you're right or not.

Stijloor.

I thought so,

 

[Stijloor]

Re: Taking my company to ISO 9001 certification - Some advice for me?

Hello driaadi,

I'll try......

Hello,

I need some help because I was appointed responsible for quality in the company and I am new in the field.

I have read a lot around, but I still have some questions and I would be most grateful for your help:

1. Is it OK to put it as a quality objective in the Quality Policy:
"1.Maintaining the market leader position at the local level and raising our market share, trough high-quality products that meet our customer requests"

The standard also requires that the policy includes a commitment to continual improvement.

2. Can you help me with some examples and templates of procedures (the 6) and forms for such a small company? I dont want to complicate things, given the fact we are small. We are: the manager-owner, the engineer - brother of the owner and I, we also have 1 shop with 1 seller employee, and 6 workers at the plant.

There are many good examples in the post attachments section of this site. Look at the header of the Cove Page.

3. How can we comply with 7.4. when the German company is actually controlling us, trough regular audits...we can't afford to ever audit them, we only use their materials, put them together according to client requests and our measurements. We only do visual inspections post purchase.

In Romania, a lot of people are changing their old doors and windows now... they come with their measurements, we make a draft offer, if they accept, we go measure the place, we say a final price, if they accept it, it takes 3-10 days to do the order and then we deliver it and install it. That's all, in large.

How can we not complicate this by inefficient rrecording? That's killing us.

We use a software the supplier gave us, that records the order, the draft offer, the final offer, the design of the final product, we print it, give it to the workers, they manufacture the final product, and deliver.

That's it...

From this, I conclude that you only have one supplier, the German (parent) company? If so, it should not be too difficult. Monitor them on quality, delivery, responsiveness, and possibly other important criteria. Record this, and you should be OK.

4. Is it possible that 21 categories of records actually mean less that 21 records? Because a file of an order in our software plus the printed final offer signed by the customer, given into work by the engineer and signed as done, verified and delivered by subsequent workers can cover more categories.

Even though there are 21 references to "records" in ISO 9001:2000, that does not mean that they all apply to you. For example, if you are not product design responsible, 5 records would drop of the list. In addition to the "mandatory" records, you decide what other records you need to maintain. That's determined by internal and external needs.

We are working in developing the system, we have a lot to do, but we are confident!

Thank u all, for being so helpfull.

driaadi

P.S. appologize if stupid questions...

There are no stupid questions. My Fellow Covers are ready to help to the best of their abilities...Let us know if you have more questions.

Stijloor.

 

[JaneB]

Re: Taking my company to ISO 9001 certification - Some advice for me?

Even though there are 21 references to "records" in ISO 9001:2000, that does not mean that they all apply to you. For example, if you are not product design responsible, 5 records would drop of the list. In addition to the "mandatory" records, you decide what other records you need to maintain. That's determined by internal and external needs.

Good advice from Stijloor. Also, it's not necessarily a 1:1 ratio, because sometimes one type of record in your company can meet more than one requirement. For example, one of my clients has an online system they developed that includes their processes & workflow, and by following the system, records are generated within the system that cover off multiple different records requirements, from customer requirements to delivery of product.

 

[CliffK]

Re: Taking my company to ISO 9001 certification - Some advice for me?

KISS!

Don't over document

Don't over engineer

Don't overkill the system

Very little to add to this excellent advice. But here are a few points:

Know the purpose of ISO registration. There are implications for how you should proceed.

Rules of thumb for deciding if you need a documented procedure:
If they're getting the work done without a documented procedure, why do they need one?
If the person doing the job is run over by a beer truck, does her successor need a documented procedure? Note the answer is no if there are several potential successors or others who understand the work.

 

[driaadi]

Re: Taking my company to ISO 9001 certification - Some advice for me?

Thank u all for your answers.

We don't think we need documented work instructions, but do we have to justify this anywhere in our documentation? Where?

If we had to hire someone else for a job we would need to do a short training but I believe that is covered when we say that we identify the training necesities and assure resources for that.

Regarding 6.2.2. b, is it ok if we say in our QM that "the activity of the employees is guided and evaluated on a continuous basis"?

Do we have to justify in our QM the choices we make regarding the way we design and document procedures? Does it matter from the registrar's Point of view?

 

[Jim Wynne]

Re: Taking my company to ISO 9001 certification - Some advice for me?

We don't think we need documented work instructions, but do we have to justify this anywhere in our documentation? Where?

There is no requirement for documented work instructions. What is required, beyond the documented procedures specified in the standard, is documentation necessary to the operation of the quality system. You don't need to document the absence of work instructions, but you should be able to demonstrate that they aren't necessary.

If we had to hire someone else for a job we would need to do a short training but I believe that is covered when we say that we identify the training necesities and assure resources for that.

You need to be able to determine the competence of people, not just training.

Regarding 6.2.2. b, is it ok if we say in our QM that "the activity of the employees is guided and evaluated on a continuous basis"?

The clause you're referring to says, "The organization shall...(a) determine the necessary competence [and] (b) provide training or other actions to satisfy these needs" [and] (c)...evaluate the effectiveness of the actions taken. It sounds to me like you're trying to avoid having to define what "competence" means for each position, and what training might be necessary to help achieve it, and how to evaluate whether or not your strategy was successful in producing competence. You should keep in mind that building a quality system won't be successful if you keep looking for loopholes in the standard. People need to be competent at their jobs, and your company needs to have a way of helping them to be competent, and evaluating whether they are or not.

Do we have to justify in our QM the choices we make regarding the way we design and document procedures? Does it matter from the registrar's Point of view?

The overall design of the documentation system isn't prescribed in the standard. Do it so that it's reasonably consistent and so that it works for your company, and the registrar will probably be satisfied with it.

 

[CliffK]

Re: Taking my company to ISO 9001 certification - Some advice for me?

A slightly different take on your questions.

Thank u all for your answers.

We don't think we need documented work instructions, but do we have to justify this anywhere in our documentation? Where?

No.

If we had to hire someone else for a job we would need to do a short training but I believe that is covered when we say that we identify the training necesities and assure resources for that.

What Jim Wynne said. Can't improve on that.

Regarding 6.2.2. b, is it ok if we say in our QM that "the activity of the employees is guided and evaluated on a continuous basis"?

Why are you addressing this at all in your QM? I fear you are on the verge of over-documenting.

Do we have to justify in our QM the choices we make regarding the way we design and document procedures? Does it matter from the registrar's Point of view?

No and no. Be aware, though, that individual auditors may "require" you to embrace certain format conventions such as Page X of Y numbering and similar claptrap.

 

[driaadi]

Re: Taking my company to ISO 9001 certification - Some advice for me?

You need to be able to determine the competence of people, not just training.

We have the Job Descriptions reffered to. They contain requirements for competences, studies, abilities and experience for each position.

The clause you're referring to says, "The organization shall...(a) determine the necessary competence

That is determined in job description requirements.(not sure this is the right translation in english, but organizations in Romania are anyway forced by labour law to have this )

[and] (c)...evaluate the effectiveness of the actions taken.

How do we evaluate that ? We do it continously using indicators like: W, time to complete a simple/complex job, customer complaints. Do we have to write this in our QM, or just do it and know why we do it?

 

[driaadi]

Re: Taking my company to ISO 9001 certification - Some advice for me?

Could you please review this model? I am using it in our QM to describe interaction and succesion of proceses (4.1.b.). Do you think it is adequate, or should we have smthg more detailed?

I also did a similar model, more detailed, but only for product realisation process, this one containing support, responsabilities, ins and outs.

Thank you