ISO 9001

[Pacificaman]

Hi,

Has anyone implemented an ISO 9001 quality system into their business from scratch and can advise on the cost.

It would be for a small start up manufacturing business.

Cheers

[trickywoo]

Is it required by customers? If no one asks for it there isn't any point having it. It's a Pita and they fail you for the smallest thing even if it has no impact on the quality of the product you are supplying.

My business used to have it but it got really onerous (tail wagging the dog) we dropped it and it had no impact on business other than giving us more time to focus on customers rather than pointless box ticking.

[Pacificaman]

That is a good point.

Some do, and as long as you are working to an ISO system and have traceability, they are ok with it but most don,t.

I

[mrloudly]

It's purely an instrument that shows you follow a set routine/system. Make the rules as simple or as onerous as you wish, as long as you stick to them you'll have no problem come audit time.
Personally, having had it for probably 15 years, I think it's an utter waste of time...

[madmover]

Cost will inevitably depend how big your business is. A lot of it shouldn't cost much aside your time and some of your employees time as they will need to be briefed on everything applicable to their roles.

[Paulgooner]

A company called CQS can set it up for you, costs are about £500pa, which includes annual visit. Ideal for v small business. I think they are in Worcester

[Birkin1932]

We have ISO 9001, 14001 and are currently putting in place 18001.

It has been instrumental driving our sales with larger ISO registered companies.

Standard ISO9001 only requires 6 main procedures, so if you just want the badge do that. However if you have a good consultant who builds the system round your current system you may end up with 25 or so. Its when this happens that the system works for you.

We have KPI's for all parts of the business, it has highlighted many issues we have been able to address. Staff must be integral in its rollout

Used correctly ISO systems are a really helpful business tool

It cost us about 15k to put the two ISO systems in place on one site.

[NORTS]

All depends on your client requirements. If a client requirement then invest. With the industry we are in if you don't have ISO9001:2008 you won't even make it to pre-qual on a lot of tenders.

Also make sure the 9001 certifying company you use is UKAS approved as if not its not really worth a great deal, plenty of cowboys out there.

I would recommend BSI, we've used them for both 9001 & 18001.

[Pacificaman]

Hi all,

Thank you for your replies. I guess I would rather have it than not, particularly for the intended market it will be an advantage.

I'll take a look at the company in Worcester. At £500 it's a no brainer and should be easier for a start up.

[GT03ROB]

Think carefully if you need it. It doesn't give you quality. It gives you a system which you then demonstrate you follow. It does not verify/validate the system gives you quality. As a QA manager once told me "the system may give you crap results, buts thats fine, as long as you follow the system"

[mrloudly]

GT03ROB said:

Think carefully if you need it. It doesn't give you quality. It gives you a system which you then demonstrate you follow. It does not verify/validate the system gives you quality. As a QA manager once told me "the system may give you crap results, buts thats fine, as long as you follow the system"

Read my post above ;-) This is the stupidity of the whole thing! Those auditing systems, in the main, don't have a clue what they're looking at! Refer to my previous post... Waste of time...

[mrloudly]

Pacificaman said:

Hi all,

Thank you for your replies. I guess I would rather have it than not, particularly for the intended market it will be an advantage.

I'll take a look at the company in Worcester. At £500 it's a no brainer and should be easier for a start up.

Just be careful! You need to make sure the company is approved to register you, not just thinks it is... We're with Zurich and they don't have a clue what they're looking at... They're obviously approved though LOL

[NORTS]

Pacificaman said:

Hi all,

Thank you for your replies. I guess I would rather have it than not, particularly for the intended market it will be an advantage.

I'll take a look at the company in Worcester. At £500 it's a no brainer and should be easier for a start up.

That sounds very cheap, I'd be very cautious. As I advised before, make sure they are UKAS approved or the 9001 certification you will end up with is more or less worthless. I believe you can see on the UKAS website which auditors they approve, see if this firm is listed on there. No different to me writing you one out though if not UKAS approved.

[Birkin1932]

GT03ROB said:

Think carefully if you need it. It doesn't give you quality. It gives you a system which you then demonstrate you follow. It does not verify/validate the system gives you quality. As a QA manager once told me "the system may give you crap results, buts thats fine, as long as you follow the system"

He must be a st QA manager then. Our system red flags errors in our processes in ISO 9001 to give us continuous improvement. Our ISO 14001 system monitors and measures what we do, so again we have continuous improvement in how much electricity usage we have, how much scrap we reduce etc etc

So its the system that is written for a company that can be useless, not the ISO system in general

£500 is far too cheap, look up ISOQAR. taken seriously you need to be looking at £3k minimum for a bespoke system and £1.5k for the initial assessments and £600 per year thereafter to have a yearly audit. You may also have ongoing fee's from your consultant if you cannot do regular internal audits

[b0rk]

Legally your not obligated to use an auditor that issues UKAS certificates and many alternative schemes exist some good, some not so good. Quite a few surprisingly large businesses use alternative (non UKAS) certified quality schemes.

We used to use CQS our initial certification cost near on 2.5k in cert fees plus 3k in consultancy then around £800 pa in audit fees. The £500 mentioned earlier sounds more like the ongoing audit fee not the certification fee. They are a helpful bunch in terms of being willing to sit down and go through your business to identify key process points that should be measured by the system including ongoing continuous improvement.

We only moved away from them due to regulatory changes requiring our product to be CE marked and ourselves to hold factory production control and welding control certificates which they couldn't offer, whilst another provider could along with QMS, EMS,H&SMS. If you have any particular industry requirements in terms of certification it will be best to go with an industry specialist.

[RYH64E]

b0rk said:

Legally your not obligated to use an auditor that issues UKAS certificates and many alternative schemes exist some good, some not so good. Quite a few surprisingly large businesses use alternative (non UKAS) certified quality schemes.

If you're going to go through the ballache of getting an ISO9000 certificate you might as well use a UKAS approved provider, it carries a lot more weight when a knowledgeable customer comes to audit you. As others have said, if you're going to use a non-UKAS provider you might as well save your money, print your own certificate and get your mum to sign it, then you can display it on the wall next to the degree certificate you bought online.

For what it's worth, the system doesn't have to be really complicated, ours isn't, and our certificate is issued by BSI. Having said that, the system isn't much use on a day to day basis, takes a fair bit of time to maintain, and costs about £1500 for an annual audit and fees. The only benefit is that it certain customers demand it, it makes filling in various quality related forms much easier, and helps when you get a customer audit.

[Birkin1932]

I agree, it has to be UKAS.

I've seen ISO providers that issue 10 year certification?? Your just kidding yourself and large client will think your nuts

[b0rk]

RYH64E said:

For what it's worth, the system doesn't have to be really complicated, ours isn't, and our certificate is issued by BSI. Having said that, the system isn't much use on a day to day basis, takes a fair bit of time to maintain, and costs about £1500 for an annual audit and fees. The only benefit is that it certain customers demand it, it makes filling in various quality related forms much easier, and helps when you get a customer audit.

You know the system if properly designed really should reflect day to day processes and not be a semi infrequent paper exercise. The auditors shouldn't really accept systems that do not reflect the reality of the process. Anyway I digress, but yeah the system doesn't have to complex and really shouldn't be.

In terms of the OP if the type of customers being targeted want UKAS accredited 9001 then yes pick a UKAS accredited provider BSI being an obvious and good choice. If the customers want 9001 but do not care about UKAS accreditation EMS and CQS are both decent and cheaper than BSI.

However in my experience if client is big enough to want 9001 and they'll also be looking for a 14001 certified EMS and possibly OHSAS 18001. The case of the later when starting from scratch now you would be completely bonkers not ensure the system manual is compliant with ISO 45001 draft 2 in concept terms.

Do remember that a revision to 9001 due to be published by the end of this year so a three year transitionary period will then commence before you have to recertify under 9001:2015, holding off until later this year would save you the complexity of rewriting the quality manual in a couple of years.

As a micro SME manufacturer you may be entitled to help from MAS (manufacturing advisory service) now part of Business Growth Service it's a government backed service that is free to eligible manufacturing businesses and can provide consultancy on growing your business including the likes of independent certification, accessing new markets etc.