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Informational Required Documents/Records in ISO 9001:2015

#41
It should be the result of a risk based determination; complexity of the activity, competence level of the people doing it, degree of automation, need for knowledge preservation and management, etc... Not easy, because you can never account for all possible scenarios and it will stifle process improvements. Hundreds of procedures, forms, etc it consumes a lot of time, effort, energy, money, etc. to be sustained.
That's another mistake; it has to work FOR THE ORGANIZATION and the workforce. Never make decisions on system design based on what (external) auditors would like or want to see.
However, it is to your advantage to make your documentation auditor friendly, particularly when doing so also makes it more organization friendly as well. Properly done, it will.
 

L.Soad

Starting to get Involved
#42
First of all, thanks for the feedback.
Not easy, because you can never account for all possible scenarios and it will stifle process improvements. Hundreds of procedures, forms, etc it consumes a lot of time, effort, energy, money, etc. to be sustained.
My company is a «niche» company. Pollution sampling (with A LOT of methods depending on the pollutants), every project is very specific. I went with «administrative» or «general» documentation (approx 20 procedures), and «technical» documentation (few procedures, like 3 or 4, such as «prepping for a project on the client site», «samples management», «writing of the report», and a shitload of records forms (for each method), and a methodological guide that keeps all the methods in 1 place, that can be brought on field).

That was «easy», but that sounds like a lot, and took me a lot of time indeed, but these methods are how the company earns some money ! and its the place where a mistake could cause the analysis (our prime product) to be off.

That's another mistake; it has to work FOR THE ORGANIZATION and the workforce. Never make decisions on system design based on what (external) auditors would like or want to see.
I know I should be thinking like that, but when you are alone vs 50 ppl who don’t give a crap about ISO 9001 (because of many reasons, the most important is: they have no time, always running, I’ll be happy if I can have a 2hours meeting with all the directors, they are always out at clients sites), it’s all that matters in the end. I think I could do a 2 hours presentation on why this company is not made for the 9001 and the 9001 is not made for us.

But... we need the ISO9001 to comply with the ministry, as it’s a prerequisite for an official countrywide accreditation. The fact is, they don’t care about ISO9001, I don’t have that much time to do it, that much support, and as usual, I’m the annoying guy even though I try to explain how it could help them.

I’m just a guy trying to get the ISO for the time I’ll be in the company, get paid, find another job, so sad to say that but they are not ready.

Sorry for the long post and the off topic discussion.

Soad
 

L.Soad

Starting to get Involved
#43
Soad,

So, second guessing the auditors?

Here, perhaps, we see the value of becoming a competent (or at least well-trained) auditor before documenting a management system.

As a rule, if you can show that “it works” for your company and it’s customers the auditor will be happy.

John
I hope it will, i have no idea :/

Sadly the ones creating a QMS seems to often be rookies like me, i've been reading you all for months now, thank you for your help

Soad
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#44
I know I should be thinking like that, but when you are alone vs 50 ppl who don’t give a crap about ISO 9001 (because of many reasons, the most important is: they have no time, always running, I’ll be happy if I can have a 2hours meeting with all the directors, they are always out at clients sites), it’s all that matters in the end. I think I could do a 2 hours presentation on why this company is not made for the 9001 and the 9001 is not made for us.

But... we need the ISO9001 to comply with the ministry, as it’s a prerequisite for an official countrywide accreditation. The fact is, they don’t care about ISO9001, I don’t have that much time to do it, that much support, and as usual, I’m the annoying guy even though I try to explain how it could help them.

I’m just a guy trying to get the ISO for the time I’ll be in the company, get paid, find another job, so sad to say that but they are not ready.

Sorry for the long post and the off topic discussion.

Soad
I don't think you need to apologize and your situation is not that uncommon. You've been tasked with "getting us that ISO 9001 thing". In most cases, situations like this one are extremely frustrating because you are not expected to mess with the way the company really operates and still, attain certification. However, the only smart and sustainable way to comply with ISO 9001 is to intelligently embed it in the organization business processes; (check ISO 9001:2015 5.1.1.c)).

Good luck to you and I hope you find some fulfillment in the current assignment.
 

L.Soad

Starting to get Involved
#45
I don't think you need to apologize and your situation is not that uncommon. You've been tasked with "getting us that ISO 9001 thing". In most cases, situations like this one are extremely frustrating because you are not expected to mess with the way the company really operates and still, attain certification. However, the only smart and sustainable way to comply with ISO 9001 is to intelligently embed it in the organization business processes; (check ISO 9001:2015 5.1.1.c)).

Good luck to you and I hope you find some fulfillment in the current assignment.
Thanks ! In fact i do find some fullfillment. hard to express why but i do. its hard, i can do alomost whatever i want to achieve the goal i have, i can speak about ISO9001 to all of the employees (its so easy to find the people i need to rely on (mostly young ing. and Msc.) and the ones going full break (more experienced with less studies), voluntary or not).

I'm trying to only change 3 things and all the rest is stuff already done (more or less) just going on paper, and some rigor in recording evidences , formalizing actions, etc. I think for the 15 years this company existed, it never had any formal action plan. its like a 5 person small business but with 50 employees.

I still don't know yet how i'm going to achieve my goal with regards to 5.1.1 a), f), i), j) ,etc ! but i'll keep you informed

Soad
 
#47
Sydney,
I apologize for hijacking this thread. I've been unable to post an original thread. We are about be nonresponsive to an AS9100 NCL based on the auditor having found a non-current SDS for a metal stamping ink. This is the second year that she has written us up for being out of compliance with OSHA regulations. I have copied every section of the standard referring to regulatory compliance, and it all except two relate to PRODUCTS meeting regulatory requirements. However, I am looking for other sources that support what you and I both believe to be accurate. Failure to keep the SDS binder up to OSHA standards is outside the scope of the QMS. Please help. We're a fantastic company with a successful and robust QMS, and we're about to get hammered for having an MSDS sheet instead of an SDS sheet.
 
#49
Sydney,
I apologize for hijacking this thread. I've been unable to post an original thread. We are about be nonresponsive to an AS9100 NCL based on the auditor having found a non-current SDS for a metal stamping ink. This is the second year that she has written us up for being out of compliance with OSHA regulations. I have copied every section of the standard referring to regulatory compliance, and it all except two relate to PRODUCTS meeting regulatory requirements. However, I am looking for other sources that support what you and I both believe to be accurate. Failure to keep the SDS binder up to OSHA standards is outside the scope of the QMS. Please help. We're a fantastic company with a successful and robust QMS, and we're about to get hammered for having an MSDS sheet instead of an SDS sheet.
This is inexcusable. Call your certification body and ask to talk to a member of their executive committee and tell them about this bogus nonconformity. Let them straighten up their auditor.
 
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