QMS (Quality Management System) and Calibration Procedure

  • Thread starter sagespecialized
  • Start date
S

sagespecialized

#1
First off, WOW!!! I stumbled into this site and it has been a wealth of knowledge on my quest for ISO9001/2008 compliance/ certification.

A little about me. I'm a machinist that has decided to start my own shop. Been doing it for 21 years. I have been process orientated for all of them, say what you do and write it down. I have worked in all departments in manufacturing including quality but have never been part of the ISO/AS team that put together the docs so this is a first for me. My approach is a little different than most shop owners in that I want my establishment to be driven by the documentation, most do it the other way around, so i'm on a journey to start with the basic 6 procedures then build on it as I grow. I do have a plan.

I'm working without a standard at the moment but I have learned what's required from all the great threads here. Being unemployed at the moment money is a little tight but I know I will have to invest in one soon to verify I have all my ducks in a row up to this point.

I'm stuck on the part about needing a calibration process in my QMS manual. I plan on sending all my measuring tools our to an accredited lab for calibration and certification then retaining all docs in one file hyperlinked within my QMS manual, but i'm just not sure how to word the procedure that tells an auditor and employees that. Purpose, Scope, Responsibility etc. Each of my current processes contain those items and I'm looking for fluidity in my system so I feel I need to add some depth to the process and not just a one liner. ex. all measuring tools go to XYZ and I have the certs on file. to vauge for me.

Could I get a little help to point me in the right direction on handling this situation? Do I need a laundry list of work instruction explaining "How To" if it's all outsourced at this point? I wouldn't think it would be needed but you are all the experts.

Oh and I'm a one man band working out of his garage at this point. These docs will open the door to my prospective customer and get the ball rolling. 3-4 months here to get the docs in motion then it's off to a building. :thanx:
 
Elsmar Forum Sponsor
T

trainerbob

#2
Re: QMS and Calibration Procedure

Do what you say - Say what you do!!!!!! Keep it simple and tell it like it is. The biggest concern here, and it must be addressed, is what happens when when a measuring device is found to be out of spec. What do you do then? How critical is it for your customers? This also should be part of your calibration procedure. The calibration procedure not only takes care of your measuring devices, it also protects your customer. Good luck to you in your new venture.
 
S

sagespecialized

#3
Re: QMS and Calibration Procedure

Thanks. Plan B is to send out a gage block set to be certified and then reference that in the prodecure."Inspection tools to be verified with certified standard prior to use during inspection procedures". My issue now is time. I don't have alot to sit down an address all procedures/ work instructions required for all of my measuring devices. I figure I can update that at a later date and up the rev. on the main processs.
 
F

falconer65

#4
Re: QMS and Calibration Procedure

Plan B may work until you can get to Plan A.

The important thing is to get acceptable parts to your customer. If you fail in that, you may lose the customer. That is the reasoning behind a calibration system.

And if you start with Plan B, there is nothing to say you can't make 100 revisions to fully implement Plan A. Or you may change to a Plan C. The documentation should not limit your process.
 
J

jojohartwell

#5
Re: QMS and Calibration Procedure

When we implemented ISO 9001/2008 people were horrified with the big words & complex statements in the standards. I had to break everything down into simple terms everyone in the company could understand. I have a big dry erase calendar laid out in year format that I write in big RED marker on the month that certain test equipment has to be sent out for calibration. I find the simpler the better. That way you always do what you say you do and don’t forget to do what you’re supposed to do. If so, there are always CAPA's to fill out.
 

BradM

Staff member
Admin
#6
Re: QMS and Calibration Procedure

Hello everyone! :bigwave: We have two new Covers in this thread!! That's great! :agree1:

You state this:

I'm stuck on the part about needing a calibration process in my QMS manual.
And then include this:

I plan on sending all my measuring tools our to an accredited lab for calibration and certification then retaining all docs in one file hyperlinked within my QMS manual, but i'm just not sure how to word the procedure that tells an auditor and employees that. Purpose, Scope, Responsibility etc. Each of my current processes contain those items and I'm looking for fluidity in my system so I feel I need to add some depth to the process and not just a one liner. ex. all measuring tools go to XYZ and I have the certs on file. to vauge for me.
You're work is pretty much done, IMHO. :D Now, if you want to have fillers for Purpose Scope Responsibility that should be easy enough (purpose/scope who would this be applicable for; responsibility should be easy enough).

Now... I might address a few other things like remedial action (how to handle when an instrument is out of tolerance), tamper resistant, etc. But for goodness sakes, keep it simple. It's easier to communicate, and a heck of a lot easier to stay in compliance. :)
 
S

sagespecialized

#7
Re: QMS and Calibration Procedure

You guys rock, Thanks for the sound advise. I'm going to add my calibration date to outlook and have it remind me so I know when the date is coming up. I sent my tools out last week to a third party calibration house and am going that route for now. As time goes on I will start getting procedures and work instruction together so next year I can flip it and do it in house.

Now it's time to work on a solid quoting spread sheet so I can have some consistency in my numbers.If anyone has one to share and get me going in the right direction that would be great.

Time to hammer down.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#8
Calibration Certificate Contents

<snip> I sent my tools out last week to a third party calibration house <snip>
Make sure they provide you with "certs" with the proper information which is typically defined in your RFQ (aka "Request for Quote").
 
S

sagespecialized

#9
I had them calibrate and refer to ISO-17025. I will be getting all certs back with my tools and hyperlinking them within my QMS so they are at a mouse click away.

As I go thru this process I am trying to be as organized as possible and think to the future not just what I am doing today but at 3 months, 6months a year etc. Is it advisable to add into my QMS procedures and work instructions now for how I want things to be at those points in time? Or should I just hold them in my bag of tricks and implement them at those time periods.

I guess what I'm asking is there a way to write them in now and say "coming soon..." or does that lead to issues with an auditor. Does it just make it more confusing?
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#10
Your approach to send everything to an accredited lab is the right one. If your ISO9001 auditor has an issue with that, fire him.
 
Thread starter Similar threads Forum Replies Date
John Predmore Explain Quality Management System (QMS) for the uninitiated ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T IATF 16949 Quality Management System (QMS) Scope Requirements IATF 16949 - Automotive Quality Systems Standard 11
A QMS (Quality Management System) for Logistic Agency ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Where does the QMS (Quality Management System) fit in your organization? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
P What is a QMS (Quality Management System), really? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
0 Feedback on proposed restructure of Quality Management System (QMS) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
K The differences between ISO 9001 vs a QMS (Quality Management System) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
F How to set-up a Dual Company QMS (Quality Management System) Quality Manager and Management Related Issues 2
A Software Tools for managing a QMS (Quality Management System) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
L Processes required for the Quality Management System (QMS) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
Q Where to include the SIPOC results in QMS (Quality Management System)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Shortcomings of Compliance Focus Quality Management System (QMS) Quality Manager and Management Related Issues 3
M Building an AS9100 QMS (Quality Management System) AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 21
J Difference between Management System and QMS (Quality Management System) General Auditing Discussions 5
J Supplier Quality Management System (QMS) Audit - Formal Documented QMS does not exist ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
B Where do policies fit in the setting up of a Quality Management System (QMS)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S Marketing Process as part of QMS (Quality Management System)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
C How do you measure the Effectiveness of a QMS (Quality Management System) Quality Manager and Management Related Issues 34
S Including Product Trade-Ins in our Quality Management System (QMS) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
O QMS (Quality Management Systems) Team Structure & Responsibilities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
W Sustaining a TS16949 QMS (Quality Management System) IATF 16949 - Automotive Quality Systems Standard 15
Y Training on the Basics of a QMS (Quality Management System) for ISO 13485 Training - Internal, External, Online and Distance Learning 4
D QMS (Quality Management System) on Intranet - Business Case ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Marc Definition QMS - Quality Management System - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
J Sitting Back and Reflecting on ISO 9001 QMS (Quality Management System) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
R BMS Vs QMS (Business Management Vs Quality Management System) AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6
J Building the QMS (Quality Management System): Getting Started Document Control Systems, Procedures, Forms and Templates 16
G Requirements for Implementing an ISO 9001:2008 Quality Management System (QMS) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
L Definition Quality Management System (QMS) as per ISO 9000:2005 - Definition of Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
V ISO 9001 QMS (quality management system) for MBA College ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
N Help a newbie to develop a QMS (Quality Management System) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 50
Q QMS (Quality Management System) Fundamentals Training Training - Internal, External, Online and Distance Learning 4
G Must the QMS Management Representative be part of the quality department? Quality Manager and Management Related Issues 23
Pancho Interesting Discussion Using a Wiki to implement a Quality Management System (QMS) Document Control Systems, Procedures, Forms and Templates 271
O QMS (Quality Management System) in a Project Implementation Organisation Quality Manager and Management Related Issues 3
I Developing Quality Objectives for a Quality Management System (QMS) Quality Manager and Management Related Issues 7
K Quality Management System (QMS) Echo Training or Refresher ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
P Creating a New QMS (Quality Management System) from Old AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
M Evaluating my QMS (Quality Management System) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Q Writing a QMS (Quality Management System) Manual from Scratch Quality Management System (QMS) Manuals 2
R ERP/MRP system as part of the QMS (Quality Management System) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
F Training Employees on the QMS (Quality Management System) Training - Internal, External, Online and Distance Learning 4
Q How can I make the QMS (Quality Management System) interesting to employees? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
B When is a QMS not a "Quality" Management System? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
T QMS (Quality Management System) for a business support organisation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K Quality Management System (QMS) audit checklist needed General Auditing Discussions 3
F Quality Management System vs. Effects of Local Culture on Implementing a QMS Misc. Quality Assurance and Business Systems Related Topics 22
P How to Assess the Effectiveness of the QMS (Quality Management System) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
L What TYPES of documents are in your QMS (Quality Management System)? Document Control Systems, Procedures, Forms and Templates 7
D Inform Customer of Changes to QMS (Quality Management System)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Similar threads


















































Top Bottom