ISO 17025 Guide and Ideas for a New Calibration Business

[jialun]

Good day guys ,

I'm have made the first step by planning my own business which is a one-man-show calibration service mainly for force calibration.

I noticed there are many customers whom I had visited in the past need the calibration service provider to be accredited to ISO 17025. Hence, I would like to get the business accredited in order to convince the customers.

Having no record in customer service and calibration record due to new business, I wonder if this accreditation is possible for a totally new business.

I realized there is this uncertainty budget which is needed for ISO 17025, it's has been making me scratching my head.

I'll purchase the required calibration equipment from a ISO 17025 accredited manufacturer and they have given me the CMC information, which I believe should fulfil the CMC report required by ISO 17025.

Hopefully I would be able to get some ideas and any comment is highly appreciated.

Thanks

 

[dwperron]

There is a lot to cover in your short post!

Yes, a one man calibration lab with no history or customer service record can be accredited... but it is going to take a lot of effort.

One thing I would immediately recommend is choosing the Accrediting Body that you will be associated with. They will have people and programs there to assist you in the process, and you will be doing things the way that they expect them to be done.

I assume that you have purchased a copy of ISO 17025, read it. Read it many times to get familiar with all of the document. You will be required to do everything in there: set up a management system, generate policies and procedures, set up records... we're talking everything from training records to proficiency testing to customer complaint records to corrective action process.... there is a lot of stuff in there!
Don't let the uncertainty budget issue be the one that scares you. There is a lot of information and training opportunities out there to help with this.

I don't know where you are located, but some of the accreditation bodies, like A2LA, do run seminars on 17025 accreditation. They do this for labs like you who are looking to get started. It would probably be a good idea to attend one of these sessions to get your feet wet and see if it is really where you want to go. I have worn many of the hats in an accredited lab. One person can wear them all, but it will be a big job.

 

[jialun]

There is a lot to cover in your short post!

Yes, a one man calibration lab with no history or customer service record can be accredited... but it is going to take a lot of effort.

One thing I would immediately recommend is choosing the Accrediting Body that you will be associated with. They will have people and programs there to assist you in the process, and you will be doing things the way that they expect them to be done.

I assume that you have purchased a copy of ISO 17025, read it. Read it many times to get familiar with all of the document. You will be required to do everything in there: set up a management system, generate policies and procedures, set up records... we're talking everything from training records to proficiency testing to customer complaint records to corrective action process.... there is a lot of stuff in there!
Don't let the uncertainty budget issue be the one that scares you. There is a lot of information and training opportunities out there to help with this.

I don't know where you are located, but some of the accreditation bodies, like A2LA, do run seminars on 17025 accreditation. They do this for labs like you who are looking to get started. It would probably be a good idea to attend one of these sessions to get your feet wet and see if it is really where you want to go. I have worn many of the hats in an accredited lab. One person can wear them all, but it will be a big job.

Thanks for the input and suggestions, I appreciate it. I'm from Malaysia where the AB here is not very helpful unlike AB in developed countries. I have actually got myself a copy of the ISO 17025 standard document and other relevant ISO documents and planning to attend ISO 17025 related training as you suggested.

Looking at the ISO 17025 document, there is policy and procedure needed for most of the clauses, I can already imagine tonnes of paperwork. The good news is, I only have to deal with one field, which is force, so, hopefully it will not be as tough as I thought.

I'm have just made a decision to purchase the calibration standard from a manufacturer (ISO 17025 accredited company), section 4.6.4 in ISO 17025 says "The laboratory shall evaluate suppliers of critical consumables, supplies and services which affect the
quality of testing and calibration, and shall maintain records of these evaluations and list those approved", it's beyond my experience level on how to get this done and what is the criteria the supplier should have. Hopefully can get some help on this part.

 

[dwperron]

Yes, there is a policy and procedure needed for everything, there is nothing you can do to reduce that problem. Even for a single parameter you will have to come up with a quality management system for the entire standard.

Something else you should consider: there is a new version of 17025 scheduled for release hopefully by the end of this year. There will be several changes that will affect you, so I recommend that you find out more about the proposed 17025:2017 document before you actually start putting your program together. Otherwise you will be revising all this work in the next 3 years.

Regarding the decision to purchase, your evaluation process can be made much simpler by stating that you will only use critical supplies and services from 17025 accredited providers. Then you need to keep a copy of the supplied product documents with the 17025 logo (proving you evaluated the supplier), and begin making a list of the approved suppliers that you have chosen.

If you are not using an accredited supplier you will have to document your decision process, stating what you are looking to procure, the technical requirements, the demonstrated capability of the supplier, etc. It can be done, but it takes a lot more work. Use 17025 accredited suppliers whenever possible.

 

[jialun]

That's very helpful, Thanks for the guidance.

Since CMC and uncertainty budget are needed, and I'll be using the calibration standard from the manufacturer and will be calibrated by them before they are shipped to me, does that mean the CMC and the uncertainty budget will be calculated by them since the only factor on my end which can affect the test result is human error, ambient and UUT specification.

 

[dwperron]

First thing, your manufacturer is not supplying you with a CMC. They are providing their calibration uncertainties on your calibration standard. You will be generating your own CMC, using the supplied calibration uncertainties along with environmental conditions, Type A contributors like repeatability and reproducibility, UUT specification, and any other possible significant contributors such as measurement resolution.

 

[jialun]

For a newly setup calibration company which has never done nor performed any calibration, may I know how do we generate the statistic based on repeatability, reproducibility, and UUT specifications?

 

[dwperron]

It appears to me that you might be in need of some basic understanding of the measurement uncertainty process. There is a lot of training opportunities out there for this, and here are a couple of resources that I have found useful.

This document is from the NPL, and it is very good for explaining the process from an "entry level" position:
https://www.wmo.int/pages/prog/gcos/documents/gruanmanuals/UK_NPL/mgpg11.pdf

Another document has a number of examples worked out to demonstrate how to calculate specific measurement uncertainties for a group of calibration examples in Supplement B:
http://www.european-accreditation.org/publication/ea-4-02-m-rev01-september-2013

Here is a document that deals specifically with uncertainty in force measurements. It is more detailed, and it will include a lot of information on the possible uncertainty contributors that you must take into account in calculating your CMC:
https://www.euramet.org/Media/docs/...__v_2.0_Uncertainty_of_Force_Measurements.pdf

 

[jialun]

Thanks for the suggested links.

I have heard and seen one person calibration lab accreditted with ISO 17025, but how did they get pass the management review part since as a one-man-show operation, there is no way you can do a management review and it cannot be done with thri party?

 

[dwperron]

4.15 says that "management shall periodically conduct a review of the laboratory's management system and testing and/or calibration activities..."

Since you are management, that means you will undertake the review. There is a checklist of what will be included in the management review, so you will research and respond to each item. This is objective evidence, so you must show that you reviewed your policies and found the suitable, your internal audit results, your corrective action responses, etc. You will make recommendations to yourself for areas for improvement, and in future years you will ensure that you carried those out.

In your case, all you need to do is to review your organization's performance. This is something you should be doing anyway. The Management Review is just putting that process into a document.