23 Must Have Items to Survive an ISO 17025 Accreditation Audit

23 Items for ISO17025 Audit

Introduction

Preparing for a ISO/IEC 17025:2005 accreditation assessment is stressful, especially if it is your first assessment. No matter how much experience you have with ISO17025 accreditation assessments, you will always be a little nervous and unsure of the outcome.

To help ease the stress of your upcoming assessment, I have prepared a list of 23 items you should have readily available when your assessors walk through the door. When I say readily available, I mean you should have these items pre-organized in folders, binders, and(or) boxes at the location you will hold meetings with the assessors.

If all of your records are digital, prepare these items electronically and put them on a flash drive for each assessor. While you at it, make a copy for yourself, so you can follow along with your assessors and see what they are seeing when they have questions.

 

“Make copies of your records. NEVER give your assessors the original records; they may damage or loose them!”

 

Why You Should Prepare

Now, I know that you are wondering why you should collect these items beforehand; so, let me explain why it is a good idea:

Primarily, first impressions are key. By having these items readily available, you are setting the presumption that your organization is professional, well organized, and on top of your game. You are psychologically setting the stage of the assessment in your favor.

Second, you will save a ton of time searching for items requested by your assessors. When your assessment fees are increasing at an hourly rate, you may be able to shave off several hundreds, or even thousands, of dollars by expediting the assessment process.

Finally, you will likely prevent your assessor from finding additional deficiencies. When you are searching for items that your assessors have requested, you are giving them additional time to dig deeper into your documents, records, and processes. The more time they have, the more likely they are to find something.

Plus, preselecting your records allows you to choose records that are free from mistakes which will equate to fewer citations and deficiencies. It truly gives you the advantage in the assessment.

 

The Benefits of Preparation

Again, the three main benefits of using my checklist to prepare for your ISO17025 accreditation assessment are;

• Save Time
• Reduce Costs
• Fewer Deficiencies

Having this information readily available is a huge time saver. The less time it takes to complete your assessment, the lower your assessment fees will be, which saves your company money. Additionally, you will be less stressed and able to focus on the assessment, think clearly, and answer questions more confidently.

 

iso17025 audit records

“Organize records into folders, binders, and(or) boxes
at the location you will hold meetings with the assessors.”

 

My Assessment Experience

In the past, I went into assessments with just my quality management system, my standard operating procedures, and my normative documents. As a result, I spent most of the assessment running around frantically collecting documents and records for my assessors.

When assessors asked me questions, I was not focused and I could not answer questions confidently. My assessors had the psychological advantage. They had gotten the best of me because I was not prepared.

In the end, my assessments took longer and I was cited tons of deficiencies. The worst part was that I was not even sure what I had been cited for until reviewing the final report after the assessment.

If this sounds like you or has happened to you in the past, share your story in the comment section below.

 

My Solution to Better Assessments

Fed up and tired of being stressed and unprepared, I started to rethink how I prepared for my ISO/IEC 17025 accreditation assessments. So, I created a list of items that my assessors had frequently requested in the past. Then, I used that list to prepare for my future assessments.

The first time that I put my list to use, I was astounded by the results. My assessment took 3 days instead of 5 days. I reduced the number of cited deficiencies by 60%, and I cut my assessment costs by 39%. I was impressed with the results! From then on, I have used this list to help me and my clients prepare for ISO/IEC 17025 assessments.

Now, I know that some of you are thinking that part of the reduction in cited deficiencies could be the result of improvements from my last assessment. You are probably right; but, I am confident that my preparation contributed to fewer deficiencies. However, if you are still skeptical, you cannot argue about the reduction time.

Typically, my assessments involve two assessors for 5 days. By reducing my assessment to just 3 days, I reduced the amount money spent on my assessors’ fees; hourly rate, lodging, per diem, and travel costs.

 
iso17025-audit-digital-records

“If your records are digital, prepare these items electronically and put them on a flash drive.”

 

Preparing for ISO 17025 Accreditation Assessment

Collect and organize the following items in preparation of your ISO/IEC 17025:2005 assessment.

1. Quality Manual
The quality manual is the heart of your quality management system. Having it readily available for your assessor may sound obvious, but many laboratories forget to make extra copies. So, make sure to make a copy for yourself and each assessor.

2. Standard Operating Procedures
When ISO/IEC 17025:2005 standard states that you shall have a procedure, your assessors will want to verify that you do have a procedure to meet the requirement. So, it is best to have your procedures (e.g. SOPs) ready to go when an assessor requests to see them.

3. Normative Documents
Normative documents are those which make up or form part of your quality system. For most laboratories, they are requirements and policy documents published by their accreditation body.  However, you may have some documents, published by ILAC, that you may want to have available too.

It is quite common for laboratories to receive deficiencies for out of date or obsolete documents. So, make sure to check for the latest revisions to these documents and make sure you have them readily available for your assessors.

4. Scope of Accreditation
Your scope of accreditation is your best marketing tool after receiving your ISO 17025 accreditation. Make sure that you take the time to review this document for mistakes, changes, and updates.

To ensure that your assessors know your intentions to update this document, make sure that you have it available for them to review. Additionally, they will want to use your scope of accreditation when assessing the competency of your laboratory personnel and capability.

5. Master Document List
Your master document list is one of the key elements to your quality system. It lists all of the documents that form your quality management system. Therefore, you can see why your assessors will want to see it. Make sure you take the time to review your master document list and make updates, changes, and corrections before your assessment.

6. Approved Subcontractors List
If you subcontract tests and(or) calibrations, you should have a list of your approved subcontractors. It may be a good idea to review your list and make any necessary updates or changes prior to your assessment. Your assessors will ask to see this list during your assessment, so make sure it is readily available.

Additionally, it is a good idea to have a copy of or an internet link to your subcontractor’s scope of accreditation. Your assessors will want to see that your subcontractors are accredited to perform the services that you subcontract to them.

7. Approved Suppliers List
Another list that you should have available is your list of approved suppliers. Similar to your subcontractors list, review it and make any necessary changes prior to your assessment. Your assessors will ask to see this list too.

8. Complaint Log
However you are documenting complaints, make sure that you have it available for your assessors to review. They will want to make sure that you are documenting these events in accordance with your quality manual.

9. Feedback
Surveys are a great way of receiving feedback from your customers. If this is how you receive feedback, make sure that you have returned surveys available for review.

If you do not use surveys, make sure to have copies of records you have collected of your customer feedback.

10. Nonconformance Reports
Have any nonconformities since your last assessment? Make sure that you have copies of your nonconformance reports available. Assessors like to know what nonconformance events your laboratory has encountered and what corrective and(or) preventative actions you implemented to control them. Furthermore, assessors want to see how you perform root cause analysis.

11. Corrective Actions
Performed any corrective actions since your last assessment? Prepare copies of your corrective action records and make them available for your assessors to review. Your assessors will want to review these records and see evidence that you have implemented them and monitored their effectiveness to prevent recurrence.

12. Preventative Actions
Implement any preventative actions? Your assessors will want to see records of preventative actions that you have implemented and evidence that you monitored have them to ensure their effectiveness.

13. Internal Audits
Internal audits are your chance to assess your laboratory’s quality management system for nonconformities, effectiveness, and opportunities for improvement. Assessors know this and want to see what findings you uncovered from your internal audit. Furthermore, they want to ensure that you are performing internal audits. So, make sure that you have copies available for them to review.

14. Management Reviews
Management reviews are an important aspect of your quality management system, and assessors want to see that company management is involved in the quality of laboratory operations. Therefore, it is important to have evidence of management reviews and their findings available during your assessment.

15. Training Records
Your laboratory personnel are the backbone of your laboratory. How well they are trained and qualified is important to testing and calibration activities and the quality of their work. To assess the competency of your laboratory personnel, assessors will ask to see their training records.

Additionally, they will want to know how you formulate training goals for your personnel. So, have these records available as well.

16. Personnel Qualifications List
When assessors audit the capability of your laboratory and the competency of personnel, they request to see the qualifications list. This list makes it easy for assessors to determine who is qualified to perform certain tests and(or) calibrations when they need to witness demonstration of capability and competency.

It should be noted that not all accreditation bodies require that you have this list. However, it is beneficial to your laboratory. Having a qualifications list saves your assessors from continuously reviewing your personnel training records, which reduces assessment time.

17. Environmental Condition Logs
Every day you monitor the environmental conditions of your laboratory. Your assessors will want to see these records as objective evidence that you monitor laboratory conditions. Additionally, they want to see if your laboratory conditions have drifted out of specification. If so, they will want to see evidence that you stopped performing accredited work.

18. Test/Calibration Methods and Procedures
To perform tests and calibrations, you must have methods or procedures to provide instructions. Assessors will want to review these methods to ensure that they are adequate, up to date, and validated. So, make sure that you have them readily available and validated.

19. Uncertainty Budgets
You are required to report estimates or statements of measurement uncertainty in your test and(or) calibration reports. To accomplish this, you must first to estimate measurement uncertainty using an uncertainty budget.

Uncertainty budgets show how you estimated measurement uncertainty and what influences contributed to your estimate. Guess what! Your assessors want to review your uncertainty budgets to verify that you calculated uncertainty correctly and considered the appropriate influences.

To learn more about measurement uncertainty, download my uncertainty guide or check out my list of free uncertainty guides.

20. Equipment Calibration Reports
To provide accredited measurement results, you need traceability. To ensure that your test and(or) calibration results are traceable, assessors need to review the calibration reports for your equipment. Therefore, it is a good idea to have them available.

I recommend putting digital copies on a flash drive or putting hardcopies in three-ring binders with tabs. This will help you locate the requested reports faster; especially, if you have a lot of calibration reports. Furthermore, it is not a bad idea to have 2 to 3 cycles of calibration reports. Some assessors may request to see the previous calibration report for a particular instrument. If you already have them prepared, you will not have to go looking for them.

21. Proficiency Testing Results
Another ISO/IEC 17025:2005 requirement is that you must participate in a proficiency testing program; and, you must cover your entire scope within a four year period (However, this ILAC requirement can vary depending on your accreditation body). To make sure that you are compliant, assessors will want to see your proficiency testing schedule and the results of the tests that you participated in.

22. Sample Test and(or) Calibration Reports
Since you are going to issue test and(or) calibration reports with your accreditation body’s logo and a statement that the results are ISO/IEC 17025:2005 accredited, assessors want to see a sample of what you are going to report to your customers.

They are checking to make sure that you comply with ISO requirements and accreditation body advertising policies. Additionally, they want to verify that you are not reporting measurement results that you are not accredited for, as accredited work.

23. Calibration Records
Finally, you should preselect some calibration records for each parameter, function, or discipline listed in your scope of accreditation. Assessors will want to review your records to see how you control and manage records, such as contact review and test or calibration data.

The records that they will most likely want to review;

• Contact review (e.g. requests, quotes, purchases orders, etc.)
• Identification/Handling of test or calibration items
• Test or calibration data
• Reports issued to customers

Having these records available will allow your assessors to see how you process work from beginning to end. Additionally, they are reviewing them to verify that you are operating in accordance with your quality manual and procedures.

 

iso17025 checklist download

Conclusion

Collecting these items before your assessment and having them readily available for your assessor will not only make you look professionally, well prepared, it will reduce the amount of time spent on your assessment (i.e. Saving you money). Additionally, your preparation efforts will prevent you from frantically searching for these items under pressure which may cause you to deliver your assessor incorrect information or allow him/her extra time to discover more deficiencies.

If I have left anything out of this list or if you can think of any additional tips that would improve this list, please leave a comment or contact me to share your advice.

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About the Author

Richard Hogan

Richard Hogan is the CEO of ISO Budgets, L.L.C., a U.S.-based consulting and data analysis firm. Services include measurement consulting, data analysis, uncertainty budgets, and control charts. Richard is a systems engineer who has laboratory management and quality control experience in the Metrology industry. He specializes in uncertainty analysis, industrial statistics, and process optimization. Richard holds a Masters degree in Engineering from Old Dominion University in Norfolk, VA.

Connect with Richard on Google+ and LinkedIn.

24 Comments

  1. The list you prepared for Iso 17025 accreditation is a big help for me and very timely. By next month our lab will undergo assessment for ISO 17025. Thank you very much Mr. Richard.

  2. Thanks for your spot on list. I have been involved in four A2LA audits. Not in the uncertainty budget and administration portion, but as a technician and I have seen my managers go through hell running back and forth looking for a requested item. If they had your list it would have been very smooth and efficient.
    Again thanks.

    • Hi Dennis,

      Thank you for your comments. I am glad that you liked this article. I have been through many A2LA audits myself. That is where I derived my inspiration to develop this list and write this article. Please share my article with your coworkers. I know Trescal has really been growing the last few years. Maybe I will send this article to Tim Osborne at Trescal; we are both members of A2LA’s technical advisory committee.

      Rick Hogan

  3. Hi, Richard,

    thank you for the article. May be it would be better if the items from no.5 to no.23 have been demonstrated by samples. Just plain table or file without data but with a form. It could reduce assessment time if all of the items for every labs would have similar forms. Have you some samples to show?

    • Hi Olesia,

      Thank you for your comments. If you download my guide, you will find a checklist at the end of the guide that you could print and use. I could also provide some samples that I will add to a future article (most likely in 2016). Furthermore, I am working on an accreditation tool kit that customers can purchase for ISO/IEC 17025:2005 accreditation. It too will be available in 2016 and will contain a quality manual, policies, procedures, forms, and more.

    • Hi Maria,

      Thank you for your feedback. I am glad that you find this article helpful. ISO 17025 audits can be stressful! So, I decided to share my preparation tips to help others reduce stress and put themselves in a more favorable position regarding the audit.

      Rick

  4. Good, precise and helpful document. Can also be used as a checklist for preparing for upcoming assessments. If you planning to do anything further, please make this in a power point presentation which can be used in the regular quality training. We have 14 independent accredited labs which will be recertified in near future.

    • Hi Mohammed,

      Thank you. I am glad that you found the article helpful. If you download the guide, I have included a checklist in the back. Also, I will consider making a PowerPoint Presentation for training purposes. That is a really great idea!

  5. Well done Richard! So glad I came across this article. Our initial assessment is 1 month from today. I appreciate your helpful suggestions!

  6. A2LA is coming at the end of January 2017. What is the best methodology and best practice to prepare young Metrology Engineer Technician?

    • Hi Miguel,

      To best prepare for your audit;
      1. Read and know your quality system;
      2. Train your staff/personnel;
      3. Perform a thorough internal audit.

      The most important thing is to know your quality system and operate in accordance with it. Doing these 3 tasks will improve knowledge, prepare the staff, and find any nonconformities before assessors will.

      I hope this helps.

      Rick

  7. Hi Hogan,
    This is good information for me because i am preparing for ISO 15189 accreditation by December 2017. Does this apply to iso 15189 as well? Please share with me more tips that apply to ISO 15189.

    • Hi Wambele,

      Thank you for your comments and feedback. I am happy that you like the guide. I am not sure if it is applicable to ISO 15189. However, the key is to readily prepare for your audit before the assessors arrive. I will take a look at ISO 15189 and see if it something that I should write a guide on in the near future. Good luck with your audit. I hope it goes well and that you get accredited.

  8. I am a beginner in this field. I believe if I were an auditor, during performing audit, reviewing of control chart (internal quality control) would be at the very top of my checklist. Give me your thought.

    • Hi Amresh,

      I would recommend that you start by assessing the laboratory’s quality management system to learn how they operate and assess whether or not they meet their intended requirements.

  9. Hi Hogan,
    I love the way you spotted things out. This is very helpful to my team for our next assessment with A2LA. Actually we have been with A2LA since 2015 and fully hope to welcome more fruitful auditors from there.
    Thanks a lot
    Hoa Tran

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