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.
“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.
“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.
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.
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.
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.