The ISO 17025 accreditation
The preparation for an iso 17025 accreditation assessment usually comes with a bit of nervousness and uncertainty, irrespective of how experienced you are. It can also be stressful if you have not been through one before. With a background knowledge of such demands, we have compiled a list of 23 must-have items to have a successful audit when the assessors come around. In addition to having these items, they must be well-organized in the right folders, binders, and boxes, and near the venue of the assessment for the ISO 17025 accreditation .
In the case of digital records, ensure they are correctly compiled electronically, and save them on a flash drive. Let each assessor have a flash drive, and a copy for yourself as well. This helps you keep up with the assessors and answer questions easily during the assessment for the iso 17025 accreditation.
“Give only copies of your records to the assessors, as they may lose or damage the originals. The originals remain with you.”
The need for adequate preparation for the ISO 17025 accreditation
You are probably trying to figure out the need to have these items readied before the ISO 17025 accreditation assessment. Well, here are the reasons.
First, you need to make the right first impression. When your assessors see how organized and ready you are for them; they perceive your organization to be professional, disciplined, and on track. Thus, it is the first step into tilting the assessment to favor you.
Second, being ready and well-organized means you do not have to start searching for items when your assessors request for them. This helps you save money up to hundreds and thousands of dollars. After all, your assessment duration will not extend, and you do not have to pay extra.
Lastly, being prepared leaves no loopholes whatsoever, so your assessors cannot find any other deficiencies. The time spent on searching for documents give your assessors the opportunity to look deeper into your records, documents, and processes and if this extends too much, they may find something.
When you preselect your records, you will have the opportunity to choose the best records – without irregularities or mistakes. This reduces citations, deficiencies, and questions from your assessors. And you already have an advantage in the assessment.
Advantages of Preparation
The benefits that come with proper preparation for your ISO 17025 accreditation Audit can be categorized into three viz;
- Reduction in costs
- Lesser deficiencies
When you are properly organized and have the information already prepared, you spend less time. Less time means you spend less on assessment fees, thus saving your company some expenses. Likewise, there is lesser stress, and you can easily focus on the assessment proper, and answer all questions with confidence and a mind free of distractions.
“Your records must be well-organized into the right folders, binders and boxes, and in close proximity to the venue of the assessment.”
My ISO 17025 Accreditation Audit Experience
Years ago, my quality management system, my standard operating procedures, and my normative documents were the only things I used to bring along to my assessments. Thus, most of the period of the assessment is spent on the search for records and documents once requested by my assessors, and this affected me negatively. My attention was divided; thus I couldn’t answer questions confidently. All these were to the psychological advantage of my assessors, and they leveraged the same against me. After all, I was not adequately prepared.
Likewise, I had to spend more than the normal time on the assessment, and several deficiencies were identified. It was so bad that I couldn’t understand what deficiencies were identified until I reviewed the final report of the assessment.
Feel free to tell us about your past encounters with ISO 17025 accreditation Audit in the comment section below.
The secret to better ISO 17025 accreditation assessments
After many accreditation assessments without proper preparation and much positive results, I reviewed my methods of preparation. I identified those items my assessors asked for more frequently in my past assessments, and I used the list to prepare for upcoming assessments.
The first assessment where I used my list, the results were amazing. I spent three instead of five days, thus reducing my assessment cost by 40%. My cited deficiencies also dropped by about 60%. I was impressed, and I vowed to stick to that list while maximizing the same for the benefits of myself and my clients in preparing for ISO 17025 accreditation Audits.
While the improvements on my last assessment results may be the reason for my reduced deficiencies, I strongly believed that my proper preparation played a pivotal role too. My belief is even strengthened further by the apparent reduction in the duration of the assessment.
There are mostly two assessors for my assessments, and they are expected to conduct the assessment for five days. Once I was able to reduce the duration to three days, the expenses incurred due to my assessors were significantly reduced, i.e., I spent less on the hourly rate, lodging, and travel costs among others.
“In the case of digital records, ensure they are correctly compiled electronically, and save them on a flash drive. Let each assessor have a flash drive, and a copy for yourself as well.”
The 23-Item List Require For A Successful ISO 17025 accreditation Assessment
When preparing for your ISO 17025 , ensure the collection and organization of the following items:
1- Quality Manual
The quality manual is quite important. While you may see it as an obvious item on the list, you should not forget to make copies, at least a copy for each assessor as well as yourself.
2- Standard Operating Procedures
According to the stipulation of the ISO 17025, you are required to have a standard procedure. Thus, your assessors will be interested in verifying if you really have a working procedure that meets the standard requirement. Ensure you have your SOPs and other procedures in place when your assessor asks for them.
3- Normative Documents
These form part of your quality system and may include requirements and policy documents published by accreditation bodies of laboratories. Likewise, they may include other documents, for instance, those published by ILAC. Assessors are known to cite deficiencies due to obsolete or outdated documents, thus, ensure that you present only the latest versions of the documents, and of course make them available on request.
4- Scope of Accreditation
With your ISO 17025 accreditation secured, your scope of accreditation becomes your best marketing tool. Thus, it is important that you carefully check for updates, changes, or mistakes before submitting to your assessors. Make them readily available for review, as this shows your willingness to have the document updated. Your scope of accreditation will also come in handy in the assessment of your laboratory personnel’s competencies and capabilities.
5- Master Documents List
This is an integral part of your quality system and is always required by the assessors. The list contains all the documents that make up your quality management system, thus explaining its importance. Ensure you have it well-reviewed, and effect the necessary updates, changes, and corrections before your assessment.
6- Approved Subcontractors’ List
A list of approved subcontractors is peculiar to laboratories that subcontract tests and(or) calibrations. You should endeavor to have it reviewed and updated before the assessment period. It is one of the items your assessors will ask for, so keep it close. It is advisable that you also keep a copy of the scope of accreditation of your subcontractor, or an internet link to the same, as your assessors may require to see it.
7- Approved Suppliers’ List
Just like your approved subcontractor’s list, you should have your approved suppliers’ list also. Ensure that it is reviewed and corrected as needed, as you do not want your assessors to cite a deficiency on that. Keep it close as well.
8- Complaint Log
You can have your complaints recorded in various ways, but whichever way you adopt, keep it close for your assessors to review. They will review it to ensure that you are documenting as required, and in line with your quality manual.
Whether you are using surveys, or other means of obtaining and documenting feedbacks, ensure that such is available for review by your assessors. Your assessors will always be interested in checking the feedbacks from your customers. You should also make copies to go round each assessor and yourself.
10- Nonconformance Reports
You should keep records of any nonconformity right from your last assessment. Such records must also be available for the assessment of your assessors. They will like to see how your laboratory has handled these non-conformities (if any) and which corrective or preventive actions applied. Likewise, your assessors are interested in seeing how you go about your root cause analysis.
11- Corrective Actions
If you had effected any corrective action since you had your last assessment, ensure they are documented appropriately. Make copies of such records and make it accessible to your assessors for checking. The idea behind the assessment is to check if you really implemented the corrective actions and see how effective they have been since their implementation, and also to ensure they don’t occur again.
12- Preventative Actions
All preventative actions implemented from your last assessment must be recorded, as your assessors will be interested in checking them. They will also be interested in seeing if you have truly monitored them to confirm their effectiveness.
13- Internal Audits
Through internal audits, you can check your laboratory’s quality management system for effectiveness, non-conformities, as well as avenues for improvement. With such knowledge, assessors are eager to learn about your discoveries as per your internal audit. Likewise, they want to confirm if you are auditing your laboratory in the first instance. Thus, you need to make this document readily available in copies for them for an easy review.
14- Management Reviews
This is another crucial segment of your quality management systems that assessors take a special interest in. It is a means of verifying the level of involvement of the management of the company in the quality of laboratory operations. Hence, evidence of management reviews and their findings must be available during your assessment.
15- Training Records
Your laboratory obviously cannot function without the contributions of your laboratory personnel. Thus, assessors will be interested in knowing how qualified and trained they are, as this is vital to calibration and testing activities, as well as the quality of their services. And to do such an assessment, training records are the required documents.
They can also use the document to create training goals for your personnel. Thus, make the records available and have enough copies ready.
16- Personnel Qualifications List
Apart from the capability and competencies of your laboratory and the personnel, assessors are also interested in seeing the qualification list of your personnel. Through the list, they easily verify which personnel is qualified enough to handle specific tests and(or) calibrations when it is time for demonstrations of competencies and skills.
While some accreditation bodies will ask you for the list, others do not. However, having such records is advantageous to your laboratory, as it saves time. With the personnel qualifications list, the assessors need not review the training records of your personnel.
17- Environmental Condition Logs
The environmental conditions of your laboratory are usually monitored and recorded daily. During your assessment, your assessors will need these records to verify if you truly monitor your laboratory conditions. Likewise, it is a means of checking if your laboratory conditions are normal and in line with the specifications. And in instances when the conditions are against the specifications, they are interested in seeing whether you stopped or continued with accredited works.
18- Test/Calibration Methods and Procedures
Procedures or methods of providing instructions are required to perform calibrations and tests. Thus, assessors will be interested in reviewing these methods, while confirming their adequacy and validity, as well as if they are updated. These are the reasons you must keep them handy and validated.
19- Uncertainty Budgets
There are estimates or statements of measurement uncertainty, as encountered in your test and(or) calibration reports. The adequate recording of this information is important, and to go about this; you need to first estimate the measurement uncertainty with the aid of an uncertainty budget.
Apart from revealing how you estimated measurement uncertainty, uncertainty budgets also show how your estimate is affected and what affects it. However, your assessors are interested in this record to ensure that your uncertainty was calculated rightly while considering the proper influences.
20- Equipment Calibration Reports
Traceability is a prerequisite for calculating measurement results. Assessors are interested in verifying if your test and/or calibration results are traceable. Thus, they will review your equipment’s calibration reports. Several copies should be made for you and them as well.
For best results, you should organize the hard copies in three-ring binders with tabs, and the digital copies on a flash. With this, it takes no time to locate the reports in question, especially, if there are several calibration reports on the list. You can also provide two or three cycles of calibration reports. This is because it is possible for assessors to ask for the report of previous calibrations for certain equipment, but if you have everything organized and prepared, you can easily locate them.
21- Proficiency Testing Results
This is another item on the long list of the ISO 17025 requirements. As a laboratory, you are required to take part in a proficiency testing program, and ensure that you cover the entire scope in the space of four years (this varies across different accreditation bodies).
Assessors want to see if you met this requirement. Thus, they ask for your proficiency testing schedule and the results of the test you took.
22- Sample Test and (or) Calibration Reports
Assessors are interested in seeing a sample of your usual test or calibration reports. Such report must contain the logo of your accreditation body, alongside ISO 17025 accredited results. When assessors ask for these records, they want to verify if you comply with the requirements of the ISO and the accreditation body advertising policies. Likewise, they are out to check if you are reporting ONLY the measurement results that you have accreditations for as part of your accredited work.
23- Calibration Records
The last item on the 23-item ISO 17025 requirement list is calibration records. You are advised to preselect few calibration records for each discipline, function, or parameter identified in your scope of accreditation. When assessors check for your calibration records, they are interested in seeing how you manage and control your records, including calibration or test data and contact reviews.
The calibration records which your assessors will most likely ask for include:
- Contact review, including purchase orders, quotes, and requests among others
- Identification or handling of test or calibration items
- Reports issued to customers
- Calibration or test data
With these records, it is easier for your assessors to check the process of your works and services, from start to finish. Likewise, they review the records to ensure that you comply with the stipulations in your quality manual and procedures.
By having these items prepared accordingly before your assessment, you are presenting yourself as a professional, well-prepared, and organized individual to your assessor. Thus, you spend less than the planned time for your assessment, which in turn saves you money. In addition to this, proper preparation saves you the unsettling and stress that you undergo each time you set out to anxiously search for any of these items. Under such pressure, you are most likely going to provide incorrect information, or spend more time on the search, thus giving your assessors ample time to dig deeper and identify deficiencies.
Perhaps, certain documents or records have been omitted in this list and which are pivotal to a successful ISO 17025 assessment, feel free to share them in the comments section below.
Thank you for reading!