Version 1.6.1
David Trew
Consulting Ltd
9 Onsite Assessment
The onsite assessment will be carried out by a team of two or three assessors, depending on the size of your laboratory, consisting of a lead assessor and one or two other assessors. At least one of the assessors will be an expert in your field of testing or calibration.
The lead assessor will work with you to devise a schedule for the onsite assessment and will send you an agenda before the visit, together with any accommodation needs. The assessors will usually accommodate any requests to make changes to the agenda before the assessment.
The onsite assessment will consist of the following three phases:
1. Opening Meeting
2. The assessment or audit
3. Closeout Meeting
9.1 Opening Meeting
The assessment will start with an opening meeting which will be chaired by the lead assessor, covering the following:
1. Introductions are the opportunity for the assessment team and the laboratory’s staff to be identified
2. Objectives confirming the objectives of the assessment
3. Scope. A confirmation of the scope of the assessment
4. Documented system. A confirmation that all documents you have supplied assessors are still current.
5. Schedule. Reconfirm the agenda. It may be possible to make some changes to the agenda to accommodate changing business needs.
6. Guides/hosts. Confirm who will accompany the assessors and who will sign any nonconformity reports.
7. Logistics Addressing access to office/meeting facilities and is also an opportunity for you to advise the assessment team of any fire precautions or evacuation procedures, especially if there are any evacuation drills planned.
8. Confidentiality and security clearance is an opportunity to discuss any specific confidentiality or security issues. The lead assessor will state that all information collected during the visit will be treated as confidential. No laboratory documents should be taken offsite by the assessors.
9. Safety equipment. The assessment team should be made aware of any requirements for safety equipment during the planning stages but confirm any necessary arrangements have been made, including any instructions or training.
10. Reporting methods. The lead assessor will explain the accrediting body’s arrangements for reporting assessment findings.
11. Restrictions. This can be used to appraise the assessment team of any sensitive labour relations, ethnic or language issues the team need to be aware of. In particular, if anyone is particularly sensitive or under stress.
12. Limitations. The lead assessor will confirm that as the assessment is based on the examination of a sample of records and a snapshot of time, any issues identified are based on that sample or snapshot. There can be no guarantee that all nonconformities have been identified, and the absence of nonconformities is no guarantee that none exist.
13. Clarification is your opportunity to ask questions.
14. Closeout meeting will confirm the time and place of the closeout meeting and who will attend.
9.2 Assessment
The purpose of the onsite assessment is to collect evidence of technical competency, and the laboratory is conforming to the requirements of its quality management system and the ISO/IEC 17025:2017 International Standard. This will be done by:
1. Reviewing training records: Ensure all your records are up to date and all training requirements have been completed.
2. Looking at the laboratory facilities and environmental controls: Clause 6.3.2 requires you to document your requirements for facilities and environmental conditions. You should have this information readily available. It is also recommended that you document your current facilities, including accommodation (laboratory and sample storage space, controls to prevent contamination, and separation of incompatible activities), utilities (including the capacity of electric circuits), and access controls.
3. Reviewing equipment calibration and maintenance records: Ensure all your calibrations are current and all maintenance activities have been carried out. If any equipment is outside its calibration period, ensure it has been taken out of service or appropriately labelled.
4. Reviewing your records for external providers
5. Tender and contract reviews.
6. Witnessing the performance of specific tests or calibrations: One of the objectives of the onsite assessment is to determine that the laboratory is competent to perform the tests it is seeking accreditation. Ideally, this will be done by observing laboratory staff performing their routine work. However, the assessors can request a demonstration of a specific test if it is not currently being carried out. You may be asked to explain how you select a suitable method to test specific samples or calibrate a particular item
7. Witnessing sampling procedures: The assessors will probably want to observe sampling taken place, including a demonstration of the sampling processes. The assessors will ask you to explain the controls necessary to ensure the validity of the results.
8. Witnessing the handling of samples or calibration items: The assessors will need to see how samples are handled as they arrive in the laboratory. This will include:
i. Inspecting the samples for deviations from specified conditions
ii. Recording the samples or calibration items into the laboratory’s sample or calibration item management system. Including identifying the specific sample or calibration item
iii. Storing the samples or calibration items
9. Reviewing technical records: The assessors will review a sample of the records created during testing or calibration activities to ensure all the required information has been captured contemporaneously together with the identity of the person performing the task and the date the entry was made. You can expect to be asked to reconstruct the calibration or test from the records.
10. Reviewing the results of activities to ensure the validity of results: The assessors will review the results of the proficiency tests or interlaboratory comparisons you have participated in, together with your intralaboratory activities. The assessors will review your analysis of data from monitoring activities and any action you have taken as a result of that analysis. NOTE: You should have sufficient evidence from proficiency testing or interlaboratory comparisons to convince an expert of your competency to perform each test or calibration you wish to be accredited.
11. Reviewing your reports or certificates: The assessors will review your reports or certificates to ensure they conform to the requirements of the International Standard.
12. Reviewing complaint and nonconformity records: The assessors will ask to see your complaint and nonconformity records to ensure complaints and nonconformities are being handled correctly. The assessors can be expected to ask to see evidence to demonstrate you have sought to identify any trends or reoccurrences and have taken actions to address them.
13. Checking your information management systems: The assessors may ask you to demonstrate or discuss the controls you have in place to ensure your computer systems are secure and the data is protected against tampering, corruption and loss.
14. Discussing the actions, you have taken to identify and address risks and opportunities. The assessors may wish to discuss with you the risk and opportunities you have identified. In particular, you should have discussed any risks to the laboratory’s impartiality.
15. Discussing your improvement activities: In particular, the assessors will wish to see your customer feedback.
16. Reviewing internal audits reports: The assessor will review your internal audit reports. You should have reports for each audit carried out, and you should carry out all audits on schedule.
17. Reviewing management review records: The assessors will review the outputs from your management reviews. You should have carried out at least one management review before your onsite assessment.
The assessors may identify nonconformities with either the ISO/IEC 17025:2017 International Standard or with your laboratory’s quality management system during the assessment. These should be discussed with the assessors at the time. Any evidence that corrects or mitigates nonconformities should be presented as soon as possible and before the closing meeting.
You may wish to perform corrective actions on simple nonconformities during the assessment and present that to the assessor during the assessment. Although you can do this, the assessor may be reluctant to consider this during the assessment as it requires time to consider which could be spent carrying out the assessment. The nonconformity will still appear in the record of the assessment. Many accrediting bodies have now established a policy of not accepting corrective actions during assessments. Any nonconformity raised during the audit will require a written response after the assessment.
9.3 Closing Meeting
A closing meeting will be held at the end of each assessment consisting of a meeting between the assessment team and the laboratory’s management. You can decide who in your laboratory will attend. This meeting communicates the findings of the assessment and the recommendation to be made to the accrediting body. It is not intended to be a training session for your laboratory staff.
The closing meeting will discuss the following:
1. Introductions. Only necessary if any of the attendees have not previously met.
2. Objectives. outline the objectives of the assessment
3. Scope. A confirmation of the scope of the assessment
4. Reporting: The lead assessor will explain the accrediting body’s arrangements for reporting the assessment and is often a written report. The lead assessor will provide an estimate of the time when it will be available.
5. Limitations. The lead assessor will confirm that as the assessment is based on the examination of a sample of records and a snapshot of time, any issues identified are based on that sample or snapshot. There can be no guarantee that all nonconformities have been identified, and the absence of nonconformities is no guarantee that none exist.
6. Presentation of all findings. Including an explanation of all nonconformities identified during the assessment. All nonconformities identified during the assessment should have been discussed, and any evidence that may mitigate or remove a nonconformity presented when the nonconformity was raised. The closing meeting is not the place for discussions on evidence that should have been made available during the assessment. Any information supplied during the closing meeting will be considered later.
7. Summary. Including the recommendation for accreditation.
8. Clarification. Your opportunity to ask questions.
10 Corrective Actions
If any nonconformities are identified during an assessment, you will be required to correct the nonconformity and take corrective actions to prevent a reoccurrence, if appropriate. All nonconformities require a written response, including how you have corrected the nonconformity and your actions to prevent a reoccurrence. As your proposed corrections and corrective actions must, in fact, correct and prevent a reoccurrence of the issue, you should explain how your actions will achieve this. You will usually have between sixty and ninety-
11 References
1. International Organisation for Standardisation, International Standard ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories Geneva, 2017
2. European Union Regulation 765/2008, Off. J. E. U. L218, 30 – 47.
3. United Kingdom Statutory Instrument 2009/3155, The Accreditation Regulations 2009.
4. International Organisation for Standardisation, International Standard ISO 3696:1995 Water for analytical laboratory use —Specification and test methods, Geneva 1995
5. United Kingdom Accreditation Service, Guidance Document Lab 15 Traceability: Volumetric Apparatus, Edition 3, London 2019. https://www.ukas.com/download/publications/publications-
6. United Kingdom Accreditation Service, Guidance Document Lab 14 Guidance on the calibration of weighing machines used in testing and calibration laboratories, Edition 6, London 2019. https://www.ukas.com/download/publications/publications-