The Process of Achieving ISO 17025 Accreditation
Dr David Trew BSc (Hons), PhD, CChem MRSC
This article discusses the process of achieving accreditation to the International Organisation for Standardisation (ISO) International Standard ISO 17025 General Requirements for the Competence of Testing and Calibration Laboratories. This paper is intended to provide laboratories seeking accreditation to the ISO 17025 International Standard the activities that need to be carried out to achieve accreditation and of what will happen at each stage of the assessment process.
This article is primarily targeted at laboratories seeking accreditation for the first time. However, parts of it will also be of interest to laboratories seeking reaccreditation.
The International Standard ISO 170251 establishes a set of requirements that form a framework for individual testing and calibration laboratories to construct a quality management system (QMS) to meet their specific requirements. Accreditation of a testing or calibration to the ISO 17025 International Standard provides objective, impartial and independent evidence that a laboratory is both technically competent to perform the tests or calibrations and, in addition, maintains a quality management system that is designed to assure the quality of the tests or calibrations carried out.
Because ISO 17025 is recognised as the gold standard for laboratory quality management systems the results delivered by laboratories that have achieved ISO 17025 accreditation are internationally recognised and such laboratories have access to the global marketplace.
Assessment and accreditation to the ISO 17025 International Standard is carried out by accrediting organisations. Such organisations must be party to the International Laboratory Accreditation Cooperation (ILAC) mutual recognition agreement and/or one of the regional mutual recognition agreements. Such as European Co-
When selecting an accrediting body, it is important to consider the following:
1. Does the organisation have experience with your type of testing or calibration? This can be checked by reviewing the accreditation certificates issued by the body. These should be on the body’s website.
2. Is the accrediting body recognized for its accreditation program? This can be checked reviewing either the International Laboratory Accreditation Cooperation website (www.ilac.org.) or the regional accreditation cooperation website.
3. Does the accrediting body have assessors qualified to conduct assessments in your particular scope of calibration or testing? Where are the assessors located?
4. Is the accrediting body willing to provide you with a complete description of its accreditation process? What are their policies or contract restrictions that may affect you?
5. Is the accrediting body allowed to operate in your jurisdiction?
6. Is the company financially stable? Will the accrediting body still be in business during the period that your accreditation certificate is valid?
Although some of the details of the accreditation process may depend on the accrediting body you choose, the overall process will be same irrespective of the body you use and consists of the following steeps.
1. Prepare for Accreditation
2. Filing an Application
3. Preliminary Assessment (Optional)
4. Document Review
5. Onsite Assessment
6. Corrective Action
Your laboratory will ready for accreditation after you have implemented an ISO 17025 compliant quality management system, your employees have become familiar with the system and you have developed a sufficient evidentiary trail of documents and records that can be assessed.
Documentation should include the following:
Quality Manual: Outlining how your laboratory conforms to the International Standard;
Procedures: Describing how the activities required by the QMS are carried out in a consistent manner;
Work Instructions: Defining specific job activities affecting the quality of calibration or
Quality Documentation: Documents, which explain how quality will be, managed for
individual calibration or testing projects or contracts, as well as other
types of specific documents;
Quality Records: Various records such as testing or calibration records, assessment results, and any other records which provide objective evidence that you are conforming with the requirements of the ISO 17025 International Standard.
Internal Audit Reports: Recording the areas, documents and records that have been examined to ensure conformance with the QMS. Together with any nonconformity reports.
Records Supporting the Validity of Test or Calibration Results: This should include results of performance tests or inter – laboratory comparison studies. Together with the results of intra – laboratory studies
Staff Training Records: Including all training undertaken, together with a plan of intended training activities
Equipment Calibration and Maintenance Records: This should include calibration certificates and maintenance records, together with a calibration and maintenance program.
The timings of these activities will depend on the selected accrediting body. Some bodies require applicants to have at least implemented the quality management system and be able to submit a quality manual and procedures at the time of submitting their application. Whereas other accrediting bodies will wait until the applicant is ready to submit these documents.
Filling an application for assessment for accreditation to the ISO 17025 International Standard, after you have selected your accrediting body, will usually involve completing an application form. This will usually entail providing information about your laboratory including the following:
1. What is your desired time frame for accreditation?
2. What is your laboratory's scope of testing and/or calibration? You will probably also be asked to provide information about your laboratory’s capability such as ranges of measurement and the associated uncertainty.
3. What is the legal status of your laboratory?
4. Is your laboratory freestanding or part of a larger facility?
5. What is the status of your existing laboratory management system implementation?
6. What is the state of your laboratory management system documentation?
Along with the application forms you may be asked to submit uncontrolled copies of some or all of the following documents:
1. Quality Manual
2. Set of quality procedures
3. Quality policy
4. Test or calibration methods you with to be accredited for
If these documents are not required at the application stage, they will be required latter on during the assessment prior to the initial document assessment.
It is important that the information you provide is as complete, and as accurate as possible, as this will allow the accrediting body to provide you with the best estimates of cost and the likely time frame involved.
After you have completed and submitted the application package, the accrediting body will send either a quote or an estimate of the costs for the assessment. If you have submitted application to several accrediting bodies (this will not always be possible) it is important to compare the estimates or quotes carefully and ensure you are clear about what you are being offered for your money, and what you are being offered meets your requirements.
You will be required, at some time, to sign some documents establishing a contract between your laboratory and the accrediting body. This may be required as part of the application, or after the body has provided you with an estimation of the costs.
Many accrediting bodies will offer applicants an optional preliminary assessment of their laboratory management system, prior to the accreditation assessment. Preliminary assessments are not required for ISO 17025 accreditation and are strictly optional, depending upon a laboratory’s needs. The extent of the preliminary assessment is also up to the laboratory.
The principle advantage of a preliminary assessment is that it allows the laboratory to identify and correct any potential problems before the accreditation assessment begins. A preliminary assessment also gives the accrediting body an opportunity to identify, in advance, any weaknesses that may exist in the laboratory quality management system.
During the preliminary assessment, the accrediting body will send an assessment team to the applicant’s laboratory. This team is composed of competent assessors, and will assess the laboratory’s QMS, records and other documentation, alerting the applicant to any concerns that may interfere with a successful accreditation assessment.
The first phase in the assessment consists of a review of the documentation associated with the quality management system. This will consist of, at a minimum a review of:
1. Quality manual
2. Quality policies
3. Quality Procedures
However, depending on your selected accrediting body the following may also be reviewed:
1. Internal audit schedule
2. Plan of activities to ensure the validity of test or calibration results
3. Test or calibration methods
4. Method validation or verification reports
This review will determine that your QMS meets the requirements of the ISO 17025 International Standard, together with any policies established by the accrediting body or relevant mutual recognition agreements. Any deficiencies discovered during the stage 1 review will be reported to you, and you will need to correct these prior to the onsite assessment.
The onsite assessment will be carried out by a team of two or three assessors, depending on the size of your laboratory. This will consist 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 prior to the visit, together with any accommodation needs. The assessors will usually accommodate any requests to make changes to the agenda prior to the assessment.
The onsite assessment will consist of the following three phases:
1. Opening Meeting
2. The assessment or Audit
3. Closeout Meeting
The assessment will start with an opening meeting which will be chaired by the lead assessor. This will cover the following:
1. Introductions. This is the opportunity to for the assessment team and the laboratory’s staff to be identified
2. Objectives. This will confirm 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. This will cover access to office/meeting facilities. This 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. This 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. This should include any instructions or training.
10. Reporting methods. The lead assessor will explain the accrediting body’s arrangements for reporting of assessment findings.
11. Restrictions. This is your opportunity 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 or a snapshot of time, any issues identified are based on that sample or snapshot and the absence of nonconformities is no guarantee that none exist.
13. Clarification. This is your opportunity to ask questions.
14. Closing meeting. This will confirm the time and place of the closeout meeting and who will attend.
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 17025 International Standard. This will be done by:
1. Reviewing training records. Make sure all 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 capacity of electric circuits), 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 of its calibration period, ensure it has been taken out of service and/or appropriately labelled.
4. Reviewing your records for external providers.
5. Tender and contract reviews.
6. Witnessing the performance of specific tests or calibrations. 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 being currently carried out. You may be asked to explain how you select a suitable method to test particular samples or calibrate a particular item
7. Witnessing sampling procedures. The assessors will probably want to observe sampling taken place. This could be 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 sample or calibration item
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 in a contemporaneous manner together with the identity of the person performing the task and the date the entry was made.
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 intra laboratory activities. The assessors will also review your analysis of the data from monitoring activities and of any action you have taken as a result of that analysis. NOTE: You should have the results from at least one proficiency test or inter laboratory comparison for each test or calibration you wish to be accredited for.
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 may also ask to see if you have sought to identify any trends or reoccurrences and the actions you have taken 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 your management review outputs. The assessors will review the outputs from your management reviews. You should have carried out at least one management review prior to your onsite assessment.
During the assessment the assessors may identify nonconformities with either the International Standard or with your laboratories quality management system. These should be discussed with the assessors at the time. If you can present evidence that either corrects or mitigates the nonconformity this should be presented as soon as possible, and in any event prior to 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. All nonconformities raised will require a written response after the assessment.
A closing meeting will be held at the end of each assessment. This will consist of a meeting between the assessment team and the laboratory’s management. You can decide who in your laboratory will attend. However, be aware that the purpose of the closing meeting is to communicate the findings of the assessment and the recommendation that will be made to the accrediting body. It is not intended to be training session for your laboratory staff.
The closing meeting will discuss the following:
1. Introductions. This will only be necessary if any of the attendees have not previously met.
2. Objectives. This will 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 of the assessment. This will often be 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 was based on the examination of a sample of records or a snapshot of time and any issues identified are based on that sample or snapshot and the absence of nonconformities is no guarantee that none exist.
6. Presentation of all findings. This will include 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, at the time 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. This will include the recommendation for accreditation.
8. Clarification. This will be your opportunity to ask questions.
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. This should include how you have corrected the nonconformity and the actions you have taken to prevent a reoccurrence. As it is particularly important that your proposed corrections and corrective actions do, in fact, correct and prevent a reoccurrence of the issue, you should explain how this will be achieved by your actions. You will usually have between sixty and ninety day to provide your response. Once the assessors are satisfied with your response, the nonconformity(ies) will be closed and the accrediting body will make its accreditation decision.
1. International Organisation for Standardisation, International Standard ISO 17025:2017. 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.