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 Laboratories1. 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 who are already accredited and are seeking reaccreditation.
The ISO 17025 International Standard 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 Actions
The timings of these activities will depend on the accrediting body you have selected. 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 allow you to submit your application without these documents and are happy to wait until the applicant is ready to submit them.
Your laboratory will ready for accreditation after:
1. You have implemented an ISO 17025 compliant quality management system,
2. Your employees have become familiar with the system, and
3. 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 each clause of 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,
In addition, the following records will be required:
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 performance monitoring 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.
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.