What is ISO17025? Requirements, benefits of obtaining certification, and the certification process
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What is ISO17025? An international standard that specifies the general requirements that testing and calibration laboratories that evaluate products and measuring equipment must comply with. It is also a means for testing and calibration laboratories to improve their technical capabilities and reliability. On the other hand, ISO 17025 is also important for manufacturers, as it serves as a standard for assessing the capabilities of testing and calibration services when requesting quality evaluation.
This article will provide an easy-to-understand explanation of ISO 17025, from its overview to its benefits and the process for obtaining certification. This article is recommended for not only those in charge of testing and calibration laboratories, but also quality control personnel at companies that use these services to ensure the quality of their products.
Overview of ISO 17025 (ISO/IEC 17025)
First, we will explain basic matters such as the definition, purpose, and requirements of ISO17025.
What is ISO17025 (Laboratory Accreditation)?
ISO17025 (Laboratory Accreditation) is an international standard for verifying testing and calibration laboratories and evaluating their technical capabilities regarding calibration results. An external, neutral accreditation body guarantees the consistency and accuracy of test and calibration results.
Testing laboratories and calibration organizations that are accredited under ISO17025 are able to display an accreditation symbol on their test reports and calibration certificates.
In this context, testing refers to analyzing and evaluating the product itself, its functionality, the characteristics and condition of raw materials, etc. Calibration, on the other hand, refers to checking the measurement accuracy of measuring equipment. The places and organizations that perform testing and calibration are called testing laboratories and calibration organizations, respectively.
Purpose of ISO 17025
The purpose of ISO17025 is to internationally certify the technical capabilities of testing and calibration laboratories, helping to ensure safety and quality for various industries and consumers by providing highly reliable test results.
Furthermore, in order for ISO17025 to continue to fulfill its purpose as time goes on, it will need to be revised to keep up with innovations in testing and calibration technology and changes in the market environment. The third edition of ISO17025, the first revision in 12 years, was published in November 2017, and the corresponding JIS standard, JIS Q 17025, was also revised the following year in 2018. This revision expanded the scope of certification to include facilities that only perform sampling. As of October 2024, this edition is still in use.
Incidentally, ISO17025 includes JIS Q 17000 and VIM (Vocabulary of Basic Terms in Metrology) as reference standards, and some of the content of these standards also applies to ISO17025.
ISO17025 requirements
Management System Requirements
It ensures that testing and calibration laboratories are operated efficiently. It is a set of general requirements for the operation of a quality management system (QMS), record management, customer service, etc. It also includes items related to risk management, corrective actions, management reviews, etc. The description format is performance-based, in accordance with ISO9001, which has a process approach as its central concept.
Technical requirements
This standard defines the technical standards for testing and calibration to ensure their accuracy and reliability, including requirements for personnel capabilities, equipment, organizational structure, testing and calibration methods, environmental conditions necessary for uncertainty estimation, and resources.
Incidentally, ISO9001, another international standard for quality management systems, does not have any provisions regarding these technical requirements. In essence, the difference between ISO17025 and ISO9001 is whether or not there are requirements for maintaining technical capabilities, with ISO17025 specifying more detailed requirements. The requirements for "competence management" for engineers and internal auditors are particularly strict.
Benefits of obtaining ISO17025
The main benefits of obtaining ISO 17025 certification are as follows:
Improving the technical capabilities of testing and calibration laboratories
Meeting the requirements of ISO17025 will improve your technical capabilities. ISO17025 requires that you conduct regular proficiency tests. By using the test results to make improvements, you can achieve a continuous improvement in your technical capabilities. Standardizing your testing and calibration work will also lead to improved productivity and stability.
Increased customer trust
This is because customers recognize that testing and calibration laboratories that have acquired ISO17025 meet quality assurance standards. ISO17025 accreditation is objective evidence that the quality of testing and calibration services is maintained at a certain level or higher, and is an appealing point to customers.
One-stop testing
Acquiring ISO17025 certification enables customers to have one-stop testing, as re-inspection is no longer necessary when exporting products.
One-stop testing means that data obtained from a single testing laboratory or proofreading organization can be trusted and accepted by all business partners and certification bodies, both domestic and international. Because ISO 17025 is an international standard, test reports issued by accredited laboratories are valid anywhere in the world.
Therefore, for example, if a product passes testing at a domestic ISO17025-accredited testing laboratory before being exported overseas, there is no need to undergo testing again in each of the export destination countries. This one-stop testing service offers customers the benefits of reduced product costs and a shorter time to market.
ISO17025 certification process
The process for obtaining ISO17025 certification is roughly as follows. There are four main steps.
Step 1. Apply for certification and conduct a preliminary examination
You apply for certification by submitting a certification contract and initial certification application to a certification body. The main review bodies are IAJapan and JAB. Once you have submitted your application, you will undergo a preliminary review before the main review.
A pre-audit is a procedure to check the readiness of a company for a formal audit. The pre-audit involves a document review and an on-site visit.
The following four points are particularly important when preparing for the certification review and preliminary review.
(1) Clarification of the scope of certification applications
(2) Participation in skill tests
(3) Establishment of metrological traceability
(4) Evaluation of measurement uncertainty
Step 2. Certification review
The certification audit involves an evaluation of whether the ISO 17025 standards are met and validation is carried out. An on-site visit is generally conducted by auditors. The final decision is made by a judging committee based on the report prepared by the auditors.
The following nine points are the main points that are checked for conformity during the ISO 17025 certification audit.
- A system that meets the requirements of ISO17025 has been constructed, and its contents are clearly documented in a manual.
- The uncertainty of the test and calibration equipment is required, and the stability of the equipment is also confirmed.
- The testing and calibration sequence is clearly documented
- The validity of the test and calibration methods has been confirmed.
- The sources of uncertainty in the testing and calibration process are clarified and the uncertainty is estimated.
- Testing and calibration personnel are appointed based on sound standards of competence and training
- Measurement equipment used in the testing process is calibrated, traceable, and has clear uncertainties
- Meets standard requirements for pre-use inspection of equipment, environmental stability, and sample storage
- We have created a four-year quality assurance plan that includes participation in external proficiency testing and internal proficiency testing.
Step 3. Certificate issuance
If the certification examination is passed, a certificate will be issued. The certificate proves that the laboratory meets the ISO17025 standards. After certification, the laboratory can also use the certification symbol and the phrase "ISO17025 certified laboratory."
Step 4. Review for continued maintenance
An on-site surveillance audit is conducted one year after the initial accreditation. The surveillance audit is a check to ensure that the status at the time of ISO 17025 accreditation is being maintained. The audit takes less time than the initial audit, and only checks a few items within the scope of accreditation to ensure that the laboratory's management system and capabilities are in good condition.
Get ISO17025 certified!
Obtaining ISO17025 certification is an initiative that is expected to improve both your technical capabilities and reliability. It will also be beneficial for customers as it will enable one-stop testing, which will likely lead to the development of testing and calibration services. Take this opportunity to consider obtaining ISO17025 certification.
Furthermore, if you are using paper forms, we recommend switching to electronic forms to deal with the increased management workload that comes with obtaining certification. The on-site form digitization system "i-Reporter" digitizes on-site forms for quality inspections, equipment inspections, internal audits, and more, dramatically improving work efficiency. It can be used at low cost using your iPad, iPhone, or Windows, so it is also recommended for those looking to keep costs down. If you are even slightly interested in implementing i-Reporter, please feel free to contact us.
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