What Is Laboratory Accreditation ISO 17025?
Laboratory accreditation is becoming more and more relevant worldwide for procurement and regulatory purposes. Trust in research results is key to product acceptance. Users are searching for confirmation of high-quality goods and the ability to test suppliers without incurring the costs involved with auditing each manufacturer. Reliance on third-party accreditation to execute this role for suppliers of test data is an appealing choice. The use of ISO / IEC 17025 as the accreditation criterion is also considered useful for foreign recognition of test results.
Why is laboratory accreditation needed?
Most of the requirements for laboratory accreditation is motivated by the market. Customers depend on the expertise of laboratories to produce the findings from which critical decisions are taken. Accreditation enhances the public confidence in those test results. Increasingly, regulators and manufacturers expect laboratory test reports to be certified to the ISO / IEC 17025 level.
Besides labs, there are three classes that profit from accreditation, even more so than labs themselves. These three groups are users of laboratory services, specifiers (private and public bodies that need accurate test data to make appropriate decisions), and the general public.
Why has ISO / IEC 17025 been revised?
It is important to keep track of updates and improvements in the norm and train the laboratory to comply with them. ISO / IEC 17025 has been updated owing to increased instances of error and inaccuracy of the results. ISO / IEC 17025 has seen two updates so far, it was updated first in 2005 and again in 2017 to keep up-to-date with the market and to adopt as strictly as possible the ISO 9001:2015 standard.
ISO / IEC 17025 has been modified to reflect recent laboratory climate and job procedures improvements. The recent ISO / IEC 17025 revisions include a new chapter on risk-based thinking, tracking non-conforming research and calibration function, adding new vocabulary, integrating computer systems and data management, and expanding area for measurement, calibration, and sampling as well. The process approach also complies with international criteria such as ISO 9001 (Quality Management), ISO 15189 (Quality of Clinical Laboratories) and ISO / IEC 17021-1 (which lays out the auditing and inspection bodies requirements).
Is it difficult to have the laboratory certified to ISO / IEC 17025?
The specification ISO 17025 is large and nuanced, needing a comprehensive understanding and preparation to obey its guidelines. When the goal is to standardize procedures in all research laboratories and to guarantee the integrity of the produced results, it turns out to be a major challenge to perform routine internal audits in order to ready a laboratory for third party evaluations. It is also difficult to find a stable and cohesive software solution that helps to meet the regulatory requirements.
It’s important to incorporate a Laboratory Information Management System (LIMS) that lets the facility follow ISO / IEC 17025 standards and other state and local legislation. A LIMS not only allows you to satisfy ISO / IEC 17025 compliance and technological standards but also encourages the facility to conform with certain regulatory codes, such as ISO 9001:2015, GLP / GALP, and 21 CFR Section 11.
A popular query from new customers is “Will I have to use certified laboratory ISO 17025, or can I rely on data from any laboratory? ” R&D and medical product regulatory applications also require correct and consistent results. The usage of a professionally run facility minimizes the possibility of producing or delivering a defective medical product owing to erroneous results or methods for research.
Laboratory accreditation provides a means of assessing laboratories’ technical competence to provide specific testing as specified. Accredited testing suppliers must be in accordance with ISO 17025 professional specifications. Such include (but not restricted to):
- A suitable environment for research
- Specific qualifications, training as well as experience of the personnel
- Equipment ideal for training purposes which are correctly designed and maintained
- Traceability of measuring according to national standards
- Proper quality control (QA) protocols
- Ongoing internal auditing by independent QA personnel
- Appropriate research procedures, which are verified
- Accurate procedures for recording as well as reporting
- For 2 years, receiving inspections from accredited bodies
- Participation in the Proficiency Testing
What is the added value of an ISO 9001 certified laboratory instead?
Laboratories can also be audited and certified for ISO 9001. This standard has been widely in use for manufacturing, service organizations, and more, for the evaluation of their system to manage the quality of the organization’s product and/or service. Certification of the quality management systems of an organization against ISO 9001 is intended to confirm that the management system complies with this standard, but does not specifically assess the technical competence found in a laboratory.
Things to be aware of during the accreditation process
Whether you’re implementing the new accreditation system or merely changing your current one, these are the most common pitfalls any lab needs to be aware of. Still the most popular is measuring ambiguity. It’s critical that correct leaders of the company know how to quantify and apply calculation ambiguity to the processes. Bear in mind because measuring ambiguity isn’t a term that can be attached to one instrument or any piece of equipment. Yet, rather it is connected to a method of configuration, examination, or checking. Additionally, all measured calculation uncertainty values will represent the true capability of your laboratory. Many laboratory accreditations have been delayed because of the complexity in the calculation and the best measuring capacity standards do not represent reliable capacity.
Another concept to be aware of when utilizing an external calibration laboratory is traceability. The ISO 17025 standard states, “When you use external calibration services, measurement traceability shall be ensured through using laboratory calibration services that can show competence, measurement capability as well as traceability.” Importantly, the standard also notes that in a laboratory that is “competent” is one meeting all of the requirements set out in the ISO 17025 standard. It is welcome to know that there are two approaches to show competence: using a facility that is certified by a recognized accreditation agency or get the facility officially assessed by qualified specialists from ISO / IEC 17025.