ISO/IEC 17025 Testing & Calibration Laboratories Implementation
Trade liberalization and business integration have driven up foreign competitiveness. This has caused companies in developed countries specific challenges. This also gives them the ability to take advantage of their comparative advantages with domestic raw resources and reduced labor costs. To make the best of these incentives, developed countries need a reliable framework for conformity testing to ensure that their goods are in accordance with international norms. Laboratory research is an integral part of this network.
However, research laboratories in developed nations experience significant problems such that their tests and drug approvals in certain nations are still not recognized. The World Trade Organization has accepted this as a technological barrier to trade and has formed a TBT Treaty to combat the activity, which is binding on all member states. However, the WTO recognizes that test findings will only be mutually reasonable if there is a method by which the customer has faith in the laboratories’ scientific expertise and the soundness of their measurements. To do that, the International Cooperation for Laboratory Accreditation has established a regional quality evaluation program for research laboratories.
This assessment system is based on testing laboratories that operate in accordance with ISO / IEC 17025, the international standard for testing laboratory quality systems. Evidence of laboratory compliance is issued by nationally recognized laboratory accreditation bodies through their accreditation. Those accreditation bodies enter into Mutual Recognition Agreements under the aegis of ILAC with related accreditation bodies in other countries or with a national organization of those bodies.
Establishing a quality management system in a test laboratory in line with ISO / IEC 17025 can be a complex task for laboratories in developed countries. Over the last 20 years, U.S. organizations have implemented foreign quality control programs to increase the consistency of their goods and services. Throughout that period, the frameworks have since developed and strengthened, and they also acted as guidelines for many external specifications such as ISO / IEC Guide 25. That review would address accreditation problems relating to the ISO / IEC 17025 framework, which has been de-established.
Present specifications for calibration
If your company is registered with QS-9000, you are aware that an accredited laboratory must perform off-site calibration services, specifically, as the standard states, “ISO / IEC Guide 25-accredited.” Because QS-9000 was created and continues to be maintained by experts in the automotive industry, the Automotive Industry Action Group is publishing the currently recognized accreditation bodies on www.aiag.org.
ISO / TS 16949 is a new international quality management standard for automotive suppliers, the majority of whose calibration supplier requirements are identical to those found in QS-9000. However, with ISO / TS 16949, the internal calibration requirements are very different: it has adopted some of the same technical and procedural requirements as ISO / IEC 17025.
The ISO / IEC 17025 specification is organized into two sections. The first describes all the standards related to the quality management system. The second details all the “professional expertise” criteria. Several organizations neglect the latter portion of the norm when setting up a new laboratory project. Laboratory accreditation is quite distinct from a quality management system.
As a rule, approved accreditation bodies hire consultants in each area of accreditation and render decisions based on professional processes, educational documents, evaluations, and evaluation of qualified staff. They use this knowledge to assess if the institution is professionally capable of any component specified in the scope of accreditation.
Once a facility is accredited, the qualification and classification become very valuable credentials. Laboratory accreditation is one of the best ways to prove traceability to a national or international level. When a laboratory went through its original and surveillance tests, one of the main topics investigated is traceability.
Just how important is accreditation?
The growing interest in your goods and services indicates that an ever-growing pool of potential clients poses the question: should they depend on your data? Should your laboratory apply for accreditation? This is where ISo Pros will assist and help you to begin the accreditation application phase.
Yet what determines an accreditation? What is its aim? Why is it critical for your company and its laboratory to apply using the ISO system?
What is the Laboratory Accreditation Standard?
The general laboratory competency requirements are described in standard ISO / IEC 17025. This standard sets out a global baseline for accreditation of all laboratory types.
Accreditation involves on-site evaluations and performance evaluations as well as ongoing competency testing. Competence assessment requires individuals who not only recognize the requirements of the standard but have adequate depth of understanding of the specified tests to render competency judgments. The evaluators must also understand the principles underlying ISO / IEC 17025 requirements which are not always obvious.
What is the accreditation of a laboratory?
Laboratory accreditation is a third-party evaluation by the Facility Accreditation Body (Dutch RvA- Raad voor Accreditation) of a Calibration or Evaluation laboratory to determine the laboratory ‘s compliance with any relevant accreditation policy requirements.
Accreditation offers the fundamental guarantee that companies conform to requirements accepted globally. The standard is ISO / IEC 17025 for validation and testing laboratories.
Why accreditation to ISO / IEC 17025 is important for laboratory testing?
Different laboratories of analytical testing frequently produce different test results for a given sample due to a difference in the competency of the personnel, the equipment used and the standard operating procedures ( SOPs) adopted during the study. Such variations are due to the use of uncalibrated and unmaintained equipment, environmental testing conditions, and the level of competence of a laboratory technician performing a study. The explanation for this difference is power monitor processing to raise the retail value. This is often accomplished by modifying methods for the selection and test results. So there can be innumerable factors that contribute to the incoherence and inaccuracy of the results of the tests and their decisions!
Are there any regulations that a test lab can follow to ensure consumer safety and the quality of the product?
ISO / IEC 17025 is one such regulation, which contains a list of test laboratory requirements. Testing labs must be certified to ISO / IEC 17025 to show their technological expertise and to guarantee that the test reports are correct. ISO Pros will always help illustrate the importance of accreditation of ISO / IEC 17025 for your laboratory.
Firstly, ISO / IEC 17025 is one of the most important accreditations conducting testing and validation for all types of labs, universities, and research centers. ISO / IEC 17025 includes management and technical requirements that enable a laboratory for testing or calibration to claim its technical competence. Second, having regulatory bodies accredited certifies the results are consistent and accurate and are generated using industry-standard protocols.
Can you be confident of the technical competence of a laboratory?
This method called laboratory accreditation is used by several countries as a way of assessing scientific competence. Accreditation uses explicitly defined standards and processes to assess professional competence. In a laboratory that involves the output of test or validation results, qualified professional assessors perform a detailed review of all the variables. The requirements are focused on the globally agreed ISO / IEC 17025 specifications and are used worldwide to test laboratories. Accreditation bodies explicitly use this criterion to determine factors relating to the capacity of a laboratory to deliver reliable, detailed test and calibration results, including:
- validity and appropriateness of research procedures
- traceability of tests and calibrations according to national requirements
- suitability, configuration, and management of laboratory equipment
- Testing environment
- collection, storage and transfer of research items
- quality control of laboratory and calibration results
Accreditation also covers elements of the quality systems dealt with in the ISO 9001 certification. To ensure continuous enforcement, certified laboratories are regularly re-examined to check that they uphold their professional competence levels. As a continuing indication of their expertise, these laboratories may often be expected to engage in daily skill training programs.
How much would accreditation cost?
Accreditation costs depend on the Assessment Area and the amount of staff to be witnessed for competency. Defining the scope is up to you, having the costs as big or small as you want them to be. The AB will quote on the scope given, and days to observe the technicians, and the management system testing and scale. If the laboratory of the company is maintained to comply with ISO17025, the reputation as a manufacturer has improved, enabling the laboratory to supply the internal and external clients with comfortable, accurate, and repeatable samples. That also provides rigorous research and helps the organization to sell its technological competence.
When you are certified to ISO17025, the qualification and scope of training are open to the public. Your AB keeps a registry of labs and scopes which they have audited for compliance. You’ll be able to include management reports on the laboratory competencies of your competitors, manufacturers, consumers, and others. There will be customers who even require an organization to have accreditation. For starters, the Automotive QMS – ISO / TS 16949 – requires their Tier 1 vendors to be approved before submitting qualified test results.
If you are not an approved laboratory at the moment and depend on external tests, those test costs could escalate rapidly. Additionally, external customers usually need regular upgrading of test reports and results. If you have on-site accreditation, you can monitor these annual maintenance expenses and produce accredited, revised reports more efficiently than you can depend on an external provider. Instead of budgeting updated testing with external laboratory services, your annual budget can be focused on updating and maintaining your laboratory QMS, allowing your testing scope to grow – providing an advantage in your current market space while at the same time supporting the development and competitively expanding your marketing test footprint. ISO17025 will offer you the demonstrated technological trust and flexibility needed to close new business or close quality opportunities.
While the benefit to outside customers is more tangible, your accredited testing laboratory will also provide enhanced perception to internal customers. Competence in testing can provide management with the confidence required for further expenditure in the test site’s facilities, such as modern and more complex equipment, improved controls (environment, i.e.), laboratory IT, and much more. Accreditation will also allow the company to mitigate risk with data from approved evaluations. Typically, the laboratory test is identified for internal consumption and benefit; however, pending Scope of Accreditation Testing, your laboratory may also be used as a source of income or profit center if external testing is carried out.
Accreditation according to ISO 17025 or ISO 9001?
Two different groups supervise the accrediting agencies of the nation. The IAF, or International Accreditation Board, assesses organizations that accredit entities that run systems, products, or individuals certifying. The International Cooperation for Laboratory Accreditation (ILAC), which evaluates groups who accredit laboratories for calibration and testing.
The misunderstanding regarding certification and accreditation arose in part when some certification organizations started assessing laboratories according to ISO 17025, a norm intended to determine the credentials of testing/calibration laboratories, and thus the ILAC region. In terms of intent, focus, and requirements the ISO 9001 standard program is distinct from ISO 17025. The criteria are similar in certain ways because they’re different, so meeting one doesn’t imply you’ve achieved the other.
Do you want ISO 9001 or ISO 17025?
IAF and ILAC both said ISO 17025 requires accreditation and no registration. However, you may be reading this and thinking if a company needs ISO 9001, ISO 17025, or both.
Certification in ISO 9001 refers to a whole organization. It is an effective management tool but does not include the necessary technical information to illustrate the reliability of the test/inspection/calibration data. Laboratories that conduct testing – and do not produce products – need to follow ISO 17025 specifications, and not generally ISO 9001 requirements.
Suppliers seeking accurate testing backed by a quality system will search for laboratories certified to ISO 17025. And the accreditation will come from an institution recognized under the mutual recognition arrangement or MRA of the ILAC. Such arrangements seek to establish a network of accreditation bodies whose research is known all over the globe. It is normal for businesses that do more than just laboratory services to get ISO 9001 approved without getting an ISO 17025 accredited laboratory.