ISO 17025:2005

What is EN ISO 17025?

This is the international standard defining how a test or calibration laboratory should be managed. It fundamentally looks for accurate and repeatable measurements to be made and recorded. The standard contains a number of rules to help you avoid making erroneous measurements.

Why should I get my laboratory EN ISO 17025 approved?

Organisations and companies purchase formal testing and calibration to demonstrate to the user their products or services deliver what they say they do. Hence they want professional laboratories to perform the tests and so ISO 17025 accreditation is evidence of professional testing or calibration.

Government and other authorities also want professional testing to demonstrate those suppliers are delivering to a requirement. A well-known example of this is National Weights and Measures in the India. It is common for product safety or EMC to be tested in ISO17025 approved laboratories.

There are research laboratories that are working at the leading edges of technology and so want excellent testing or calibration and hence use ISO 17025 as the foundation of their laboratory management systems.

If you want to discuss this then contact Ascent INSPECTA.

History

Before the release of ISO 17025:1999 there was hardly any globally acceptable standard for laboratory quality management systems that could provide a internationally accepted source for accreditation. Accreditation used to be based on national standards and national standards body guidelines. Nevertheless, there was a sizabledegree of consistency between the requirements articulated in these different standards due to the presence of ISO Guide 25, a document that was established by the ISO Council Committee on Conformity Assessment (CASCO) against a request by the International Laboratory Accreditation Cooperation (ILAC) held in Auckland, New Zealand, in October 1988. The declared intent of ISO Guide 25, as taken from it, is to create foundation of principles that "third party accreditation systems [for laboratories] should, as far as possible, be based on globally agreed standards and procedures". ISO guides are intended to be used by local standard organizations when preparing their individual national standards. Thus, it is expected to achieve a higher degree of compatibility between standards established in different countries, so as to facilitate bilateral and multilateral recognition arrangements. (Captured from the foreword to ISO Guide 25, 3rd Edition.)

The document is currently known as ISO 17025 was born as an amendment of the III edition of ISO Guide 25. As a part of revision process it was resolute to transform the guide to a standard, thus facilitating a global foundation for accreditation. The new standard was developed keeping compatibility between ISO 17025 and the generic quality management system standard ISO 9001, which too was on amendment at the same time. Apparently, the idea was to construct a logical relationship between ISO 9001 and ISO 17025 such that the former can behave as a master standard with ISO 17025 being a specific application of that standard to the discipline of testing and calibration laboratories. ISO 17025: 1999 was endorsed by the subscribing countries in late 1999 and came into effective usage during the beginning of 2000. The standard was accepted by the countries after its adoption as a national standard by most countries around the world. The new version of ISO 9001:2000, however, was accepted at a later date. The program intended to harmonize ISO 17025 and ISO 9001 was later regarded as not-too-perfect, especially on the context that ISO 9001 had higher inclination on continual improvement in the effectiveness of QMS. This was included in ISO 17025, but its significance as a part of the standard was not robustly emphasized. As a response to this situation, an amendment to ISO 17025 was undertaken this led to the emerging of ISO 17025:2005 and was adopted as an ISO standard at the end of May 2005. There were no fundamental differences between ISO 17025:1999 and ISO 17025:2005 and nothing was apparent which interrupts essentially on the previously established technical requirements. The main differences can be summed up as follows:-

• Firmness on a demonstrated commitment to continually improve the effectiveness of QMS and identified mechanisms for achieving this.
• Increased emphasis on the need to communicate with customers, especially, to actively seek feedback on service quality, keen ears for complaints if any and ensuring that the resultant information is utilized as the basis for determining action to improve the QMS.
• Increased emphasis on the need to utilize information from quality control data to evaluate the performance of the QMS and to identify opportunities for improvement.

The transitional period between ISO 17025:1999 and ISO 17025:2005 lasted two years, with the two standards running parallel. In May 2007, ISO 17025:1999 became invalid and existing laboratories who had not been assessed against the 2005 version ceased to be accredited.

Who is ISO/IEC 17025 for?

ISO/IEC 17025 is useful for any organization that performs testing, sampling or calibration and wants reliable results. This includes all types of laboratories, whether they be owned and operated by government, industry or, in fact, any other organization. The standard is also useful to universities, research centres, governments, regulators, inspection bodies, product certification organizations and other conformity assessment bodies with the need to do testing, sampling or calibration.

International recognition

Accreditation of laboratories always used to be generally carried out by national accreditation bodies. The primary occupation of such bodies is, to provide assessment services to laboratories in their respective countries against the valid version(s) of ISO 17025. Nevertheless, they also respond to requests to perform assessments in other countries, especially when the requesting laboratory is in a country that doesn't have its own national accreditation body. In instances where a national accreditation body is existent within the country and a laboratory seeks to use a accreditation body from another country of its choice, the incoming accreditation body normally, as a courtesy, seeks a consent from the inhabitant accreditation body before operating within the country. As a choice, a laboratory may have a preference to use an accreditation body other than the domesticated one when the latter has either limited or no international recognition or where it is deficient in recognition in parts of the globe relevant to the laboratory’s operations.

Global recognition of accreditations awarded by nationalized bodies is based on the conclusions of Mutual Recognition Agreements (MRAs) between the nationalized bodies. To recognize each other’s accreditations, the nationalized bodies, generally audit each other’s operations against ISO 17011 Conformity Assessment (General requirements for accreditation bodies accrediting conformity assessment bodies). ISO 17011 is the international standard to which accreditation bodies are expected to demonstrate their conformity. The nature of the MRAs could be multi-lateral (involving more than two accreditation bodies). This could be rather burdensome and it could take many years for a new nationalized body to establish significant international recognition, with a wider coverage. However, this rather burdensome method is being swiftly rationalized through regional laboratory accreditation conferences linked through ILAC. To facilitate this, the regional accreditation body applies the available rules for membership, including conformity to ISO 17011, and assesses the nationalized bodies for their demonstrated conformity. Mutual recognition is then arranged between the regional bodies, thus simplifying the whole arrangement and lessening the timelines. Major regional groups are the Asia Pacific Accreditation Cooperation (APLAC), the European Cooperation for Accreditation of Laboratories (EAL) and the Southern Africa Development Community in Accreditation (SADCA). Such regionalization of international recognition is increasing swiftly but has not been completely established. And we are still likely to come across accreditation bodies who are members of a particular regional group preferring to choose another group which the other members would recognize. On this perspective of the nationalized accreditation bodies and their mutual recognition it has to be known that not all nations choose to develop their own domesticated accreditation service. For relatively smaller nations with limited numbers of laboratories, this may take significant economic acumen to develop such nationalized bodies. In such situation, the laboratories can opt for other nationalized bodies for their accreditation, either on the basis of an agreement with a particular nationalized body to provide such services to the country or on adhoc basis where each laboratory organization chooses its own accreditation body. Efforts are being made to establish provisions where several countries can unite together to use a single regional accreditation body. Apparently, such initiatives will bear fruit in Southern Africa.

The recent initiatives of World Trade Organization (WTO) to deal with technical obstructions to trade have sought to address the concern on global recognition of test data against major quality concerns in international trade segment. This has been widely understood as a need that all countries need to institute nationalized ISO 17025 accreditation body for laboratories. However, on this context, the following items need to be understood:-

Accreditation must bear sufficient trustworthiness, which means, that the accreditation body must apply ISO 17025 thoroughly and operate on ISO 17011 requirements.

The trustworthiness of the accreditation body on an international scale requires MRAs, especially with countries which are recipients of trade goods needing testing support. The trustworthiness of laboratories can be established by their direct assessment by either customers or accreditation bodies from trading partners. Endorsement from nationalized accreditation body may not be essential, based on the requirements and business environment.

Selection of Accreditation Body

Based on previous discussions, the major issue in choosing an accreditation body is to ensure that it has recognition in the context in which the laboratory’s data needs to be used. Where a laboratory operates purely in a domestic market and where the data is used only within the country, for example for local food safety or environmental protection, then a national accreditation body, even one with no international recognition, will normally be entirely suitable. However, if the laboratory is servicing exporters who need to present its data internationally, it is critical that the accreditation body is recognized by importing countries. Hence the laboratory needs to establish the range of MRAs held by the accreditation body and especially which other countries, other than the home country of the accreditation body, will recognize accreditation awarded by it.

Coverage of accreditation scope

Being a relatively generic standard, strategically all types of laboratory practiced methods performed by laboratories are covered by ISO 17025 and hence included in accreditation criteria against the standard by-default, this is rarely the case. In practical scenario, a particular laboratory may have only some of its methods added within the scope of accreditation and perchance not even the majority. In spite of this, accreditation bodies often expect to see a comprehensively operating QMS. However, the audit focuses on the scope of methods, personnel and on the equipment used to deliver them and take diminutive interest outside the applied scope. On this context, the term ‘accredited laboratory’ is inaccurate. Rather we should call it a laboratory accredited for a definite list of methods. The laboratory should select methods to apply as scope when it makes its application for accreditation. The following criteria should be considered:-

It would lack sufficient data to demonstrate a track record of performance. If such methods are included in the scope of accreditation, a considerably higher quantity of quality control data may be expected by the auditors.

Calibration/ test methods with little objective content are less likely to be accredited since its consistency in application may not draw enough confidence for a guarantee. Commercial laboratories should select methods based commercial feasibility. Otherwise the cost and effort may not yield a satisfying return.

In some nations, data generated for environmental, food safety or lawful reasons must be covered in the scope of accreditation, to be acceptable.

The policies of ABs differ in particular how they classify the scopes. Some permit a reasonably generic scope in some areas of laboratory activity. In such situations, they evaluate the laboratory organization for an application of a method and a procedure followed when rolling-out the method to other applicable areas.

Applicability & relation between ISO 9001 and ISO 17025

As discussed above, ISO 9001 is the general standard which specifies the requirements for a quality management system. Laboratories which meet the requirements of ISO 17025 also operate in accordance with the requirements of ISO 9001 that are relevant to calibration and testing activities. What this means in practice is that an organization which holds ISO 9001 certification may use a laboratory accredited against ISO 17025 as a supplier of test data without the need to carry out its own audit of the laboratory’s quality system. The confusion often arises whether laboratories should be accredited or certified to ISO 9001 or to ISO 17025. It is an established fact that the most appropriate accreditation for testing and calibration laboratories has to be against ISO 17025. Consequently, due to the agreements with laboratory accreditation bodies, majority of ISO 9001 certification bodies might not allow their certification to be cited by testing or calibration laboratories in support of their services (product). It can thus be well interpreted that if an organization is ISO 9001 certified with an inhouse lab that is an integral part of the established quality management system, the laboratory will be included in the ISO 9001 external audits. Nevertheless, if the organization wants to sell the services of the laboratory to external parties as testing or calibration, the organization cannot advertise it as an ISO 9001 accredited/certified laboratory. For this, the only way is to obtain accreditation to ISO 17025, specifically for the laboratory. However, it is also common for organisations with inhouse labs used solely for internal quality control purposes to seek accreditation of lab to ISO 17025. Such steps are majorly taken to enhance the laboratory’s credibility that brings added assurance to the quality control activities. Generally, the ISO 9001 external auditors usually don't perform detailed audit of such an internal laboratory hiding ISO 17025 compliant. Since lab accreditation procedures as per ISO 17025 accreditation requirements, are overtly customized for laboratories, they are comparatively easier to interpret for the laboratory as against rather shallower requirements of ISO 9001, which are designed for a more generic context. Another major benefit of accrediting an internal lab is that it helps in generally reducing the extent of audits by customers as it enhances their assurance levels too.

The requirements in ISO 17025, over and above ISO 9001, include involvement in proficiency testing, conformity to documented & validated procedures and the specific technical competence requirements. Besides, there is also a variation in the method of auditing of laboratories under ISO 9001 as compared to ISO 17025 audits. ISO 17025 accreditation bodies use technical auditors who are experts in the discipline and perform peer review of the procedures being implemented by the laboratory and the methodology how those procedures are implemented.

From the purview of a lab’s clients, labs conforming to ISO 17025, automatically meet the requirements of ISO 9001 when delivering services.

Main Benefits of Correctly Implemented ISO/IEC 17025:

Implementing ISO/IEC 17025 as part of laboratory quality initiatives provides benefits for both, laboratory and business, such as:

• Having access to more contracts for testing and/or calibration. Some public and private organizations only give contracts to accredited laboratories. Accreditation will also help in getting more contracts from organizations that don’t mandate accreditation, but do give preference to accredited laboratories in competitive situations.
• Improved national and global reputation and image of the laboratory.
• Continually improving data quality and effectiveness of the laboratory.
• Having a basis for most other quality systems related to laboratories, such as Good Manufacturing Practices and Good Laboratory Practices.

Conclusion

If the credibility of the laboratory is the concern, an ISO 17025 accreditation is the only solution. Although, it is more rigorous exercize than normal ISO 9001 application, it helps the laboratory understand the requirements, responsibilities, and more on the possibilities of inaccuracy and the consequences therein.

Ascent INSPECTA Consultants are highly trained and experienced, not only on the tricks to fulfill the requirements of the ISO 17025 standard, but also the added requirements of the accreditation bodies in the geographical regions where Ascent INSPECTA has its wings. The Ascent INSPECTA Consultants have been participating in many compliance journeys that have helped infer the expectations of the assessing personnel from the various accreditation bodies.

For a medium sized lab, which is working of optimized resources including manpower, a rigorous effort of about 7 to 8 months should be sufficient. However, such timelines are highly influenced by various other factors that include response times from accreditation bodies, other participating laboratories for ILC, rigorous business months (where applicable) and majorly, the availability of qualified personnel. Ascent INSPECTA helps through a set of general guidelines that helps bring about sufficient preparedness, in situations where such accreditation is sought in priority, or in a lesser period of time.

Why has ISO/IEC 17025 been revised?

The last version of ISO/IEC 17025 was published in 2005 and, since then, market conditions and technology have changed. The new version covers technical changes, vocabulary and developments in IT techniques. It also takes into consideration the latest version of ISO 9001.

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