Laboratory Accreditation (ISO/ IEC 17025:2005)-Implementation, Achievements and Real Challenges

Laboratory Accreditation (ISO/ IEC 17025:2005)- Implementation, Achievements and Real Challenges in Nepal

Krishna Prasad Rai* Department of Food Technology and Quality Control Central Food Laboratory, Babarmahal, Kathmandu, Nepal

*The author is working as Technical Manager in Central Food Laboratory

Introduction ISO (International Organization for Standardization) the term was derived from the Greek isos, meaning ‘equal’, which is the world’s largest non-governmental organization for developing and publishing of International Standards. It is a net work of the 162 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, which co-ordinates the system. ISO enables a consensus to be reached on solutions that meet both the requirements of business and the broader needs of society. It has developed over 18,500 International Standards on a variety of subjects including ISO/IEC 17025 and some 1100 new ISO standards are published every year.

History of ISO 17025: 2005 Prior to the issuing of ISO 17025:1999 there was no internationally accepted standard for laboratory quality systems that could provide a globally accepted basis for accreditation. Accreditation was based on national standards. However, it was derived from ISO Guide 25 as a main standard for testing and calibration laboratories after the third revision of ISO Guide 25 issued by the International Organization for Standardization in 1999.

Although, ISO 17025:1999 was accepted by ISO subscribing countries in late 1999 and came into effective use during the first quarter of 2000 after its adoption as a national standard by most countries around the world. The exercise intended to harmonize ISO 17025 and ISO 9001 was, in the event, regarded as imperfect, especially in that ISO 9001 placed great emphasis on continual improvement in the quality system. Although this was included in ISO 17025, its importance as a part of the standard was not strongly emphasized. Hence a revision of ISO 17025 was undertaken and this led to ISO 17025:2005 which was adopted as an ISO standard in late May of 2005.

What is ISO/IEC 17025:2005? ISO/IEC 17025:2005 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling regardless of the number of personnel or the extent of the scope of testing and/or calibration activities. Since the standard is about competence, accreditation is simply formal recognition of a demonstration of that competence. A prerequisite for a laboratory to become accredited is to have a documented quality management system. The usual contents of the quality manual follow the outline of the ISO/IEC 17025 standard. ISO/IEC 17025:2005 is for use by laboratories in developing their management system for quality, administrative and technical operations. Laboratory customers, regulatory authorities and accreditation bodies may

1 also use it in confirming or recognizing the competence of laboratories. ISO/IEC 17025:2005 is not intended to be used as the basis for certification of laboratories.

What is Laboratory Accreditation? Accreditation means that evaluators i.e. testing and calibration laboratories, certification and inspection bodies have been assessed against internationally recognized standards to demonstrate their competence, impartiality and performance capability. Organizations those provide certification, testing, inspection and calibration services need accreditation from internationally recognized body.

International Recognition of Laboratory Accreditation Laboratories seek accreditation in order to achieve international credibility so that their test results may be accepted across national borders. Accreditation involves assessment of the laboratory by an internationally recognized accreditation body and is organized through a national laboratory accreditation board which has a mutual recognition agreement with other such accreditation boards in other countries. In order for accreditation bodies to recognize each others' accreditations, the International Laboratory Accreditation Cooperation (ILAC) has establish methods of evaluating accreditation bodies against another according to ISO standard (ISO/IEC Guide 58 - which became ISO/IEC 17011: Conformity assessment—General requirements for accreditation bodies accrediting conformity assessment bodies).

Around the world, geo-political regions such as the European Community, and Asia-Pacific, the Americas and others, established regional co-operations to manage the work needed for such mutual recognition. The regional body applies rules for membership, including compliance with ISO 17011, and audits national bodies for compliance. Mutual recognition is then organized between the regional bodies, so simplifying the whole system and shortening the timescale. These regional bodies (all working within the ILAC umbrella) include the European Cooperation for Accreditation of Laboratories (EAL), the Asia Pacific Laboratory Accreditation Cooperation (APLAC), Southern Africa Accreditation Cooperation (SADCA), the Inter-American Accreditation Cooperation (IAAC) and African Accreditation Cooperation (AFRAC).

International recognition of accreditations awarded by national bodies is based on the conclusion of Mutual Recognition Agreements (MRAs) between national bodies. The mechanism is that the bodies seeking to agree to recognize each other’s accreditations will audit each other’s operations against ISO 17011: Conformity assessment—General requirements for accreditation bodies accrediting conformity assessment bodies.

In some developed countries such as USA and Canada there are more than one Accreditation Bodies (ABs). In other countries there is often only one Accreditation Body. Typically these bodies encompass accreditation programs for Management Systems, Product Certification, Laboratory, Inspection, Personnel and others. The first laboratory accreditation bodies to be established were NATA in Australia (1947) and TELARC in New Zealand (1973) most other bodies are based on the NATA/TELARC model and include UKAS in the UK, FINAS in Finland and DANAK in Denmark to name a few. In India National Accreditation Board for Testing & Calibration Laboratories (NABL) under the Ministry of Department of Science & Technology, Government of India provides accreditation.

2 . Benefits of Accreditation to Laboratory i. A formal and international recognition of testing competence ii. A recognition of testing and calibration competence iii. A competitive marketing advantage iv. A benchmark for quality and performance v. Better control of laboratory operations and continual improvement vi. Increase of confidence in testing/calibration as well as personal performance vii. Litigation purpose viii. Establishment of public credibility and reliability upon the testing so able to make a good will ix. Compliance of GLP x. Environmental friendly activity xi. Development of good professional practice (GPP) xii. Employee satisfaction and confidence

Benefits of Accreditation to Users i. According to the principle of tested once acceptance everywhere, the savings in terms of time and money due to reduction or elimination of the need for re-testing of products. ii. Government departments/authorities/agencies may use test report for regulations, investigational work or for planning of project etc. iii. Private and public enterprises can use test report to ensure the compliance with specifications. iv. Manufacturers may use data for product development, failure analysis, quality control, quality management certification purpose, truthful advertising etc. v. Users of accredited laboratories will enjoy greater access for their products, in both domestic and international markets, when tested by accredited laboratories. vi. Consumer satisfaction and confidence on products

Scope of Accreditation Mainly the scopes of Accreditation in food would be testing of different food laboratories of chemical and biological. However, NABL India has categorized different laboratories as per given below (Table 1). Besides testing laboratory it has categorized other two i.e. calibration and medicinal laboratories too. Moreover, the scope of accreditation can be extended to RM providers, PT providers etc. Table 1. Scopes of Accreditation

3 Requirements for Laboratory Accreditation According to ISO/IEC 17025:2005, there are major two categories of requirements, which are given as below. 1. Management Requirements 2. Technical Requirements

Management requirement comprises the clauses numbers from 4.0 to 4.15, while Technical Requirements comprises the clauses from 5.0 to 5.10. Legal entity of organization, management system, document control, review of requests, Complaints handling, Control of non-confirming testing, CAPA, Internal audit and MRM are the major components of Management requirements. In other hand, competent personal, environmental control, standard test methods, calibration, MU, equipments, RM, Sampling, Quality Assurance, Reporting the results, Document archiving are the major Technical requirements for ISO/IEC 17025:2005.

Apart from these two requirements, laboratory should fulfill the specific requirements of Accreditation body, if any.

Procedure for Accreditation The application procedures are more or less similar to all accreditation bodies. However, the general steps are given below based on NABL, India, protocol.

Stage I . Preparation of application for accreditation body giving all desired information and specific requirements of the body. . Normally Laboratories are required to submit multiple set of duly filled in application forms for each field of testing / calibration along with sets of Quality Manual and Application Fees. . Secretariat of Accreditation body receipts the application and will issue acknowledgement to the laboratory. After scrutiny of application for it being complete in all respects, a unique Customer Registration Number will be allocated to laboratory for further processing of application.

Testing Laboratories Calibration Laboratories Medicinal Laboratories

. Biological . Electro-Technical . Clinical Biochemistry . Chemical . Mechanical . Clinical Pathology . Electrical . Fluid Flow . Haematology and . Electronics . Thermal & Optical Immunohaematology . Fluid-Flow . Microbiology and Serology . Mechanical . Radiological . Histopathology . Non-Destructive . Cytopathology . Photometry . Genetics . Radiological . Nuclear Medicine (in-vitro tests . Thermal only)

4 . Accreditation body will then nominate a Lead Assessor for giving Adequacy Report on the Quality Manual / Application submitted by the laboratory. A copy of Adequacy Report by Lead Assessor will be provided to Laboratory for taking necessary corrective action, if any. The laboratory shall submit Corrective Action Report. . After taking satisfactory corrective action by the laboratory, a Pre-Assessment audit of the laboratory will be organized by Accreditation body. Laboratories must ensure their preparedness by carrying out its internal audit and management review before Pre- Assessment.

Stage II . Accreditation body will organize the Pre-Assessment audit at laboratory site by Lead Assessor . A copy of Pre-Assessment Report will be provided to Laboratory for taking necessary corrective action on the concerns raised during audit, if any. . The laboratory shall submit Corrective Action Report to the Accreditation body . After laboratory confirms the completion of corrective actions, Final Assessment of the laboratory will be organized.

Stage III . The accreditation body will organize the Final Assessment by a team at the laboratory site for its compliance to ISO 17025:2005 and specific criteria of own. . Assessors shall raise the Non-Conformance(s), if any, and provide it to the laboratory in prescribed format so that it gets the opportunity to close as many Non-Conformance(s) as they can before closing meeting of the Assessment. . The Lead Assessor will provide a copy of consolidated report of the assessment to the laboratory and send the original copy to Accreditation body. . Laboratory shall take necessary corrective actions on the Non-Conformance(s) / other concerns and shall submit a evidential report to Accreditation body within a prescribed time frame.

Stage IV . After satisfactory corrective action by the laboratory, the Accreditation Committee examines the findings of the Assessment Team and recommended additional corrective action, if any, by the laboratory. . Accreditation Committee shall make the appropriate recommendations regarding accreditation of a laboratory to Accreditation authority. . Laboratories are free to appeal against the findings of assessment or decision on accreditation by writing to the top management of Accreditation body.

Stage V . Accreditation body will grant the Accreditation to laboratory based on the recommendation of Accreditation committee. It will be valid for a certain period. For example NABL grants for 2 years and it will conduct periodical Surveillance audit of the laboratory at intervals of one year.

5 . Laboratory shall apply for Renewal of accreditation to it at least 6 months before the expiry of the validity of accreditation.

Challenges for Laboratory Accreditation in LDCs . National Accreditation board and other supportive facilities . Infrastructures set up facilities . A strategic planning and implementation of Quality Management System . A clear sustainability plan . Competent human resource and retention plan . Bureaucracy and change resistant behavior . Motivation tools . Recession and International trade business . Compliance to WTO agreements on SPS and TBT . Public expectation . Customer Requirements

Achievements on Laboratory Accreditation in Nepal: In SARC region many private laboratories as well as government ones are already got accreditation; however, some are still under progress for that. Recently, Zest Laboratories (Pvt) Ltd, Bhaktapur, become the first accredited private lab from NABL in 2011. Laboratories under DFTQC and NBSM have already applied for accreditation and waiting for the assessment procedure. Hopefully, these two laboratories are likely to be accredited within 2012 as they have been already assisted technically and financially by different national and international donor agencies such as UNIDO, WTO, PTB, PACT projects.

Is the Laboratory Accreditation a really difficult Task? Since, laboratory management system is a team work approach; therefore a clear delegation of authority, taking a responsibility and accountability as well as practicing good professional practice (GPP) are the major factors, which are overlooking scenario of Nepalese bureaucracy causing hindering in goal achievement in government laboratories. Unfortunately, the country has no National accreditation board yet, though the draft of National Accreditation Board Act for testing, calibration and certification has already been prepared.

In other hand, Nepal is in slow progress in implementing the SPS and TBT requirements of WTO. Accreditation in all competent scopes (test wise) and establishment of residual monitoring plan are still under progress. Lack of competent human resource, National Accreditation Board, Calibration service, PT facility within the country directly influenced upon the accreditation work.

Concluding Remarks Laboratory Accreditation now became a challenging task for the nation to meet the WTO implications for SPS and TBT. However, Central Food Laboratory under DFTQC and Food laboratory and Metrology laboratory under NBSM are in progress of achieving accreditation from

6 NABL, India very soon. Meanwhile, a private laboratory called Zest Laboratories (Pvt) Ltd has succeeded to achieve the accreditation from NABL in 2011. Slowly, other private laboratories mainly pharmaceuticals showed interest for accreditation.

Many International agencies like UNIDO, WTO, PTB etc are supporting to the government testing laboratories for implementing the ISO/IEC 17025:2005 and to remove the technical barrier in international trade of Nepal. They have already invested tens of thousands dollar in LDCs including Nepal with the same objective. Therefore, the need of today is to analyze the situation and finding the root cause of hindrances in managerial as well as in technical levels.

In other hand, the government should seriously take action on the draft Act for establishing National Accreditation Board in Nepal, which could be milestone in QMS to facilitate for certifying and accreditation of remaining business organizations.

References http://en.wikipedia.org/wiki/ISO/IEC_17025 http://www.ilac.org/ http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=39883 http://www.ukas.com

International Standard (ISO/IEC 17025), (2005). General requirements for the competence of testing and calibration laboratories, Second Edition, 2005.

Lal, H. (2010). Quality Management System for Laboratories- Guidelines for the Accreditation of Laboratories, Quality Council of India, New Delhi-110 002, India.

www. nabl - india .org