All in one hand

In the current global scenario, it is an essential pre-requisite of trade that products and services accepted in one economy should meet global norms and accredited certification facilities go a long way towards reducing the need for extensive re-testing. Usha Sharma finds out the necessity of laboratory accreditations in the life sciences industry

The globalization of the Indian economy with an increased awareness among the public for quality services and acceptance of test data makes it imperative for accredited laboratories to meet international levels of competence. In line with this trend, the Central Government Health Scheme (CGHS), Ministry of Health and Family Welfare, Government of India has recently made accreditation from the National Accreditation Board for Testing and Calibration Laboratories (NABL) mandatory for private laboratories for empanelment purpose. This mandate saw an increase in the number of applications for NABL accreditation. Similar mandates might be issued by insurance agencies, corporate employers and Public Sector Undertakings (PSUs) for using accredited laboratory services for their employees.

The laboratory accreditation services towards testing and calibration laboratories are provided in accordance with ISO/ IEC 17025: 2005 'General Requirements for the Competence of Testing and Calibration Laboratories' and ISO 15189: 2007 'Medical laboratories - Particular requirements for quality and competence'. The fields and groups under which the accreditation services are offered are listed in the scope document of NABL Accreditation'. Formal recognition of competence of a laboratory by NABL in accordance with international criteria (ISO 15189) has many advantages.

"There is no authentic data available on the number of laboratories operating in country. However number may be over one lakh. Overall, there are approximately 198 accredited labs spread across India" - Dr B K Rana Deputy Director National Accreditation Board for Hospitals and Healthcare Providers (NABH) Quality Council of India (QCI)

Dr B K Rana, Deputy Director, National Accreditation Board for Hospitals and Healthcare Providers (NABH) Quality Council of India (QCI), highlights the importance of laboratory accreditation saying, "The concept of laboratory accreditation was developed to provide a means for third-party certification of the competence of laboratories to perform specific type(s) of testing. It provides formal recognition to competent laboratories, thus providing a ready means for customers to find reliable testing and calibration services in order to meet their requirements. Laboratory accreditation enhances customer confidence in accepting testing reports issued by accredited laboratories."

Putting it in a nutshell, Rana points out, "Just as chemical and biological testing laboratories test drugs or pharmaceutical products, services of a NABL accredited medical laboratory are availed in the case of clinical studies. This makes the data generated by these laboratories reliable and technically valid. It gives confidence to the sponsor of study as well to the regulatory authorities and government in accepting the data."

Accreditation is considered as the first essential step for facilitating mutual acceptance of test results and measurement data. Laboratory accreditation is a procedure by which an authoritative body gives formal recognition of technical competence for specific tests/ measurements, based on third party assessment and international standard. WTO recognizes that non-acceptance of test results and measurement data is a technical barrier to trade. Global sourcing of components calls for equivalence of measurement, which can be facilitated by a chain of accredited calibration laboratories.

"The laboratory management should declare a quality manager who will be over all responsible for NABL accreditation and all documentations and a Technical Manager who will see the technical part of its operation. Both these Officers will thoroughly read ISO/IEC 17025/ISO 15189 standards, prepare quality manual and quality policy, standard operation procedure and trained their staff" - Dr D R Lohar Director Pharmacopoeial Laboratory for Indian Medicine Department of AYUSH Ministry of Health and Family Welfare

"To get NABL accreditation requires lots of technically corrected data but key basic requirements are state of the art Infrastructure, sophisticated equipments and instruments, documentations and records and skilled as well as trained man powers" - H G Koshia Commissioner Food and Drugs Control Administration Gujarat State

Focusing on the current scenario of government labs in India Dr D R Lohar, Director, Pharmacopoeial Laboratory for Indian Medicine Department of AYUSH, Ministry of Health and Family Welfare says, ,"Very few Indian government laboratories have NABL accreditation, however their results are equally reliable and authentic in drugs testing."

Certain states seem to be ahead. H G Koshia, Commissioner, Food and Drugs Control Administration, brings to notice the Gujarat government's initiative towards NABL accreditation, revealing that "In the state of Gujarat under Food and Drugs Control Administration, Gujarat State (FDCA) there are three laboratories which are engaged in the testing of the food and drugs samples, based out of this one lab in Baroda and it has been accredited by NABL. This is a first of its kind government lab in the country where state government owned lab has received NABL recognition in the area of food and drugs sample analysis."

Rajaram Kalpathi, Country Manager, Intertek Oil, Chemical, Agri and Minerals comments, "As far as drug testing is concerned, the Central Drugs Standard Control Organization (CDSCO) assumes control over the quality of the drugs under consideration. The statutory samples drawn by drug inspectors are usually tested at government drug testing labs and only those certificates which are issued by these labs are valid."

Kalpathi explains need of the laboratory accreditation saying, "Laboratory accreditation provides formal recognition of competent laboratories, thus providing a ready means for customers to find reliable testing and calibration services in order to meet their requirements. It further enhances customer confidence in accepting testing / calibration reports issued by accredited laboratories. "

He continues that, "Confidence in accreditation is obtained by a transparent system of control over the accredited laboratories and an assurance given by the accreditation body that the accredited laboratory fulfils the accreditation criteria, at all times. Accredited laboratories can objectively state conformance of product or service to specified requirements. It is important for the purchaser, regulator, government, and the public to be able to identify accredited testing and calibration laboratories."

A Directory of NABL accredited testing laboratories (NABL 400), calibration laboratories (NABL 500) and medical testing laboratories (NABL 600) as on 31st July 2009 is available in the 'Publication' section under 'Accreditation Documents' on the NABL website free of cost. Rana says, "There is no authentic data available on the number of laboratories operating in country. However number may be over one lakh. Overall, there are approximately 198 accredited labs spread across India."

Basket of benefits

Once accreditation is received, the accredited laboratory benefits as accreditation stimulates continuous improvement. It enables the laboratory to demonstrate commitment to quality. It raises community confidence in the services provided by the laboratory. It also provides an opportunity to the laboratory to benchmark itself with the best. The patient benefits as accreditation results in high quality and patient safety as they get services by credentialed staff. Patient satisfaction too is regularly evaluated.

Sharing more details on the need and importance of laboratory accreditation, Lohar says,"Laboratory accreditation provides a ready means for customers to find reliable testing and calibration services in order to meet their demands. A team of assessors will assess for quality system documentation, its implementation by the laboratories and verify for its compliance. The laboratory management shall demonstrate to the NABL assessment team that all requirements of ISO/IEC 17025/ISO 15189 standard, guidelines / requirements of NABL are being followed."

Rana continues, "The staff in an accredited laboratory is a satisfied lot as it provides for continuous learning, good working environment and leadership. It improves overall professional development of laboratory specialists and paramedical staff and provides leadership for quality improvement."

NABL accreditation procedure

"Confidence in accreditation is obtained by a transparent system of control over the accredited laboratories and an assurance given by the accreditation body that the accredited laboratory fulfils the accreditation criteria, at all times. Accredited laboratories can objectively state conformance of product or service to specified requirements. It is important for the purchaser, regulator, government, and the public to be able to identify accredited testing and calibration laboratories" - Rajaram Kalpathi Country Manager Intertek Oil Chemical Agri and Minerals

NABL accreditation for medical laboratories is based on international standard ISO 15189 'medical laboratories- particular requirements for quality and competence'. In addition to ISO 15189, NABL 112 'specific criteria for accreditation of medical laboratories' is also applicable. NABL accreditation is currently given in testing, calibration and medical laboratories fields. Accreditation to a laboratory is given on the basis of its capability to perform tests / calibrations and provide accurate and reliable results. "It provides an interpretation of ISO 15189 and describes specific requirements for some general clauses of ISO 15189. Also, laboratory shall follow national, regional and local laws and regulations as applicable from time to time," says Rana.

A laboratory may apply for accreditation from as little as one to as many tests / calibrations provided it is performing these in accordance with NABL criteria based on ISO 17025:2005 and also the respective NABL document applicable for that criterion.

Giving details of the the accreditation procedure Rana explains, "It varies from laboratory to laboratory as it depends on type of laboratory, scope of services and existing infrastructure and quality system of a laboratory. NABL has clearly defined different steps for its accreditation process and therefore, the time taken by NABL to process an application would be more or less same. However, the time taken by (individual) laboratory would differ depending upon how well (each) laboratory is prepared for accreditation process. "

To become an accredited laboratory, addressing the requirements of ISO 15189 and NABL 112 are a must. Requirements of ISO 15189 are divided into Management and Technical requirements. Management requirement includes organization and management, document control, review of contracts, examination by referral laboratories, external services and supplies, advisory services, resolution of complaints, identification and control of non-conformities, corrective action, preventive action, continual improvement, quality and technical records, internal audits, and management review. Technical requirement includes personnel, accommodation and environmental conditions, laboratory equipments, pre-examination procedures, examination procedures, assuring quality of examination procedures, and reporting of results.

Along the same lines Lohar comments, "Generally it takes about six months, but it also depends on laboratory management, how prompt they are in arranging facilities, calibrations of equipments and preparation of required documents. The laboratory management should designate a quality manager who will be over all responsible for NABL accreditation and all documentations and a Technical Manager who will see to the technical part of its operation. Both these Officers will thoroughly read ISO/IEC 17025/ISO 15189 standards, prepare quality manual and quality policy, standard operation procedure and trained their staff."

In addition, some other requirements are specific to the scope of services. For example, to be eligible for accreditation in the area of Histopathology and Cytopathology, a laboratory should receive at least 300 specimens every year. Facility for primary sample collections away from the site of main laboratory should also comply with the relevant requirements of ISO 15189.

Putting the basics in place

The laboratories seeking accreditation are assessed in accordance with ISO/IEC 17025:2005 for testing and calibration laboratories and ISO 15189:2007 for medical laboratories. A laboratory wishing to be accredited by NABL must have a quality manual on its quality system satisfying the requirements as described in various clauses of ISO/IEC 17025:2005 or ISO 15189 standard. Quality system documentation and its implementation by the laboratories shall be verified by the assessors for its compliance in accordance with ISO/IEC 17025 or ISO 15189 standard. The laboratory management shall demonstrate to the NABL assessment team that all requirements as laid down in the ISO/IEC 17025/ISO 15189 standard, specific criteria and other guidelines / requirements of NABL are being followed. All applications for accreditation shall have to be in accordance with ISO/IEC 17025:2005 or ISO 15189 Standard, as applicable.

Highlighting the need for increased NABL accreditation in India, Koshia comments, "It is the reports issued by the lab who are more reliable, accurate and precise, which are many a time conclusive for taking actions against the wrong doers in pharma and food industries. To get NABL accreditation requires lots of technically corrected data but key basic requirements are state-of-the-art Infrastructure, sophisticated equipments and instruments, documentations and records and skilled as well as trained man powers."

In addition to the fee structure given in the table, overhead charges of Rs.6,000 per assessment and assessment charges comprising of travel, boarding and lodging and honorarium to team members is also to be paid by the laboratory.

Kalpathi lists the positive outfalls from NABL accreditation like, "Quality system of any organization and particularly those of laboratories is a vital element which is required to ensure safety and reliability of end products and services. The system has to be implemented in the true spirit with all seriousness and needs to be totally supported by the top management. Continual improvement will be the key to success. All global standards are developed after considerable efforts with valuable inputs from related stakeholders and hence following the stipulations therein will enhance value addition to the concerned entity."

Due to the awareness brought in by several accreditations, the concept of quality in testing has improved. Indian labs have grown to promote, coordinate, guide, implement and maintain an accreditation system suitable for the country in accordance with the relevant national and international standards and guidelines. "This will enable them to establish and maintain strong international and regional linkages such as International Laboratory Accreditation Conference (ILAC), European Accreditation Cooperation for Laboratories (EAL), Asia Pacific Laboratory Accreditation Cooperation (APLAC) etc. and to take active participation in Plenary Sessions, Committee Meetings etc. in order to keep pace with the latest developments. This in turn will help them undertake all activities which shall promote undertaking Bi-lateral / Multilateral Recognition Agreements between NABL and laboratory accreditation bodies in other countries so that test results of NABL accredited laboratories become acceptable in all countries. The future looks positive, growth and quality oriented and exciting," Kalpathi avers.

Whether it's the retail customer or corporate firms engaged in exports, NABL accredited laboratories are a must especially where high accuracy is required, like in the auto and pharma industries. Government tenders too demand test reports from NABL accredited laboratories Therefore it is no wonder that more Indian laboratories are getting NABL accreditation. In the near future, no laboratory will be able to survive without NABL accreditation and unlike today, it will become the norm rather than the exception.

u.sharma@expressindia.com