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Journal of the Academy of Hospital Administration

ISO/IEC 17025:1999 - COMPLIANCE TO CLINICAL LABORATORY AND PROCESS OF ACCREDITATION

Author(s): Umanath. V, Nasna Rasheeda Alam, Vidya Gayathri A

Vol. 18, No. 1 (2006-01 - 2006-12)

Umanath. V(1), Nasna Rasheeda Alam(2), Vidya Gayathri A(3)

Key Words: ISO/IEC 17025: 1999 Compliance, Accreditation process, proficiency testing

Key Message:

  • To understand the importance of ISO/IEC 17025: 1999 compliance in clinical laboratory.
  • To comply with ISO/IEC 17025: 1999 standard and implement its specific requirements in clinical laboratories.

ABSTRACT

A number of healthcare sectors have emerged in recent times due to the era of specialisation. There is a rift in growing specialties where volume of cases per day is more important than quality service provision. To meet this demand as a check over quality service, many accreditation bodies have come up which are compliant with international standards. Such bodies provide a continuous check through audits and National Accreditation Board for testing and calibration laboratories (NABL) is one of them. This article outlines the accreditation process which has to be followed, the pre requisites, and resultant benefits due to accreditation.

INTRODUCTION

Laboratory accreditation is a process by which an authoritative body gives formal recognition of technical competence for specific tests/measurements, based on third party assessment and following international standards.

Role of NABL:

“National Accreditation Board for testing and calibration Laboratories” (NABL), it is an autonomous body under the aegis of Department of Science & Technology, Government of India1 and is functioning since 1985 under Quality Council of India (QCI).

It’s a sole accreditation body for testing and calibration laboratories authorized by Government of India, established with an objective to provide government, industry associations and industry in general with a scheme for third-party assessment of the quality and technical competence of testing and calibration laboratories. NABL maintains a linkage with International Laboratory Accreditation Co-operation (ILAC) & Asia Pacific Laboratory Accreditation Cooperation (APLAC).

ISO 17025/IEC 17025: 1999

International Organisation for Standerdisation (ISO) 17025 (more specifically ISO/IEC International Electromechanical Commission 17025:1999) is an international standard for calibration and testing labs “General Requirements for the competence of testing and Calibration Laboratories”2.

It requires labs to demonstrate that they:

  • Operate a quality system covering processes, documentation and management.
  • Generate technically valid results taking account of the equipment, procedures, and personnel.

This standard is an evolution of the former ISO Guide 25. It replaces EN45001 in Europe and has been adopted in the US as an ANSI standard that provides a migration path to international standards from the older Z540-19994.

All national accreditation bodies have adopted ISO 17025 as a way to ensure standardization. Several industries or countries have incorporated it into their industry-specific or application-specific regulations.

The laboratories seeking accreditation are assessed on the basis of its capability to perform tests(s)/ calibration(s) and provide accurate and reliable results, in accordance with ISO/IEC 17025:1999 and relevant specific criteria.

The growth in use of quality system generally has increased the need to ensure that laboratories that form a part of larger organizations or offer other services can operate to a quality system that is seen as compliant with ISO 90013 or ISO 90024 as well as with this international standard. ISO 17025 is an output of ISO 9001 and ISO 9002, which incorporates all the requirements relevant to the scope of testing, and calibration services that are covered by the laboratory’s quality system. This international standard is applicable to all organizations performing tests and/or calibrations; the standard consists of 5 main clauses and 24 sub clauses.

Accreditation Process:

                         Accreditation Process 1
  Accreditation Process 2
  Accreditation Process 3
(Click the images for a larger view)

DISCUSSION

The complexity most of the laboratories find is to accomplish the documentation of Quality Manual and implementation of quality standards as per ISO 17025 “General requirements for the competence of testing and calibration laboratories” and quality control checks. The ISO standard does not specify fixed rules or a rigid structure for the contents of the quality manual. Though NABL-160 “Guide for preparing a quality manual” does provide the guidelines for preparing the quality manual but, NABL does not issue the publication, as its been withdrawn. However, the manual should address all the elements of the standard; if particular elements of the standard are considered relevant to the laboratory in question, the reasons for this should be given in the manual.

A quality manual should normally contain the following:

  • Name of company
  • Table of contents
  • Scope and field of application
  • Introductory text on the company
  • The manual’s issue number and date of issue
  • Status of amendments with amendment record sheet
  • Designation of the person authorized to issue copies of the manual and subsequent changes.
  • Definition of standard forms

Another important level of documentation is Quality System Procedures (QSP) and Standard Operating Procedure (SOP).

A Procedure is “a specified way to perform an activity”. When the procedure is documented it is usually referred to as a “written procedure” and/or “documented procedure”. A written procedure usually covers the following:

  • Purpose of an activity
  • Scope of an activity
  • Responsibilities: what and how it shall de done
  • What materials, equipment and documents shall be sued
  • Documentation: how it shall be controlled and recorded.

Typically SOP includes: Title, specimen, principle procedure; primary responsibility, secondary responsibility, patient preparation, pre-test preparatory, conducting test, safety precautions, equipment/ instrument, calculations, reagents, units, reference range, clinical significance, notes, quality control, reporting, copies, references and approval.

Proficiency testing:

The most important requirement of NABL accreditation is participation of laboratory in proficiency testing programme.

“Proficiency testing is the use of inter-laboratory comparisons to determine the performance of individual laboratories for specific tests or measurements”. Proficiency testing techniques vary depending on the nature of the test item, the method in use and the number of laboratories participating. Most possess the common feature of comparison of results obtained by one laboratory with those obtained by one or more other laboratories. In some schemes, one of the participating laboratories may have a controlling, coordinating, or reference function.

The following are common types of proficiency testing schemes5.

1. Measurement comparison schemes: This scheme involves the test to be measured or calibrated successively from one participating laboratory to the next.

2. Inter-laboratory testing schemes:

  • The same samples, or parts of the same sample, are tested in two or more laboratories to ascertain that the results are reproducible.
  • It is necessary to ensure homogeneity of samples.
  • All the participating laboratories have to use validated test methods and calibrated equipment only.
  • One of the laboratories to act as coordinator.

3. Split-sample testing scheme; This programme involves samples of a product or a material being divided, into two or more parts with each participating laboratory testing one part of each sample.

4. Qualitative schemes: Evaluation of laboratory testing performance also involves the capabilities of laboratories to characterize specific entities like to identify a specific pathogenic organism etc.

5. Know-value schemes: This involves preparation of test items with known amounts of the measurand under test. It is then possible to evaluate the capability of an individual laboratory to test the item and provide numerical results for comparison with the assigned value.

6. Partial-process schemes: Evaluation of laboratories abilities to perform parts of the overall testing or measurement process.

Benefits of Accreditation

  • Accreditation brings recognition as a quality-focused organization, both internally among employees and externally in dealing with customers, clients and suppliers.
  • Pride and accomplishment among the employees in achieving the goals of quality process.
  • Results increase in teamwork, communications, and motivation throughout the organization.
  • Reduced potential liability, control of business processes, process improvement, and more effective management strategies at all levels.
  • Users of accredited laboratories will enjoy greater access for their products/services in both domestic and international markets, when tested by accredited laboratories.
  • Customers are more benefited and can identify laboratory accredited by NABL for their specific requirements from the directory of accredited laboratories.
  • Savings in terms of money due to reduction or elimination of the need for retesting of products.

The deterrents identifed are:

  • Laborious documentation.
  • No common policy for documentation.
  • Labs are too burdened with records to satisfy the audit requirements.
  • Accreditation is not mandatory rule, it is a voluntary process.

CONCLUSIONS:

Laboratory accreditation through NABL is not the end to achieve quality standards; it’s just a beginning towards continuous quality improvement. It will be an advantage if laboratory is already certified by ISO 9001:2000, this approach will reduce the documentation job, since most of the requirements of ISO 9001:2000 and ISO 17025 overlap in terms of quality system documentation, procedures, work instructions, SOP’s, forms, formats, registers, records etc. and ISO 9001:2000 standard filters many of the requirements for ISO 17025. Once lab is NABL accredited the next step towards enhancing the quality should be US FDA regulations i.e. GLP, a step towards continuous quality improvement. Some of the requirements of the 17025 requirements are similar to the GLP principles. The meaning and in some cases even the wording is identical. For example the section 5.2.1 of the ISO/IEC standard 17025 on personnel is similar to the text used in the US FDA regulations (58.29).

Hence, the approach of any laboratory to achieve International quality standards should be continuous efforts from every member of the organizations, and laboratory should end up as a quality Icon.

REFERENCES:

  1. General requirements brochure June 2002 (NABL-100)
  2. Indian standard-General requirements for the competence of testing and calibration laboratories– second reprint February 2002
  3. ISO 9001:1994 IS/ISO 9001:1994 Quality systems- Model for quality assurance in design, development, production, installation and servicing.
  4. ISO 9002:1994 IS/ISO 9002:1994 Quality systems- Model for quality assurance in production, installation and servicing.
  5. Guidelines for proficiency testing programme for testing and calibration laboratories issue no 03 issue date April 2001 (NABL 162)

(1) Umanath. V – CEO (Chief Executive Officer) Elbit Medical Diagnostics Ltd., Banjara Hills, Hyderabad-34
(2) Nasna Rasheeda Alam – Quality Assurance Officer-Elbit Medical Diagnostics Ltd.
(3) Vidya Gayathri A – Quality Assurance Officer & Purchase Executive-Elbit Medical Diagnostics Ltd.
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