Laboratory studies play an important role in assessing product quality. Test results must be reliable to be accepted at national and international levels. This is possible only when the systems in those laboratories meet certain quality requirements. The process of certifying this is called accreditation.
Definition:
Accreditation of laboratories is a process through which an
authorized, independent agency examines and certifies the competence and
quality systems of a laboratory-based on particular predefined standards.
Accreditation provides formal recognition of the technical competence of a
laboratory for particular measurements or tests based on results from a
third-party assessment.
Fig: Accreditation Process
Advantages of Accreditation:
1. Higher level of confidence in calibration/testing reports
that the laboratory issues.
2. Increased business with greater customer confidence in
testing reports.
3. Improved control over laboratory operations to maintain a
sound quality management system.
4. Guarantee of reliable test results, reducing the need for
re-testing, resulting in savings.
5. Improved visibility in the market as a good quality
service provider.
Accreditation versus ISO 9000 Certification:
Accreditation is the recognition of the technical competence
of a test service provider or Conformity Assessment Body (CAB). Thus, it is a
step beyond system certification provided by ISO 9000. ISO certification will
evaluate the CAB’s system for quality management; however, it will not give any
insight into its ability to provide accurate and reliable test data or its
technical competence in testing. By assessing the CAB for compliance with
internationally accepted criteria, accreditation provides a greater level of
information than mere ISO certification.
In most countries, accreditation for laboratories is
mandatory; in India, however, it is a voluntary exercise.
India’s Accreditation Body – NABL:
In India, the accreditation body is named the National
Accreditation Board for Testing and Calibration Laboratories – NABL. This body
is a signatory of the Mutual Recognition Agreement with the regional body
called Asia Pacific Laboratory Accreditation Cooperation and the apex body
called International Laboratory Accreditation Cooperation. By this,
NABL-accredited laboratories can also achieve international recognition.
NABL is an autonomous body that is under the Department of
Science and Technology, Government of India. It was first established to
provide accreditation to laboratories involved with testing and calibration.
Later, its scope was extended to accreditation for clinical laboratories, too.
This is the only accreditation body authorized by the Government of India for
the testing and calibration laboratories.
Standards:
Internationally, the acceptable standard for laboratories is
ISO 15189. NABL provides accreditation in keeping with ISO/IEC 17025: 2005
“General Requirements for the Competence of Testing and Calibration
Laboratories” and ISO 15189: 2012 ‘Medical laboratories — Requirements for
quality and competence’.
Fields of CABs covered by NABL
|
Testing Laboratories |
Calibration Laboratories |
Medical Laboratories |
|
Biological |
Electro-Technical |
Clinical
Biochemistry |
|
Chemical |
Mechanical |
Clinical
Pathology |
|
Electrical |
Fluid Flow |
Haematology
& Immunohaematology |
|
Electronics |
Thermal &
Optical |
Microbiology
& Serology |
|
Fluid-Flow |
Radiological |
Histopathology |
|
Mechanical |
|
Cytopathology |
|
Non-Destructive
Testing |
|
Genetics |
|
Photometry |
|
Nuclear
Medicine (in-vitro tests only) |
|
Radiological |
|
|
|
Thermal |
|
|
|
Forensic |
|
|
|
Proficiency Testing Providers |
|
Reference Material Producers |
|
Testing |
|
Chemical
Composition |
|
Calibration |
|
Biological
& Clinical Properties |
|
Medical |
|
Physical
Properties |
|
Inspection |
|
Engineering
Properties |
|
|
|
Miscellaneous
Properties |
Source: NABL India website
How often accreditation must be done?
Accreditation must be done periodically, at regular intervals, to effectively maintain quality performance and reliability of results. NABL accreditation has a validity period of 2 years. The CAB must apply for accreditation renewal a minimum of 6 months before the validity period expires.
Procedure for NABL Accreditation:
CABs must follow the following process to obtain
accreditation:
Step 1: CAB applies in the prescribed form in
triplicate and attach two copies of their quality manual describing their
management system as per ISO or IEC guidelines as applicable. CAB also pays the
application fee prescribed by NABL.
Step 2: On receiving the application, quality manual,
and fee, the NABL Secretariat issues an acknowledgment number with a unique ID
number. This must be used for any correspondence. NABL scrutinizes the
application and may ask for any clarification or information as necessary.
Step 3: NABL appoints a lead assessor who organizes a
pre-assessment visit to the CAB premises. During this visit, any non-conformity
in quality system implementation is evaluated.
This visit helps to evaluate:
(a) How prepared CAB is for the assessment?
(b) How many assessors will be required?
(c) Which key locations must be visited?
Step 4: Lead assessor submits a report of the
pre-assessment visit to the NABL Secretariat. A copy is sent to the CAB too.
Step 5: CAB takes corrective measures regarding the
non-conformity pointed out in the assessment report. CAB sends a report on this
to the NABL Secretariat.
Step 6: Based on the satisfactoriness of the CAB’s
corrective actions, NABL sets up the assessment team after consulting with the
CAB. Along with the lead assessor, this team will include experts in the fields
in which accreditation is sought by the CAB. Sometimes, an observer may also be
nominated.
Step 7: The assessment team visits the CABs site. It
reviews its systems and verifies compliance with the relevant certification
standards. The team evaluates the CAB's technical competence and identifies
non-conformities that may be present.
Step 8: The assessment team prepares an assessment
report, and based on the findings, recommends whether accreditation may be
granted or not. This report is sent to the NABL Secretariat. A copy of the
report is given to the CAB at the end of the inspection.
Step 9: NABL examines the assessment report and
initiates any follow-up action for non-conformities. It monitors the corrective
actions taken by the CAB.
Step 10: Once all non-conformities have been
addressed, the CAB is granted accreditation by the Chairman, NABL. The
accreditation certificate will have the NABL hologram, unique number,
discipline, and scope of accreditation along with the validity date.
If the CAB does not agree with the NABL's decisions, it may appeal to the NABL Director with the necessary information.
NABL will survey the accredited CAB annually to ensure they
continue to comply with certification requirements.
Preparing for Accreditation:
When a CAB wishes to apply for accreditation, they must
prepare in advance for the process. Here are some important steps to be
performed.
1. Obtain NABL documents from the NABL Secretariat to get
familiar with the assessment process and details required for the application.
2. Ensure training of one person by NABL on Quality
Management Systems and Internal Audit.
3. Prepare a quality manual in keeping with the standards.
4. For each test/investigation done in the laboratory,
prepare a Standard Operating Procedure (SOP).
5. Calibrate instruments and equipment used in testing;
ensure correct environmental conditions are maintained in the laboratory.
6. Train personnel on documentation aspects.
7. Check the status of the current technical competence and
quality system by comparing it with NABL standards and address deficiencies
encountered.
8. Prepare the Quality Manual and all other documents
required by NABL.
9. Include Internal Quality Control (IQC) in sample
analysis.
10. Take part in External Quality Assessment Schemes (EQAs).
11. Evaluate compliance with IQC and EQAs; take corrective
actions where necessary.
12. Perform internal audit and management review to assess
preparedness for NABL assessment.
13. After everything is satisfactory, apply for
accreditation to NABL with the prescribed fees.
Laboratory testing is a vital component of the health care
system. Accreditation is an efficient tool to assess the quality of laboratory
services and is therefore highly beneficial to healthcare providers. For it to
be effective in maintaining quality performance and reliability of results,
accreditation must be done periodically, at regular intervals.