1. STEPS TO NABL Medical Laboratory Accreditation in India
Dr Thuppil Venkatesh
Lead Assessor & TC member NABL
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

2. “Quality & Competence” in Medical Testing Laboratories ISO 15189:2003 and NABL – 112 requirement a stepwise approach
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

3. Indian Scenario
Over 100,000 medical testing laboratories provide diagnostic services
Over 80% are small, 18% medium and less than 2% are large in number
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

4. Lab size in India
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

5. Accreditation status of large and medium labs :- as they
can afford to meet the accreditation cost
are able to maintain quality requirement
are under the supervision of senior consultants
are having state of art technology with them
are able to get external contracts
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

6. Future of small labs Do not have adequate financial or the manpower
Eventually will become part of medium/large labs
Get converted in to collection centers
Might close down if not accredited
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

7. Medical labs need to get accredited
By whom?
How?
When?
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

8. Ten steps towards accreditation
Get a copy of the IS/ISO 15189
Indian Standard
MEDICAL LABORATORIES – PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
Details can be obtained from
Bureau of Indian Standards
Manak Bhavan, 9 Bahadur Shah Zafar Marg New delhi
Telephones , , website :
Do not use Xerox copies
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

9. Ten steps towards accreditation
Download a copy of the NABL document NABL-112
from the NABL website
This is free of cost
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

10. Ten steps towards accreditation
From Google.com download SAMPLE model quality manual ISO of a section
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

11. Ten steps towards accreditation
Understand terms and definitions under section 3 on page 1 of IS/ISO 15189
There are 17 terms with foot notes provided. You need to refer to and stick to these internationally accepted terminologies all through your documentation
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

12. Terms and definitions
Provided on pages 1 and 3 of the IS/ISO : 2003 of the August 2005 issue. Total of 17 are listed
Example: referral laboratory refers to other laboratory to which a sample is submitted for a supplementary or confirmatory examination procedure and report.
3.14 Sample is one or more parts taken from a system and intended to provide information on the system, often to serve as a basis of decision on the system or its product. A volume of serum taken from a larger volume of serum
3.11 Primary sample Specimen set of one or more parts initially taken from a system
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

13. Ten steps towards accreditation
Understand carefully all 15 Clauses under the MANAGEMENT REQUIREMENT
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

14. Management requirement (15)
4.1 Organization and Management (4.1 to a to j)
4.2 Quality Management System (4.2 to a to f, a to w & 4.2.5)
4.3 Document Control
4.4 Review of Contracts
4.5 Examination by Referral Laboratories
4.6 External services and supplies
4.7 Advisory Services
4.8 Resolution of Complaints
4.9 Identification and Control of Non Conformities
4.10 Corrective Action
4.11 Preventive Action
4.12 Continual improvement
4.13 Quality and Technical Records
4.14 Internal Audit
4.15 Management Review
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

15. 4.1 4.1 ORGANISATION AND MANAGEMENT 4.1.1 Legal identity :
4.1.2 Laboratory design appropriate to meet the needs :
4.1.3 Conformity with relevant requirements for permanent facilities,
Decentralized facilities :
4.1.5a appropriate authority for all personnel, resources to carry out their duties:
4.1.4 Possible conflict of interest, financial or political considerations:
4.1.5b
4.1.5c Confidentiality, impartiality and operational integrity
4.1.5d
4.1.5e Organizational structure, relation with other organizations
4.1.5f Function descriptions and interrelationships
4.1.5g Staff training (to be considered along with NABL-112)
4.1.5h Technical management
4.1.5i Quality manager (authority and responsibilities)
4.1.5j Deputies for all key functions
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

16. 4.2 4.2.1 Documentation, communication and implementation
4.2.2 IQC and EQA
4.2.3 Quality policy statement : content and availability
4.2.4 Content of the quality manual
4.2.5 Calibration, monitoring and preventive maintenance of instruments
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

17. 4.3 4.3.1 Procedures for document management 4.3.2
4.3.3 Identification of documents
4.3.2 a-d, g Availability, release, review, amendments
h Changes
4.3.2 e-f Archives and removing of invalid documents
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

18. Ten steps towards accreditation
STEP 5 continued
Understand carefully all 8 Claus under the TECHNICAL REQUIREMENT
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

19. Technical requirement (8)
5.1 Personnel
5.2 Accommodation and Environmental Conditions
5.3 Examination Procedures
5.4 Laboratory Equipment
5.6 Assuring the Quality of Examination Procedures
5.7 Pre-examination Procedures
5.8 Reporting of Results
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

20. 5.1 5.1.1 Organizational plan, personnel policies, job descriptions
5.1.2 Records of education and qualification
5.1.3 Supervision and competency
5.1.4 Responsibilities of the laboratory director
5.1.5 Adequate staff resources
5.1.6 Training of personnel in quality assurance
5.1.7 Authorization to perform specific tasks
5.1.8 Use of and access to computers
5.1.9 Continuing education program
Training to prevent or contain the effects of adverse incidents
Assessment of competency after training and re-evaluation
Qualification for professional judgements
Confidentiality of information regarding patients
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

21. 5.2 5.2 ACCOMMODATION AND ENVIRONMENTAL CONDITIONS
5.2.1 Adequacy and suitability of the lab space (including other sites)
5.2.4
5.2.2 Risk of injury and protection from hazards
5.2.3 Accommodation for sample collection
5.2.5 Control and registration of environmental conditions
5.2.6 Separation of incompatible activities
5.2.7 Access control
5.2.8 Adequate communication system within the facilities
5.2.9 Storage of samples and documents assuring integrity
Housekeeping
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

22. Ten steps towards accreditation
Study in detail all clauses (scope wise)
referred in NABL-112
This is the Regional /National requirement
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

23. NABL - 112 Provides description and type of laboratory
Covers all 23 elements from the angle of local/regional regulatory requirement
Annexure – I describes routine and special tests under each discipline
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

24. Ten steps towards accreditation
Prepare your Quality System Manual covering both requirements under
IS/ISO and NABL-112 requirement
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

25. Check and re check your system
STEP 9
Conduct at least one Internal Audit followed by the management review meeting and document the action taken and provide the evidence for the effectiveness of the action taken and document the proceedings prior to your pre assessment.
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

26. Example : under requirements
Storage and retention of samples and specimens
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

27. Ten steps towards accreditation
Now obtain application form from :
The Director NABL
Fill it out carefully annex all details and submit along with the prescribed fee
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

28. Three stages of NABL Accreditation Process
Stage 1 Quality System Manual adequacy study by NABL lead Assessor
Stage II Pre-assessment visit by the Lead Assessor (One day)
Stage III Final Assessment by the NABL team (two days or more)
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

29. After final assessment
Report will reach NABL with total knowledge of the laboratory
NABL technical committee will review the report and recommendations
Will communicate to the laboratory about the accreditation status
Accredited labs need to go in for periodic surveillance with annual fee
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006

30. Take home message
Irrespective of Laboratory size, Quality needs to be validated by Third Party
Documentation is easy under ISO 15189
NABL guide lines provide local/ regional requirements
Laboratory can be accredited by any authorized Third Party
Quality Control and PT requirements are the integral components of accreditation
Focus should be continual improvement
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006