NABL Accreditation

What is NABL?

NABL is the Constituent Board of Quality Council of India. The aim behind NABL establishment is to give the government, associate’s of industries and generally industries a scheme for Conformity Assessment Body’s Accreditation that involves third-party technical competence assessment of testing for Calibration and medical labs, referred productive material and proficiency test providers.

The accreditation offered by NABL is a non-discrimination certification. The accreditation offered by NABL is developed in accordance to ISO/IEC 17011:2017. NABL is signatory to ILAC as well as APLAC Mutual Recognition Arrangements (MRA) for accreditation of Testing including Medical and Calibration laboratories.

How it is developed?

NABL pursues ISO 15189:2007 standard that is recognized world over for labs and medical certification. APLAC (Asia Pacific Laboratory Accreditation Cooperation) and ILAC (International Laboratory Accreditation Co-operation) both follow these guidelines. Means, with NABL India is also following international accreditation levels followed by the world.

Process of achieving NABL

Assessment Criteria

The labs that want to access accreditation accordance to ISO/IEC 17025:2017 for their testing and laboratory facility and ISO 15189:2007 for medical labs, need to follow the below guidelines.

To be assessed you need a quality manual clarifying the quality system is maintaining the requirements as per the clauses stated in ISO/IEC 17025 or ISO 15189 standard. These quality system documents and it’s implementing process will be scrutinized by the NABL assessors to see if they meet the ISO/IEC 17025 or ISO 15189 standards. The testing or lab facility has to show case the NABL team they are meeting all the specific criteria, guidelines, requirements and standards given by ISO/IEC 17025/ISO 15189.

Benefits of NABL

With accreditation business increases as customers feel more confident in taking services from such facilities. Money and time is saved as re-tests are not required. The reason for this is, if equipment and staff is of standards then there is almost no place for mistakes.

Better maintenance of the equipment and reviews received on how much is the quality maintained both system and technical wise. Customers can also find you by searching for NABL accreditation labs in the Accredited Laboratories Directory.

WHY NABH Consultancy

NABH Consultancy is known for it’s commitment for presenting value based services and consultancy, Documentation & training for NABL accreditation for Labs that help in improving your business better. NABH Consultancy has group of NABL Assessors, Auditors, Trainers & Consultants for NABL Training, Documentation & Consultancy.

Steps for achieving NABL Accreditation

Duration of Project

The duration of the project may vary on the laboratory size. The project will be implemented over a period of 3-4 months in Six stages. Some laboratories will be able to do this faster, and some will never complete the process.

Stages of the project Stage

  1. Awareness of NABL Stage
  2. Documentation Stage
  3. Training and Indicator Monitoring Stage
  4. Internal Audit Stage
  5. Applying for NABL Accreditation Stage
  6. Audit & NABL Accreditation
  • Mile stones of Stage 1: Awareness of NABL
    • Awareness of NABL
    • Appointment of NABL Coordinator/Quality Manager
  • Mile stones of Stage 2: Documentation
    • Documentation
    • Prepare Quality Manual (Policy Document)
    • Prepare Procedural Manual
    • Prepare Safety Manual
    • Finalization of organization & Departmental organogram
  • Mile stone of stage 3: Training and Indicator Monitoring
    • Training on essential topics of NABL
    • Indicator Monitoring
    • Finalization of documents and verifying it contents
  • Mile stone of stage 4: Internal Audit
    • Internal Audit
    • Gap closure
    • Corrective and Preventive action
  • Mile stone of stage 5: Applying for NABL Accreditation
    • Applying for NABL Accreditation
    • Submit three sets of duly filled in application forms for each field of testing / calibration along with two sets of Quality Manual and Application Fees.
  • Mile stone of Stage 6. Audit & NABL Accreditation
    • NABL assessor will come for Stage 1 & 2 Audit,
    • In stage 1 they will verify documents & in stage 2 audit they will check the compliance with standard.
    • In both visits our consultant will come at your organization, support and add value during the audits.
    • Remove non-conforming that found during the audit by NABL Auditor.
    • Submit the Corrective actions to NABL • Finally you will get accreditation from NABL.

Project Outcomes:

  • Improves the systems
  • Improves the Services
  • Improves the client satisfaction
  • Improves the staff morale and confidence
  • Benchmarks and adopts the best practices across the globe.
  • Gives scope for continues quality improvement.
  • Potential increase in business due to enhanced customer confidence and satisfaction.
  • Savings in terms of time and money due to reduction or elimination of the need for re-testing of products.
  • Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent.
  • Increase of confidence in Testing / Calibration data and personnel performing work.

RESOURCES NEEDED FOR THE PROJECT:

  • We solicit a strong commitment from the management so as to make the drive seamless. There is a requirement of an accreditation coordinator and a core team who would be totally dedicated to the process and to the consultants for a minimum period of 3 to 4 months. We should be prepared and committed to complete the pre-assessment by 4th month and Final Assessment by the 5th month. • Resources should be earmarked for some structural alterations, modifications, training and document preparation for the process of accreditation. • The above with an office space and office equipments (Computer with an internet and printing facilities) and stationeries are pre-requisite. If you still have any query, Please send us email at: bpmedicalservices@gmail.com

Let us be your guide to NABL Accreditation success. Contact us today to learn more about our services and to get started on the road to success. We look forward to hearing from you soon!

We look forward to hearing from you!