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Benefits of ISO 17025 Accreditation

Implementing ISO/IEC 17025 in a laboratory provides both external and internal benefits. Externally, it establishes customer confidence, provides marketing advantages, reduces multiple assessments, and enables international recognition. Internally, it establishes good systems, enhances technical competence, ensures consistent operations, improves communication and employee motivation, and lays the foundation for quality improvement. To fully realize the external benefits, a laboratory should pursue accreditation from NABL, which provides formal recognition of the laboratory's competence. The process of establishing a quality management system and pursuing NABL accreditation involves gap analysis, documentation, training, internal audits, and assessments.

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20 views12 pages

Benefits of ISO 17025 Accreditation

Implementing ISO/IEC 17025 in a laboratory provides both external and internal benefits. Externally, it establishes customer confidence, provides marketing advantages, reduces multiple assessments, and enables international recognition. Internally, it establishes good systems, enhances technical competence, ensures consistent operations, improves communication and employee motivation, and lays the foundation for quality improvement. To fully realize the external benefits, a laboratory should pursue accreditation from NABL, which provides formal recognition of the laboratory's competence. The process of establishing a quality management system and pursuing NABL accreditation involves gap analysis, documentation, training, internal audits, and assessments.

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WHY IMPLEMENT IS/ISO/IEC 17025 IN YOUR LABORATORY?

EXTERNAL BENEFITS

 Establishing confidence to customers.


 Marketing advantage.
 Reduction in customer/multiple assessments.
 International recognition.
WHY IMPLEMENT IS/ISO/IEC 17025 IN YOUR LABORATORY?

INTERNAL BENEFITS
 Establishment of good systems.
 Enhancing technical capability and competence.
 Ensuring consistency in operations.
 Better internal as well as external communication.
 Increased awareness regarding Quality, among employees.
 Improved performance due to motivation and
 confidence among employees.
 Foundation for Quality improvement.
 Better control of Laboratory operations.
WHY LABORATORY ACCREDITATION ?

 External advantages are accrued in the fullest only when the Quality
Management System established as per ISO/IEC 17025:2017 is
accredited by the appropriate agency – NABL.

 Laboratory Accreditation provides formal recognition of competence


of a laboratory.
ESTABLISHMENT OF LAB QMS

IMPLEMENTATION
 Decision and commitment of Top Management.
 Identification of Facilitator/Coordinator.
 Secure all relevant information on NABL.
 Training of the Key Personnel.
 Identify the technical areas to be covered under the QMS.
 Do a Gap analysis of the existing systems and technical competence
vis-a-vis the requirements of the standard (ISO 17025).
ESTABLISHMENT OF LAB QMS

Fill the gap and establish the required systems and document them.
 Establish a core group .
 Divide the task.
 Involve key persons engaged in different activities.
 Establish and document systems for management review, internal audit,
document control, corrective & preventive actions, training, etc.
 Consolidate on existing systems for technical requirements.
ESTABLISHMENT OF LAB QMS

 Consolidate documentation.
 Quality manual,
 Procedures,
 Technical manual,
 SOP’s, Instructions, etc.
 Audit documentation for Adequacy.
 Training of all concerned, both for ISO 17025:2017 and the established
system.
 Internal Audit.
 Take Corrective action.
 Another Internal Audit & conduct Management Review.
 Approach NABL.
PREPARING FOR NABL ACCREDITAION

 Nominate person responsible for coordinating all activities


related to seeking accreditation (QUALITY MANAGER).
 Obtain all the relevant NABL Brochures / Specific criteria
(NABL 100 , NABL 120, NABL 131 , NABL 151, NABL 163 etc )
 NABL Website [Link]
 Get fully acquainted with NABL requirements.
PREPARING FOR NABL ACCREDITAION

 Ascertain the status of its existing quality system and technical


competence with regards to requirements for NABL.
 Meeting essential prerequisite requirements of NABL.
 Successful participation in the proficiency testing program conducted by competent PT
Providers or any other international body - one parameters/ per discipline.
 At least one internal audit and a management review.
PREPARING FOR NABL ACCREDITAION

Some of the steps involved in establishing the QMS in laboratory


and that for obtaining NABL accreditation should normally run
concurrently.
NABL ACCREDITATION

VARIOUS STEPS INVOLVED


 Application to NABL (ONLINE)
 Acknowledgement and scrutiny by NABL Secretariat.
 Adequacy of Quality Manual.
 Pre-Assessment of Laboratory (Optional)
 Final Assessment of Laboratory.
NABL ACCREDITATION

VARIOUS STEPS INVOLVED (CONTD.)


 Scrutiny of Assessment Report.
 Recommendation for Accreditation.
 Approval for Accreditation.
 Issue of Accreditation Certificate.
 Scope of Accreditation.
Accreditation Procedure
30 Unique ID
days Application for accreditation by the laboratory no. XXXX
30 Feedback
days Acknowledgement & scrutiny by NABL Secretariat to
60 Laboratory
days Adequacy quality Manual
60
days Pre-assessment of the laboratory by Lead assessor And
Necessary
Final assessment of the laboratory by the assessment team
Corrective
Scrutiny of assessment report by NABL secretariat Action
by
Recommendation for accreditation by accreditation committee Laboratory
Certificate
Approval for accreditation by Chairman, NABL no. XXXX

Issue of NABL certificate by NABL

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