ISO/IEC 17025 Accreditation Procedure

APPLICATION FOR ACCREDITATION

The laboratory shall apply to THE ACCREDITATION MEMBER BODY in the prescribed application form (THE ACCREDITATION MEMBER BODY 151 or/ and THE ACCREDITATION MEMBER BODY 152), in five copies along with five copies of the laboratory's quality manual that describes the quality system in accordance with ISO/ IEC 17025: 2005. The application shall be accompanied with the prescribed application fee as detailed in the application form. Laboratory has to take special care in filling the scope of accreditation for which the laboratory wishes to apply.

ACKNOWLEDGEMENT AND SCRUTINY OF APPLICATION

THE ACCREDITATION MEMBER BODY Secretariat on receipt of application forms, the quality manual and the fees shall issue an acknowledgement to the laboratory. After scrutiny of application for its completeness in all respects, a unique customer registration number shall be allocated to the laboratory, which shall be used for correspondence with the laboratory.

ADEQUACY OF QUALITY MANUAL

The preliminary scrutiny of the application and quality manual is done by THE ACCREDITATION MEMBER BODY Secretariat. The Secretariat may ask for additional information/ clarification(s), if found necessary. If there are gross inadequacies, the quality manual will be returned to the laboratory for re-writing. If this is seen to be generally in order, a copy of the quality manual along with a copy of the application of the laboratory shall be forwarded to the lead assessor to study in depth and verify the compliance in accordance with ISO/ IEC 17025: 2005 and relevant specific criteria. The lead assessor shall submit a report to THE ACCREDITATION MEMBER BODY indicating inadequacies (if any) in the quality manual.

PRE-ASSESSMENT

In case there are no inadequacies in the quality manual or after satisfactory corrective action by the laboratory, a pre-assessment visit of the laboratory shall be organised by THE ACCREDITATION MEMBER BODY. Laboratories must ensure their preparedness by carrying out its internal audit and a management review before the pre-assessment.

The Pre-assessment of the laboratory is conducted to:
* Have a better understanding of the documentation;
* Familiarise with the facilities, sites/ location, circumstances and to have better knowledge of operations;
* Make the methodology to be adopted for the assessment;
* Check the preparedness of the laboratory to undergo assessment;

Review the scope of accreditation and to ascertain the requirement of the number of assessors/ experts and the duration of assessment

The lead assessor shall submit a pre-assessment report to THE ACCREDITATION MEMBER BODY Secretariat with a copy to the laboratory within 10 days of completion of pre-assessment. The laboratory shall comply with the inadequacies of the documented quality system and its implementation and submit a corrective action report to THE ACCREDITATION MEMBER BODY Secretariat.

ASSESSMENT

After the laboratory confirms removal of inadequacies, THE ACCREDITATION MEMBER BODY shall propose constitution of an assessment team. The team shall include the lead assessor (already appointed), the assessor(s)/ technical expert(s) in order to cover various disciplines within the scope of accreditation sought. Thereafter THE ACCREDITATION MEMBER BODY shall fix up dates for on-site assessment of the laboratory in consultation with the laboratory, the lead assessor and assessor(s).

The assessment team reviews the laboratory's documented quality system and verifies its compliance with the requirements of ISO/ IEC 17025: 2005 and specific criteria. The documented quality system, SOPs, work instructions, test methods etc. are assessed for its implementation and effectiveness. The laboratory's technical competence to perform specific tests / calibrations is also adjudged. The non-compliances, if identified are reported in the assessment report.

The assessment report shall contain the evaluation of technical manpower, all relevant material examined, test witnessed; compliance to ISO/ IEC 17025: 2005 & relevant specific criteria and the non-conformances, if any.

It shall also provide a recommendation towards grant of accreditation or otherwise. The assessment report is prepared by the lead assessor, in the formats prescribed in THE ACCREDITATION MEMBER BODY 215. The details of the non-conformances observed during the assessment, is handed over to the laboratory by the Lead Assessor and the detailed assessment report is sent to THE ACCREDITATION MEMBER BODY.

SCRUTINY OF ASSESSMENT REPORT

The assessment report shall be examined by THE ACCREDITATION MEMBER BODY, who shall communicate the outcome of the assessment to the laboratory and shall ensure that the non-conformances raised by the assessment team, which were not closed during the assessment, are well understood by the laboratory.

Laboratory shall take necessary corrective action on the remaining non-conformance(s)/ other concerns and shall submit a report to THE ACCREDITATION MEMBER BODY Secretariat within a maximum period of 3 months. THE ACCREDITATION MEMBER BODY shall monitor the progress of closing of non-conformances. When there are significant non-conformance(s) identified during the on-site assessment, THE ACCREDITATION MEMBER BODY may arrange for a verification visit for the closure of the non-conformance(s).

ACCREDITATION COMMITTEE

After satisfactory corrective action by the laboratory, the Accreditation Committee examines the assessment report, additional information received from the laboratory and the consequent verifications.

In case the Accreditation Committee finds deficiencies in the assessment report to arrive at the decision, the Secretariat obtains clarification from the Lead Assessor/ Assessor/ Laboratory concerned. In case everything is in order, the Accreditation Committee shall make appropriate recommendations regarding accreditation of a laboratory to the Chairman, THE ACCREDITATION MEMBER BODY.

ISSUE OF ACCREDITATION CERTIFICATE

When the recommendation results in the grant of accreditation, THE ACCREDITATION MEMBER BODY shall issue an accreditation certificate which shall have unique number, discipline, date of validity alongwith the scope of accreditation.

The accreditation certificate on testing laboratories shall define field of test, materials/ products tested, specific tests performed, specification/ standard method or technique used, range of testing/ limit of detection and accuracy.

The accreditation certificate on calibration laboratories shall define the calibration field, product/ item calibrated, range of measurement, best measurement capability and measurement/ calibration equipment used.

The applicant laboratory must make all payments due to THE ACCREDITATION MEMBER BODY, before the certificate(s) is/ are issued to the laboratory.

All decisions taken by THE ACCREDITATION MEMBER BODY regarding grant of accreditation shall be open to appeal by the laboratory, to Chairman THE ACCREDITATION MEMBER BODY.

SURVEILLANCE AND RE-ASSESSMENT

Accreditation to a laboratory shall be valid for a period of three years. THE ACCREDITATION MEMBER BODY shall conduct and annual surveillance of the accredited laboratories. The laboratories may enhance and reduce the scope of accreditation during Surveillance.

The laboratories may apply for renewal of accreditation, atleast six months before the expiry of validity of accreditation for which a Re-assessment shall be conducted.

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