SOP On Qualification procedure for External Calibrating Agency

SOP On Qualification procedure for External Calibrating Agency

Objective : To lay down a procedure for qualification of external calibrating agency.

Scope : This Standard Operating Procedure is applicable for qualification of external calibrating agency, for instruments /equipment for which in-house calibration facility is not available.

Responsibility : Heads of Engineering, Quality Control and Quality Assurance departments or their designee shall be responsible for assessing and approving the external calibrating agency as per procedure mentioned in this SOP.

Head, QA or his designee shall authorize the external calibrating agency.

Procedure :

Head, QA or his/her designee in consultation with Head Engineering shall initiate qualification of external calibrating agency by sending “Questionnaire for Evaluation of Calibrating Agency” to the prospective agency/laboratory.

Head, QA or his/her designee after receiving the filled questionnaire shall evaluate and assess the need of the site audit of the external calibration agency. The site audit, if required, shall be planned along with Head, Engineering and QC or their designee.

In case of audit, the external calibrating agency shall be informed in advance.

On the basis of audit’s findings and/or Questionnaire for Evaluation of Calibrating Agency, Head QA shall decide the approval of calibrating agency.

Respective heads of Engineering, QC and QA shall finally be responsible for approval for external calibrating agency.

If calibrating agency qualifies, then Head, QA shall intimate the concerned person from Intellectual Property Rights and Legal Affairs Department for preparation of written contract with external calibrating agency if applicable.

Intellectual Property Rights and Legal Affairs department shall provide a copy of written contract to QA.

Master copy of “Certification – Qualification of External Calibrating Agency” shall be maintained at QA and a copy shall be provided to QC and Engineering for their record.

CONTRACT FOR CALIBRATION SERVICES

BY AND BETWEEN

M/s _____________________________________

AND

M/s Electronics Test and Development Center, Standardization Testing and Quality Certification Directorate, Govt. of India, Ministry of Communication and Information Technology, B-108, Phase VIII, Indl. Area Mohali – 160017, who hereby declare that none of us is/are not related to any Director, of “Company name_____________________”. In which any of us or relative is a Director/Proprietor/Partner, member or firm in which such director or relative of such Director is a partner/proprietor in any way whatsoever.

1. Scope of Agreement

It includes the following services:

1. ETDC, Mohali shall carry out the calibration of process control devices, viz. Digital Temperature Indicator and Controller, Temperature Sensors Gauges, Weighing Balance, Weight Box, Incubators, Pressure and Vacuum Gauges, Portable pH meters, Bench type pH sensors etc., as required by Company Name.
2. ETDC, Mohali shall carry out the calibration as per the Master Calibration Plan. The calibration schedule of equipments and instruments shall be intimated to ETDC, Mohali by Company Name.
3. Calibration shall be carried out strictly as per standard written calibration procedures before implementing it.
4. Calibration shall be carried out strictly as per standard written calibration procedure of ETDC, Mohali.
5. ETDC Mohali shall notify any change in the standard, equipments and procedures before implementing it.
6. Supporting documents to master calibrators shall be made available by ETDC, Mohali.

Information including: Data, know-how, formulae process, design specification, samples, photographs, sketches, results of experimental reports and any evaluation derived from there shall be provided by ETDC, Mohali.

2. Validity

The Term of this Contract shall be for year commencing from 01.12.2025 and terminating on 01.12.2026.

Either party can terminate the Contract by giving 30 days notice served on the above addresses of the parties.

The rates changes per item shall be communicated by ETDC, Mohali to Company Name.

Signed on behalf of:

Company Name and address with seal