ISO 17025:2017 Accreditation Process Followed by Global Manager Group

Following are the list of process followed by world’s leading ISO 17025 accreditation consultant – Global Manager Group, in actual implementation of ISO/IEC 17025 under Global Manager Group’s consultancy.

• Gap Analysis – Diagnostic Study of the existing processes & controls, Identification of Gaps with respect to ISO 17025:2017
•  Requirements and make demonstration of test Vs requirements to carryout micro level survey of the system.
• Training – Providing training on QMS awareness, QMS Documentation, and QMS Internal Auditing to identified core team personnel or cross-functional Team (CFT). Provide 5 types of training during the implementation of the project as listed below.
  • ISO awareness and Quality Policy
  • Internal ISO 17025:2017 auditor training
  • Uncertainty of measurement
  • Inhouse calibration methods  
  • Documentation Training
• Documentation of ISO 17025:2017 – Providing templates and necessary guidance in the preparation of documentation as required by the standards and to fulfill the organizational requirements in respect of implementing and maintaining an effective QUALITY Management System.
• Implementation of documented QMS – Providing guidance in implementing the system and queries for calibration, software validation, method validation, technical training as well as provide software for calculation of uncertainty of measurement.
• Conducting Internal Audit and provide guidance for initiating corrective action for the reported audit findings.
• Provide guidance for conducting Management Review in accordance with the requirements of the standards.
• Certification Audit: Provide guidance for initiating corrective action for the external audit (Initial visit and Certification audit) findings reported by the certifying body are reviewed and suggestions are given to implement the corrective actions to close the findings

Deliverables of the Laboratory

• Appoint Quality Manager and technical Manager and deputy to them
• Providing necessary inputs during gap analysis i.e. existing documented Process / legal documents etc.
• Approval of QMS Scope, Policy, Objectives
• Selection of participants for the training programs and availability of team for the same. Implement all gap analysis points
• ISO 17025:2017 documents; review of their adequacy; Finalization and release
• Support Quality Manager & core group during developing, implementation and maintenance of QMS
• To qualify as internal auditors & Conduct one round of internal audit.
• Report system audit findings to Quality Leader, and to Take Corrective and Preventive Actions as per Internal Audit Report
• To conduct Management review meeting
• Closing of CARs after Final Certification Audit.

Phase wise Steps for ISO 17025 Accreditation

The following Phases are involved in actual implementation of ISO/IEC 17025 under Global Manager Group’s consultancy.

• Phase-1 Micro level survey, gap analysis, and ISO 17025 training to all, Calibration advice, documentation, and other training.
• Phase-2 Offside document preparation (Implementation of gap analysis findings and change in system as per suggestions.
• Phase-3 Implementation follow up, Internal auditor training, uncertainty, Calibration training and discussion on documentation. Apply to certifying.
• Phase-4 1^st internal audit as per ISO17025. Uncertainty measurement; Inter lab result analysis, 1^st management review meeting.
• Phase-5 Action on Adequacy audit report and witness testing for assessment agenda.
• Phase-6 Mock audit and assess status of implementation and identify problems, if any.
• Phase-7 Final assessment by accreditation body.

What does ISO 17025:2017 require for laboratory measurement equipment and related procedures?

How can ISO 17025 help improve laboratory measurements? Present industry research and development depends heavily on precise measuring. To be able to meet that requirement, modern laboratories must use high-quality measuring equipment. Also, to obtain the correct measurement result, the laboratory must employ an organized approach in the measurement process.

The process approach to this topic clearly highlights the large number of activities that could influence a measurement result. For any test you wish to be accredited for, the starting point is to map the processes and activities related to the measurement test. Then, look at the risks and determine which controls should be put in place.

• Management of personnel competency
• Document control of procedures
• Effective technical records
• Suitable facilities and conditions
• Suitable calibrated equipment
• Certified reference materials
• Suitable reagents
• Suitable test method
• Validated methods
• Correct handling of samples

As the requirements of the ISO 17025:2017 standard state that laboratories must demonstrate their competence, practical work requires the proper use of laboratory equipment and commits to following controlled ISO 17025 procedures.

Laboratory equipment – Procedures and usage

The main tools for work in a laboratory are known as laboratory equipment. Laboratory equipment may include the main measurement instruments, measurement software, auxiliary measurement modules and equipment, reagents, consumables, and certified reference materials needed for the correct performance of the measurement procedure.

Not all measurement equipment ensures success in the laboratory. The laboratory must provide proof that it uses uniquely identified and calibrated equipment, that this equipment is in the correct state and that it is regularly tested and maintained and, of course, that it provides skilled personnel to operate that equipment.

Valid use of laboratory equipment is influenced by the place where the measurement is performed. Measurement can be done on the laboratory premises, where environmental conditions are controlled and it is easier to maintain repeatability for any consecutive measurement. But, in some cases, measurements must be performed onsite, where environmental conditions vary and may influence the validity of the measurement.