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.
A.Gap Analysis - Diagnostic Study of the existing processes & controls, Identification of Gaps with respect to ISO 17025:2017
B. Requirements and make demonstration of test Vs requirements to carryout micro level survey of the system.
C.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 implementation of project as listed below.
1. ISO awareness and Quality Policy 2. Internal ISO 17025:2017 auditor training 3. Uncertainty of measurement 4.Inhouse calibration methods 5. Documentation Training
D.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.
E.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.
F.Conducting Internal Audit and provide guidance for initiating corrective action for the reported audit findings.
G.Provide guidance for conducting Management Review in accordance with the requirements of the standards.
H.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
Following Phases are involved in actual implementation of ISO/IEC 17025 under Global Manager Group's consultancy.
1.Phase-1 Micro level survey, gap analysis and ISO 17025 training to all, Calibration advice, documentation and other training.
2. Phase-2 Offside document preparation (Implementation of gap analysis findings and change in system as per suggestions.
3.Phase-3 Implementation follow up, Internal auditor training, uncertainty, Calibration training and discussion on documentation. Apply to certifying.
4.Phase-4 1st internal audit as per ISO17025. Uncertainty measurement; Inter lab result analysis, 1st management review meeting.
5.Phase-5 Action on Adequacy audit report and witness testing for assessment agenda.
6.Phase-6 Mock audit and assess status of implementation and identify problems if any .
7.Phase-7 Final assessment by accreditation body.
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