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ISO 17025 Implementation Planner

The document outlines an implementation plan for ISO 17025 in a Microbiology Lab, detailing steps, activities, and deliverables required for compliance. It includes management commitment, training, gap analysis, and various operational procedures necessary for accreditation. The plan also specifies responsible personnel and estimated time required for each activity.

Uploaded by

Talha Awan
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261 views2 pages

ISO 17025 Implementation Planner

The document outlines an implementation plan for ISO 17025 in a Microbiology Lab, detailing steps, activities, and deliverables required for compliance. It includes management commitment, training, gap analysis, and various operational procedures necessary for accreditation. The plan also specifies responsible personnel and estimated time required for each activity.

Uploaded by

Talha Awan
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLSX, PDF, TXT or read online on Scribd

ISO- 17025 Implementation plan on Microbiology Lab

Step Activity Deliverables


1.1 Management Commitment Policy letter, meeting minutes
1.2 Appoint ISO 17025 Implementation Team Team List
1.3 Awareness Training Training material, attendance
1.4 Gap Analysis Gap analysis report
1.5 Create Implementation Plan Action Plan/Gantt Chart
2.1 Impartiality & Confidentiality Policies, declaration forms
2.2 Organization Structure Org Chart, Job Descriptions
2.3 Personnel Competence Training matrix, records
2.4 Equipment Calibration Logbooks, calibration schedule
2.5 Environmental Monitoring Controlled condition SOPs
2.6 Review of Requests SOP, forms
2.7 Selection of Methods Validation protocols
2.8 Sampling Procedure Sampling plan & SOP
2.9 Handling of Test Items Sample handling SOPs
2.10 Equipment Verification Qualification reports
2.11 Measurement Uncertainty MU SOPs, tools
2.12 Ensuring Result Validity QC charts, SOP
2.13 Reporting Results Templates, approval flow
2.14 Complaints Handling Complaint log, SOP
2.15 Nonconforming Work NCR log, CAPA SOP
2.16 Control of Data LIMS/data integrity SOP
2.17 Management System Docs Quality Manual, procedures
3.1 SOP Implementation Acknowledgment forms
3.2 Conduct Internal Training Training records
3.3 Begin Record Keeping Controlled forms/records
3.4 Internal Audits Audit plan, checklist, reports
3.5 Management Review Meeting MRM minutes and plan
3.6 Corrective Actions CAPA log
4.1 Select Accreditation Body Application file
4.2 Apply for Assessment Submitted application
4.3 Pre-Assessment Audit (Optional) Report
4.4 Final Audit Audit plan, evidence
4.5 Close Audit NCs CAPA report
4.6 Receive Certificate ISO 17025 Certificate
Microbiology Lab
Responsible Time Required
Lab Head/QA 2 days
QA Head 1 day
QA/Trainer 1 week
QA 1 week
QA/Management 3 days
QA Manager 3 days
HR/QA 4 days
QA/HR 1 week
QA/Engineering 1 week
QA/Microbiologist 4 days
QA 3 days
Microbiologist 1 week
Microbiologist 3 days
Lab Staff 3 days
QA 1 week
QA/Statistician 1 week
Microbiologist 4 days
QA 3 days
QA 3 days
QA 3 days
IT/QA 4 days
QA 2 weeks
Lab Heads 2 weeks
QA/Trainer 2 weeks
All Departments Ongoing
QA/Internal Auditor 2 weeks
Top Management 1 week
QA 1 week
QA/Top Management 3 days
QA 1 week
External Consultant 1 week
Lab Team 2–3 days
QA 1–2 weeks
Accreditor N/A

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