ISO/IEC 17025:2017 Gap Analysis Tool

Overview

This Gap Analysis Tool is designed for laboratories preparing for accreditation or transitioning to the 2017 version of the standard. It helps you systematically review each clause and determine if your current system meets the requirement.

How to Use

1. Review: Go through each item in the list.
2. Assess: Determine your current status:
   • Compliant: We do this and have evidence.
   • Partial: We do some of this, but it needs work.
   • Missing: We don’t do this at all.
3. Action Plan: For any “Partial” or “Missing” items, write down what needs to be done, who will do it, and by when.

Gap Analysis Table

Clause	Requirement Summary	Current Status	Action Required	Owner	Due Date
4.1	Impartiality: Risks identified? Commitment from top management?
4.2	Confidentiality: Policies in place? Staff agreements signed?
5.0	Structure: Legal entity defined? Org chart current? Key personnel appointed?
6.2	Personnel: Competence requirements defined? Training records up to date?
6.3	Facilities: Access controlled? Environmental conditions monitored?
6.4	Equipment: Master list complete? Calibration status known? Maintenance logs active?
6.5	Traceability: Calibrations traceable to SI/NMI?
6.6	Purchasing: Suppliers evaluated? Incoming supplies verified?
7.1	Review of Requests: Contracts reviewed before work begins?
7.2	Methods: SOPs available for all tests? Methods validated/verified?
7.7	QC: QC charts used? Proficiency testing participation?
7.10	Nonconforming Work: Procedure for halting work and RCA?
8.5	Risk: Risk register established?
8.8	Internal Audit: Audit schedule in place?
8.9	Management Review: Annual review conducted?

Next Steps

Once you have completed the gap analysis, prioritize the “Missing” items that are critical for the validity of your results. Use the Action Plan to drive your implementation project.