ISO/IEC 17025:2017 Clause 4-8 Breakdown Table
Clause Requirement Description Auditor Questions Required Documents
4.1 Ensure impartiality in lab activities. How is impartiality ensured? Impartiality Policy, Declarations
4.2 Ensure confidentiality of information. How is confidentiality maintained? Confidentiality Policy, NDA
5.1 Lab must be a legal entity. Is the lab a legal entity? Company Registration
5.2 Define lab management Who manages the lab? Org Chart, Roles Document
responsibilities.
5.3 Define lab scope of activities. What is the lab's scope? Scope Document
5.4 Operate per ISO 17025. How does the lab ensure ISO Quality Policy, SOPs
compliance?
5.5 Define organizational structure. Can you show the org chart? Org Chart
5.6 Ensure authority for QMS Who is authorized for QMS? Authorized Signatory List
implementation.
5.7 Ensure communication of QMS. How is QMS communicated? QMS Communication Records
6.1 Ensure availability of resources. How are resources planned? Resource Plans
6.2 Ensure competent and impartial How is competence ensured? Training Records, Competence
personnel. Matrix
6.3 Control facilities and environment. How are facilities controlled? Environmental Monitoring
Records
6.4 Ensure equipment suitability and How is equipment maintained? Equipment List, Calibration
calibration. Records
6.5 Ensure metrological traceability. How is traceability ensured? Calibration Certificates
6.6 Control external services. How are providers evaluated? Approved Supplier List
7.1 Review requests and contracts. How do you review contracts? Contract Review Records
7.2 Select, verify, validate methods. How do you select and verify Method Validation Records
methods?
7.3 Plan and control sampling. Is there a sampling plan? Sampling Plan
7.4 Control handling of items. How are samples handled? Sample Logs
7.5 Maintain technical records. Can you show technical records? Technical Records
7.6 Evaluate measurement uncertainty. How is MU calculated? MU Procedure, Worksheets
7.7 Ensure validity of results. How is validity ensured? PT/ILC Records
7.8 Report results clearly. Can you show a report? Report Templates
7.9 Handle complaints. How are complaints handled? Complaint Records
7.10 Control nonconforming work. How is nonconforming work NC Records
handled?
7.11 Control data and information. How is data protected? Data Protection Policy
8.1 Choose management system option. Which option does the lab follow? Management System Overview
8.2 Establish system documentation. Can you show the QMS documents? Quality Policy, Objectives
8.3 Control documents. How are documents controlled? Document Control Procedure
8.4 Control records. How are records controlled? Record Control Procedure
8.5 Manage risks and opportunities. How are risks managed? Risk Register
8.6 Ensure continual improvement. How is improvement ensured? Improvement Logs
8.7 Implement corrective actions. How are corrective actions taken? CAPA Records
8.8 Conduct internal audits. Can you show audit records? Audit Reports
8.9 Conduct management reviews. Can you show management review Management Review Minutes
minutes?