ISO/IEC 17025:2017 Implementation Kit | Lab Management System (Digital Download)

Build, document and run a management system for ISO/IEC 17025:2017 with one organized, editable kit: an implementation guide, a quality manual template, 18 SOPs, 43 Word forms, an 18-worksheet Excel workbook and 6 training resources. Written in plain language for testing, calibration and sampling laboratories in the US and around the world, including forensic, toxicology and drug testing, DNA, environmental and calibration laboratories.

**What you get**
- Implementation Guide (Word + printable PDF): structure of the standard, what changed from the 2005 edition, Option A or B, gap analysis method, roadmap from first steps to assessment, measurement uncertainty and decision rule examples, validity of results, audit and management review guidance and an assessment-readiness evidence list

- Quality Manual template (Word) with policy statements, governance fields and a document map to every SOP and form

- 18 SOPs as separate Word files, each with an approval page (prepared by, reviewed by, approved by laboratory management: name, signature, date), annual review and revision history

- 43 editable Word forms in 6 packs: documents and governance; risk, planning and gap analysis; personnel, facilities and equipment; traceability, suppliers and customers; methods, items and results; nonconformity, audit and management review

- 18-worksheet Excel workbook: gap analysis for 42 clause areas, risk register, methods register (verification, validation and uncertainty status), audit plan and findings, nonconformities and CAPA, complaints, equipment and calibration, competence and authorization, documents, suppliers and subcontractors, proficiency testing, measurement uncertainty, management review, dashboard and data checks

- 6 training resources: instructor guide, learner handbook, ten exercises, answer key, internal auditor practical assessments and an audit simulation

- Read Me First (Word + PDF) with setup steps and troubleshooting

**Built to be practical**
- Covers the clauses of ISO/IEC 17025:2017: general, structural, resource, process and management system requirements, including impartiality, metrological traceability, method verification and validation, sampling, technical records, validity of results, reporting and statements of conformity

- Excel flags overdue and due-soon items, calculates proficiency testing deviation and measurement uncertainty, tracks method status and shows gap analysis progress by chapter

- Example rows are fictional and clearly labeled; delete or overwrite them before real use

**Important notes**
- You need a copy of ISO/IEC 17025:2017 from ISO, IEC or your national standards body. This kit does not include or reproduce the standard; it uses its own wording and clause numbers only as a guide.

- No acceptance criteria, limits, intervals or retention periods are supplied. Your laboratory, customers, regulators and accreditation body set them. Values in examples and training are fictional.

- Laboratories are accredited by an accreditation body; this kit does not provide accreditation. Check current requirements, any amendments to the standard and the rules of your accreditation body. US clinical laboratories must still meet CLIA requirements.

- These are editable templates, not completed evidence. Purchase does not guarantee accreditation, compliance or assessment results, and this is not legal or regulatory advice.

- Independent resource, not affiliated with or endorsed by ISO, IEC, ILAC or any accreditation body.

**Files and requirements**
Microsoft Word and Excel (or compatible apps). Extract the zip before opening. Digital download only; nothing is shipped. Licensed for internal use by one laboratory or organization; no resale or redistribution.

**About LabCendence™ Regulatory Advisors**
LabCendence™ Regulatory Advisors creates practical regulatory and compliance tools for laboratories.

**AI disclosure:** Created by with AI-assisted design. Laboratory-specific review, customization and authorization are required.