ISO 15189:2022 Implementation Kit | Quality Manual, SOPs, Forms, Training (Digital Download)

Build, document and run a management system for ISO 15189:2022 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 laboratories in the US and around the world.

**What you get**
- Implementation Guide (Word + printable PDF): structure of the standard, what changed in the 2022 edition, gap analysis method, roadmap from first steps to assessment, measurement uncertainty basics, 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 director: 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; calibration, reagents and providers; examination and post-examination; nonconformity, audit and management review

- 18-worksheet Excel workbook: gap analysis for 45 clause areas, risk register, quality indicators, audit plan and findings, nonconformities and CAPA, complaints, equipment and calibration, competency, documents, suppliers, EQA, 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 chapters of ISO 15189:2022: general, structural and governance, resource, process and management system requirements, including risk management, point-of-care testing oversight, information management and continuity planning

- Excel flags overdue and due-soon items, calculates indicator status, EQA deviation and measurement uncertainty, 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 15189:2022 from ISO 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 targets, limits, intervals or retention periods are supplied. Your laboratory and director set them from applicable law, accreditation body requirements and clinical needs. Values in examples and training are fictional.

- ISO 15189 accreditation is voluntary in most settings and does not replace CLIA requirements for US laboratories. Check requirements and transition dates with your accreditation body.

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

- Independent resource, not affiliated with or endorsed by ISO, ILAC, CMS, CAP, COLA, the Joint Commission 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 clinical laboratories.

Laboratory-specific review, customization and authorization are required.