Achieving ISO 15189:2022 accreditation is essential for medical laboratories to demonstrate competence and ensure quality management compliance. To simplify this process, Global Manager Group offers a comprehensive ISO 15189 Documentation Kit, providing all necessary documents required for seamless accreditation.
What is ISO 15189:2022?
ISO 15189:2022 is the latest edition of the medical laboratory accreditation standard, aligned with ISO/IEC 17025. It introduces significant updates, including a stronger emphasis on risk management and incorporating requirements for Point of Care Testing (POCT) previously covered under ISO 22870.
Content of the ISO 15189 Documentation Kit
The ISO 15189 documentation kit consists of editable files, making documentation efficient and hassle-free. Key inclusions:
- ISO 15189 Manual – Defines the implementation of the standard.
- Quality Procedures – Covering various departments for a structured approach.
- Standard Operating Procedures (SOPs) – Essential for collection, testing, and operational processes.
- Exhibits – Guidelines for effective implementation.
- Blank Forms & Templates – Ready-to-use formats for record-keeping.
- Job Descriptions – Sample templates to define roles and responsibilities.
- ISO 15189 Audit Checklist – Over 500 audit questions to assess compliance and improve efficiency.
- Risk Assessment and Opportunity Sheet – A structured approach to managing laboratory risks.
- ISO 15189:2022 Compliance Matrix – A reference guide for understanding documentation requirements.
Features of the Documentation Kit
- Easy to edit – Provided in MS Word format (.docx) for quick customization.
- User-friendly – Written in simple English for easy understanding and implementation.
- Time-saving – Reduces document preparation efforts significantly.
- Cost-effective – Provides value for money by minimizing documentation costs.
- Audit-ready – Ensures laboratories are well-prepared for accreditation audits.
How This Kit Benefits Medical Laboratories
- Helps laboratories achieve ISO 15189 accreditation efficiently.
- Assists ISO 15189 consultants in guiding laboratories with pre-prepared templates.
- Ensures compliance with risk-based approaches and quality requirements.
- Saves time, effort, and cost in document preparation and training staff.
Get Your ISO 15189 Documentation Kit Today
For a seamless and structured approach to ISO 15189 accreditation, leverage the comprehensive ISO 15189 documentation kit by Global Manager Group. This kit ensures compliance, enhances laboratory efficiency, and simplifies the documentation process.
For more details, visit: Global Manager Group - ISO 15189 Accreditation Documents
