ISO 15189 Documents – Ready-to-use templates
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The ISO 15189 documentation kit with ready-to-use templates is offered by documentationconsultancy.com. The ISO 15189:2022 Documentation Toolkit for the accreditation of medical laboratories meets the most recent standard requirements, which is a set of ready-to-use templates designed as per the latest version of standard requirements. The Ready-to-use ISO 15189:2022 documents for medical laboratories cover sample copies of the 15189 manual, ISO 15189 procedures, standard operating procedures, blank and filled formats, as well as ready-to-use ISO 15189 audit checklists, etc., drafted and endorsed to ensure effective accreditation. To know more, visit here: https://www.documentationconsultancy.com/iso-15189-documents.html
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ISO 15189 Documents – Ready-to-use templates
- 3. What is ISO 15189:2022 Documentation? The ISO/IEC 15189:2022 is a standard for the accreditation of medical and clinical laboratories. Complete revisions were made to the ISO 15189:2022 standard version to bring it into compliance with the ISO/IEC 17025 standard.
- 4. ISO 15189:2022 Documentation Requirements • Quality Manual • Quality Procedures • Exhibits • Standard Operating Procedures • Blank Formats / Templates • Job Description • ISO 15189:2022 Audit Checklists
- 5. Quality Manual • It covers a sample copy of the quality manual for ISO 15189:2022 standard. It describes how all requirements of ISO 15189:2022 standard requirements. It covers a list of procedures as well as an overview of the organization and covers tier 1 of ISO 15189:2022 documents. Some of the Manuals are listed below. • 4.0 General Requirements • 5.0 Structural and Governance Requirements • 6.0 Resource Requirements • 7.0 Process Requirements • 8.0 Management System Requirements
- 6. Quality Procedures • Sample copies of mandatory quality procedures as per ISO 15189:2022 are provided, which cover all the details like purpose, scope, responsibility, how the procedure is followed as well as the list of exhibits, reference documents and formats. The list of sample procedures provided in the kit is given below. • Procedure for maintaining impartiality • Procedure for personnel and training • Procedure for Equipment • Procedure for equipment calibration • Procedure for sample receipt List of Quality Procedures • Procedure for verification of examination method • Procedure for reporting the results • Procedure for control of documents • Procedure for control of records
- 7. • It covers Skill requirements, Codification system, Calibration periodicity, Secrecy rules, Recommended conditions for sample collection, transport and storage for conventional cytogenetic analysis, Minimum retention period for identified records, Impartiality policy, Patient’s rights etc. • Calibration periodicity • Secrecy rules • Recommended conditions for sample collection, transport and storage for conventional cytogenetic analysis • Patient’s right List of Exhibits • Skill requirements • Codification system • The minimum retention period for identified records • Impartiality policy Exhibits
- 8. Standard Operation Procedures • It covers a sample standard operating procedures covering all the specific practice areas and provides details for the operation of the training organization. List of SOPs • SOP for Collection and transportation of sample • SOP for Specimen acceptance & rejection criteria • SOP for Treatment and disposal of biomedical waste • SOP for Housekeeping • SOP for Use of PPE and personal safety • SOP for Examination by lateral flow method • SOP for Examination of COVID–19 by CT Value
- 9. • It covers sample copy of blank forms required to maintain records as well as establish control and make system in the organization. The samples given are as a guide and not compulsory to follow and organization is free to change the same to suit own requirements. • Sample collection register • Sample disposal register • Customer feedback form • Complaint report • Equipment history card • Audit Plan / Schedule List of Blank Formats • Method verification report • Goods inward register • Gate pass • Change Note • Corrective action report • Quality objectives Blank Sample Formats
- 10. • Sample copies of job description as per ISO 15189:2022 are provided. The list of sample job description provided in the kit is given below. Job Description List of Job Description • Job description for Director • Job description for Quality Manager • Job description for Technical Manager • Job description for Lab Technicians / Microbiologist • Job description for Sampling Technicians • Job description for Receptionist
- 11. How This Documentation is Useful? • The user’s ISO 15189 consultant can modify readymade templates as per their working system and they can create their own documents for quick accreditation. • Procedures and formats provided in the documentation kit can help in fine- tuning the processes and establishing better control over the management system. • An audit checklist for ISO 15189 accreditation is given with more than 500 internal audit questions, which is useful to train all the employees for an accreditation audit.
- 12. Features of Documentation kit • The kit contains all necessary documents as listed and complies with the requirements of system standards. • The ISO 15189 documents are written in easy-to-understand English language. • This kit will save much time in typing and preparing your documents on your own. • The kit is user-friendly to adopt and easy to learn. • The contents of this kit are developed under the guidance of experienced experts.