4 Days Online ISO15189:2022 & Quality Management Training with Certification

Training Syllabus

Four live online sessions of three hours each (08:00 AM – 11:00 AM IST), 12 hours in all. The course starts from NABL's requirements and the standard's terms, then works through clauses 4 to 8 of ISO 15189:2022, so no prior knowledge of the standard is needed.

1. Day 1

   NABL awareness

   • Overview of NABL's instructions and assessment procedures
   • How the NABL application is filled in, and what it asks for
   • What compliance means in practice for an accredited medical laboratory

   You understand how NABL accreditation works before studying the standard itself.

2. Day 2

   Terms and definitions of ISO 15189:2022

   • The terminology specific to ISO 15189:2022, explained and clarified
   • The medical and quality definitions that matter for compliance
   • Using the standard's terms correctly in your documents and with assessors

   You can read the standard's clauses with a clear grasp of what each term means.

3. Day 3

   Clauses 4 to 6

   • Clause 4, general requirements: impartiality, confidentiality and requirements regarding patients
   • Clause 5, structural and governance requirements: the laboratory director, structure and authority, objectives, policies and risk management
   • Clause 6, resource requirements: personnel, facilities, equipment, calibration and metrological traceability, reagents and externally provided services
   • Practical insight into implementing these clauses in a laboratory

   You know what the general, structural and resource requirements ask of your lab.

4. Day 4

   Clauses 7 and 8, and practice test

   • Clause 7, process requirements: pre-examination, examination and post-examination processes, method verification and validation, IQC and EQA, nonconforming work and complaints
   • Clause 8, management system requirements: document and record control, risks and opportunities, corrective action, internal audits and management reviews
   • Review of the course, then a practice test to check your understanding

   You can relate every clause from 4 to 8 to everyday laboratory work, and you receive a certificate on completion.

Key Benefits

• The Latest ISO 15189:2022 Standard: Dive deep into the revised requirements of the international standard for medical laboratory quality and competence.
• NABL Accreditation Demystified: Learn the intricacies of the National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation process, preparing your laboratory for a successful audit.
• Building a Robust QMS: Master the principles of establishing and implementing a comprehensive Quality Management System tailored to your laboratory's specific needs.
• Standard Operating Procedures (SOPs) Creation and Management: Develop clear, concise, and effective SOPs to ensure consistency and quality in all laboratory processes.
• Document Control Fundamentals: Learn best practices for establishing and maintaining an efficient document control system, ensuring all documentation is accurate, up-to-date, and readily accessible.
• Internal Audit Techniques: Gain the skills and knowledge to conduct effective internal audits, identifying and addressing any potential nonconformities within your laboratory's QMS.