Consultant, Medical Laboratory Accreditation (ISO15189) Programme
Job Description
Title: Consultant, Medical Laboratory Accreditation (ISO15189) Programme
Company Name: CS Lab Limited
Vacancy: --
Age: 25 to 50 years
Job Location: Dhaka
Salary: Negotiable
Experience:
Published: 2026-01-22
Application Deadline: 2026-02-21
Education:
- Bachelor of Science (BSc) in Biochemistry
- Bachelor of Science (BSc) in Microbiology
- Bachelor of Science (BSc) in Biomedical Engineering
- Bachelor of Medicine and Bachelor of Surgery(MBBS)
- Bachelor of Science (BSc) in Biotechnology
- Bachelor/Honors
Training & Certification in ISO 15189 is highly preferred.
Requirements:
Skills Required: Bio-Chemistry,Biotechnology,Clinical Laboratory,Clinical Pathology,Consultant,Medical Technology,Microbiology,Microsoft Office,Quality assurance and control,Reporting and Documentation
Additional Requirements:
- Age 25 to 50 years
Responsibilities & Context:
Key Responsibilities
Gap Analysis: Conduct a comprehensive audit of existing laboratory management systems against the ISO 15189:2022 requirements.
Documentation Development: Draft and refine the Quality Manual, Standard Operating Procedures (SOPs), and clinical governance frameworks.
Risk Management: Implement a robust clinical risk management program as per the new 2022 requirements, focusing on patient impact and diagnostic accuracy.
Technical Advisory: Provide guidance on measurement uncertainty, equipment calibration, and the validation/verification of examination procedures.
Training & Mentorship: Lead workshops for lab personnel on internal auditing, EQA (External Quality Assessment) interpretation, and the cultural shift toward quality-centric operations.
Documentation & Scopes
Documentation Architecture: Design and implement a four-tier documentation structure (Quality Manual, MSPs, SOPs, and Records) aligned with the ISO 15189:2022 restructuring.
Management System Procedures (MSP) Preparation:
Draft and standardize core MSPs including Risk Management (Clause 5.6), Impartiality & Confidentiality, Document Control, and Management Review.
Develop procedures for Actions to Address Risks and Opportunities to ensure clinical safety.
Standard Operating Procedure (SOP) Development:
Pre-Examination: Preparation of SOPs for patient identification, sample collection, transport, and receipt (aligned with ISO 20658).
Examination: Authoring technical SOPs for specific laboratory disciplines (e.g., Biochemistry, Hematology, Molecular), including detailed step-by-step analytical instructions.
Post-Examination: Developing SOPs for result reporting, clinical interpretation, and sample retention/disposal.
Document Control & Revision:
Manage the master list of all SOPs and MSPs.
Implement a rigorous review cycle to ensure all documents remain current with clinical guidelines and manufacturer updates.
Internal Audits: Plan and execute internal audits to ensure readiness for formal assessment by [Relevant Accreditation Body, e.g., CAP, NABL, UKAS].
Non-Conformance Management: Assist in identifying root causes for non-conformities and implementing effective corrective actions.
Job Other Benifits:
- Salary Review: Yearly
- Festival Bonus: 2
As per company policy.
Employment Status: Full Time
Job Work Place:
Company Information:
Gender: Male and Female can apply
Read Before Apply: Please apply only who are fulfilling all the requirements of this job
Category: Healthcare/Medical
