History • Necessity recognized in an early stage as ENSI had grown fast • Build-up: Start in the mid nineties, 2 „Failures“ (Quality Handbooks developed by 1 person) • rd 3 attempt in 2000 with a process oriented approach and coached process teams • Certified according to ISO 9001 in 2001 • Laboratory accredited ISO 17025 in 2005 • Certified according to ISO 14001 in 2007 • Inspection body accredited ISO 17020 in 2015 Management System | IAEA Regulatory ...
Learning Objective To understand the requirements of QMS in Quality Control Laboratory and be able to implement same in a GMP environment and meet the quality objectives of the company. OUTLINE Definition of QMS Quality Management System Responsibility Resources Organization Personnel Accommodation Documentation Occurrence Management Self Audit Monitoring laboratory QMS Effective implementation of QMS in the laboratory Quality Management System Is the organizational structure,responsibilities,procedures ,processes, and resources for implementing quality management. Organizational structure Responsibilities Processes and Procedures - ...
From the From the National Serology Reference Laboratory, National Serology Reference Laboratory, Australia Australia 41 Victoria Parade, Fitzroy, Vic Australia 3065 41 Victoria Parade, Fitzroy, Vic Australia 3065 WHO Collaborating Centre on HIV/AIDS since 1985 WHO Collaborating Centre on HIV/AIDS since 1985 Roderick Chappel, Sandy Walker and Roderick Chappel, Sandy Walker and Roderick Chappel, Sandy Walker and Roderick Chappel, Sandy Walker and Elizabeth M. Dax Elizabeth M. Dax Elizabeth M. Dax Elizabeth M. Dax www.nrl.gov.au www.nrl ...
QUALITY CONTROL QUALITY CONTROL KEMRI-Wellcome Trust Research Programme 2 Learning Objectives At the end of this module, participants should be able to: Define quality control and describe its relationship to the overall quality management system. Describe differences in quantitative, qualitative, and semi-quantitative examinations. 3 Definition QC is examining “control” materials of known substances along with patient samples to monitor the accuracy and precision of the complete examination (analytic) process. 4 Internal Quality Control (IQC) refers to the set of ...
DOCUMENTATION Jean Paul Assam Assam, PhD Senior Lecturer (University of Yaounde 1, Cameroon) Learning Objectives At the end of this module, participants should be able to: Define Good Documentation Practice and purpose of Laboratory documentation as foundation of Quality Management System (QMS) Cite Essential documents required for QMS Know the document control process and the importance of master list Complete laboratory records in compliance with good documentation practice (GCP) guidance Understand the Compliance with documentation in audits Understand the format ...
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