Courses

Objectives This course is to equip and prepare the participants on skills and knowledge to take on Risk Management and its Mitigation. It illustrates commonly used risk-identification and risk-reducing methods. Through examples, it shares practical applications implementing tools described by several of the recently enacted or updated standards. Through quizzes, and case studies, the instructor…

Objectives Upon completion of this course, learners are able to: Interpret and apply of ISO 9001:2015 Identify product/ service realisation cycle Apply of the QMS principles Apply appropriate work improvement activities for different customer segments Prepare for an internal audit with teams with an intended KPIs Assess compliance of QMS and provide constructive feedback Follow…

Objectives This program is designed to enable the participants to acquire the practical knowledge and skills in identifying the Documented Information (DI) necessary for ISO 9001:2015 that require documents / records control activities in the context of Annex SL with a view to maintain their Management Systems effectively. Duration 1 day | 9am – 5pm…

Objectives This CQI & IRCA training course provides participants with in-depth Quality Assurance knowledge and Auditing Know-how. Highlight the significant changes on the new 2015 standard as compared to the interpretation and application of the current Standard. Focus on the appreciation of The Seven Quality Management Principles, ISO 9001, ISO 19011 and ISO/IEC 17021 Standard…

Introduction Title 21: Food and Drug Part 820: Quality System Regulation Current Good Manufacturing Practice (cGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labelling, storage, installation, and servicing of all finished devices…

Objectives ISO 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. The functions & requirements of the ISO 13485:2016 Medical Devices standard. The understanding & implementing of the ISO 13485 Medical Devices standard…

OBJECTIVES This training course provides participants with an in-depth Quality Assurance knowledge and Auditing Know-how. 1. Focus on the appreciation of ISO 13485, ISO 19011 and ISO/IEC 17021-1 Standard requirements 2. Strengthen the foundation of audit methodology, skill & techniques to perform First Party & Second-Party Audits and draw audit conclusion based on audit findings….

Objectives To equip the participants with the basic knowledge and skills to interpret and to integrate the new requirements into their current Management System effectively. To enable the participants to conduct their internal audit in accordance with ISO 19011:2011 Guidelines. Duration 2 days | 9am – 5pm | 14 hours Who should attend This program…

Objectives To equip the participants with the basic knowledge and skills to interpret and to apply the requirements for enhancing Quality & Competence in Medical Laboratories. To enable the participants to conduct their internal audit based on ISO 15189:2022. Duration 2 days | 9am – 5pm | 14 hours Who should attend This program is…