ISO Standards

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…

Introduction We have entered a chaotic period in our evolution, where almost every country and business in the world is in a process of re-defining itself in a rapidly changing environment. Business continuity is the capability of the organisation to sustain delivery of products or services at acceptable predefined levels following a disruptive incident. Business…

Introduction Risks affecting organisations can have consequences in terms of economic performance and professional reputation, as well as environmental, safety and societal outcomes. Therefore, managing risk effectively helps organisations to perform well in an environment full of uncertainty. ISO 31000:2018, Risk management – Guidelines, provides principles, framework and a process for managing risk. It can…

Introduction OHSAS 18001 was created via the concerted effort from a number of the world’s leading national standards bodies, certification bodies, and specialist consultancies. A main driver for this was to try to remove confusion in the workplace from the proliferation of certifiable OH&S specifications. The OHSAS ISO45001:2018 specification gives requirements for an occupational health…

Objectives This course is designed for anyone who wishes to learn and know more about the ISO 9001:2015 Quality Management System which includes the standard requirements and to equip participants with the skills and knowledge on the audit methodology for the ISO Quality Management System. Trainer This course is conducted by registered lead auditors with…

Objectives To equip the participants with the basic knowledge and skills to interpret and to integrate the new requirements into their current Quality Systems effectively. To introduce the application of Risk-based Thinking in establishing QMS. To enable the participants to understand the application of Measurement Uncertainty (MU) in the context of a Calibration System and…