QCertify Global

  ISO 21500:2021 – Project, Programme, and Portfolio Management ISO 21500:2021  is a comprehensive framework designed to guide organizations in effectively managing projects, programmes, and portfolios. It provides  universal principles, processes, and terminology  that can be applied to projects of varying complexity across industries, enabling organizations to achieve strategic objectives through improved project management practices. https://qcertifyglobal.nl/ Key Features of ISO 21500:2021 Holistic Scope : Covers the management of  projects ,  programmes , and  portfolios , integrating them to align with organizational strategy. Universal Applicability : Adaptable to organizations of any size or type, regardless of the nature of their projects. Alignment with Strategic Goals : Focuses on linking project outcomes with broader organizational strategies to maximize value creation. Principles-Based Guidance : Outlines core principles for effective gove...

Medical devices | Application of risk management to medical devices is the most recent version of the international standard for managing risks associated with medical devices. It provides a comprehensive framework for identifying, evaluating, controlling, and monitoring risks throughout the lifecycle of a medical device, including design, production, and post-market activities. Key Features of ISO 14971:2019 Scope and Applicability Applies to all types of medical devices, including  in vitro diagnostic devices  and software as a medical device (SaMD). Encompasses risks to patients, users, caregivers, and others exposed to the device during its lifecycle. Core Risk Management Process Risk Analysis : Identify potential hazards related to the medical device. Analyze foreseeable sequences or situations that could result in harm. Risk Evaluation : Compare identified risks against risk acceptability criteria. Risk Control : Implement measures to reduce risks as far as possible. Ver...