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Quality Management of Medical Devices – ISO 13485 Implementation Guide

September 27, 2023/

Introduction ⮯ ISO 13485:2016 is a quality management system specifically designed for medical devices and related services. It helps organizations to demonstrate their ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. Manufacturers of medical devices…

What is the ISO 13485 standard for medical devices?

September 26, 2023/

In the fast-paced and ever-evolving world of the medical device industry, ensuring the highest standards of quality is paramount. With patient safety at stake, it is crucial for companies operating in this sector to have robust quality management systems in place. This introduction will shed light on the importance of…

What is the role of ISO 22000:2018 Certification in ensuring the Safety of Food Products?

September 26, 2023/

The common concern shared by customers and food supply chain industries is related to the safety and quality of food products. Food safety is significant for public health and the reputation of food companies. Moreover, it is the responsibility of organisations to ensure the delivered food people are safe and…

Why ISO 22301 is Crucial for Business Continuity and Disaster Recovery

September 25, 2023/

What is ISO 22301:2019 Certification? ISO 22301:2019 is an international standard for Business Continuity Management (BCM). It is designed to help organizations protect their business operations from disruptions and ensure the continuity of services. The standard outlines the best practices for developing, implementing, operating, monitoring and maintaining a Business Continuity…

Achieving ISO 27701 Compliance: A Step-by-Step Journey

September 25, 2023/

We live in an increasingly data-driven world, where data privacy and security have become paramount concerns for organizations. Data collected and stored by the organization is an invaluable information asset. However, it is the responsibility of the organizations to safeguard vulnerable data of their clients and customers. Customers and regulatory…

ISO 22000 Food Safety Management Systems

September 22, 2023/

ISO 22000 is an international standard for food safety management systems, designed to ensure the safety of food products during production and distribution. It specifies the requirements for a food safety system that involves Hazard Analysis and Risk-based preventive controls (HACCP), as well as other aspects such as product traceability,…

The Roadmap to GMP Certification: Steps and Benefits

September 21, 2023/

Good Manufacturing Practices (GMP) accreditation has emerged as a critical benchmark for guaranteeing product safety, quality, and compliance in today’s highly regulated and quality-driven sectors. Organisations can outline the road plan to attain GMP certification and maintain high manufacturing standards. This article outlines the essential procedures for acquiring GMP certification…

The Cost of Non-Compliance: Why ISO 21001 Matters?

September 12, 2023/

ISO 21001:2018 certification is a globally recognised standard that signifies an educational organisation’s commitment to delivering high-quality education services. It focuses on establishing an effective Educational Organisation Management System (EOMS) that ensures the fulfilment of educational objectives, student satisfaction, and continuous improvement. The certification involves a rigorous audit by an accredited…

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