The medical sector is one of the key and sensitive sectors in terms of products quality. When we say quality then it can only be achieved when we know and have control over all processes which combine to make the life cycle of a product. The cycle where we plan, manufacture, store, ship, and deliver a product to the customer.
ISO 13485 provides a complete framework to develop a quality management system. Where an organization can ensure to produce and deliver quality products. The products which meet the customer requirements in terms of technical specifications.
This standard is especially for all those companies that deal in medical devices. No matter if the company is a manufacturing, trading or just a service provider. Furthermore, ISO 13485 applies to all these companies regardless of their size, type, and nature of business. ISO 13485 standard provides a complete set of guidelines to manage the activities covered under an overall operations management system.
ISO 13485 covers all key areas of a management system. Whether it’s defining the scope, controlling of documents/records, risk assessment of processes, role of top management, defining policies and objectives. Also managing internal/external communication, having competent workforce, knowing complete customer requirements, managing products quality, its handling, suppliers and after sales. This standard covers it all.
