ISO 13485 Medical devices. Quŕlity management systems. Requirements for the purposes of regulations
BDS EN ISO 13485:2016 scope:
ISO 13485 is an international standard that sets specific requirements for the quality mŕnagement systems of organizations that manufacture medical devices and related services. The standard complements the technical requirements of the products. Such a quality management system is applicable to organizations that:
- design, develop, manufacture, store, distribute and install medical devices;
- provide services related to medical devices.
ISO 13485 is designed for:
- medical devices manufacturers;
- organizations providing products or services related to medical devices (such as importers, distributors, agents, medical device designers, etc.);
- certification bodies that assess the conformity of the implemented quality management system according to the requirements of ISO 13485.
Benefits of implementing a quality management system according to ISO 13485:
- Increasing customer satisfaction – through the ability to continuously provide products/services that meet customer requirements and applicable regulatory requirements;
- Reduction of current costs – by continuous improvement of processes and increase their efficiency;
- Legality – ensuring compliance with regulatory requirements and reducing/minimizing the risk of regulatory violations;
- Increasing the image and competitiveness – through a proven commitment to quality, namely the introduction of a quality management system according to an internationally recognized standard and its certification;
- Access to markets that require certification – by obtaining an official certificate;
- Increasing the trust in the provided products/services by the interested parties (customers, suppliers, regulatory/control bodies and employees) – through a transparent and objective process of reviewing complaints, withdrawals of products from the market, etc.;
- Upgrading management system – by implementation of ISO 13485 or be integration with other international standards – ISO 9001; ISO 14001, ISO 45001, etc.;
An organization with an implemented and certified quality management system according to ISO 13485 is an important unit of the national quality infrastructure.
ISO 13485 Medical devices. Quŕlity management systems. Requirements for the purposes of regulations
Implementation of management standards
CONSEJO EOOD is a consulting company formed by a team of consultants with over 15 years of experience in management systems in the field of international standards. The focus of the company is the provision of consulting services in the development and implementation of management systems that meet the requirements of international standards for quality, the environment, safe working conditions, information security, good production practices based on international standards: ISO 9001, ISO 14001, ISO 45001, ISO 22000, ISO 27001, IFS Food, HACCP and others.
The CONSEHO team has participated in the realization of projects in all branches of the economy. The projects implemented by the CONSEHO team are over 1000, in the fields of production and design, construction, trade, information and communication technologies, transport and forwarding, hotel and restaurant industry, special production, energy, design, food industry, services, etc. The company has established a strict procedure for monitoring the compliance with the agreed requirements with the clients, both the terms of the contracts and the quality of service performance. The established working style of the company consists of developing real management systems together with our customers, on the basis of conducting multiple trainings and providing full assistance in the implementation process. Through its approach to work, CONSECO ensures and guarantees trouble-free certification of the built systems in extremely short terms.
