PN-EN ISO 13485

Medical Products. Quality Management Systems. Requirements for regulatory purposes

The ISO 13485 international standard includes requirements referring to management system and is intended for organizations willing to evidence the ability to provide medical products and related services. The basic objective of the standard is to facilitate harmonizing the requirements of regulations concerning medical products with quality management systems.

The benefits resulting from ISO 13485 implementation and certification mostly quoted by organisations:

• increased prestige of company,
• strengthening of competitiveness of organization on the home and foreign market,
• reduced risk of appearing of a non-compliant product,
• limited number of claims,
• increased quality of services,
• increased confidence of clients,
• fulfilment of one of requirements of many tender specifications.

The ISO 13485 management system certification carried out by us is confirmed by both the PCBC certificate and the IQNET Association – The International Certification Network certificate recognized all over the world

The ISO 13485 standard is dedicated to organizations dealing with designing, production, confectioning and import of medical products. Sectors particularly interested in the ISO 13485 certification: Health and Medicine.