Development, implementation and maintenance of quality management system ISO 13485

Advantages of the quality management system ISO 13485 implementation:

improving company image as declaring the policy of compliance with global standards and applying significant efforts to improve product quality;
sales growth as a result of increased buyers confidence and manufactured medical devices competitiveness;
additional preferences for participation in tenders and competitions;
reducing the cost of manufacturing medical products through a more efficient allocation of internal resources, clear distribution of employees responsibilities and authorities;
proper alignment of company business processes from production to the organization of the supply chain;
possibility of entering international markets.

Opportunity to ensure economic stability and great further development prospects for your company - these are your results of QMS ISO 13485 imlementation!

ISO 13485 is designed specifically for the medical industry and contains requirements affecting aspects of medical devices life cycle and related areas.

ISO 13485 is a stand-alone standard, it can be used separately or in conjunction with other management systems standards.

Our company offers full range of services in the field of development, implementation and maintenance of quality management system ISO 13485:

Advisory and methodological assistance in the development, implementation and improving of the QMS in accordance with the requirements of GOST ISO 13485, GOST ISO 14971, GOST ISO 9001, namely:

→ Development of the implementation programme;
→ Identification of the processes, elaboration of criteria, evaluation methods and processes interaction scheme;
→ Development of responsibility matrix;
→ Documents structure formation;
→ Development/examination of QMS documents (quality policy, quality manual and other required documented procedures);
→ Complete cycle of system operation.

Preparation of QMS for certification:

→ Pre-certification audit;
→ The choice of the certification body;
→ Preparation and submission of application to certification body.

Consulting and methodical assistance in implementing the requirements of the European Directives:

→ Preparation and submission of application to certification body.

As well as other services:

Quality management system audit;
Existing QMS maintaining and improving;
Existing business processes description and optimization;
Organization of specialized training workshops for development and implementation of the QMS teams, including the study of risk management and process validation.

For your information:

On March 01, 2016 new edition of ISO 13485:2016 is published. Implementation of it's requirements becomes mandatory in 2019.

ISO 13485:2016 sets out the requirements for quality management systems for companies whose activities are connected with any of medical devices life cycle stages:

design and development;
production, including the supply of raw materials or components;
warehousing, selling and shipping;
installation, putting into operation and maintenance;
recycling;
implementation of related services associated with the production, treatment or use of medical devices.