Group of companies «AiLFARMA»

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An international industry standard developed by the International Organization for Standardization
The standard contains requirements for the quality management system of manufacturers of medical devices

Service Description

An international industry standard developed by the International Organization for Standardization. The standard contains requirements for the quality management system of manufacturers of medical devices. The requirements for the quality management system established in the standard are additional to the technical requirements for products. This type of standard is voluntary to apply.

MAIN BENEFITS FROM THE INTRODUCTION OF A QUALITY MANAGEMENT SYSTEM BASED ON ISO 13485:

• Organization of strategic and tactical planning;
• Distribution of responsibility and authority of personnel;
• Adaptation of the organization to changing market conditions;
• Constant monitoring of consumers (dealers, clinicians, etc.);
• Validation of all special production processes and reduction of associated risks;
• Traceability of information about a specific product or product batch, which allows you to quickly identify the source of possible failures
• Cost reduction through the use of a system of constant monitoring of defects and their causes; selection of optimal suppliers of raw materials and materials; selection of optimal sales channels and development of a marketing strategy;
• Quality control at all stages (intermediate and final);
• Structural organization of project activities, including the development of new products;
• Management of improvements;
• Increasing the competitiveness of products;
• Total risk management and continuous improvement of product safety.

With the help of the ISO 13485 certificate, the organization can obtain:

• additional improvement of your rating and image;
• assistance in obtaining the necessary permits;
• membership in various self-regulatory organizations and other professional associations;
• the opportunity to participate in tenders where the presence of a certificate is one of the conditions;
• the possibility of entering the international market;
• other benefits.

Stages:

1. Audit of regulatory documentation of the Customer`s management system.
2. Development of a package of documents (if necessary)
3. Issuance and registration of the certificate of conformity
4. Implementation (if needed)

Group of companies «AiLFARMA»

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