QMS Audit

According to the rules for registration of medical devices in the Eurasian Economic Union (EAEU), the established quality management system (QMS) meeting the criteria of GOST ISO 13485 at an enterprise becomes mandatory for manufacturers of medical devices of risk classes 2a sterile, 2b and 3, and recommended for manufacturers of medical devices of risk classes 1 and 2a non-sterile.

A quality management system is a set of organizational structure, processes, methods and resources needed to ensure stable quality of manufactured products. It is designed to continuously improve the quality of work, to increase the competitiveness of an enterprise in the national and world markets.

Audit is one of the most important procedures both in implementing and maintaining a QMS.

A regulatory compliance audit is a review of a quality management system with a view to assess its compliance with regulatory requirements.

The audit can be internal or external (conducted by a second or third party).

Internal audit is conducted by an organization itself.

External second-party audit is conducted by parties interested in the entity's business, e.g., customers.

External third-party audits are conducted by an external independent entity that provides certification services or is a government body.

First Complex Registration Company provides a service of audit of an enterprise’s quality management system in order to assess its compliance with the requirements of GOST ISO 13485.

This service will help you in the following situations:

• When it is planned to implement a QMS, but it is not clear what state the enterprise management is in (diagnostic audit)
• When the QMS has been implemented at an enterprise and its initial certification or re-certification is pending (pre-certification audit)
• When the QMS has been implemented at an enterprise and an inspection by Roszdravnadzor is pending (pre-inspection audit).

Goals and Objectives of Audit:

1. To ensure compliance of the QMS with the requirements of GOST ISO 13485
2. To give confidence to the management
3. To give confidence to the consumers
4. To track the functioning of business processes
5. To provide feedback for corrective actions.

Audit program and duration depend on:

• Size of an entity (staff number, number of production sites)
• Type and nature of an entity
• Volume and type of activities
• Available outsourcing/subcontracting policy.

Main Principles of Work of Our Auditors:

• Objectivity
• Confidentiality
• Independence
• Evidence-based approach
• Risk-oriented approach.

Audit process includes:

1. Establishment of contact with an entity being audited.
2. Preparation for the audit.

   2.1. Analysis of documented information.

   2.2. Audit planning.

   2.3. Preparation of working documents.

3. Audit conduct.

   3.1. Opening meeting.

   3.2. Exchange of information during the audit.

   3.3. Collection and verification of information.

   3.4. Analysis of information during the audit.

   3.5. Formation of audit conclusions.

   3.6. Preparation of audit reports.

   3.7. Final meeting.

4. Preparation and distribution of an audit report containing the results of observations, audit findings, conclusions about compliance / non-compliance with the requirements.