The enterprise-level effective operation of the QMS primarily depends on the training of the responsible specialists. First Complex Registration Company is ready to help you train the quality specialists within the framework of preparation for the inspection control of Roszdravnadzor or for a certification audit.
Pursuant to GOST ISO 13485-2017:
- Personnel responsible for quality control of the resulting products shall be competent, properly educated, trained, skilled and experienced
- An entity is responsible for documenting the processes that determine the competence of employees, training and informing of personnel
- An entity shall determine and maintain the necessary competence of its employees, ensure the training and education of its personnel, and keep records of education, experience and training of its personnel up to date.
Scope of Training of Quality Specialists
The specialist training includes the following questions:
1) The concept of quality and quality management system. General requirements: scope. Structure and terminology of the ISO 13485.
2) Documentation in accordance with the requirements of ISO 13485: structure, scope, management rules. Records. Technical file for products.
3) In-process approach: management of in-house and outsourced processes. Identification and classification of processes. Risk-oriented approach to processes. Model of the entity’s QMS processes. Description of QMS processes in maps. Types of process maps.
4) Management responsibility in ISO 13485. Quality policy. Pyramid of quality goals. Determination of responsibility and authority. Analysis of the management system by top management.
5) Human resources: personnel selection and assessment. Human resource development: planning, conducting and evaluating the efficient training activities. Infrastructure and production environment. Hygiene requirements.
6) Consumer in the quality management system of medical device manufacturers. Processes related to consumers. Satisfaction assessment.
7) Procurement. Supplier management. Supplier selection: initial assessment. Monitoring of supplier activities.
8) Design and development of new products/services. Formation of a package of Project documents. Implementation of production processes/service provision. Product purity and contamination control. Validation. Identification and traceability. Handling of consumer property. Ensuring product safety.
9) Management of monitoring and measurement tools. Measurement and analysis. Types of measurements. Control in the quality management system of medical device manufacturers. Organization of control of manufactured products/services. Internal audit (general provisions). Management of non-conforming products. Analysis tools.
10) Corrective and preventive actions.
11) Internal audit as implementation of most of QMS principles.
- The concept of audit. Basic terminology associated with auditing.
- Purposes of audit.
- Classification of types of audit.
- Methodological basis of audit.
- ISO 19011 and its structure. Principles of auditing.
- Auditor. The concept of competence, quality, knowledge and skills of an auditor. Responsibility, rights and obligations of auditors.
- The role of top management in the audit process.
- Audit process. Preparation stage. Drafting of an annual audit plan.
- Audit process. Performance stage. Introductory meeting, field analysis. Field audit techniques—methods and activities, examples of questions, interview techniques. Psychological aspects of audit.
- The concept of non-conformity. Assessment of non-conformities and their documentation.
- Audit process. Performance stage. Final meeting.
- Audit process. Report preparation stage. Requirements for audit reports.
- Audit process. Analysis phase and corrective actions.
12) Requirements for risk management of medical devices based on ISO 14971 and ISO/TR 24971, and recommendations for the practical application of these requirements.
13) Planning of QMS implementation and development of a schedule for standard requirements implementation.
14) Certification procedure. Certification body selection.
15) Inspection of the enterprise’s quality management system in accordance with the requirements contained in Resolution No. 106 of November 10, 2017 of the Eurasian Economic Commission Council.
First Complex Registration Company can train the quality specialists, and not only conduct an audit of your enterprise’s QMS and prepare all the necessary documentation. We cooperate with organizations licensed for educational activities and entitled to issue certificates of advanced training.
Therefore, if you contact us, you will have your enterprise prepared for inspection control by Roszdravnadzor or certification audit on turnkey basis, saving your time and money.