ISO 13485 Trainings

Management Representative and Internal Auditor of the Quality Management System for medical devices

Comprehensive training to prepare for the implementation and auditing of a quality management system compliant with the ISO 13485 standard. The training gives the authority to act as a QMS Management representative and Internal Auditor. A detailed discussion of the requirements of the ISO 13485 standard allows participation in the training even for people who are just starting their adventure with ISO. It will also be a great reminder and broadening of knowledge for people already working with QMS.

Time:

2 days

 Participant profile:

  • Executives, middle and senior managers

Training schedule:

DAY 1: Fundamentals of Quality Management System according to PN-EN ISO 13485:2016

  • Requirements for quality management system acc to ISO 13485 – general requirements
  • Linking of ISO 13485 with medical directives: AIMD, MDD, IVDD
  • Detailed discussion of documents and records requirements
  • Management commitment and its role in QMS operation
  • Resource management
  • Product realization
  • Design and development in relation to the standard
  • Control of monitoring and measuring equipment
  • Measurement, analysis and improvement

DAY 1 continued.: Management Representative of Quality Management System according to PN-EN ISO 13485:2016

  • Definitions of quality, process and how to achieve total quality
  • Basics of quality – Shewhart’s cycle and Deming’s cycle
  • Definition of medical devices quality
  • Method of standard markings
  • Terminology according to ISO 9000, ISO 13485
  • Defining the process of ISO 13485 system
  • Quality control
  • Designing the control system for ISO 13485
  • Quality assurance
  • Identification of medical devices class and directives which concern this product
  • Designing of device control, monitoring of the device during lifetime, medical incidents management.
  • Quality management
  • Designing of quality management system

DAY 2: Internal auditor of Quality Management System according to PN-EN ISO 13485:2016

  • Fundamental definitions of audit, nonconformities, post-audit actions
  • PDCA cycle applied to planning audit
  • Audit process
  • Audit notification: who prepare, for what and who concerns?
  • Opening meeting process
  • Auditing – How to correctly check compliance with the requirements of the standard?
  • Nonconforming products identification, audit report and non-compliance cards
  • Post-audit actions – planning, realization, efficiency check
  • Exam

Cost:

  • 600 €/person net – onside training
  • 450 €/person net – online training

 

Trainers:

Our trainers have many years of practical experience in implementing, auditing and developing quality management systems in many industries.
Most of our trainers have the authorization of the Leading Auditor of the Quality Management System allowing to carry out certification audits on the part of the certification body.

Advantages:

  • participation in training in a small group
  • entitlements to perform the function: Management Representative for QMS (Management Representative for ISO 13485, Management Representative for the Quality of Medical Devices) and Internal Auditor of the Quality Management System in accordance with ISO 13485
  • certificate of participation in the training
  • after passing the exam, the certificate of the QMS Management Representative and Internal Auditor ISO 13485
  • certificate from the certification body (after an additional fee and passing the exam)
  • practical knowledge supported by numerous exercises carried out during the training
  • training materials rich in a lot of useful information about ISO and examples of procedures and instructions that can be an invaluable help in creating and improving a quality management system according to ISO 13485
  • answers to questions about ISO bothering participants both during training and after training, because our trainers are at your disposal for help and advice (additional service – SUPPORT).
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