I. ISO 13485 ?
Equipment, medical instruments whose role is particularly important in the work of healthcare and have a direct impact on the lives and health of humans. Products in this sector must not only meet the standards of the manufacturer and must also comply with the requirements statutory and regulatory provisions in order to ensure that equipment, medical devices provide the market always meet customers’ requirements and the provisions of law.
ISO 13485 is the standard specifies the requirements for quality management system applied at facilities providing medical equipment and related services to ensure the ability to supply products to meet your requirements goods and provisions of the law. ISO 13485 is based on the foundation of ISO 9000, is International Organization for Standardization ISO published the first edition in July 2003 (equivalent National Standard ISO 13485: 2004 ).
Although based on the ISO 9000, ISO 13485, but insists on the harmonization of the requirements of the quality management system with the statutory requirements for the medical device industry. ISO 13 458 have been accepted and is widely applicable for manufacturers of medical devices worldwide, and is a requirement to have in the current period if such a production organization Facilities health wants its products are widely recognized worldwide.
As part of the system of general management, so organizations / businesses can build quality management system to ISO 13485 alone or in combination with management systems such as ISO 9000, ISO 14000, ISO / IEC 17025, ISO 15189 …
II. OBJECTS OF APPLICATION
- Unit of production, distribution equipment and medical instruments;
- Certification organizations for assessment, the ISO 13485 certification for the production units, distribution equipment and medical instruments.
III. BENEFITS
– Enhances meet customer requirements and regulatory requirements of national, regional and international for equipment, medical instruments;
– Enhance competitiveness, expand markets;
– Risk management, minimize waste;
– Improve effectiveness and efficiency of current control systems.
IV. STEPS FOR IMPLEMENTATION
1. Preparation
- Establishing the project team;
- Assessment of the status of the unit compared to the requirements of ISO 13485;
- Training general awareness of ISO 13485;
- Planning system developed on the standard request based on the status of the organization.
2. Develop quality management system upon request ISO 13485
- Training system construction documents as required standards;
- System design documents should build on the requirements of ISO 13485 and demand management unit results;
- Conduct set of processes and system construction documents identified.
3. Perform
- Popular application procedures, system documents issued;
- Monitor and oversee the implementation of the system to ensure the building is operational effectiveness and efficiency;
- Documenting the activities under the standard requirements.
4. Review and improve the system
- Training internal auditors ISO 13485;
- Perform internal audits;
- Overcome, improve the system.
5. ISO 13485 Certification Audit
- Choice of certification organizations;
- Reviewing and preparing evaluation or assessment bodies test (if necessary);
- Evaluation and certification.
