ISO 13485 stands for Medical devices -- Quality management systems Requirements for regulative purposes is an International Organization for Standardization. ISO 13485 was first announced in 1996 and the current standard was published on 1 March 2016. The latest version has a higher accent on risk management and risk-based decision making, as well as differences related to the enhanced regulatory requirements for companies in the supply chain.
ISO 13485 describes the specifications for a complete quality management system for the design and manufacture of medical devices and the organizations involved in the medical device industry. ISO 13485:2016 can be applied by external and internal parties, such as certification bodies, to support them including their auditing manners. The medical profession is observing continuous improvement in its technologies and equipment. It is also essential for the world to ensure safety measures for it.
Benefits Of ISO 13485
- Improve customer satisfaction
- ISO 13485 allows the establishment of the Quality management system in medical device production, life-cycle process, and maintenance.
- Improve the process of production and maintenance of medical devices.
- Enhances the effectiveness of medical devices
- Improve your processes
- Ensures safety in medical devices.
- Reduces operational cost.
- Improve decision-making.
- Continuous Development in medical devices
- Better employee engagement
- Natural trust in stakeholders and consumers
- Validate customer fulfillment and well-being.
- Encouragement of staff and employee training in medical service providers.
- Improve your company’s credibility and image
- Create a culture of continual improvement
Requirements Of ISO 13485
ISO 13485:2016 defines requirements for a quality management system where an organization needs to demonstrate its capacity to provide medical devices and similar services that consistently meet consumer and managerial requirements.- Define adequate quality of design and development plan for medical devices.
- Identification of Quality management process in medical device production and further process.
- Consider customer’s requirements throughout the process.
- Production of sterile medical devices.
- Proper maintenance, control, and repair of medical devices.
- Review the quality of design and development in medical devices.
- Meet documentation requirements fundamental to ISO 13485.
- Safe distribution of medical devices.
- An internal audit of the organization.
Who Can Apply ISO 13485?
ISO 13485 can be implemented by any size of medical co-operation provider during the life-cycle of the device. It is entitled in every stage of device life, from planning, production, supply, distribution, storage, installation, controlling, monitoring, maintain and even for post-production.It is currently applied by the organization in 21 countries. ISO has adopted a process plan which serves the PDCA act (Plan – Do – Check – Act) cycle which begins in a drive for continued fulfillment in the process of the organization. The Organizations connected to one or various steps of a Medical Device Life-cycle or a Supplier or other External Parties giving such organizations with products for example.
| Organizations involved in one or more stages of the medical device life-cycle | Suppliers or External Parties who provide products to such Organizations |
| · Design and Development | · Raw materials |
| · Production | · Components |
| · Storage | · Sub-assemblies |
| · Distribution | · Medical devices |
| · Installation | · Sterilization services |
| · Servicing | · Calibration services |
| · Distribution services | |
| · Maintenance services |
How To Get ISO 13485
6 steps to achieve ISO 13485:2016 certification
- Planning the quality system
- Meeting regulatory requirements
- Implementing design controls
- Documents, records, and training
- Management processes
- The Certification audit
- Gap analysis
- Formal assessment
- Certification and beyond
- ISO 13485 Plan & how to get Certified
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