Medical devices have become an increasingly important health care area in relation to their impact on health and health care expenditure.
The medical device industry consists of firms that produce a wide range of products used for diagnosis and treatment of ailments, and which include the following: medical, surgical and dental equipment (including electromedical equipment and related software), furniture, supplies and consumables, orthopaedic appliances, prosthetics and diagnostic kits, reagents, and equipment.
The standard ISO 13485: 2003 Medical devices - Quality management systems - Requirements for regulatory purposes has become the world standard for the medical device sector.
What is the ISO 13485:2003 standard?
The ISO 13485:2003 Medical Devices. Quality management systems. Requirements for regulatory purposes is an international standard that specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services.
In addition to a quality management system based on the ISO 13485:2003 standard, it is also necessary to comply with all relevant product and service oriented technical standards and regulations.
Structure of the ISO 13485:2003 Standard
The standard "ISO 13485:2003. Medical devices. Quality management systems. Requirements for regulatory purposes." has the following structure:
The medical device industry consists of firms that produce a wide range of products used for diagnosis and treatment of ailments, and which include the following: medical, surgical and dental equipment (including electromedical equipment and related software), furniture, supplies and consumables, orthopaedic appliances, prosthetics and diagnostic kits, reagents, and equipment.
The standard ISO 13485: 2003 Medical devices - Quality management systems - Requirements for regulatory purposes has become the world standard for the medical device sector.
What is the ISO 13485:2003 standard?
The ISO 13485:2003 Medical Devices. Quality management systems. Requirements for regulatory purposes is an international standard that specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services.
In addition to a quality management system based on the ISO 13485:2003 standard, it is also necessary to comply with all relevant product and service oriented technical standards and regulations.
Structure of the ISO 13485:2003 Standard
The standard "ISO 13485:2003. Medical devices. Quality management systems. Requirements for regulatory purposes." has the following structure:
| • | Quality management system. |
| • | Management responsibility. |
| • | Resource management. |
| • | Product realization. |
| • | Measurement, analysis and improvement. |
Who should benefit from the implementation of the ISO 13485:2003 Standard?
Organizations that need to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
What can you expect in return for your investment in the implementation of the ISO 13485:2003 standard?
Organizations that need to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
What can you expect in return for your investment in the implementation of the ISO 13485:2003 standard?
| • | Establishing a quality management system for medical devices. |
| • | Certifying your quality management system for medical devices. |
| • | Proving your ability to supply medical devices and related services that meet customer expectations and comply with regulatory requirements. |
| • | Certifying your quality management system. |
| • | Access to new markets. |
Consulting services in the design, development, implementation, maintenance and continual improvement of Quality Management Systems based on the requirements of the ISO 13485:2003 standard.
Audit services of Quality Management Systems based on the requirements of the ISO 13485:2003 Standard.
Audits are performed following the requirements of the international standard: ISO 19011:2002 Guidelines for Quality and/or Environmental Management Systems Auditing.
Audit services of Quality Management Systems based on the requirements of the ISO 13485:2003 Standard.
Audits are performed following the requirements of the international standard: ISO 19011:2002 Guidelines for Quality and/or Environmental Management Systems Auditing.
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