ISO 13485 Medical Device Industry Quality Management System Consulting
Understanding ISO 13485 Business Management System
ISO 13485 is a Quality Management System that is specific to the medical device industry. Specifically, it was created to put in place a system that shows an organization’s ability to meet customer and regulatory requirement related to medical devices on a consistent basis. It is a Quality Management System (QMS) that applies risk based assessment to every step of the medical manufacturer’s processes.
ISO 13485 Certification Requirements
In order to obtain ISO 13485 certification, an organization is required to demonstrate:
- A QMS that is effectively implemented and maintained,
- Regulatory requirements that are promoted by top management and employees are made aware of applicable,
- Controls in the work environment to ensure product safety,
- Focus on risk management and design control during product development,
- Specific requirement for inspection and traceability for implantable devices,
- Specific requirement for documentation and validation of processes for sterile medical devices, and,
- Specific requirement for verification of the effectiveness of corrective and preventive action.
Benefits of Getting ISO 13485 Certified are:
- Improved efficiency and effectiveness,
- Improved product quality and customer satisfaction,
- Improved supplier performance,
- Increased revenue, and,
- Improved employee commitment.
ISO 13485 Implementation Process
Depending on the size and scope of your organization, setting up and implementing ISO 13485 Quality Management System certification process, and ISO 9001 registration can take anywhere from a few months to up to a year. Listed below are the steps that our ISO 13485 consultants will follow in order to prepare your organization for successful ISO registration:
- Core management team training,
- Manual preparation – define scope, policy and interaction of business processes,
- Draft core processes necessary to show conformance to the standard,
- Assist with risk assessment process,
- Assist in putting together regulatory requirements,
- Draft supporting procedures needed to support your processes,
- Ensure that all necessary records are identified, created, and implemented,
- Conduct a full system Internal Audit, and,
- Assist in conducting first Management Review.
How GlenView Group Can Help You Obtain ISO 13485 Certification?
GlenView Group employs a team of adept and qualified ISO 13489 consultants who will help you understand the needs of ISO 13485 certification process for your organization along with guiding you step by step in obtaining and maintaining certification. For more information on ISO 13485 consulting, contact the consultants at GlenView Group.
