Medical Devices - ISO 13485 – Do You Really Know What You Need To?
A detailed look at each section of the standard. Real world examples of what to expect, and what to prepare and repeal within the audit guidelines. What must a documentation system look and feel like to ensure compliance?
These and many other key details to ensure that your organization has the ability and knowledge to ensure that ISO 13485 is within your grasp.
Clean rooms 101, we can assist in what to do and what not to do. From the infrastructure, to the maintenance, PPE, etc. It is a holistic system that must be maintained at optimal standards at all times.
How is the quality within the organization? Materials must be accounted for and properly maintained. Only the highest quality materials should be utilized to create a unique and durable product.
Your suppliers must be chosen carefully. Ensure that each vendor is vetted and reviewed at least annually. The product you are making cannot be at or maintain any level of quality unless the supply chain is acceptable and consistent.
A true and complete internal audit is key to ongoing certification. The system must be looked at entirely each year, and by independent parties to validate that each section of the standard is being met, and is consistently documented to be functional. Who should audit which section, what type of documentation must be kept this will be reviewed and explained.
Management plays a key role with any certification. Their support is needed to implement and maintain the system for certification. Their roles should be clear, and they must be involved in the annual review to ensure that the system overview is known and communicated to all. This way ongoing changes, both good and bad, are feed back into the system to keep it live and continually improving as a whole.
Why should you Attend:
Are you prepared, do you have an audit planned, are your clients requesting or demanding certification? If so, can you actually accomplish your goal with your current knowledge base and personnel in place?
What is your infrastructure like? Do you have the ability to have a proper clean room?
When is the last time your vendors were reviewed? It is a key step to ensuring that the right materials are consistently supplied for the manufacturing of devices.
Management should know what is happening, and how to update the organization.
Areas Covered in the Session:
Who Will Benefit:
- An overview of the standard and the different areas needed to create, maintain, and sustain a proper documentation system to ensure certification
- Know what to look for and where to prepare to enable one's organization and personnel to assist in an audit for certification
- Clean rooms
- Supplier demands
- Quality from when materials are received, until after the devices leaves the facility
- Annual upkeep
- Management representation and participation
- Quality Managers
- EH&S Reps
- Quality Control
- QCQA, CEOs
- Sales, buyers, vendors, etc