Installation Process [ISO 13485 Cl 7.5.3]
Installation
Clause 7.5.3 of ISO 13485 emphasizes establishing and maintaining documented procedures for installation activities to ensure that medical devices are installed correctly and consistently to maintain the safety and performance of the device throughout its intended use.
The documented procedure should be defined:
- The activities involved in the installation of the device to ensure consistency and adherence to specifications.
- The competence required of personnel performing the installation.
- The details of specific tools or equipment needed.
- The verification is to confirm that the installed device meets the specified requirements and operates as intended.
Frequently Asked Questions
Are post-Installation Verification records audited by Certification Body?
Yes. It’s a crucial audit item.
- Is there a process for post-installation verification to ensure the device operates correctly?
- Are the results of post-installation verification documented in QMS?
Are Installation Records audited by Certification Body?
Yes. It’s crucial
- Are records of installation activities maintained?
- Do the records include information on any deviations or issues encountered during installation and how they were resolved?