Sisäiset ja toimittajien auditoinnit

Internal audits

Labquality provides medical device manufacturers with internal auditing services.

Internal audits help you to identify items in your quality management system which need to be improved.
They give you a tool for getting information about the effectiveness of your quality management system.

Internal audits give you confidence that regulatory requirements are implemented in your processes.

Labquality’s experienced auditors will take care of your internal audits. A single audit can be done to ensure that your quality management system
has been implemented and is effective. Labquality can also take care of your annual internal audit program.

Labquality’s internal audits cover:

✔ ISO 13485:2016 Medical devices   ✔ Quality Management Systems   ✔ Requirements for regulatory purposes

Supplier audits

The quality of the materials you use in your medical device is a prerequisite for the quality of your product.

Labquality provides medical device manufacturers with supplier auditing services that will assure you of the quality of your suppliers.

Quality management system standards, medical device and in vitro medical device regulations require that manufacturers control their suppliers.

A supplier audit is the most effective way to ensure that your suppliers comply with applicable standards and regulations, as well as your needs.

Labquality’s experienced auditors will take care of your supplier audits. They can audit your candidate supplier before you approve it
and take care of follow-up audits.

Labquality’s supplier audits cover:

✔ ISO 13485:2016 Medical devices   ✔ Quality Management Systems   ✔ Requirements for regulatory purposes