Templar Consulting conducts quality system review audits for companies with ISO 13485 certification by a Notified Body or Registrar.
The two main audit types are internal and external audits. Audits are a key components and to become certified (ISO 13485). Internal audits are compulsory to pass registrar audit conducted by an external party in order to become ISO 13485 certified.
An ISO 13485 audit determines the status of your current QMS and processes. Quality audits are to ensure that manufacturing, development, and related control facilities meet current manufacturing processes, as well as conform to ISO 13485.
An ISO 13485 audit determines the status of your current QMS and processes. Quality audits are to ensure that manufacturing, development, and related control facilities meet current manufacturing processes, as well as conform to ISO 13485.