Conducting effective internal audits is crucial to maintain the effective operation of the QMS.
Using the feedback provided by such audits and other information sources,
such as complaints and service records, your organization closes the feedback loop
to provide assurance that the processes used to realize your product / service
are operating in a state of control.
NDK Compliance and Design can audit your QMS or parts thereof to verify conformity with the requirements of ISO 13485, other ISO’s, and compliance with applicable regulatory requirements.
(This audit can be performed on-site as well as online when preferred.)
During this audit, we will review your procedures to ensure adequacy with regard to conformity with ISO 13485 and compliance with the applicable regulatory requirements and determine whether the procedures are effectively implemented.
The results of the audit are stated in a written report which indicates the non-conformities and recommendations found. NDK Compliance and Design can use your audit report template, or can use their own template which covers all necessary content according to ISO 13485.
A series of limited, well-defined audits can be as effective as one single comprehensive audit.
The approach to auditing is up to you an can be operated flexibly to give special or repeated attention
to any areas of weakness or of other concern.
In addition to the periodic internal audits, a special internal audit can be initiated for the following purposes:
- when verifying that your QMS continues to meet specified requirements and is being implemented, if required, within the framework of a contractual relationship (supplier audit);
- when undergoing significant changes in functional areas (e.g. reorganizations or procedural revisions);
- when investigating safety, performance or reliability of the product which are, or which are suspected to be, in jeopardy due to nonconformities;
- when verifying that required corrective actions have been taken and have been effective.
- Prior to an initial audit by a Notified Body.
Internal audits can be partially or fully subcontracted to NDK Compliance & Design