ISO 13485 Measurement analysis and improvement
ISO 13485 Standard - 8.2.1 Feedback E-mail
ISO 13485 customers feedbackThe organization is to continually and systematically evaluate whether the medical device meets the requirements throughout its life cycle, and that residual risks are controlled constantly. While the ISO 9001 standard demands the evaluation of customer satisfaction, the ISO 13485 standard does not, but requires the evaluation of feedback regarding the use of the medical device:
  • Does the medical device meet the intended use requirements?
  • Does the medical device meet the regulatory requirements?
  • Are residual risks still controlled and have new risks been identified?

ISO 13485 Standard - 8.5.2 Corrective Action E-mail

Corrective action is one of the foundation elements of quality management, and is essential for sustaining improvement of the quality management system. The main concept of corrective action promotes a systematic analysis of quality problems that have already occurred, and the elimination of any root causes of nonconformities through the implementation of controlled measures.
The main principle of corrective action is to eliminate any cause of nonconformity in order to prevent such from occurring again. The initiation of a corrective action in an organization is not to be submitted or assigned to one person, role, function, or department, but it is an issue that relates, covers, and involves all levels of the organizationómanagement, design and development, purchase, production, assembly, quality, service, and logistics.

ISO 13485 Standard - 8.2.2 Internal Audit E-mail
ISO 13485 internal audit
One of the most effective activities that organizations may implement in order to monitor, analyze, control, and improve its quality management system (QMS) is the internal audit.
The auditís main goal is to give a status report regarding your quality management system. The tactic of an audit (external or internal) is to evaluate the organizationís performances with reference to any kind of requirements. Your organization is required to maintain several activities. The audit evaluates whether the activities are performed and how well they are performed.


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