Protomatic Exceeds ISO Requirements - Verdict Medical Devices
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Protomatic Exceeds ISO Requirements

Protomatic completed an internal audit and management review on 20 February 2015 to remain up-to-date with ISO audit requirements, which is conducted annually.

Protomatic’s first party audit phase was completed. The company is ready for the third party audit scheduled for April 2015.

First party audit (internal audit) is an evaluation of the quality management system (QMS) by trained internal staff who do not work in the department.

The process involves a detailed evaluation of all business procedures, and the output of this evaluation is a formal report submitted to Management Review.

Management and the quality manager look for improvements and make corrections to procedures, if required.

Protomatic used qualified contractors to conduct an internal audit, eliminating cross-functional requirements and providing more experienced staff to handle the internal audit.

Second party audit (customer audit) is performed by customers who review what is important to support their business interests. They are detailed concerning customer product requirements.

Experienced teams go over up to 80% of the QMS and focus on important elements. A second party audit requires up to two days of off-site interviewing and another one to two days of report write-ups and evaluation.

A third party audit (registration audit) is managed by the independent registration body. The audit reviews adherence to the ISO standard with the company’s procedures.

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