Quality Management Systems

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DNA Certificatie & Consultancy can assist in drawing up the quality manual, the mandatory procedures, the working instructions and the quality registrations in accordance with the requirements of the standards. We also provide implementation support, internal training, internal audits, ..

ISO 9001 QUALITY MANAGEMENT SYSTEM

EN ISO 9001 is an international standard for quality management.  It is not the intent of this standard to enforce uniformity of quality systems.  EN ISO 9001 can be used to assess whether the organization is able to meet the customer’s requirements, the laws and regulations applicable to the product and the organization itself.  Also, the requirements are a good starting point for the design and implementation of a quality management system.

ISO 13485 QUALITY MANAGEMENT SYSTEM

The EN ISO 13485 is an international standard for quality management. This standard is similar to the EN ISO 9001, but incorporates a few supplementary requirements relating to medical devices. Furthermore, the term “continuous improvement” in the EN ISO 9001 is replaced by the term “maintaining the effectiveness of the quality system”.