The ISO 13485 standard provides manufacturers, designers, and suppliers to the medical device industry with a framework necessary to demonstrate compliance to regulatory requirements and mitigate risks to stakeholders.
It places more emphasis on risk-based thinking and decision-making, while also offering stronger interoperability between the clauses and requirements.
It focuses on ensuring consistent quality, product safety, and the sustainable success of your products or services, using competent and efficient quality management systems to support them.
Persistent pressures from global competition demand that organizations continually improve their products, services, and business processes to remain competitive.
One of our core services is the implementation of the customized management system according to your specific needs and available resources. During the implementation phase we prepare companies for the certification audit.
The internal audit is typically part of the implementation phase but can also be arranged as an independent service provided by an independent party. The scope of the audit is to assess compliance with the requirements of ISO 14001.
To guarantee that your supply chain is ready to support your company's scaling ambitions, we conduct supplier audits according to ISO 9001, ISO 14001, ISO 27001, and/or VDA 6.3. During the supplier audit, we also assist in establishing appropriate Quality Assurance Agreements and setting up supplier performance metrics.
We can help coordinate the process improvement to achieve the desired quality targets. Depending on the industry, we use a set of internationally recognized tools and practices. The output of this process is improved process performance, effectiveness, and efficiency.