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Quality Management

Nextrasearch offers consulting support for the ISO 9001 and ISO 13485 certification process and can assume the roles of QA and PRRC.

Service scope

Quality systems and certification pathway.

From the design of a tailored quality system to support for ISO 9001 and ISO 13485 certification.

ISO 9001 ISO 13485 Organizational context Quality Management
01

Quality system engineering

Based on an analysis of actual operational workflows.

02

External audits

Management of audits of suppliers and third parties in accordance with regulations.

03

Audit support

Management of audits by notified bodies and clients, both prior to and during the audit.

04

Assuming the QA and PRRC roles

Ensuring coverage of critical roles that require expertise not currently available within the company.

Tell us about your project.

For operational details, scope and support arrangements, contact Nextrasearch directly.

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