QA Service

The special areas are ISO 13485 quality systems (Quality system for Medical Device) and GLP (Quality system for non-clinical studies).

Certified Lead Auditor (ISO 9001) helps your business compete globally, build business performance and customer confidence.

MADE can offer qualified person for:

Internal audits

One of the most effective activities that an organization may implement in order to monitor, analyze, control, and improve its Quality Management System (QMS) is the internal audit (Ref. ISO 13485 A complete Guide to Quality Management in the Medical Device industry, CRC Press; ISO 9001:2015).

Process audits

The aim is to understand and improve operational processes; identifying problems quickly and systematically. (ISO 13484 and 9001)

Subcontractor audits/Second-party audits

A second-party audit is an external audit performed on a supplier by a customer or by a contracted organisation on behalf of a customer. (ISO 13484 and 9001)

The audit service includes audit plan, audit on site, audit report and audit follow up at a fixed price.

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Business models:
  • Full Time Equivalent (FTE) Basis
  • Per hour basis
  • Per audit basis
  • Per Project basis