Quality Services

MADE's speciality areas are ISO 13485 (quality systemf or medical device) (Quality system for Medical Device) and GLP (quality system for non-clinical studies) quality systems.

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

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

MADE can offer qualified person for:

  • Internal audits
    • One of the most effective activities that an organisation can 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.
  • 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.