Audit

Medifocs provides Audit and Inspection services for an objective assessment of compliance with specific requirements or standards, according to EN ISO/IEC 17020 and ISO 19011.

Medifocs auditors are all qualified with experience on the ground.

Medical devices

  • Internal audits according to the ISO 13485:2016 standard: standard applicable by any company operating in the medical device supply chain. These audits are tailored to the company’s role and aim to verify the degree of compliance with the standard.
  • Supplier Qualification Audit: is intended to select, qualify or maintain the qualification of a critical supplier that may affect the quality or safety of a medical device or outsourced process, whether specialty or non-specialty.
  • GDP Audit: devices must be stored and distributed under controlled conditions, under the distributor’s responsibility for the period during which the device is in its custody (MDR 2017/745 art. 14). Consequently, all partners in the supply chain must be selected and qualified.
  • Product audit (DDM 93/42/EEC – MDR 2017/745): compliance with the regulatory requirements set out for medical devices in Directive 93/42/EEC and Regulation (EU) 2017/745 is a requirement for maintaining the marking of a medical device.

Food supplements

  • GMP Audit and Certificate according to GMP FDA CFR Title 21, Volume 2, Part 111: the Code of Good Manufacturing Practice (GMP) issued by the FDA is a recognised guideline ensuring the quality and safety of food supplements throughout the product manufacturing and storage cycle. The purpose is to verify the application of procedures to ensure that the manufacturing, packaging and storage processes are carried out in accordance with Good Manufacturing Practices.
  • Internal audits according to the ISO 9001:2015 standard: its purpose is to assess the degree of effectiveness of the management model for the quality of products/services offered to the customer by the company.

Cosmetics

  • Audit and Certification according to ISO 22716 for cosmetic products.
  • Internal audits according to the ISO 9001:2015 standard: with the purpose of assessing the degree of effectiveness of the management model for the quality of the products/services offered to the customer by the organisation.

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