quality assurance audit

To maintain your quality system it is essential that you carry on routine quality assurance audit to eliminate the reduction in product quality, improve processes, eliminate loss of third party certification of FDA enforcement.



ISO 9001 defines an audit as a "systematic, independent and documented process for obtaining audit evidence [records, statements of fact or other information which are relevant and verifiable] and evaluating it objectively to determine the extent to which the audit criteria [a set of policies, procedures or requirements] are fulfilled." Quality assurance audits could be carried out through Process, Product, and Systemic verification.

Process Audit: This form of audit examines whether processes operate within defined limits. This assesses the method for measuring the compliance within requirements and the reliability of the instructions against pre-determined guidelines and standards.

System Audit: These are audits conducted on management systems. Verifiable activities relate to examination and evaluation of objective evidence through documentation or observations.

Product Audit: An audit that examines a product or service to evaluate its conformance to established requirements such as specifications, performance standards, and customer requirements.

QMS audits help to evaluate the quality management program of a company or organization based on its conformance to company policies, contract commitments, and regulatory requirements.

Medical Device


  • ISO 13485:2016

  • US FDA 21 CFR Part 820

  • European MDD / AIMDD / IVDD

  • ISO 14971 Risk Management

  • IEC 60601 Electrical Equipment

  • Brazil ANVISA


  • Canada CMDR

  • Australian TGA

  • Japan MHLW Ordinance 169 Pharmaceutical

  • US FDA 21 CFR 210 & 211

  • PIC/S GMP Guide

  • ICH Q7 GMP Guide for APIs

  • ICH Q10 Pharmaceutical Quality Systems

  • PS 9000:2016 Pharmaceutical Packaging

Quality Management

  • ISO 9001:2015
  • ISO 17025 Testing & Calibration

Other Management Systems

  • ISO 14001:2015 Environmental Health & Safety
  • OHSAS 18001 & ISO 45001 Occupational Health & Safety
  • ISO 27001 Information Security