Audit Services

CCL engages qualified people with over 30 years combined experience of Auditing and assessing Quality Management Systems, covering Medical Device, Pharmaceutical and the Food & Beverage regulatory and standards requirements. Below is a non exhaustive list of Standards and Regulatory of our main areas of experiences;

  • ISO 13485:2003 – Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes.
  • 21 CFR Part 820:Revision of April 2007 – Quality System Regulation – Good Manufacturing Practice for the Medical Devices.
  • ISO 9001:2000 – Quality Management Systems Requirements
  • ISO 15161:2001 – Guidelines on the application of ISO 9001:2000 for the Food & Drink Industry.
  • ISO 14001:2004 – Environmental Management Systems – Requirements with guidance for use.
  • OHSAS 18001:2007 – Occupational Health and Safety.
  • GAMP 5 – A Risk Based Approach to Compliant GxP Computerised Systems.
  • 93/42/EEC – Directive concerning Medical Devices (14 June 1993).
  • 98/79/EC – Harmonised Standard for In-Vitro Diagnostic Medical Devices (27 Oct 1998).

For your assurance ask your Quality System Representative some simple questions:

  1. •  Is your QMS “Accreditation Ready”?
  2. •  Will your company QMS pass the next inspection by your certified body?
  3. •  When did you last inspect a product DHF, would it pass an Audit by your certified body?
  4. •  What would it mean to your business if it lost the accreditation of its QMS?

We can work within your Quality Group or separately for any given project requirement to ensure your QMS or Product DHF systems are ready for inspections / Audits.