An internal audit, also referred to as “first-party audit”, “one-party audit” or “QM-system audit” is usually carried out by an employee of the company. This person must be a qualified auditor and, on the other hand, she/he must be independent, which means she/he is not allowed to audit his/her own area of responsibility. This may become problematic particularly for small companies. Also the adequate qualification of auditors is often missing in practice. Furthermore, there is usually a certain naturally given operational blindness in every organisation. As a long term result, the quality management system is prevented from continuous improvement. In such cases, only the awarding of audits to external auditors can be a valid and sustainable solution.
Crystal Biosolutions offers the professional conduction of internal audits for biotech and lifescience companies according to ISO 9001 and ISO 13485 including final audit report. www.crystal-biosolutions.com