Regular audits should be a key component of every quality management system. Audits are intended to confirm:
The company’s quality systems are appropriate and suitable for the company’s business functions
The company’s quality systems are compliant with current regulatory requirements and expectations
The company’s operations are carried out according to its quality systems and standard operating procedures
It is a requirement of most laboratory quality systems that a laboratory carries out vendor qualification and obtains documented evidence of the suitability of its suppliers.
It has become a trend in recent years for laboratories to request an onsite audit of their major suppliers as a means of confirming compliance with their requirements. It is therefore possible that your client may request an onsite visit to examine your organisation’s quality management systems. A satisfactory audit report may be critical to establishing and maintaining a business relationship.
Audits of your quality systems performed by a friendly independent entity are an indispensable tool in achieving comprehensive quality conformance, and can also be used to optimise your organisation’s quality management systems.
For an established organisation seeking assistance with its quality systems, an audit is often a good starting point to identify requirements. A friendly audit can also serve to train staff in the mechanics and processes of a formal audit.
QUALITY ASSURANCE AUDITS FOR LABORATORY SERVICE BUSINESSES
We can perform two types of audit to achieve comprehensive coverage:
In a systems audit (also called a horizontal audit) one or more laboratory systems or processes are inspected
In a project audit (also called a vertical audit) all or some systems or processes associated with a particular project are examined
In addition we can also help your develop policies and procedures for handling an external audit, including how to respond appropriately to any observations or comments made during an audit.