LABORATORY AUDITS AS A TOOL FOR SUSTAINED COMPLIANCE
Regular audits should be a key component of every laboratory quality management system. Audits are intended to confirm:
The laboratory’s quality systems are appropriate and suitable for the laboratory’s business functions
The laboratory’s quality systems are compliant with current regulatory requirements and expectations
The laboratory’s operations are carried out according to its quality systems and standard operating procedures
Most laboratory quality standards have a requirement to perform regular internal audits. Having your laboratory audited by an independent entity is an indispensable tool in achieving comprehensive regulatory compliance, and perhaps more importantly, can be used to improve and optimise laboratory systems and processes.
For an established laboratory seeking assistance with its quality systems an audit is often a good starting point to identify requirements
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, such as: quality system, instrument qualification and calibration or sample management
In a project or sample audit (also called a vertical audit) all or some systems or processes associated with a particular project or sample are examined
In addition we can also perform audits of your vendors to confirm they meet your requirements.
However, irrespective of the type, the number of weaknesses or deficiencies that will be discovered during an audit will depend on its comprehensiveness and the time spent on the inspection.