An initial audit, when applicable for confirmation of conformance with regulatory requirements, will generally be an audit of all elements of the quality system
A surveillance audit for a previously audited facility can either constitute a full audit or partial audit of the quality system.
The time interval between surveillance audits will depend upon:
a)the risk associated with the intended use of the medical devices;
b)the number of the quality system elements to be examined;
c)the nature of the quality system elements to be examined;
d)the scope and results of the previous audits;
e)the post market surveillance data available on the subject devices indicating a possible deficiency in the quality system;
The time interval between surveillance audits should not be greater than 3 years but in the case of high risk devices not greater than 2 years.
If partial audits are used for surveillance, within a maximum period of 5 years all elements of the quality system should be audited.
These audits may be required when:
a) external factors apply such as:
i) available post-market surveillance data on the subject devices indicate a possible significant deficiency in the quality system;
ii) significant safety related information becoming known to the auditing organisation.
b) significant changes occur to a manufacturer, which have been submitted as required by the regulations or become known to the auditing organisation, and which could affect the decision on the manufacturer's state of compliance with the regulatory requirements.
The following are examples of such changes which could be significant and relevant to the auditing organisation when considering that a special audit is required, although none of these changes should automatically trigger a special audit :
i) Modifications to the manufacturer's quality system policies caused by:
• new ownership of the manufacturer;
• relocation of the manufacturer's activities or controls to a new site;
ii) Modifications to the defined authority of the management representative that impact:
• quality system effectiveness or regulatory compliance;
• the capability and authority to assure that only safe and effective medical devices are released;
iii) Addition of a new device category to the manufacturing scope within the quality system (e.g. addition of sterile single use dialysis sets to an existing scope limited to haemodialysis equipment, or the addition of magnetic resonance imaging to an existing scope limited to ultrasound equipment);
iv) Modification of the site operation involved in the manufacturing activity (e.g. relocation of the manufacturing operation to a new site or centralising the design and/or development functions for several manufacturing sites);
v) Significant modifications to special processes (e.g. change in production from sterilisation through a subcontractor to an on site facility or a change in the method of sterilisation)
An unannounced audit may be necessary if the auditing organisation has justifiable concerns about implementation of corrective actions or compliance with regulatory requirements