6.3 Infrastructure

The organization shall document the requirements for the infrastructure needed to achieve conformity to product requirements, prevent product mix-up and ensure orderly handling of product.

Infrastructure includes, as appropriate:

a) buildings, workspace and associated utilities;

b) process equipment (both hardware and software);

c) supporting services (such as transport, communication, or information systems).

The organization shall document requirements for the maintenance activities, including the interval of performing the maintenance activities, when such maintenance activities, or lack thereof, can affect product quality. As appropriate, the requirements shall apply to equipment used in production, the control of the work environment and monitoring and measurement. Records of such maintenance shall be maintained (see 4.2.5).

6.4 Work environment and contamination control

6.4.1 Work environment

The organization shall document the requirements for the work environment needed to achieve conformity to product requirements.

If the conditions for the work environment can have an adverse effect on product quality, the organization shall document the requirements for the work environment and the procedures to monitor and control the work environment.

The organization shall:

a) document requirements for health, cleanliness and clothing of personnel if contact between such personnel and the product or work environment could affect medical device safety or performance;

b) ensure that all personnel who are required to work temporarily under special environmental conditions within the work environment are competent or supervised by a competent person.

NOTE Further information can be found in ISO 14644 and ISO 14698.

6.4.2 Contamination control

As appropriate, the organization shall plan and document arrangements for the control of contaminated or potentially contaminated product in order to prevent contamination of the work environment, personnel, or product.

For sterile medical devices, the organization shall document requirements for control of contamination with microorganisms or particulate matter and maintain the required cleanliness during assembly or packaging processes.