6 Resource Management Flashcards
6 Resource management
6.1 Provision of resources
The organization shall determine and provide the resources needed to:
6.1 Provision of resources
The organization shall determine and provide the resources needed to:
a) implement the quality management system and to maintain its effectiveness;
b) meet applicable regulatory and customer requirements.
6.2 Human resources
Personnel performing work affecting product quality shall be
6.2 Human resources
Personnel performing work affecting product quality shall be competent on the basis of appropriate
education, training, skills and experience.
The organization shall document the process(es) for establishing competence, providing needed
training, and ensuring awareness of personnel.
The organization shall:
a) determine the necessary competence for personnel performing work affecting product quality;
b) provide training or take other actions to achieve or maintain the necessary competence;
c) evaluate the effectiveness of the actions taken;
d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives;
e) maintain appropriate records of education, training, skills and experience (see 4.2.5).
NOTE The methodology used to check effectiveness is proportionate to the risk associated with the work for
which the training or other action is being provided.
6.3 Infrastructure
The organization shall document:
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).
- 4 Work environment and contamination control
- 4.1 Work environment
The organization shall document:
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:
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.
