Resource management of ISO 13485
Resource management of ISO 13485
Clause 60
6.1 Provision of resources
The organization shall determine and provide the resources needed
a) to implement the quality management system and to maintain its effectiveness, and
b) to meet regulatory and customer requirements
6.2 Human resources
6.2.1 General
Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.
6.2.2 Competence, awareness and training
The organization shall
a) determine the necessary competence for personnel performing work affecting product quality,
b) provide training or take other actions to satisfy these needs,
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, and
e) maintain appropriate records of education, training, skills and experience (see 4.2.4).
NOTE National or regional regulations might require the organization to establish documented procedures for identifying training needs.
6.3 Infrastructure
The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable
a) buildings, workspace and associated utilities,
b) process equipment (both hardware and software), and
c) supporting services (such as transport or communication).
The organization shall establish documented requirements for maintenance activities, including their frequency, when such activities or lack thereof can affect product quality.
Records of such maintenance shall be maintained (see 4.2.4)..
6.4 Work environment
The organization shall determine and manage the work environment needed to achieve conformity to product requirements.
The following requirements shall apply.
a) The organization shall establish documented requirements for health, cleanliness and clothing of personnel if contact between such personnel and the product or work environment could adversely affect the quality of the product (see 7.5.1.2.1).
b) If work environment conditions can have an adverse effect on product quality, the organization shall establish documented requirements for the work environment conditions and documented procedures or work instructions to monitor and control these work environment conditions (see 7.5.1.2.1).
c) The organization shall ensure that all personnel who are required to work temporarily under special environmental conditions within the work environment are appropriately trained or supervised by a trained person [see 6.2.2 b)].
d) If appropriate, special arrangements shall be established and documented for the control of contaminated or potentially contaminated product in order to prevent contamination of other product, the work environment or personnel (see 7.5.3.1).
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