5 Leadership
5.1 Leadership and commitment
5.1.1 General
See ISO 9001:2015 requirements
5.1.1.1 Corporate responsibility
The organization shall define and implement corporate responsibility policies, including at a minimum
an anti-bribery policy, an employee code of conduct, and an ethics escalation policy (“whistle-blowing
policy”).
5.1.1.2 Process effectiveness and efficiency
Top management shall review the product realization processes and support processes to evaluate
and improve their effectiveness and efficiency. The results of the process review activities shall be
included as input to the management review (see Section 9.3.2.1).
5.1.1.3 Process owners
Top management shall identify process owners who are responsible for managing the organization’s
processes and related outputs. Process owners shall understand their roles and be competent to
perform those roles (see ISO 9001, Section 7.2).
5.1.2 Customer focus
See ISO 9001:2015 requirements
5.2 Policy
5.2.1 Establishing the quality policy
See ISO 9001:2015 requirements
5.2.2 Communicating the quality policy
See ISO 9001:2015 requirements
5.3 The organizational roles, responsibilities, and authorities.
See ISO 9001:2015 requirements
5.3.1 Organizational roles, responsibilities, and authorities - Supplemental
Top management shall assign personnel with the responsibility and authority to ensure that customer
requirements are met. These assignments shall be documented. This includes but is not limited to the
selection of special characteristics, setting quality objectives and related training, corrective and
preventive actions, product design and development, capacity analysis, logistics information,
customer scorecards, and customer portals.
5.3.2 Responsibility and authority for product requirements and corrective actions
Top management shall ensure that:
a) personnel responsible for conformity to product requirements have the authority to stop
shipment and stop production to correct quality problems;
NOTE__Due to the process design in some industries, it might not always be possible to stop production immediately. In this case,
the affected batch must be contained and shipment to the customer prevented.
b) personnel with authority and responsibility for corrective action are promptly informed of
products or processes that do not conform to requirements to ensure that nonconforming
product is not shipped to the customer and that all potential nonconforming product is
identified and contained;
c) production operations across all shifts are staffed with personnel in charge of, or delegated
responsibility for, ensuring conformity to product requirements.
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