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LEADERSHIP
5.1. Leadership and Commitment
5.1.1 General
Things to consider:
• Top management commitment towards the QMS to demonstrate that they have a presence in the
organization, provide direction, lead by example, make decisions and have:
o Taken accountability for the effectiveness of the QMS e.g. established measures, system/process
performance monitoring, management review, realization of planned activities, achievement of
planned results and taking action when process performance is not meeting intended results
o Established and maintain the quality policy and objectives aligned to the strategic direction e.g.
context of the organization, external/issues (see 4.1)
o Integrated quality requirements into the organizations business processes e.g. system architecture,
business model, process model, organization footprint, functional alignment (Engineering,
Purchasing, IT, Finance, HR etc.)
o Promoted the process approach and risk based thinking e.g. process modeling, process mapping,
inputs, outputs, activities, interactions, interfaces, resources, controls, risk management
(identification, severity, ownership, treatment etc.)
o Supported process owners in their process management activities e.g. deployment, governance,
process evaluation, process improvement
o Enabled the resources (including people) required for an effective QMS e.g. resource planning,
workload, priorities, constraints, balance, organization flexibility, business benefits, organization
growth
o Communicated the importance of conformity to the QMS and effective quality management e.g.
meetings, briefs, e-mail, intranet, campaigns, roadshows, focused training, voice of the
regulator/customer, consequence of nonconformity
o Created an environment for continual improvement e.g.
o proactive - product/service/process improvement initiatives, improvement projects, waste reduction
(lean), process re-engineering, cost reduction etc.
o reactive - acting on process performance results, audit findings, complaints, escapes etc.
o Supported other relevant management roles e.g. organization hierarchy, trust, empowerment,
responsible delegation, coaching, sharing knowledge, removing barriers, route to escalation