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Risk Based Thinking

Since the new versions of ISO 9001 and 14001 were released in 2015, and conversion from older versions is due by 9/15/2018, in the next few issues we will look at some of the new concepts and their application.


Leadership Requirements - 10 things to watch.


Section 5 of both 9001 and 14001 have 10 requirements of Top Management – that’s the owners, boards, and CEO’s of companies, those who function at the strategic more than tactical level. While much of the language was always there, with the removal of the title Management Representative, this is now a requirement that applies to all top management.

Management is called to demonstrate their leadership and commitment by taking an active role in engaging, promoting, ensuring, communicating, and monitoring the effectiveness of their quality or environmental system, while ensuring that the system is integrated with their everyday business processes. Management responsibilities now include:

  • Accountability for the effectiveness of the QMS or EMS, even when other responsibilities are delegated,

  • Ensuring that the quality policy and objectives are tied to the strategic direction and context of the organization, and are monitored during routine management meetings or strategic planning,

  • Ensuring that management system processes are integrated and managed within overall business process, not as “add-on” or conflicting activities,

  • Promoting the Process approach by ensuring effective interactions between processes, and Risk-based thinking by collaboratively addressing risks and opportunities, in a Plan-Do-Check-Act culture that asks What If?, and What Next?

  • Monitoring current and projected workload and schedules to ensure the needed people, tools, and equipment are available when and where needed,

  • Communicating throughout the organization the value, importance and benefits of following the system requirements,

  • Ensuring that the system and the underlying processes meet objectives by monitoring the Key Process Indicators associated with each process, and acting to assign and resource improvements when objectives are not met,

  • Engaging and supporting staff to contribute to the effectiveness of the system by participating in improvement projects,

  • Promoting improvement by communicating results from audits, performance monitoring and management reviews to those involved,

  • Providing support and guidance to help managers develop leadership skills by mentoring, and supporting improvements,

  • Monitoring personal leadership effectiveness and commitment to support better staff understanding of their contributions to achieve company goals.

Most owners do much of this naturally, but internal and external auditors must now see evidence for each of these -- so record the what and how!

Next: The QMS and its processes.

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