ISO 9001 5.1 Leadership and Commitment
In this section (5.1 Leadership and Commitment) of clause 5, top management must demonstrate leadership and commitment to the QMS by taking accountability for its effectiveness. Leadership must then ensure that the implementation of QMS aligns with the strategic direction of the organization. We will be diving deeper into 5.1 to fully understand what is expected.
In this blog post we will be discussing the following:
1 Active leadership involvement in QMS operations
2 Risked-based thinking and culture of continual improvement
3 Customer-focused culture that aligns with strategic direction
4 Engagement of employees while ensuring adequate resources to support QMS
PDAC Image and context below: www.iso.org
The PDCA cycle can be briefly described as follows:
— Plan: establish the objectives of the system and its processes, and the resources needed to deliver results in accordance with customers' requirements and the organization's policies, and identify and address risks and opportunities;
— Do: implement what was planned;
— Check: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives, requirements and planned activities, and report the results;
— Act: take actions to improve performance, as necessary.
Top 10 ways to demonstrate and commitment of leadership
1. Take accountability
2. Establish QMS policy
3. Establish QMS objectives
4. Engage and direct personnel
5. Integrate requirements
6. Support process owners
7. Meet statutory and regulatory requirements
8. Promote continuous improvement
9. Promote risk-based thinking
10. Promote the process approach
International Organization for Standardization. ISO 9001:2015 Quality Management Systems – Requirements:
5.1 Leadership and commitment
5.1.1 General
Top management shall demonstrate leadership and commitment with respect to the quality management system by:
a) taking accountability for the effectiveness of the quality management system;
b) ensuring that the quality policy and quality objectives are established for the quality management
system and are compatible with the context and strategic direction of the organization;
c) ensuring the integration of the quality management system requirements into the organization’s
business processes;
d) promoting the use of the process approach and risk-based thinking;
e) ensuring that the resources needed for the quality management system are available;
f) communicating the importance of effective quality management and of conforming to the quality
management system requirements;
g) ensuring that the quality management system achieves its intended results;
h) engaging, directing and supporting persons to contribute to the effectiveness of the quality
management system;
i) promoting improvement;
j) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.
NOTE Reference to “business” in this International Standard can be interpreted broadly to mean those activities that are core to the purposes of the organization’s existence, whether the organization is public, private, for profit or not for profit.
Active leadership involvement
Active leadership includes the involvement of top management taking full accountability for the effectiveness of the QMS. This means that top management must ensure that the QMS is functioning as intended and delivering the desired outcomes. This also includes ensuring that the QMS conforms to ISO 9001:2015 requirements and it supports all strategic objectives of the organization. During an audit the auditor will need to see evidence of top management involvement.
Top 5 ways evidence of Top management’s participation and involvement may be found in:
1. Business strategy plans and planning meetings
2. Review of annual reports and management reviews
3. Review of audit results both internal and external
4. Resource allocation
5. Quality goals and communication
Risked-based thinking & Continual improvement
Risked-based thinking involves identifying and managing risks and opportunities that could have an impact on the QMS’s effectiveness. Top management should promote the application of Risk-based thinking.
The encouragement from top leadership to have the mindset of continual improvement is crucial. This will be driving ongoing enhancements to the organization’s processes, products and services.
According to www.quality.org below:
“Risk is defined as "the effect of uncertainty" on an expected result. This encompasses any deviation, positive or negative. The intent is for an approach to risk-based thinking, which is proactive and promotes continual improvement, rather than one that is reactive, focusing preventing or reducing negative effects.”
International Organization for Standardization. ISO 9001:2015 Quality Management Systems – Requirements:
5.1.2 Customer focus
Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that:
a) customer and applicable statutory and regulatory requirements are determined, understood and consistently met;
b) the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed;
c) the focus on enhancing customer satisfaction is maintained.
Customer-focused
Why is customer focus important to your organization? Having an emphasis on customer feedback and expectations coordinates the growth and success of the organization.
Promoting a customer-focused culture is another point of emphasis for leadership. Top management must ensure customer requirements are understood, met and exceeded where possible. Promoting a customer-first culture throughout the organization is a must to improve customer satisfaction and enhance long-term relationships and goals.
3 main points of emphasis below:
1. Customer requirements and determined, understood and consistently met
2. Risks and opportunities that can affect the conformity of products and services are determined and addressed
3. Focus on enhancing customer satisfaction is maintained
Engagement of employees
Engaging with and supporting employees at all levels is a highlight for this section. Ensuring all employees are aware of their roles and contributions to the QMS. Leadership must provide the necessary support to empower their employees as well as the resources and training to effectively contribute to the QMS.
Engaging with employees can sometimes be difficult for leadership but it doesn’t have to be stressful. Your employees just want to know they are valued, needed and have a voice to be heard. Things such as daily motivation or recognition such as employee awards for hard work/ accomplishments.
Here are some more ideas for leadership engagement:
· Building rapport with employees
· Recognize employees’ efforts
· Empower employees
· Discuss company policy
· Communicate clearly and listen carefully
· Show passion for the organization’s mission and values
· Set production or sales goals
In conclusion, 5.1 ISO 9001 Leadership and Commitment highlights that leadership is just not responsible for implementing a QMS but must be actively supporting and engaging with it to ensure that the QMS is working effectively, is sustainable and that it drives continual improvement. In the next blog post we will be discussing 5.2 Quality Policy in further detail.
Related blog posts -
How to determine your QMS Scope of Certification
Improvement- The Seven Quality Management Principles
4 Steps to Achieving ISO 9001 Quality Management System Certification
References –
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