Ensuring the Effectiveness of the QMS

The top management must ensure that QMS and its intended results are effective by ensuring that
• Quality objectives are defined and measured
• Processes and business activities are planned according to the ISO 9001 Standard
requirements
• Processes and business activities are controlled and measured with the controls
required by the ISO 9001 Standard
• Risks and opportunities are addressed
• Improvement is achieved
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This requirement clearly emphasizes that the top management is not only responsible for developing the
QMS but also for controlling its effectiveness. Effectiveness will be measured when carrying out the
following fundamental activities:
• Defining a quality policy
• Establishing communication channels with the lower levels in the organization
• Implementing the quality policy throughout the organization using measurable
quality objectives
• Fulfilling them by reviewing the QMS periodically and systematically
• Allocating the required resources
Quality Policy and Quality Objectives
The top management is required to define a quality policy with the goal of demonstrating the commitment
of the top management and the organization to the implementation of a QMS and to the maintenance of
its effectiveness. In practice, the top management shall initiate a written quality policy that will clearly
demonstrate to the interested parties of the organization
• The mission of the organization
• What the top management expects
• Its values
• How the top management shall act in order to introduce and implement its policy
The content and nature of this policy will be discussed in chapter 5.2—Quality policy. After defining the
quality policy, the top management will establish quality objectives and will ensure that these objectives
are
• Appropriate to the strategy of the organization (referred by or presented in the
quality policy)
• Continually achieved
This will be done by defining objectives that are relevant to the quality policy and the nature of the
organization. After defining and determining the objectives, the top management must review their status,
collect and analyze data regarding these objectives, and evaluate whether they have been achieved or not.
Requirements regarding the quality objectives, their definition, and their planning are discussed in chapter
6.2—Quality objectives and planning to achieve them.
Communication Channels
The top management should consider different communication channels for different purposes. But all
these channels have one goal—that the interested parties are exposed to the quality policy and objectives.
Each different interested party of the organization should have its own channel with which it exchanges
information with the top management (when needed). Each communication channel will be planned and
implemented according to its nature and purpose.
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Communication of the quality policy and its objective should reach the interested parties both vertically
and horizontally.
• Vertically—The quality policy and the related quality objectives should be
communicated in a downward direction from the top management to their
subordinates with the purpose to distribute decisions and directives. Feedback,
suggestions, and opinions regarding the status of the quality objectives will flow
from the subordinates in an upward direction to the top management.
• Horizontality—Information needed for the achievement of the quality objective (the
operation of the QMS and its business activities) flows between roles or persons at
the same position. This communication is needed to coordinate activities of various
departments in the organization.
Communication channels will be internal as well as external. The type of information that will flow in
these channels is affected by interested parties’ needs and expectations (the context of the organization)
and the type of relations:
• Internal communication (with employees, stakeholders)
• External communication (with customers, suppliers)
There are many ways to publish this information:
• Publishing the policy and the objective on a bulletin board or in an organizational portal
• Maintaining a procedure that requires each employee to read the quality policy at least
once, which they must sign indicating they have read and understood the policy
• Messages or notices to the public in media
• Letters for partners
• Website
I prepared a short review of which quality elements are expected by the standard to be communicated:
• The importance of effective QMS
• The quality policy
• Organizational roles, responsibilities, and authorities
• Quality objectives
• Customer communication
• Performance data related to processes, products, services, and customer satisfaction
• Communication of related data to the external providers
Awareness of the Process Approach
Adapting the process approach is highly recommended by the ISO 9001:2015 Standard. The top
management from their side shall promote the awareness to the process approach.
• The top management shall refer to the process approach in the quality policy, define
it as a quality goal, and if applicable, define relevant quality objectives.
• The top management can initiate benchmarking like reengineering projects or process
mapping in order to evaluate the maturity and compatibility of the business processes.
44 ISO 9001:2015—A Complete Guide to Quality Management Systems
• The top management shall allocate resources for the implementation of the process
approach:
• Responsibilities and roles
• Plans and schedules for the implementation
• Tools that allow process analysis
• Required trainings
• Outsourced consulting
How can one assess whether a process approach is integrated in the organization? I will rephrase the
question: How can an auditor be convinced that the process approach is adapted in the organization?
Would it be enough to present a pair of charts or diagrams? Apparently not. The organization must prove
in action with evidence that
• A method for analyzing processes is implemented. There is no requirement for
documenting the method but yet you will need to show evidence: tools and means
with which you control your processes.
• All processes in the organization are mapped and are controlled according to this
method.
• All processes have desired results that will allow assessment of the process.
• Responsibilities in the organization are authorized for these activities.
• Results of the process mapping exist and are reviewed.
• Process inputs and process outputs are available for review.
• Processes are regularly reviewed and improvement of processes is achieved.
In practice, I would include a capital in the quality policy that relates to the implementation of the process
approach in the QMS and the business activities of the organization.