Quality Policy; When we talk about the Quality management system (QMS) in pharmaceutical industry, Quality Policy is an important term within it. This term can be easily understood by some of the below questions.
What is the definition of Quality Policy?
Term “Quality Policy” is self defining term, means a policy or statement on Quality. In Quality management system (QMS) this term is used for a documented procedure, to give you an idea about commitment and strategic direction of the organizational management towards Quality of the product. This should be the aim of the organization.
WHO says “A brief statement (Quality Policy Statement) that describes the organization’s purpose, overall intentions and strategic direction, provides a framework for quality objectives and includes a commitment to meet applicable requirements".
ICH says inline to ISO (9000:2005), “Quality policy is an overall intention and direction of an organization related to quality as formally expressed by the senior management”.
USFDA defines Quality policy as “A statement (Quality Policy Statement) of intention and direction issued by the highest level of the organization related to satisfying customer needs. It is similar to a strategic direction that communicates quality expectations that the organization is striving to achieve”.
Who prepares Quality policy and why it is important?
This is responsibility of top management / higher management of an organization, to establish a clear Quality policy statement. Organizational quality objectives can be said “operational planning” should be based on the Quality policy.
For whom it (Quality Policy) is applicable?
Quality policy is applicable for all the employees of an organization involved in the process. They contribute to achieve the goal and objectives that is defined in the quality policy. Quality objectives are defined by the Quality Policy, Top management should ensure that quality objectives are known and widely used at all levels within the organization.
Why Quality Policy is required to define?
It can be says that it is a worldwide statutory requirement, to define the Quality Policy of an organizations. It is also beneficial for an organization towards the process of customer satisfaction.
In the process of continual improvement, to deal with inevitable changes those arise within and around the organization, Quality policy should be reviewed by the organization for continuing suitability.
What is the regulatory aspect on quality policy?
✅ WHO says “senior management of an organization should make a formal commitment to the implementation of a documented quality policy that is compatible with statutory requirements and relevant objectives”.
✅ USFDA says “senior management of an organization should incorporate a strong commitment to quality into the organizational quality policy that aligns with the mission; commit to meeting requirements and improving the quality system; and propose objectives to fulfill the quality policy”.
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