• May 24, 2024

What is Quality Management System ISO 9001, and how it helps pharma manufacturers to win customer trust and loyalty?

Quality Management System ISO 9001 are specialized procedures and systems that ensure quality in all pharmaceutical manufacturing processes. It focuses on individual factors such as intermediate processes, personnel and systems, rather than working only on the result.

Pharma product directly affects human safety, health, and living. Pharma manufacturers utilize many tools to produce the highest quality products and to prevent product failure. One of many tools is Quality Management System ISO 9001.

What is a quality management system ISO 9001

Quality Management Systems is a set of written procedures that focuses on improving individual processes and procedures. It optimizes every individual process and system that affects the overall quality of the final product.

Quality Management System ISO 9001 are specialized procedures and systems that ensure quality in all pharmaceutical manufacturing processes


The primary aim of QMS is to ensure customer satisfaction by providing them the highest standards and the maximum value for the money spent.

When a QMS is implemented in an organization, it results in clear objectives, continuous improvement, and efficient monitoring, resulting in optimized product.

Quality Management Systems ISO 9001

The ISO 9001 is the internationally recognized standard for Quality Management systems. Developed by International Organization for Standardization – ISO, it guides organizations to successfully implement  Quality Management System in their routine processes and operations.

The scope of ISO in implementing QMS is not limited to Pharmaceutical Industry. It also guides the implementation of QMS in other industries such as manufacturing and software.

Principles of Quality Management System ISO 9001

Implementing Quality Management Systems in a pharma organization means applying quality principles that are the building blocks for a QMS. These principles are not strategic requirements but are the organization’s beliefs that result in customers’ trust and loyalty.

There are seven Quality Management Principles – QMP, which are summarized below.

QMP – 1 Customer Focus

The main focus of Quality Management Systems are the Customers and how their needs and expectation can be fulfilled. The organization’s products and services must satisfy customers at the highest level, and customers must get the value for their money spent.

The organization must be able to retain its existing customers, which also helps attract new customers. Every problem or a customer’s expectation is an opportunity for the organization to improve its processes and increase its market share.

QMP – 2 Leadership

Leadership is the driver for an organization toward its goals and achievements.  It guides in every situation to increase one’s abilities, effectively manage crises and prevents deviation from the organization’s quality principles.

Leadership acts as a unity of command to align the organization’s direction, policies, and resources to achieve quality objectives.

 QMP – 3 Engagement of People

This principle emphasizes engaging people from all levels in process improvement and achieving quality objectives. The decision-making process should not be limited to a higher level. Instead, the organization should include feedback from all of its employees.

The organization should devise a mechanism to include advice, suggestions and arguments from every employee.

Their advice or argument must be respected, and higher management must give them confidence about the final decision it takes

QMP – 4 Process Approach

Success in the final product is not achieved by only imparting efforts in the final stage or process; instead, it results from continual improvement in every process from start to finish.

For this purpose, it is necessary to manage all the processes as interrelated functions. The success of the later stage depends on the success of its previous stage, resulting in a product that fulfils all of its attributes.


QMP – 5 Improvement

There is always a space for improvement, no matter how perfect the system is, achieving its objectives. Improvement is necessary because the industrial world is highly dynamic.

Improvement creates customer retention, which also increases market share.

Improvement can be achieved using innovative and process improvement tools such as Root Cause Analysis, Corrective Action and Preventive Action (CAPA). Using software tools such as QMS Software, Warehouse Management System(WMS), and Computerized Maintenance Management System(CMMS) for routine operations helps prevent errors and improve the process.

QMP – 6 Evidence-based Decision Making

Decision-making in any organization is a critical process that affects its future planning and can increase or decrease its customer base. Proper inputs and monitoring techniques are essential for correct decisions. It is also necessary to correctly interpret inputs, facts, and evidence. 

Decision-making must be factual, and based on real-time data gathered by authentic monitoring methods. It enables customer-focused and result-oriented decisions.


QMP – 7 Relationship Management

Relationships are essential in today’s dynamic industrial environment and a critical tool for any organization to survive in difficult situations. Every organization must maintain a relationship with all its interested parties and stakeholders.

These stakeholders and Interested Parties play a pivotal role in an organization’s success and help them during a crisis.


Why is quality management system ISO 9001 important?

Implementing Quality Management Systems in an organization is often termed an unnecessary investment. Traditionally, it is only implemented to fulfil stakeholders’ requirements rather than using it as a tool to improve processes and products. For this purpose, organizations worldwide are reluctant to implement it, or when they do, implement it partially rather than in a whole system.

Implementation of QMS yields long term benefits for an organization and paves the way for vital successes.

Let’s look at how a QMS is essential for every organization.

  • Implementation of QMS opens a new market for the manufacturer, which results in increased market share and revenue.
  • Increased customer trust in an organization’s processes and products.
  • QMS results in cost-effective solutions for the organization. Improved processes create less waste and produce more output with less input.
  • QMS enables all the employees to take a practical part in all the processes, which results in a better working environment, increased trust among employees and more dedication.
  • It increases the trust of regulatory bodies in an organization’s processes, efforts and commitments.


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