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The 7 Key Elements of Quality Management for Life Sciences


Quality is not a choice but a pre-requisite to be in life science industry which includes pharmaceuticals, biotechnology and biomedical industry. We know that, quality does not happen by chance, therefore an organization must adopt Quality Management System (QMS) with an intention to deliver best quality products to its customers. The objective of a QMS is to define and formalize a system that documents processes, procedures and responsibilities for achieving quality policies and objectives. It basically provides the structure for various functions within an organization to work in an integrated manner, for delivering the best quality products and services to the customer.



The adoption of QMS comes with several benefits which include but are not limited to customer satisfaction, regulatory compliance, reduction in cost of poor quality, waste reduction, mistake proofing, a sense of purpose, effective utilization of resources and continuous improvement.

To describe the requirements of a Quality Management System in detail, the International Organization for Standardization has published a standard ISO9001:2015 which is the most widely used QMS standard. The standard specifies or defines requirements of a Quality Management System.

In this article, we are going to overview seven key elements of QMS in connection to Deming’s ‘Plan-Do-Check-Act cycle’ as shown in picture.



This stage in Deming’s cycle relates with strategizing organizational processes for co-ordination within the organization.

1. Defining quality
The first key element in implementing a quality management system, is understanding the meaning of quality from customer as well as compliance perspective. This involves clearly stating out the specification limits and compliance requirements.

2. Defining policies and processes
It is also important to document the vision, policies, processes and procedures which an organization is adopting in order to implement a QMS. These documents also provide for organizational structure and key roles and responsibilities of employees in every function.

It enables the employees to understand what are their key deliverables in terms of quality and how they can collaborate with employees in other functions to deliver the same.


In this stage of Deming’s cycle, it is expected to take necessary steps to execute actions for manufacturing desired quality product.

3. Quality by design
As we all already know, quality cannot happen by chance. Hence, it becomes a responsibility of product design team to build the desired quality into the products. One of the ways of building the desired quality into the product is to ensure that the natural variation in product is smaller than the defined quality specification. Scientists and researchers use various statistical and deterministic models to control the variation in product for building the desired quality in the products. This is to ensure that the desired quality of product will be manufactured consistently and repeatedly, batch after the batch.


In this stage of Deming’s cycle, it is expected to check, if the actions taken in previous stage have resulted in the desired quality of the product.

4. Quality Control
The quality control function within an organization plays a very critical role of testing or measuring the key quality performance indicators of the products. A report on test results is prepared by the quality control team.

5. Quality Assurance
The quality assurance function reviews the documented results and cross-checks for any
errors before the products are shipped to the customer.

6. Quality Management Software
It plays a very crucial role in quality management system and especially so, for the organizations having global presence. A validated Quality Management Software facilitates online report preparation, review and signature process for quality control and quality assurance functions. Additionally, a quality management software can also assist in monitoring the key performance indicators with the help of customized dashboard for every product.

Click here to learn more about the QualityKick Quality Management Software.

A QMS software also makes it possible to have a cloud storage of quality results, policies, quality specifications, compliance requirements and standard operating procedures. A software can also facilitate online training and assessment of a newly inducted employee or re-training of existing employees.

It also brings in great deal of transparency in QMS documents related to corrective and preventive action plan (CAPA) as well as change control. The best part about using a Quality Management Software for data management is, zero worry about the data integrity issues which are the leading cause for warning letters from regulatory agencies.


This stage in Deming’s cycle relates to acting on non-conformities. In this stage it is expected to make changes in process to restore the desired quality of product.

7. Improvement
If the dashboard of key performance indicators shows deviation from expected quality of product then there arises a need of improving processes.

Improvement can also be performed for incremental improvements in the quality as there is always a scope for improvement in every act that we do.


In conclusion, we have described the elements of the Quality Management Systems that enable any organization to implement QMS with no hassles. The Deming’s ‘Plan-Do-Check-Act’ cycle makes it very easy for any organization to start their journey towards implementing a strong Quality Management System.



Rucha Deshpande

Quality Assurance

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