8 Important Elements of a Quality Management System

8 IMP Elements of a Quality Management System

It’s hard to keep up with upcoming requirements and compliances in business, let alone keep quality and process consistent. This is especially true for highly regulated markets such as Life Science. Life Science companies are mandated to uphold the highest quality standards and ensure regulatory compliance. Also, make sure that standards align with the regulatory body’s specifications and customers’ needs. A QMS or Quality Management System does exactly the same. 

What is QMS? 

A QMS is a collection of formalized systems or Business processes that helps organizations keep up with customer requirements and enhance their satisfaction. A good QMS helps convert organizational goals, aspirations, and policies into procedures & documented information for members to adopt Standard Operating Procedure (SOP) and helps manage resources needed to implement and maintain it. An effective QMS can help you ensure consistent standards, comply with regulators, and set up a Standard of Quality and SOP within your organization.  

History of QMS 

At earlier stages, quality management systems were used to emphasize predictable outcomes of the industrial product line with the help of simple statistics and sampling. Later in the 20th century, most jobs were labor-intensive, so the focus shifted to team cooperation and management. In the 21st century, with the IT revolution, QMS again converged towards achieving customer satisfaction, regulatory transparency, and sustainability in a consistent way.

With these systems becoming more efficient, highly regulated markets such as life science started adopting QMS rapidly. And for a reason, with these advances in Quality management systems, companies can utilize it to increase their process efficiency, optimize improvement efforts and back their process with data for evidence-based decision making. Moreover, attaining and adhering to global standards such as ISO 9000 and ISO 13485 became easy as most of the issues, such as documentation, transparency, filing, SOPs, etc., have been taken care of by QMS only. 

Benefits of QMS 

A QMS can take a lot from your shoulders; it can further standardize your procedures and services, which can help your organization meet customers’ requirements, leading to a better customer experience that will result in more customers and sales. Good Customer service is crucial for any business to succeed, and a QMS can help ensure that your organization is providing the best possible service to your customers.

A few key benefits of QMS include;  

  • Defining, improving, and controlling SOPs 
  • Reducing wastage of resources and time 
  • Lowering costs 
  • Anticipating and Preventing mistakes 
  • Facilitating and identifying training opportunities 
  • Engaging staff in an optimum way 
  • Making sure organizational goals are met 

Now that we understand the Definition and usage of QMS or Quality Management System, Lets now dig into 

How to setup QMS and its Elements

1) Quality Policy and Objectives 

The first thing while setting up the QMS will be drafting the Quality Policy followed up with Quality objectives aligned with your Quality Policy. This is crucial for ensuring quality assurance in your organization.

Quality Policy: A Quality policy is what defines and represents your organization’s overall purpose, principles, and mission and supports its strategic direction. It also helps companies to commit and adapt to newer technologies and improvements.  

It also helps you stay in line with International Organization for Standardization (ISO) standards, including the international organization for standardization, the reason it is advisable to make your quality policy flexible and scalable. 

Quality Objectives: Quality Objectives, in brief, is just a gist of Quality Policy; further, it acts as a guide to draft Quality objectives. They are designed to encourage organizations to define strategic goals and a purpose for the QMS. Quality Objectives actuate an organization’s vision into practice by linking customer requirements and specific, measurable, and attainable goals. Quality Objectives ensure customer satisfaction by ensuring factors such as  
  • Efficiency 
  • Performance 
  • Safety 
  • Timely Delivery 
  • Defect Detection  

Examples of Quality Objectives in the Pharmaceutical industry:  

  • To ease out, structure, and organize the process by applying the QMS Software within three months and digitalize and eliminate papers and spreadsheets way of record-keeping methods. 
  • Or, in the case of a hospital, to reduce the customer complaints by 40%, setting up the standard operating procedure and workflows through QMS. 

2) Quality Manual 

The quality manual is the bible of the QMS. It includes all crucial information such as the organization’s objectives, expectations, policies, processes, etc. Document control is an essential aspect of the quality manual, ensuring that all documents are properly managed and maintained to meet regulatory requirements.

3)Organizational Structure and Responsibilities 

A well-built organization must have a chain of command same is true for QMS, which includes a clear and updated model of the organization’s structure and the responsibilities of all stakeholders within the organization. 

4) Data Management 

Data is the new oil, and for a reason, one of the most significant upsides of having QMS in your organization is its ability to provide quality data. The availability of quality data availability is crucial for the innovation, improvement, and standardization tracking of an organization, including Quality control. Lacking Data management can severely hamper your product quality, efficiency, customer satisfaction, and profitability.  

5) Internal Processes 

Your resources are limited, which means most of your efficiency depends on managing those resources (employees, machines, or technology). QMS does the same for you; one of its core objectives is to establish standardized, repeatable & replicable processes for Medical devices.

6) Customer Satisfaction with Product Quality 

A core component of QMS is the requirement for organizations to track customer satisfaction to determine if quality objectives are achieved. This feedback is essential for organizations as through feedback; only organizations can track whether or not the process and SOPs they have set up are followed and upheld. This feedback can be received through the means of  

  •  Satisfaction Surveys and ratings 
  • Analytical applications to measure satisfaction trends 
  • Management review of customer satisfaction 

7) Continuous Improvement 

Progress and adaption are the names of the game, and QMS can help you with just that. For any kind of changes or upgrades in an organization’s SOP, you need to back it up with robust data. You will also require a timeline and results of past changes, which can easily be accessed through a QMS. Product development is an important aspect of any organization, and QMS can provide valuable insights to help improve the process.

8) Quality Instruments 

 Once you have established your Quality Objectives, policies, and SOPs, you need to ensure the proper feedback. The calibration of tools to measure quality is an integral part of the QMS. These instruments are used to validate the process and quality of the whole system, so these instruments must be controlled and calibrated according to industry standards. 

So, as you can see from the 8 Essential and IMP elements of QMS, how a QMS can help your business achieve everything it is struggling with. 

QMS ensures that quality objectives are met and provides stability for organizations. With suitable systems in place, it’s easier to replicate work and achieve desired outcomes. In addition, many modern tools now make establishing and setting up workflow systems more manageable. The right tools also help companies and individuals complete and follow processes, procedures, and work instructions. They also give the managers the full day-by-day development so that goals don’t derail or get delayed. With PERFEQTA, you can not only integrate our tools into your existing Quality Management System; but you can also leverage our platform to strengthen your QMS. 

Frequently Asked Questions for Elements of Quality Management System

The 7 principles of the quality management system are:

1. Customer focus: The primary focus of any quality management system should be to meet and exceed customer expectations.

2. Leadership: Effective leadership is essential for establishing a culture of quality within an organization.

3. Engagement of people: The involvement and empowerment of employees at all levels is critical for the success of a quality management system.

4. Process approach: A process-based approach to managing operations helps ensure consistency, efficiency, and effectiveness.

5. Improvement: Continuous improvement is necessary to maintain and enhance the quality of products, services, and processes.

6. Evidence-based decision-making: Decisions should be based on data, analysis, and facts rather than assumptions or opinions.

7. Relationship management: Building strong relationships with suppliers, partners, and stakeholders is critical for achieving quality objectives and enhancing overall business performance.

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