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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. Also, make sure that standards align with the regulatory body's specifications and customer's 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 with the IT revolution, QMS again converged towards customer satisfaction, regulatory transparency, and sustainability.
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 QMS, 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 9001 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.
Now that we understand the Definition and usage of QMS or Quality Management System, Lets now dig into
The first thing while setting up the QMS will be drafting the Quality Policy followed up with Quality objectives aligned with your Quality Policy.
It also helps you stay in line with ISO standards, the reason it is advisable to make your quality policy flexible and scalable.
The quality manual is the bible of the QMS. It includes all crucial information such as the organization's objectives, expectations, policies, processes, etc.
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.
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. Lacking Data management can severely hamper your product quality, efficiency, customer satisfaction, and profitability.
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.
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
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.
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.
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