Companies that are involved in designing and manufacturing of any types of devices need to adopt the quality management system into their organization. As the name suggests, the quality management system is a set of policies and procedures aimed to make sure the right product quality.
Adopting the set of rules stated in the quality management system abbreviated as QMS helps to manufacture goods that are of the optimum quality and homogeneous.
Is there any standard available for QMS?
The basic standard has been set by ISO (International Organization for Standardization) in the ISO 9001:2015. It specifies in detail what the scope of the QMS Quality Management System is. All the companies, industries, and factories must adopt to these sets of rules for meeting the standards set by the ISO.
QMS is a very broad concept and so there are other series of ISO standards that focus on certain aspects of QMS. The ISO 14000 series is improving environmental management systems, ISO 13485 for maintaining QMS for medical devices, ISO 19011 audit management systems, etc.
There are many benefits of implementing the ISO.
- It helps to meet the requirement of your customers and clients. This gives confidence to the customer that your product is safe to use and thus they eventually become hooked to your set of products.
- It ensures making the best quality products at the optimum cost. Thus adopting the ISO is beneficial for cost-cutting and improving profit and revenues.
- It helps to identify, define and improve the process involved in manufacturing and designing
- It makes sure that there are no mistakes during the product manufacturing process and all the products are alike.
- Adopting the QMS also helps in reducing wastes as you have to deal with wastes properly.
- Lowering the cost associated with manufacturing goods.
- Providing proper training to the staff so that they become efficient workers.
- Being consistent in delivering the results.
What are the different elements or levels in a QMS?
Manufacturing of goods is a big process that can be subdivided based on the category of work they do. QMS tries to implement the rules for each of these processes. These elements are-
- The policy of an organization and its quality meeting objectives
- Quality manual
- Procedures and instructions
- Managing data
- Internal process
- Quality analysis of the products
Introducing and implementing the QMS in your manufacturing process
The steps to implement QMS can be divided into 7 steps as follows-
- Designing the product according to standards
- Manufacturing the product
- Testing the product before release so that it meets quality standards
- Correcting the flaws of the product
- Improving the entire process for better efficiency
If you want to implement QMS for medical devices and need help then you can visit the Orcanos website. It will provide you with integrated solutions for implementing QMS easily. For more information about please, visit https://www.orcanos.com/compliance/