What Are The Steps Of Iso 13485 Implementation?

By Author: niha
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Medical device manufacturing is one of the most regulated sectors in which important quality systems and product necessities must be satisfied. The regulatory requirements are intended to confirm that manufacturers constantly design, produce and place onto the market medical devices that are safe and fit for their intended purpose. The ISO 13485 standard is an actual solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 delivers a practical foundation for manufacturers to address the regulations and responsibilities as well as representing a commitment to the safety and quality of medical devices.
If any company is thinking about implementing a QMS (Quality Management System) and getting certified against ISO 13485, company may be wondering about where – and how – to get started. To get going on the right track, this list of the steps needs to take so that company don’t miss anything as work through implementation and get ready for certification.
• Get management support:
Without management support, ISO 13485 implementation project is doomed to failure. Need to craft a well-though-out ...
... presentation outlining the benefits to company can realize through ISO 13485 implementation, and get management team on board right from the start.
• Identify requirements:
The next critical step toward a successful implementation is making sure that ascertain all the requirements that need to satisfy with QMS. Such requirements usually include legal and regulatory requirements, consumer requirements, and other requirements depending on company’s requirements and culture.
• Define the scope:
If company want to avoid applying the QMS to areas of business that don’t relate to quality, but don’t want to make the scope so narrow that the company sees no benefit. When define QMS scope, company will have a better idea of what desires to be done, and the boundaries of implementation. Best tools to help organization with scope definition are the quality policy and ISO 13485 manual, so these essential to be the first documents develop for QMS.
• Define processes and procedures:
The ISO 13485 standard defines certain compulsory procedures that must be part of QMS, but also want to determine what processes and procedures within company must be clear in order to confirm adequate and constant quality. The first thing to do is to define all of company’s processes, and then see how they interact with each other. These interactions are often where problems become obvious.
• Implement processes and procedures:
For most companies, all that wants to happen is the documentation of existing processes and procedures to confirm constant quality that meets requirements. Don’t have to document every process, but essential to decide which processes need a documented procedure in order to guarantee constancy in the quality of products and services.
• Deploy training and awareness programs:
It is vital to the success of Quality Management System that every employee in organization understands how the QMS works, and where they fit into the mix. All personnel need to be trained on the basics of ISO 13485, so they get an idea of the purpose of implementation; in addition, they want to be aware of any changes to be made in the processes they are a part of.
• Choose a certification body:
The right certification body can make all the difference, because this is the company that comes in after execution to audit of Quality Management System, and determine whether or not it conforms to ISO 13485 requirements. In addition, they will also decide how effective QMS is, and whether it shows constant improvement.
• Operate the QMS / Measure the system:
This is when collect the records that will be essential in audits to show that processes meet the requirements set out for them, that are effective, and that improvements are being made in QMS as required. Certification bodies want this to happen over a certain length of time, which will identify, in order to confirm that the system is mature enough to show compliance.
• Conduct internal audits:
After operated the QMS for the prescribed length of time, but earlier the certification body conducts their audit, and need to perform an internal audit of each process. This will tell whether or not the processes are performing as planned, and if not, company have the opportunity to take corrective action to resolve any issues find. There is an ISO 13485 internal auditor training for fulfilling the needs of people who want to audit Quality management system for medical devices, and who wants to gain knowledge about ISO 13485 audit and get ISO 13485:2016 Auditor Certificate and become a certified ISO 13485:2016 Auditor.
• Conduct management review:
Not only must management be supportive of the organization ISO 13485 implementation – it is imperative that they stay complex in the ongoing maintenance of the Quality Management System. During the management review, they will examine data from the QMS activities to make sure that all processes have the resources they want to continue to be effective, and to improve over time.
• Take corrective action:
Here is where company look for the root cause of the problems discovered during internal audits, measurements, and management review, and then take the essential action to solve the problems at the source. This is a critical step in the constant improvement of the Quality Management System, which is a key aim of ISO 13485.
• Perform the certification audit:
Now is the time for the auditors from company chosen certification body to review documentation and verify that all of the ISO 13485 requirements have been addressed in QMS.