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Product conformity is important in all Industrial Sectors, especially when it comes to Medical Devices. Consistent and efficient product quality ensures patient safety, regulatory compliance.

Although ISO 13485 Standard is based on ISO 9001 Standard and has many similarities among them, ISO 13485 contains requirements and terms that are unique to the medical device industry. ISO 13485 is a quality management standard for the manufacturing of medical devices that relate specifically to manufacturing, installing, and servicing medical devices.

ISO 13485 Certification in the Organization calls for:

  • Implementing a quality management system for Medical Devices
  • Taking a risk management approach to product development
  • Validating processes
  • Complying with regulatory and statutory requirements
  • Establishing effective methods for product traceability and recall

ISO 13485 Certification Implementation Steps

Step 1: Obtain Management Support.

Management in the organization is the heart of the organization. To perform any task the management needs to take the initial step to implement or withdraw any process or procedure from the organization. It is the responsibility of the Management Team to explain the importance of ISO 13485 Certification and make up the mind of the BOD to implement ISO 13485 Certification in the Organization. ISO 13485 Certification project is doomed to failure without the support of the Management (if it gets started at all).

Step 2: Establish the Project Plan & other requirements. – Budget – HR Plan).

The second step is to plan the project to implement the ISO 13485 standard in the organization and fulfill all the requirements usually include legal and regulatory requirements, customer requirements, and other requirements. Adoption of the standard requires the systematic and well-planned process to systematically conduct the business in the organization by proper maintenance of budgeting with the help of company HR. Customers are the king of the organization. Without satisfying the customers’ needs and other requirements the organization cannot stand up in the market.

Step 3: Define Scope, Management Commitments & other requirements.

When you define your QMS scope, you will have a better idea of what tools help you with scope definition are the quality policy and quality manual. Identifying and defining the scope of the organization helps to tackle the target area and focus on the required commitments you develop for your QMS.

Step 4: Define Quality Policy, Quality Objectives and start preparing Quality Manual.

After deciding the scope of the Organization, the management needs to develop quality policy and plans to fulfill the required objectives by preparing Quality Manual to circulate to the employees to make them aware of the policy and procedure with the compliance of the ISO 13485 Certification.

Preparing to develop Support procedures for due diligence.

  • Procedures for Document & Record controls.
  • Internal Audit.
  • Corrective & Preventive actions (CAPA).

Step 5: Develop Management processes for the production 

After implementing procedures the management must evaluate to ensure consistent quality that meets requirements. Implementation of Design description and purchasing methodology, appropriate detailed description of the Device design in various languages.

  • Design & Development.
  • Purchasing etc.

All you need to develop the required necessary documents to support the process in the organization.

Step 6: Perform a Training awareness program (Develop & maintain Training Records).

It is vital to the success of all organizations to make all employees understand how the QMS works, and where they fit into the mix. Providing proper training to all levels of the employees about the Implementation of ISO 13485 Compliance helps in describing the pros & cons of the Certification in detail with the standard requirements.

Step 7: Choose Certification Body for final Audit.

Choose the Certification Body for Audit and whose Certification you choose to have. The right certification body determines whether the organization conforms to ISO 13485 requirements and they will also decide how effective your QMS is and whether it shows continual improvement.

Step 8: Operate the MDMS (Medical Device Management Systems) Maintain Records identified by MDMS.

MDMS require to follow all the legal regulations for the safety and security of the general public and to ensure that the Product or Device is ready technically to be marketed.

Step 9: Conduct Internal Audit.

It is generally done by any person within the organization who has the competence or it can be done from outside certified internal auditors. An internal audit is a systematic process of collecting and evaluating information about an organization’s processes to determine its level of compliance with the requirements of ISO 13485. This will tell you whether the processes are performing as planned, and if not, you’ll have the opportunity to take corrective action.

Step 10: Conduct Management Review Meeting (MRM).

After the Internal Audit and closure of Audit observation findings, the management to examine data from the QMS activities to make sure that all processes have the resources they need to continue to be effective and to improve over time. After the management team and BOD mutually decide to conduct a Final Certification Audit to achieve ISO 13485 Certification for the Organization.

Step 11: Take Corrective Actions

Here you solve the root cause of the problems discovered during the internal audits and take necessary actions to solve the problems which is the key element to achieve ISO 13485 Certification.

 Step 12: Perform the stage 1 Certification audit:

Right now is an ideal opportunity for the auditors  from your picked certification body to audit your documentation and confirm that – on paper – the entirety of the ISO 13485 prerequisites have been tended to in your QMS. You’ll get a review report itemizing the regions wherein you are consistent, just as those wherein you have issues. You will then, at that point be offered a chance to execute the important restorative activities to determine the issues. This is frequently done during the equivalent time span given for the underlying activity of the Quality Management System.

13) Stage 2 Certification audit:

During this review, the Certification body will send auditors to examine the records you have gathered through the activity of QMS measures. These records will incorporate those from the executives surveys, inside reviews, and remedial activities. At the point when the survey is finished, which regularly requires a couple of days, the reviewers will give you a review report that traces their discoveries, including their assurance regarding whether your QMS seems, by all accounts, to be compelling, and on the off chance that it agrees with the prerequisites of the ISO 13485 standard. In the event that they find that your QMS meets the entirety of the prerequisites set out for it, the examiners will suggest you for Certification. In the event that they have tracked down any significant nonconformance, you will have a chance to execute restorative activity to ensure the issues are settled, and that you are prepared for certification.

A sound plan goes along with the continuous improvement in the organization and helps to attain efficiency and effectiveness in the process and procedure in the working surrounding followed by surveillance audit.

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