For Medical Device ISO 13485 Certification - QMS Consultant for Medical Device
What is ISO 13485 Certification?
ISO 13485 is a certification that sets forth the standard of medical devices. Safety and quality assurance is important, especially in the case of medical equipment. To that end, prove that your medical devices fall to the right standards with ISO 13485 certification.
The international standard EN ISO 13485 forms the basis for the certification of quality management systems in companies that manufacture, distribute, and are involved in any life cycle activities of medical devices.
When it comes to medical devices, two things are necessary:
The quality of the medical device
The safety when you are using such devices
Therefore, the regulatory standards for such devices are especially stringent and must be followed through the entire life cycle of the medical device. This is not a matter of the eight qualities; many organizations must demonstrate that they can manage their medical equipment’s quality. This demonstration comes in the form of ISO 13485:2016 certifications.
ISO 13485 sets the standards regarding the quality management system associated with the medical devices industry. If you want this Certification and ISO 13485 guidelines you should get in touch with Operon Strategist, and you can begin applying for the Certification.
Quality Management Systems for Medical Devices and In Vitro Diagnostics
A robust quality management system (QMS) is fundamental to the operations of a medical device and in vitro diagnostics (IVD) manufacturer, serving as the framework for all activities and tasks. It ensures that every aspect of the manufacturing process, from design and development to production and post-market surveillance, adheres to stringent quality standards. This system is crucial for meeting both internal protocols and external regulations, including those set by CDSCO and international bodies, thereby upholding the integrity and safety of medical devices and IVD products.
Implementing a comprehensive QMS involves rigorous documentation, continuous monitoring, and regular audits to ensure compliance with industry standards and regulatory requirements. This not only helps in maintaining product quality but also enhances operational efficiency and minimizes the risk of non-compliance issues with CDSCO guidelines and other regulatory standards.
Obtaining suitable certification, such as ISO 13485, allows a manufacturer to in still confidence in its procedures and products. It demonstrates a steadfast dedication to safety, quality, and excellence, positioning the company as a trusted player in the competitive medical device and IVD market. Certification signals to regulatory authorities, customers, and stakeholders that the manufacturer adheres to internationally recognized standards and is committed to continuous improvement.
6 Steps To Obtaining ISO 13485 Certification
Understand the Standard
Conduct a Gap Analysis
Develop a Quality Manual
Implement the Medical Device Quality Management System
Conduct ISO 13485 Internal Audits
Obtain Certification
Benefits of ISO 13485:2016 Certification
Improves company’s credibility and identity
Evidence-based decision making
Continual improvement in product process and quality
Increased employee involvement.
Enhanced customer satisfaction.
Process to get an ISO 13485 Certificate:
Creating a Quality System Plan: Planning is the initial stage in every quality system. When discussing how to develop a quality system, the Plan-Do-Check-Act (PDCA) Cycle or the Deming Cycle are frequently used as examples. To deploy modifications to your QMS, you must document the quality plans.
Regulatory Requirements: After choosing your target market for your medical devices, make sure your compliance with other medical device regulations is established. For instance, if you’re creating your quality plan for US medical device firms.
Documentation, Training, and Records: Your quality system’s process interaction should be defined in your quality manual. The records will provide light on what quality control is testing.
Management Review Process:
Conducting Your First Management Review: Doing your management review only after you have finished your full quality system audit and started some corrective actions is advised to ensure that you have inputs for each of the 12 requirements in the ISO 13485:2016 standard.
Conducting Your First Internal Audit: The goal of the internal audit is to confirm that the quality system is working as intended and to detect nonconformities before the auditor for the accrediting authority does. The process approach to auditing should be used for internal audits, and the auditor should use a risk-based approach.
You will receive an internal audit report from the auditor following your internal audit. Also, you should anticipate the internal auditor’s conclusions and the identification of opportunities for improvement (OFI).
ISO 13485 Certification Audit:
To confirm that the quality system has been implemented, the certification authority is required to conduct interviews with process owners and review samples of records. The auditors for the certification body will normally confirm that your business has carried out a comprehensive quality system audit and at least one management review.
The Stage 2 ISO 13485 certification audit’s audit objectives particularly call for assessing your quality system’s performance in the following areas:
Relevant legal requirements
Technologies relating to products and processes
Tech support materials
How IQZYME Helps in Obtaining ISO 13485 Certification
Expert Guidance on ISO 13485 Requirements: IQZYME provides comprehensive guidance on the ISO 13485 standard, which specifies requirements for a quality management system (QMS) for medical devices. We help you understand the standard’s criteria and how they apply to your organization, ensuring that all requirements are clearly addressed.
Gap Analysis and Compliance Assessment: Our team conducts a thorough gap analysis of your existing quality management system to identify areas that need improvement to meet ISO 13485 standards. This assessment helps in understanding where your current practices diverge from the standard’s requirements.
Customized QMS Development: IQZYME assists in developing and implementing a customized quality management system that aligns with ISO 13485. We help design and document procedures, policies, and processes that meet the standard’s requirements and fit your organization’s needs.
Training and Awareness: We offer training programs for your staff to ensure they are knowledgeable about ISO 13485 requirements and their roles in maintaining compliance. This includes training on documentation practices, quality management principles, and internal auditing.
Documentation Support: IQZYME helps in creating and organizing the necessary documentation for ISO 13485 certification. This includes developing quality manuals, procedures, work instructions, and records required to demonstrate compliance.
Implementation Assistance: We provide support during the implementation phase, ensuring that your quality management system is effectively integrated into your operations. Our team works with you to address any issues that arise during implementation and ensure smooth execution.
Internal Audits and Pre-Assessment: IQZYME conducts internal audits and pre-assessments to evaluate the effectiveness of your quality management system before the official certification audit. These audits help identify any non-conformities and allow you to address them prior to the certification audit.
Management Review and Improvement: We assist in conducting management reviews to evaluate the performance of your quality management system and identify areas for improvement. This process is crucial for ensuring that your system remains effective and compliant with ISO 13485.
Support During Certification Audit: Our team provides support during the certification audit conducted by the certification body. We help prepare your team, review documentation, and address any questions or concerns raised by the auditors.
Post-Certification Support: After obtaining certification, IQZYME offers ongoing support to help you maintain and improve your ISO 13485 quality management system. We assist with periodic reviews, audits, and updates to ensure continued compliance and effectiveness.
Regulatory Compliance Integration: We help integrate ISO 13485 requirements with other regulatory requirements, such as those set by the CDSCO, ensuring that your quality management system supports all necessary compliance aspects.
IQZYME’s comprehensive support throughout the ISO 13485 certification process ensures that your organization is well-prepared to meet the standard’s requirements, achieve certification, and maintain high-quality practices in the medical device industry