Medical manufacturing is a fiercely competitive industry; the process needs to ensure not only quality but also patient safety. ISO 13485 will assure quality but also provide the sound basis for achieving your objectives. With this globally accepted ISO standard, the manufacturer can guarantee better-quality products, smooth operations, and more patient satisfaction. The following blog outlines in detail how the ISO 13485 Certification can transform your business by presenting the certification procedure.
Overview of ISO 13485
ISO 13485 is a unified set of QMS requirements followed by organizations that manufacture medical devices. Its development aims to ensure harmonization of regulatory requirements and effective and safe delivery of goods. Unlike other ISO standards, ISO 13485 has represented the needs of the medical device industry regarding regulatory issues of risk management practices and documentation.
ISO 13485 Certification proves that an organization is concerned with excellence, right from product design and development, production, and installation to after-sales service. It is not mere regulatory compliance; it is also a source of trust for customers, health professionals, and patients.
Improve Patient Satisfaction
Product quality and safety are directly related to patient satisfaction in the medical device industry. In addition, suitable and efficient devices will go a long way in contributing to helping the patients, adding to health outcomes, and ensuring that at least one contribution is made to the general patient experience. ISO 13485 certification helps to make your products pass some of the most stringent quality and safety standards, thus improving patient trust and satisfaction.
The new standard strongly emphasizes the feedback loop. A manufacturer should collect, analyze, and consider the improvements in products and make adjustments with the feedback obtained from the end-users. In such a way, continuous improvements will maintain the effectiveness of the devices within the ever-changing industry.
Quality Improvement in Products
Another major benefit of ISO 13485 certification is that it tends to ensure a focus on continuous improvement. A quality management system working within the standard requirements and features systematically finds problems and solutions affecting product quality. This proactive approach helps to reduce the possibility of defects, callbacks, and customer complaints.
The standard also provides a risk-based approach to product development and manufacturing. Hence, a business organization can detect potential risks in the early stage of development and manufacturing of the product and take preventive measures against them. Product quality will thus be enhanced while corrective action/recall costs are minimized.
ISO certification procedure
ISO 13485 certification is required to take a systematic approach. The ISO certification procedure consists of some key steps:
- Gap Analysis: Evaluate existing processes to identify any gaps between their current QMS and the requirements of ISO 13485.
- Documentation: Develop procedures for documents, policies, and work instructions with the standard in mind.
- Implementation: Implement the documented procedures throughout the organization and train employees.
- Internal Audit: Execute an internal audit to ensure that the QMS operates as designed to identify areas for improvement.
- Certification Audit: Hire an accredited certification body auditor to perform the external audit. The auditor will audit your QMS against the requirements of ISO 13485 and conclude for certification based on his findings.
- Continual Improvement: Operate your QMS and continually improve it for further conformance and performance.
Let's Sum Up
ISO 13485 accreditation is not limited to satisfying legal requirements but also acts as a shortcut to excellence within medical devices. Due to the ISO certification procedure, manufacturers can offer quality development and manufacturing. Together with this, they are capable of offering an efficient quality management system. In the sector, where life depends upon the reliability of your products, ISO 13485 certification takes you through all the steps to success.
In order to achieve ISO 13485 certification and enhance your medical device quality, partner with INTERCERT, a trusted certification body. With expertise in guiding companies through the ISO certification procedure, INTERCERT ensures your organization meets international standards. Therefore, contact us to start your journey toward improved product quality and patient satisfaction through ISO 13485 certification.