What is ISO 13485:2016 Certification?
ISO 13485 is a Medical Device Quality Management System (MDQMS) certification that empowers medical device manufacturers to bring the utmost quality to production for transforming change with better service standards to the nation’s health system. It's an international standard mandated by the International Organization for Standardization (ISO) brought to you by the Assurance Quality Certifications LLC, a worldwide certification body offering MDQMS ISO 13485:2016 standard for boosting the quality of Medical devices for enhanced patient care.
Medical firms and industries engaged in manufacturing several types of medical devices need to adhere to the guidelines and legal & Regulatory norms of the medical devices ISO 13485:2016 standard. This framework ensures that the products are being manufactured with the utmost quality with regulatory compliance, exercising the competency of various types of organisations in delivering top-class and safe medical devices that can easily fulfil customer needs.
Principles of ISO 13485 Certification
The primary principles of ISO 13485 standard are as follows:
Focus on Customers: The primary goal of the 13485: 2016 standard is to satisfy customers in need and work to improve the nation and state as a whole.
Leadership: ISO 13485:2016 framework empowers to achieve quality objectives based on leadership initiatives and integrity in redefining various procedures for bringing quality medication to the patients at every cost.
People Engagement: The ISO 13485 current version of 2016 works on people engagement goals by effectively communicating and sharing better understanding with medical device manufacturing enterprises.
Process Approach: The framework of the Medical Device Quality Management System helps to enhance the caliber of medical device manufacturing units through a top-class process approach for determining various types of resource constraints.
Enhancement: With the Medical Device Quality Management System (MDQMS) ISO 13485 standard, the concerned manufacturer works for the best of business enhancement goals by effective planning, strategy, acknowledgement and implementation of necessary guidelines and work with the standard of ISO.
Evidence-based decision-making: Improvement is very necessary at every manufacturing step to provide better services to each patient. An EN ISO 13485 certification has emerged as one of the largest decision-makers for MDQMS services.
Relationship Management: This framework of the Medical Device Quality Management System works on several principles and one of them is Relationship Management which empowers amiable relationships with the product and the patient in a smoother way.
Ensuring Compliance with Regulatory Requirements: ISO 13485 is an internationally recognised standard for quality management systems specifically designed for organisations involved in the design, production, installation, and servicing of medical devices. The certification ensures that an organisation consistently meets customer and regulatory requirements, providing a framework for maintaining the safety and effectiveness of medical devices throughout their lifecycle.
For countries where medical device regulations mandate compliance with ISO 13485, obtaining this certification is often a legal requirement for manufacturers, suppliers, and distributors to operate. The standard aligns with global regulatory requirements, including the U.S. FDA, European Union MDR, and other national frameworks, making it a cornerstone for accessing international markets.
Key aspects of ISO 13485 certification include:
Risk Management and Product Safety: Organizations must identify and mitigate risks throughout the product lifecycle to ensure patient safety.
Regulatory Compliance: The certification ensures that the organization adheres to the specific medical device laws and standards applicable in their region.
Documented Processes: Emphasis on maintaining comprehensive documentation for traceability and quality control.
Continuous Improvement: Establishes a culture of ongoing assessment and improvement of quality management systems.
For businesses operating in regulated environments, ISO 13485 certification not only ensures compliance but also builds trust with stakeholders by demonstrating a commitment to quality and safety. Organizations publishing their certification status on their websites reinforce their credibility and readiness to meet global healthcare demands.
By achieving ISO 13485 certification, companies enhance their ability to deliver safe and reliable medical devices, contributing to public health and safety.
ISO 13485 Benefits
This ISO standard offers the following benefits to manufacturing enterprises towards client/customer satisfaction:
- Better Reliability of the Management
- Boosts Organizational Image Towards Better service
- Legally Approved ISO Certification
- Worldwide Acceptancy for MDQMS ISO 13485
- Complies with the requirements of the International Organization for Standardization and other drugs and medical regulatory bodies of concerned states.
Key Requirements of ISO 13485
Here are the key requirements of ISO 13485 certification:
- Definition of the Scope
- Performing ISO 13485:2016 Audit and Do GAP Analysis
- Preparing for Project Plan
- Documentation
- Training
- Implementation
- Conducting Internal Auditing
- Conducting Management Review
- Apply for Certification
ISO 13485 Certification Cost
A medical device manufacturing company should follow the standards of MDQMS of version 2016 framework and abide by its norms of International organization for standardization. The cost of ISO 13485 certification may vary from one certification body to another based on their pricing, location and the type of services offered. Suppose you want an affordable and genuine solution in MDQMS. In that case, you should approach Assurance Quality Certifications LLC offering globally recognized UAF and EGAC Accredited certification of ISO 13485:2016 standard with IAF logo.
The certification cost of Medical Device Quality Management System certification will based on these factors:
- Size of the organization
- Number of employees in aggregate
- Geographical location of the enterprise
- Works/ activities involved in the manufacturing of medical devices.