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:

ISO 13485:2016

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.

We Work on PDCA

Plan
Plan

We initiate the planning and strategy-making process with the basic things required for the certification process.

Do
Do

With this strategy, we command our planned action to act suitably to achieve goals with a fruitful approach.

Check
Check

We access, judge and monitor various requirements of the ISO 13485 standard including core objectives, and policies.

Action
Action

We act on our checklist and plan to provide you with a genuine 13485 certification to boost quality standards.

Why Choose Assurance Quality Certification LLC?

Assurance Quality Certifications LLC is a trusted EGAC and UAF-accredited ISO certification company offering worldwide Quality management certifications in various domains. With extensive experience and a dedicated team of experts, the organization is providing top-notch and highly acclaimed ISO certification services to all sorts of businesses.

  • Globally acclaimed ISO certification body
  • UAF and EGAC approved/Accredited Certifications
  • Offering ISO standard of 13485 certification with International norms
  • Validated by experts and industry professionals
  • Budget-friendly certification services
  • One-stop solutions for all sorts of certifications
Why AQC?
Know What You Want to Ask

Frequently Asked Questions (FAQs) about Medical Device Quality Management System (MDQMS)

ISO 13485 is a Medical Device Quality Management System (MDQMS) standard that complies with the International standard to bring quality services in medical device manufacturing, distribution and handling of medical equipment in various healthcare units. The auditor certification of ISO 13485_2016 means the certification is successfully audited under the supervision of an experienced auditor who works to provide quality services in conducting GAP analysis and implementing changes by understanding the requirements of this certification.

ISO 13485 offers a wide range of benefits for Medical Device Quality Management Systems. Prominent are mentioned below:

  • Enhance the enterprise’s credibility and identity
  • Evidence-based decision making
  • Enhance employee involvement
  • Boost customer satisfaction

A medical device manufacturer can easily get the benefits of the ISO 13485 framework from a trusted source: Assurance Quality Certification LLC which is a premier certification body offering worldwide services with EGAC and UAF approvals.

The certification cost may vary from one certification agency to another, but if you want a genuine quality certification for a medical device manufacturing enterprise, you should contact Assurance Quality Certification LLC (AQC) which is a top-class certification company offering ISO standard certification in various realms of life, business and environment. ISO 13485 certification cost is affordable at AQC and you will get quality services from experienced professionals.

Here are the basic pointers stating internal audit requirements for the ISO 13485 certification:

  • Planning and maintaining the organization’s audit program
  • Defining the criteria and scope of the audit
  • Choose impartial auditors
  • Report results to management
  • Retaining various types of compliance documentation as evidence
  • Process management-related documents

ISO 13485 internal audit checklist is a tool for ensuring quality in medical device manufacturing units with ISO 13485 compliance. The checklist has various items that are intended for various stages of auditing based on their subsequent references to the corresponding procedure and standard. This internal checklist is designed to harmonize the international regulatory need for medical devices and their related products.

If you want ISO 13485 lead auditor certification online, then you should search for a genuine certification company like Assurance Quality Certifications LLC and then follow their guidelines with on-screen instructions to get the audit and assessment done for your MDQMS certifications.

You will get ISO validated certification from AQC which is a global certification body with UAF and EGAC approvals.

Key needs for ISO 13485 training certification:

  • PAN card related to LLP/Proprietorship/Company
  • A valid incorporation certification
  • Proprietor/LLP/Company related business objectives
  • Recent or updated purchase bills related to Medical devices
  • GST Registration certification
  • Cancelled letterhead
  • Signed/stamped attendance sheet
  • NOC from the Pollution Control Board
  • List of all medical devices/equipment with their latest testing report

ISO 13485 is an internationally approved Medical Device Quality Management System (MDQMS) framework that focuses on boosting customer satisfaction by delivering the best of services in medical devices for better treatment of patients. The latest edition of ISO 13485 was published in March 2016 and thus it is also known as ISO 13485:2016 certification.

ISO 13485_ 2016 framework is very crucial for the medical device service sector as this standard offers a sense of satisfaction and a valid authorization to manufacturers for producing quality medical devices without limits with ISO-certified testament. One can easily get this certification from AQC to promote scalability and customer satisfaction as these help in promoting the dignity and legacy of the company. The service provider is globally acclaimed for promoting Medical Device Quality Management System (MDQMS.)

For implementing ISO 13485 certification, you should follow these steps:

  • Create documentation: It helps in guiding and providing valid certification authority
  • Train your enterprise: Get your employees/staff trained with ISO 13485 (MDQMS) compliance.
  • Conduct internal audits: You should follow the auditor certification guidelines for accessing performance and to meet ISO 13485 standards.
  • Undergo third-party audits and adhere to the certification company’s guidelines: Third-party audits help you make a valid approach with the internationally approved framework.
  • Follow ISO standard requirements: You need to follow the requirements of ISO standards like risk management, change management, process validation etc.