We’ll Get Your Company ISO 13485 QMS – Guaranteed
Your customers need you to be certified. Don’t wait any longer. We will put you on the path to achieving ISO 13485 QMS certification starting this month.
What ISO 13485 QMS Certification Can Do For You
Increase Profits
ISO 13485 QMS helps your business increase profitability by improving processes and reducing errors. It also keeps your customers satisfied with reliable, high-quality products and services that encourage repeat business.
Expand your Customer Base
Your customers need you to be ISO 13485 QMS certified. Many large OEMs, distributors, and healthcare organizations only do business with ISO 13485 certified suppliers.
Save Time and Money
ISO 13485 enforces strong process control, risk management, and traceability. This reduces waste, rework, warranty claims, and product recalls, all of which are very costly in the medical device industry.
Achieve ISO 13485 QMS In 3 Simple Steps
ISO Readiness Evaluation
Precise, expert-led assessment of your current system against ISO 13485 QMS. You will receive a clear, prioritized roadmap showing where your business stands, where it is non-compliant, and what needs to happen to achieve certification.
Business Upgrade
We will implement all required actions, update your documentation, and fully align your business to the chosen standard, making it ready for certification.
ISO 3485 QMS Awarded
We will support you through the external assessment, ensuring you pass without issues and receive your ISO 13485 QMS certificate on the first attempt.
What Makes Us Different?
Guaranteed
Every client that has worked with us has achieved ISO 13485 QMS certification.
Results
Our primary focus is to guarantee our clients results. Our reputation is built on this.
Local
We are not hidden away in an anonymous call center.
We work locally, so you know where to find us if you need us.
Specialised
We work with industries where we know we can guarantee results.
30 Years Plus Experience
Our team of experts has over 30 years of combined experience assisting all types of organizations in achieving ISO certification. Our journey of excellence has been marked by a deep commitment to quality, innovation, and an unwavering dedication to helping businesses achieve and maintain the highest standards in their industry.
Track Record of Success
Our history is marked by countless successful ISO implementations, certifications, and ongoing compliance achievements for our clients. This success reflects our rigorous, client-focused approach.
Qualified Teams
Our team consists of dedicated, friendly professionals who bring a wealth of knowledge and practical experience in ISO standards, ensuring our consulting services are not just theoretical but grounded in real-world applications.
Long Term Client Relationships
The longevity of our client relationships reflects the trust and value we provide. Our commitment to their continuous improvement has made us a preferred partner for many businesses.
Contact us For A Free Quotation
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Frequently Asked Questions
What is ISO 13485 certification?
ISO 13485 certification is a globally recognized standard designed specifically for quality management systems in the medical device industry. It sets out the requirements for a comprehensive management system focused on the design, production, installation, and servicing of medical devices. Achieving this certification demonstrates a company’s commitment to the highest standards of quality and safety in the development and manufacturing of medical devices. ISO Consultants U.S. specializes in guiding businesses through the complex process of obtaining ISO 13485 certification, ensuring compliance with regulatory requirements and enhancing product quality, thereby instilling confidence among stakeholders and customers in the highly regulated medical device sector.
What is a ISO 13485 Quality Management System?
A Quality Management System (QMS) for medical devices, as defined by ISO 13485, is a structured and comprehensive framework that ensures the consistent design, development, production, and delivery of medical devices that are safe and effective. It focuses on meeting customer and regulatory requirements, risk management, and maintaining effective processes. ISO Consultants U.S. specializes in developing and implementing a QMS that not only adheres to ISO 13485 standards but also optimizes operational efficiency and product reliability. Our consultancy helps medical device manufacturers integrate critical quality processes into their operations, ensuring their products consistently meet the highest industry and regulatory standards.
The benefits of a gap analysis
A gap analysis is a crucial first step in your journey toward ISO 13485 certification, and it plays a pivotal role in our consultancy services at ISO Consultants U.S. This process involves a detailed assessment of your current Quality Management System against the specific requirements of the ISO 13485 standard. The primary benefit of a gap analysis is that it identifies areas needing improvement, enabling a targeted approach to meet the stringent quality and regulatory demands of the medical device industry. By pinpointing these gaps, we can develop a focused strategy to enhance your systems, ensuring a streamlined path to certification and bolstering your commitment to product safety and efficacy.
Why templated Management Systems do not work
In the dynamic world of medical device manufacturing, a templated system for ISO 13485 can be a misstep. Each organization in this sector has distinct processes, product types, and regulatory environments, making a one-size-fits-all QMS inadequate. At ISO Consultants U.S., we recognize that the complex nature of medical devices demands a more tailored approach. A generic template may overlook specific challenges and nuances of your products and processes, potentially leading to compliance issues and operational inefficiencies. Our consultancy prioritizes a customized QMS solution, ensuring that your system aligns perfectly with your unique operational needs and regulatory obligations, thus paving the way for excellence in quality management.
Can I integrate to include other ISO standards?
Integrating an ISO 13485 Quality Management System (QMS) with other ISO management systems offers a streamlined, cohesive approach to compliance and operational excellence. At ISO Consultants U.S., we specialize in harmonizing ISO 13485 with standards like ISO 9001 for Quality Management and ISO 14001 for Environmental Management. This integration creates a comprehensive system that manages not only medical device quality but also encompasses broader aspects of quality management and environmental responsibility. Such a unified system enhances efficiency by reducing duplication of efforts and simplifies the management of multiple certifications. Our consultancy ensures that your integrated system remains robust, compliant, and perfectly aligned with your business objectives and regulatory requirements..
How much does ISO 13485 certification cost?
The cost of implementing ISO 13485 varies depending on several factors such as the size and complexity of your organization, the current state of your existing quality processes, and the specific needs of your medical device portfolio. At ISO Consultants U.S., we provide a transparent and flexible approach to pricing, ensuring that our consultancy services are both effective and cost-efficient. We work with you to develop a tailored Quality Management System that not only meets ISO 13485 requirements but also aligns with your budgetary considerations. Our goal is to offer a value-driven service that enhances your quality management without imposing unnecessary financial burdens, ultimately leading to a beneficial investment in your organization’s future.
What is the external audit assessment process?
The external audit for UKAS ISO 13485 initial certification is conducted in two stages. The first stage is a preliminary assessment to review your company’s QMS documentation and readiness for the stage two audit. This includes evaluating your organization’s understanding of ISO 13485 requirements and the scope of the QMS, ensuring the standard has been effectively implemented within your processes. The second stage is the actual certification audit, where the auditor verifies that the QMS is fully practiced and that all ISO 13485 requirements are met in action. The auditor observes operations, interviews employees, and reviews documented evidence to confirm system effectiveness and identify any non-conformities. If successful, the UKAS certification is issued, demonstrating that the organization meets quality management system standards and reflecting a commitment to quality and continuous improvement.
What are the benefits of ISO 13485 certification?
The external audit for UKAS ISO 13485 initial certification is conducted in two stages. The first stage reviews your company’s QMS documentation and readiness, ensuring ISO 13485 requirements are understood and effectively implemented. The second stage is the certification audit, where the auditor verifies that your QMS is fully practiced, observing operations, interviewing employees, and reviewing documented evidence to confirm compliance and identify any non-conformities. Successful completion results in UKAS certification, demonstrating that your organization meets rigorous quality management standards and reflecting a commitment to continuous improvement and operational excellence.