ISO 13485:2016 Certification Guaranteed

Your Organisation Needs ISO 13485 Certification

But you already have 101 things to do on your to-do list.

Which are all important!

So How Do You Achieve ISO 13485 Certification?


Do it Yourself?

No problem if you have little to do.

But if you are already busy… then this is not a feasible option.

Hire New Staff?

Finding good people is difficult, training is expensive.

And even if you find that perfect person… you’re still dependent on 1 person!


Buy A Pre Made Templated System?

Square pegs don’t fit in round holes.

Buying a templated system that does’t fit your business will cause more issues and further expense.

Why You Should Choose Us



Every client that has worked with us, achieved ISO 13485 certification.


Our primary focus is to guarantee our clients results. Our reputation is built on this.


We are not hidden away in an anonymous call center.

We work locally, so you know where to find us if you need us.


We work with industries where we know we can guarantee results.

30 Years Plus Experience

At ISO Consultants U.K., our team of experts have over 30 years combined of experience assisting all types of organisations achieve 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 decorated with countless successful ISO implementations, certifications, and sustained compliance achievements for our clients. This success rate is a testament to our rigorous, client-focused approach.

Qualified Teams

Our team comprises of dedicated, friendly professionals who bring a wealth of knowledge and practical experience in ISO standards, ensuring that our consultancy services are not just theoretical but grounded in real-world applications.

 Long Term Client Relationships

The longevity of our client relationships speaks to the trust and value we deliver. Our commitment to their continual improvement has made us a preferred partner for many businesses.

Contact us For A Free Quotation

Would you like to know how we can help you? Fill in the form, submit your requirements and we will contact you.

No obligations, no annoying sales talk, we’re both too busy for that.

Frequently Asked Questions

What is ISO 13485 certification?

ISO 13485 certification is a globally recognised 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.K. specialises 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 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.K. specialises in developing and implementing a QMS that not only adheres to the ISO 13485 standards but also optimises operational efficiency and product reliability. Our consultancy helps medical device manufacturers to 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 towards ISO 13485 certification, and it plays a pivotal role in our consultancy services at ISO Consultants U.K.. 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 organisation in this sector has distinct processes, product types, and regulatory environments, making a one-size-fits-all QMS inadequate. At ISO Consultants U.K., we recognise 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 prioritises a customised 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.K., we specialise in harmonising 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 organisation, the current state of your existing quality processes, and the specific needs of your medical device portfolio. At ISO Consultants U.K., 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 the 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 organisation’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 organisation’s understanding of the requirements of ISO 13485 and the scope of the QMS. It ensures that the organisation has effectively implemented the standard within its processes. The second stage is the actual certification audit, where the auditor will verify that the QMS is being fully practiced and that all ISO 13485 requirements are met in action. The auditor observes operations, interviews employees, and reviews documented evidence to confirm the system’s effectiveness and identify any non-conformities. If the audit is successful, the UKAS certification is issued, demonstrating that the organisation meets the standards for quality management systems. This certification is a testament to an organisation’s commitment to quality and continuous improvement.

What are the benefits of ISO 13485 certification?

Implementing ISO 13485 certification through our consultancy services brings numerous benefits to your medical device company. Firstly, it ensures global recognition for adhering to the highest quality management standards in the medical device industry. This enhances your credibility and trust among stakeholders, including regulatory bodies, and opens doors to international markets. ISO 13485 certification also streamlines your production processes, ensuring efficiency and consistency in product quality. It mitigates risks associated with device manufacturing and boosts customer satisfaction by ensuring the safety and reliability of products. Furthermore, this certification demonstrates your commitment to continual improvement, a key factor in maintaining a competitive edge in the ever-evolving medical device sector.


  1. Global Recognition: Gains international acceptance and credibility in the medical device industry.
  2. Enhanced Product Quality: Ensures high standards in the design, development, and production of medical devices.
  3. Improved Risk Management: Provides a systematic approach to managing risks throughout the product lifecycle.
  4. Regulatory Compliance: Facilitates compliance with global regulatory requirements, reducing legal risks.
  5. Operational Efficiency: Streamlines processes, reducing errors and increasing productivity.
  6. Market Access: Opens up opportunities in global markets that recognise or require ISO 13485 certification.
  7. Customer Trust: Increases customer confidence in the safety and efficacy of products.
  8. Competitive Advantage: Differentiates the company from competitors who are not certified.
  9. Continuous Improvement: Fosters a culture of ongoing improvement in quality management processes.
  10. Employee Engagement: Improves staff morale and involvement through clear protocols and safer workplace practices.


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