Standard ISO 13485: Quality management medical devices

Prove the safety and quality of your medical devices with ISO 13485

Safety and quality. Two words you want to be inextricably associated with as Organisation in medical devices. How do you do that? By managing your quality with ISO 13485. The international quality management system for all medical devices for the diagnosis, prevention and treatment of diseases and medical conditions. From plasters to pacemakers.

The benefits for your organisation

Do you work for a organisation that designs, manufactures, installs or maintains medical devices? Then you'll experience 4 major benefits:

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NBN EN ISO 9001:2015

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Quality management - Requirements (ISO 9001:2015)

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In accordance with European requirements
You guarantee that your medical devices meet all strict European safety and quality requirements.
Conforms to CE mark and MDR 93/42/EEC
Your products are CE marked and MDR 93/42/EEC compliant. The CE label proves that your product meets all European safety, health and environmental requirements.
Clear for producers and buyers
Another big plus: the ISO 13485 quality standard creates clarity for both producers and buyers.
Safe for end consumer
Finally, you protect your end consumer thanks to guaranteed security after sale.

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The quality, conformity and safety of our equipment is essential. As IBA operates all over the world, our equipment must meet the requirements of the market authorities in different countries. International as well as local standards are an indispensable tool to ensure that we meet all those legal requirements.

CaterinaBrusasco
R&D Compliance Expert at IBA.

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Prove your quality with a certificate

Are you a manufacturer of medical devices? Then it is interesting to obtain ISO 13485 certification.

Why?

You demonstrate the ability to market safe medical devices.
Being a certified Organisation increases your chances of contracting with large companies.
You improve your internal processes and decision-making.
Certified organisations create a culture of improvement.
You prove your commitment to safety and quality.
You meet the requirements of both the side and the legislature.

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Want to know more about certification? You can read all about it here.

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Higher sales

You constantly respond to the needs of your customers and increase their satisfaction. That's how you put them first. The result: you ensure customer loyalty, attract new customers and increase your sales.

Demonstrable quality

With the ISO 9001 quality management system, you show your customers and other stakeholders that you provide high-quality, reliable products or services.

Lower costs

Thanks to the four-step cycle, you reduce the likelihood of errors. Your organisation also works more efficiently, reducing the time and resources you need to invest in it.

Greater flexibility

You focus strongly on risks and opportunities. This allows you to respond optimally to changes in the market and your organisation. Thanks to this strong adaptability, you stay one step ahead of the competition.

New markets

Does your organisation operate internationally? Then ISO 9001 is an important tool for bringing in new customers.

More customer satisfaction

You don't just say you are customer-centric, you embody it. By meeting customer expectations and needs, and even exceeding them.

Tailored to each organisation

You can use ISO 9001 for any type of organisation: small or large, private or public, NGO, college, hospital, etc.

Strong commitment

You actively involve your own employees in the quality management system. This gives them more responsibility and trust, leading to higher productivity, better decision-making and greater satisfaction in the workplace.

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Getting started with ISO 13485

Ensuring the quality and safety of your medical devices? You can easily do so by getting started with ISO 13485 on our standards platform. This gives you an instant and convenient overview of all the requirements for an effective quality management system.

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^{Getting started with ISO 13485}

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Frequently Asked Questions

How do I access the ISO 9001 standard?

I want to learn more about the basics of ISO 9001

How long is ISO 9001 valid?

Can your organisation be certified by NBN?

Is ISO 9001 mandatory?

ISO 9001 is not mandatory. It is a voluntary international quality management standard that can be applied by organisations to improve their quality performance and meet customer expectations.

Although ISO 9001 certification is not mandatory, it can be essential for certain organisations to remain competitive in the marketplace. Many customers and business partners request ISO 9001 certification as proof that an organisation meets international quality management standards. This can be especially true in government procurement, large business contracts or in industries where quality plays a crucial role, such as manufacturing, healthcare and service industries.

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