ISO 13485:2016 Medical Devices
At each stage of your product’s life, regulatory requirements are scrutinised – be it in the manufacture, delivery, or service stages. Laboratories and other organisations in your industry are expected to exemplify a sound quality management system (QMS) to demonstrate best practices.
Are you keen to ensure the devices in your medical laboratory are safe, effective, and delivered to a high standard? Do you want to be brought up to speed with national and global requirements for your industry? As a medical device manufacturer, ISO 13485:2016 is the most accepted global standard of its kind. If your business wants to put competency at the forefront of your operations, IMSM can talk you through how this certification will improve and validate the way you work.
What is ISO 13485:2016?
ISO 13485:2016 ensures that medical devices used in healthcare settings are designed, produced, installed, and serviced to the highest standards. As any business owner knows, these standards must not only meet client obligations, but also regulatory and legal specifications. Adopting ISO 13485:2016 into the heart of your practices means you will build a clear, practical foundation to address these specifications, as well as demonstrate a commitment to safety, quality, and competence.
Benefits of ISO 13485:2016:
- Taking control of your supply chain
A good tell of whether the organisations in your supply chain are quality focused is to see if they are ISO 13485 certified. You are an original equipment manufacturer (OEM) of medical devices, so it is your responsibility to ensure that every producer within your supply chain is regulation compliant. Are they all working to identify risks and prevent defects in their own processes? Without ISO 13485:2016’s mark of quality, verification can be a tedious and unrewarding task.
- Ensuring control processes are robust in every step of your product’s life
From development, to manufacture, to distribution, every stage of your product’s journey needs to be carefully controlled so that it meets regulation and avoids inadequacy at any step. ISO 13485:2016 makes the process less overwhelming by providing you with a solid, easy-to-manage framework to help you manage your control processes.
- Reducing costs through a more efficient QMS
ISO 13485:2016’s carefully curated framework not only prioritises best practices in the product journey, but also the efficiency of these practices. With a methodical approach to medical device manufacturing, you will have a logical plan for your workforce, saving time and reducing waste.
- Becoming up-to-speed with the needs of regulatory authorities in your area
In a time when public health is at the forefront of everyone’s mind, authorities are more stringent than ever when it comes to regulating the medical device manufacturing industry. ISO 13485:2016 provides you with a useful framework that has already taken into account that there will be legal requirements associated with the medical device, so it makes these easy to control and manage.
- Qualified with an internationally-recognised certification
ISO 13485:2016 is the leading qualification of its kind, meaning it is recognised across the world as a mark of quality and competence. Certification gives you confidence to emerge onto the global market and open yourself up to new business opportunities.
How can ISO specialists help your business?
Due to the technical nature of ISO 13485:2016, getting started with the certification could leave you feeling dismayed, which is why lots of businesses choose to use the expertise of an ISO consultant to support and guide you through to certification. Our experienced consultants take the lead in assessing your business, helping you use the results to improve your medical device manufacturing QMS. In addition, IMSM can provide you with internal auditor training to demonstrate your competence.
Simple: we make it simple. We have been helping businesses achieve ISO certification since 1995 and have over 150 expert consultants operating around the world. With 15,000+ clients that have trusted us to implement ISOs, we are the experts and will do the heavy lifting, saving your company precious time. With a transparent fixed fee and flexible approach, we work with your business to make the process of gaining ISO 13485 as straightforward and beneficial as possible.
We strive to make ISO certification as straightforward as possible with our:
- World-class gap analysis
- Experienced and diverse ISO Consultants
- Flexible terms and contract
- Fixed fee
- Full implementation
Steps to getting ISO 13485:2016 certification
The process of getting ISO 13285:2016 certified with IMSM is a trouble-free step-by-step approach.
- Initial consultation
We help you outline your goals, focusing on what your business wants to achieve and how it defies success, particularly in relation to your clients’ requirements. Together, you and our ISO consultant will agree reasonable outcomes and delivery dates.
- Producing your organisation’s ISO 13485:2016 documentation
Next, the IMSM consultant will assess your existing procedures and help you document the new systems that will help deliver success – both existing and how you will improve these. This documentation sets out how your business should operate going forward so that it can deliver ISO 13485:2016.
- Training you to adopt the ISO 13485:2016 framework
While the documentation is important moving forward, it is even more important that it is put to practical use. We work with the senior management team to ensure the framework is embedded throughout your organisation.We can also develop and deliver tailored training for your staff to ensure the understanding and implementation of ISO 13485:2016 is robust and to enable you to demonstrate your competence. This will create consistency across your organisation, transforming your business from day one so it is competent and risk conscious.
- Submission to a third-party external auditor
Before you can be awarded the ISO 13485:2016 certification, your organisation applies to the third-party certifying body that you have selected to conduct your audit. This audit is an objective view on whether your business is conforming to ISO 13485:2016. As we will have provided excellent support and guidance to your business every step of the way, you can be assured that the outcome will be successful.
- ISO 13485:2016 awarded
Once confirmed that you are ISO 13485:2016 compliant, your organisation will be presented with your certificate. This international certification will be recognised by current, potential, and future clients as a mark of excellence in medical device manufacturing.Take a look at our case studies to find out how IMSM has helped implement medical device manufacturing QMS from real-life examples or request a call back for more information about how we can help you.
Is ISO 13485:2016 mandatory?
ISO 13485:2016 certification is not mandatory; however, it brings your practices up to date with compliances that exist across the country, the EU and globally which very well may be mandatory.
How to get ISO 13485:2016 certification?
Medical device manufacturers often find that the assistance of expert consultants helps them to easily implement ISO 13485:2016 into their core processes. With IMSM, our consultants work directly with you to ensure your QMS works for your organisation. We help you design your control requirements in line with the standard, then submit you to a recognised, third-party certification body who will audit your business and get you ISO 13485:2016 certified.
Find out more about getting certified here.
How long does it take to get ISO 13485:2016 certification?
The length of time taken to get ISO 13485:2016 certified depends on the size and complexity of your company. It is estimated that it can take 4-6 months for companies with less than 50 employees. For larger companies, it can take 6-12 months as complex manufacturing processes like sterilisation can prolong the process.
Is ISO 13485:2016 required for CE mark?
It is not mandatory to be ISO 13485:2016 certified, but to be awarded the CE marking, you will need to provide evidence of a thorough QMS as required by the MDR. If you’re not ISO 13485:2016 certified, you will need to convince the governing body that your QMS is equally as good or better than one that has been built using the ISO 13485:2016 framework.
If you want to know more about ISO 13485:2016 and the certification process, download our guide!
For a free Quotation or Remote presentation by an ISO Specialist, contact us today!
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