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Select your ISO 13485 Auditor Course

Available 24/7 :: Any time, Any place, Any device

Products SKU Attributes Content Price Action
ISO 13485 Lead Auditor Refresher
Course 036R
+ ISO 21001 Accredited :: Available on-demand 24/7
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$1,020
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ISO 13485 Lead Auditor Extension
Course 036X
+ ISO 21001 Accredited :: Available on-demand 24/7
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$1,020
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ISO 13485 Lead Auditor Training
Course 036
+ ISO 21001 Accredited :: Available on-demand 24/7
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$1,415
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ISO 13485 Transition Training
Course 035T
+ ISO 21001 Accredited :: Available on-demand 24/7
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$865
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ISO 13485 Lead Implementer Certification
Course 035
+ ISO 21001 Accredited :: Available on-demand 24/7
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$1,180
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ISO 13485 Internal Auditor Extension
Course 034X
+ ISO 21001 Accredited :: Available on-demand 24/7
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$315
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ISO 13485 Internal Auditor Refresher
Course 034R
+ ISO 21001 Accredited :: Available on-demand 24/7
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$315
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ISO 13485 Internal Auditor Training
Course 034
+ ISO 21001 Accredited :: Available on-demand 24/7
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$470
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ISO 13485 Consultant & Lead Auditor Diploma
Course 603
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$1,415
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Courses have been updated February 2022

Our Courses have been updated to include Introduction to Regulations and Guidelines – EU, UK and USA, New US FDA QMSR regulations, Annex ZA and ZB of ISO 13485:2016 Amendment 11.

Frequently Asked Questions About ISO 13485

  • What is ISO 13485?
  • What is the purpose of ISO 13485?
  • What is a Medical Device Management System (MDMS)?
  • What is the Purpose of a Medical Device Management System?
  • Who needs a Medical Device Management System?
  • What are the Benefits of a Formal Medical Device Management System?
  • What is ISO 13485 Certification?
  • Who needs ISO 13485 Certification?
  • What are the benefits of having ISO 13485 Certification?
  • How can you be sure that the ISO 13485 Certificate is legitimate and internationally-recognized?
  • How can you get an ISO 13485 Certificate?
  • How does ISO 13485:2016 differ from ISO 13485:2012?
  • How else do the ISO 13485:2016 versions differ from the previous one?
  • What is the difference between ISO 13485:2016 and EN ISO 13485:2016?
  • How can changes in the ISO 13485:2016 versions affect organizations?
  • What is ISO 13485 Training?
  • Is this training mandatory?
  • How Can I Enroll in an ISO 13485 Training Course?

What is ISO 13485?

ISO 13485:2016, the latest version of the ISO 13485 standard, is an internationally-recognized standard that sets out the requirement for a Medical Device Management System (MDMS).

It was initially published in 1996 as ISO 13485:1996 and revised in 2003.  Associated standards since replaced by ISO 13485 include ISO 13488, EN 46001 and EN 46002. The current standard has been adopted by the EU as a harmonized standard with the title EN ISO 13485:2016.

What is the purpose of ISO 13485?

The purpose of the Standard is to specify requirements for a quality management system that can be used by an organization involved in one or more stages of the life cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g., technical support).

The requirements in this International Standard can also be used by suppliers or other external parties providing products (e.g., raw materials, components, subassemblies, medical devices, sterilization services, calibration services, distribution services, maintenance services) to such organizations. For more, visit ISO 13485 and Supplying to the Medical Device Sector: FAQs.

What is a Medical Device Management System (MDMS)?

An ISO medical device management system is a formalized system that documents processes, procedures, and responsibilities covering all aspects of design, manufacturing, supplier management, risk management, complaint handling, clinical data, storage, distribution, product labeling, etc.

It is expressed as the organizational goals and aspirations, compliance with applicable regulations and standards, and the resources needed to implement and maintain them.

Most medical devices will require some form of a QMS; the complexity of the MDMS will vary based on the classification of the device and the technical and manufacturing difficulties.

What is the Purpose of a Medical Device Management System?

A medical device management system helps coordinate and direct an organization’s activities to meet Customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis. And to provide documentary and other evidence to facilitate third-party, independent auditing of the system to demonstrate compliance with the standard requirements.

Who needs a Medical Device Management System?

All organizations involved in one or more stages of the life cycle of a medical device, whether they realize it or not, already have an informal MDMS. You look after your customers, don’t you? You strive to consistently provide customers with good medical device products, components, or services. You are always trying to improve to stay ahead of competitors?

So, you have an MDMS, and the fundamental question is, do we need to formalize the system? Invariably, the answer is yes.

As ISO 13485 becomes the recognized Standard throughout the medical device lifecycle, a formal medical device management system becomes a prerequisite. If you are a component manufacturer or logistics company wishing to break into the medical device sector, having an ISO 13485 Certificate to present will open doors.

And strangely, an organization does not need to be involved in medical device production or support in any way to qualify for an ISO 13485 Certificate. Intent to get involved is enough!

 

What are the Benefits of a Formal Medical Device Management System?

  1. A body of evidence demonstrating compliance with applicable legal and regulatory requirements. Under EU MDR and IVDR, a formidable mass of documentation can be required.
  2. Management systems are designed to:
    • Get it right the first time,
    • Be consistent and reliable,
    • Seek out the root causes of problems,
    • Not to repeat mistakes.
  3. All aspects of supply, installation, and maintenance throughout the product lifecycle are done in compliance with applicable regulations.
  4. Organized management: An organization certified to the Standard is managed in a standard and structured way.
  5. Clarity of Purpose: Staff know their responsibilities, authorities, and accountabilities.
  6. Processes and procedures suited to the Mission and strategic objectives that you have set for the organization.
  7. Internal audits to monitor compliance with requirements and highlight deficiencies.
  8. Corrective actions to prevent the recurrence of errors – try to make mistakes only once, if at all.
  9. An informed Board of Directors, knowing that the organization is focused on strategic objectives while satisfying compliance requirements and planning and acting to address future challenges.
  10. Management satisfaction knowing that the organization is functioning in line with strategic objectives.
  11. Reduce errors: Fewer costly errors, less rework, replacement of goods and/or services, and increased productivity.
  12. Fewer customer complaints as fewer errors occur.
  13. Better retention of customers: a consequence of reduced errors.
  14. Management performance improved as less time is spent apologizing to customers and managing the unnecessary repetition of work.

 

What is ISO 13485 Certification?

An ISO 13485 Certificate is recognition from a Certification Body – CAB (usually an accredited Certification Body), or in relation to EU regulations, a Notified Body, that an organization has implemented and is maintaining a quality management system that meets the requirements of ISO 13485:2016.

Who needs ISO 13485 Certification?

Organizations globally, both in the public and private spheres and from every economic sector involved in providing medical device products and associated services, need to demonstrate compliance with ISO 13485.

Relevant organizations would include distributors and those trading in medical devices, and this can apply to any stage of the lifecycle. For more, see ISO 13485 Certification for the Medical Device Supply Chain.

What are the benefits of having ISO 13485 Certification?

  1. Feedback: First and foremost, ISO 13485 Certification is about confirming compliance with regulation and then through Feedback (including PMS – Post Market Surveillance) that the device remains fit-for-purpose in fulfilling its specification and purpose and identifying opportunities for improvement.
  2. Reputation: Be taken seriously as a prospective supplier, other than a manufacturer, as the holder of ISO 13485 Certification, based on the independent assessment of an accredited certification body.
  3. Qualify for pre-tender and tender opportunities, especially for distributors to the public sector.
  4. Status: On equal terms with the ‘big’ boys’ – the size of your organization won’t hold you back. And for newcomers, you demonstrate commitment to the medical device sector.
  5. Risk management is implemented by manufacturers and others to ensure the safe and misuse of the device. Invariably, ISO 14971 is used here. Apart from this, a risk-based approach is applied to all processes.
  6. Objectives and improvement obligations focus you on setting targets for improvement and then planning and implementing them in a timely manner.

 

How can you be sure that the ISO 13485 Certificate is legitimate and internationally-recognized?

CABs issue certificates to organizations after they have undergone an ISO Certification process. This process is based on a comprehensive two-stage audit (itself based on the auditing standard ISO 19011) that involves a documentation review and an independent on-site audit.

The CAB gathers and documents objective evidence of compliance with the requirements of ISO 13485. After the CAB has confirmed that all the requirements of the ISO 13485 Standard have been implemented and are being maintained, a Certificate is issued as is permission to use logos to publicize the fact.

How can you get an ISO 13485 Certificate?

The IAF logo is important for medical device manufacturers in countries where their accreditation body is not well known on the world stage. It signifies worldwide recognition without any doubt as to legitimacy.

The EA, an association of 49 national accreditation bodies in Europe, has completed the administrative requirements of the IAF (International Accreditation Forum) necessary for the extension of their IAF multilateral recognition arrangement (MLA) to include ISO 13485.  This omission has in the past, for example, been a barrier for European medical device exporters in gaining access to markets such as Australia.

The availability of the IAF logo for ISO 13485 certification means that any conformity assessment body (CAB)accredited by the European accreditation body can apply the IAF MLA mark to their ISO 13485 Certificates.

Three logos on ISO 13485 certificates are the new normal in Europe:

  1. The CAB logo,
  2. The EA member National Accreditation Body logo and
  3. The IAF logo.

The Australian Therapeutic Goods Administration (TGA), which previously had refused to recognise the legitimacy of ISO 13485 certificates carrying EA member accreditation, now accepts (according to their website) certificates carrying the IAF MLA Mark.

How does ISO 13485:2016 differ from ISO 13485:2012?

Compared to ISO 13485:2012, the 2016 version places greater emphasis on risk management and risk-based decision-making for processes outside the realm of product realization.

This version, like its predecessor, requires the application and documentation of risk management to the control of the appropriate processes. This is not to be confused with the ‘risk-based approach’ of ISO 9001:2015.

The focus is on risks associated with the safety and performance of medical devices and compliance with regulatory requirements. In addition, the Standard asks organizations to be more stringent when it comes to outsourcing processes by putting into place controls (e.g., written agreements) for assessing their suppliers, again based on risk.

How else do the ISO 13485:2016 versions differ from the previous one?

ISO 13485:2016 incorporates significant changes to quality management systems requirements for medical devices, including…

  • Application to organizations throughout the life cycle and supply chain for medical devices;
  • Expanded requirements for…
    • document management,
    • management review, and
    • human resources;
  • Emphasis on appropriate infrastructure, work environment, and contamination control, particularly for the production of sterile medical devices, and addition of requirements for validation of sterile barrier properties;
  • Additional requirements for…
    • planning, and
    • record keeping;
  • Increased linkage and communication with regulatory requirements, particularly for regulatory documentation;
  • Additional requirements in design and development on consideration of usability, use of standards, verification and validation planning, design transfer, and design records;
  • Harmonization of the requirements for software validation for different software applications (QMS software, process control software, software for monitoring and measurement) in different clauses of the standard;
  • Emphasis on complaint handling and reporting to regulatory authorities in accordance with regulatory requirements, consideration of post-market surveillance, and
  • Planning and documenting corrective action and preventive action and implementing corrective action without undue delay.

 

Other changes include more explicit detail related to the nature of the organization and the life-cycle stages covered by ISO 13485 QMS.

It contains requirements related to the control of changes to processes. The standard also addresses new requirements to protect confidential health information.

What is the difference between ISO 13485:2016 and EN ISO 13485:2016?

The harmonized EN edition is identical word-for-word with the international edition. However, it contains three additional annexes identifying where compliance with the Standard does not adequately address requirements in EU Directives.

These three ISO 13485 Annex Z’s provide greater clarity on the applicability and alignment of the current AIMDD (active implantable medical device directive), MDD (medical device directive), and IVDD (in vitro medical device directive) with the Standard.

How can changes in the ISO 13485:2016 versions affect organizations?

The structural relationship between ISO 13485:2016 and ISO 9001:2015 is outlined in Annex B.

The mismatch between the two Standards is clearly to be seen, and those manufacturers and suppliers who require certification to both Standards are advised to have two Quality Manuals, one for each Standard, to show how quality policy will address the differing requirements. An integrated set of procedures can then implement the policies across the common processes.

What is ISO 13485 Training?

ISO 13485 involves training programs designed to equip auditors, lead implementers, quality managers, and other management system professionals with the necessary skills and knowledge to develop, implement, maintain, or audit Medical Device Management Systems and ensure their compliance with the requirements of ISO 13485.

Is this training mandatory?

Yes and No.

Management Representative or other professionals with day-to-day responsibility in maintaining an MDMS are not required to undergo ISO 13485 training. It is instead implied as already part of developing competence. It is not a specific stand-alone requirement.

That said, ISO 13485 training is strongly recommended as effective internal audits are essential to doing a professional job in maintaining your Medical Device Management System and preparing it for Certification Body audits.

How Can I Enroll in an ISO 13485 Training Course?

You can enroll in any of deGRANDSON’s online training courses by going to the product page of the course you want to enroll in. Once there, add the course to your cart and then proceed to checkout and payment.

Once you’ve paid for the course, you will be asked to provide the email address or addresses of the people who will be enrolling in the course. They will then receive an email providing the username and password they would need to access deGRANDSON’s Learning Management System where the training is delivered.

Please see this video to see a more visual demonstration of the enrollment process.

Need more information on ISO 13485 Certification?

Get a copy of our ISO 13485 FAQs eBook to see our answers to the complete list of frequently asked questions about ISO 13485.


ISO 13485 FAQs Handbook

Download free ISO 13485 FAQs eBook

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Here you'll find the ISO 13485 Training Course you want

Your specific situation will determine which is the best course for you.

I want ISO 13485:2016 Internal Auditor Certification. Which course should I take?

CLICK HERE TO LEARN MORE

This 12-hour ISO 13485 Internal Auditor training course is the course you need to become a certified internal auditor and be qualified to perform internal audits.

I'm newly responsible for my organization's Medical Device Management System. Which course should I take?

Quality Managers who don’t feel confident about ISO 13485: 2016 and its requirements are suited for this ISO 13485 Lead Implementer course. It will help you understand what an efficient and effective Medical Device Management System looks like.

CLICK HERE TO LEARN MORE

We manufacture medical device components. I've been tasked with getting our ISO 13485 certification. Which course should I take?

Our 30-hour ISO 13485 Lead Implementer course is ideal for you.  You may need some consultancy support on implementation, but that should be limited. Furthermore, you’ll know the ‘right’ questions to ask.

Implementing a Medical Device Management System yourself can be challenging. However, it’s a great way to quickly introduce changes needed to secure and retain ISO 13485 certification.

CLICK HERE TO LEARN MORE

I'm a Medical Device Management System Lead Auditor and want to upgrade to the new Standard. Which course should I take?

Update your Lead Auditor certification to the latest standard with this 24-hour ISO 13485:2016 Lead Auditor Conversion Course.

CLICK HERE TO LEARN MORE

I'm already a Lead Auditor and I'd like to add ISO 13485:2016 to my auditor certification. Which course should I take?

This 26-hour ISO 13485 Lead Auditor Extension course will let you add ISO 13485 to your lead auditor certification.

CLICK HERE TO LEARN MORE

I want ISO 13485:2016 Lead Auditor Certification. Which course should I take?

This ISO 13485 Lead Auditor course provides in-depth knowledge of the Standard and of Auditing skills. This is the certification you need if you hope to audit for a Certification Body.

CLICK HERE TO LEARN MORE

We're certified in the old standard. Now, I want to upgrade our Medical Device Management System to meet the ISO 13485: 2016 requirements. Which course should I take?

This Transition Training package includes an ISO 13485: 2016 Implementation Handbook. Packed along with it is a documentation toolkit, lots of sample paperwork, and a Gap Analysis Tool.

CLICK HERE TO LEARN MORE

I want to be an Medical Device Management System Consultant. Which course should I take?

This 30-hour ISO 13485 Lead Implementer course includes a 33-step Path to Certification, a 100+ page ISO 13485: 2016 Implementation Handbook.

It also includes a Documentation Toolkit that contains sample SOPs and record forms. Examples of audit schedules and management review agenda are included as well.  Truly beneficial to a new MDMS consultant.

CLICK HERE TO LEARN MORE

I'm a Medical Device Management System Internal Auditor and need to learn about the revised Standard. Which course should I take?

Upgrade your ISO 13485 internal auditing skills in accordance to the latest revision with this 8-hour ISO 13485:2016 Internal Auditor Refresher Course. Moreover, you can get it at a fraction of the usual time and cost it takes to finish the course.

CLICK HERE TO LEARN MORE

I'm already an Internal Auditor and I'd like to add ISO 13485:2016 to my auditor certification

This 8-hour ISO 13485 Internal Auditor Extension Course will let you add ISO 13485 to your internal auditor certification.

CLICK HERE TO LEARN MORE
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