ISO Standards ISO 13485 – Medical Devices Management System

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ISO 13485 Quality Management Certification

ISO Consulting Services is a team of highly experienced ISO 13485 consultants and advisors, with expertise in all aspects of Standards Certification and Management Systems. Our skilled team of ISO 13485 Certification specialists will work together with your organisation to understand your business needs to build a robust and tailored ISO 13485 Quality Management System at an affordable investment without the hassle.

Start the certification process by submitting the Application Form at the end of this page for an obligation free consulting proposal.

What is ISO 13485?

ISO 13485 helps the organisation involved in one or more stages of the life-cycle of a medical device to establish a quality management system applying to medical devices as well as associated services as supplied by the organisation.

ISO 13485:2016 is the current, internationally recognised standard for a business operating in the design and development, production, storage and distribution, installation, or servicing of a medical device and or provision of associated activities or services (e.g. technical support).

These days and regarding the importance of regulatory requirements in the medical device industry, more and more businesses will only deal with accredited companies as they recognise the controls in product, service and quality.

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Benefit of ISO 13485 Certification?

The application of an ISO 13485 certification to your business operations can help you boost the reliability and effectiveness of the processes and procedures within your organisation. Some ISO 13485 advantages include:

  • Increased quality of output
  • Operating more effectively
  • Increased customer satisfaction
  • Meeting legislative and regulatory requirements (e.g. TGA)
  • Enter new markets
  • Identifying and managing threats
  • Decreasing wasted expenditures
  • Boost the confidence of stakeholders (such as customers, employees, suppliers)
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What are the ISO 13485 requirements?

In order to achieve “continuous improvement” within the quality management system, the ISO 13485 standard specifies that your organisation addresses seven main areas – also known as “clauses”:

  1. Quality management system
  2. Management responsibility
  3. Resource management
  4. Product realisation
  5. Measurement, analysis and improvement

 

Why is ISO 13485 certification important?

Australian Market Opportunity

With regards to ISO 13485:2016, the Australian Business Licence and Information Service (ABLIS) government website states:

“You may be required to comply with this standard if you intend to supply medical devices and provide related services. If a therapeutic device is required to be listed or registered on the Australian Register of Therapeutic Goods (ARTG), it must be manufactured according to the requirements of this standard.”

The Therapeutic Goods Administration (TGA) is the Australian Government body (as part of the Department of Health) responsible for making decisions regarding market authorisation of therapeutic goods in Australia, such as medical devices, and assess applications for conformity assessment certificates (specified in a Conformity Assessments Standards Order) for some devices and for the inclusion of medical devices in the ARTG. The TGA also recognises matching standards in jurisdictions where ISO 13485:2016 has been adopted, including Europe, Canada, and the US.

From 1 March 2019, TGA applications must be supported by evidence that a quality management system has been implemented in accordance with the 2016 revision of the standard.

International Trade Opportunities

For Australian businesses within the medical device industry (regardless of their size and type), implementation of the highly stringent requirements of the ISO 13485 certification into their quality management system will validate their consumer, services, and regulatory compliance with globally accepted requirements for medical devices.

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How Can We Assist You?
Gap Assessment

We offer this service to organisations that have existing documents including policies, procedures, manuals, forms, handbooks, etc. and would like to check if the existing documents meet the requirements of the desired standards and what they need to do to certify the system. 

01
System Development

We offer this service to organisations that do not have any existing system (documents) including policies, procedures, manuals, forms, handbooks, etc. or the gap assessment shows that their existing system needs to improve to meet the requirements of the desired standard. 

02
Implementation

A Management system should be documented and implemented to meet the requirements of the desired standards. We will supervise and guide our clients during the Implementation of the management while they follow the policies and procedures and use the forms.

03
Internal Audit

An annual internal audit is required to get certified and maintain the ISO certificates. We offer this service to organisations that do not have the internal resources to conduct the internal audits or would like to have a new pair of eyes to detect the opportunities for improvements.

04
Attending External Audit

Dealing with the external auditor might be quite stressful and challenging for the organisations, particularly for the ones that are willing to certify their system for the first time. We will attend the external audit and assist them as a facilitator for a better and smoother experience.

05
Ongoing Maintenance

Once the organisations achieve their certificate, they will face a new challenge for maintaining what they have achieved as every year the certification body comes back for a surveillance audit. We offer this service to draw their attention to what they might miss in the routines.

06
Are you interested in our Web-based ISO system?

ISO+™ is an all-in-one flexible and fully customisable web-based (cloud-based) solution designed to streamline the documentation and implementation of various management systems and frameworks for compliance and certification purposes.

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Application Form

Please complete our comprehensive application form and help us understand your unique needs to receive an accurate and competitive proposal tailored to your specific requirements.

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