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As you aim to achieve international recognition and access to the global medical device market, consumer trust is won through the assurance of having a proper ISO 13485-certified Quality Management System (QMS) in place.
ISO 13485:2016 Medical Devices Quality Management Systems
Our experienced team of in-house ISO consultants can plan and guide you through this process smoothly, covering critical areas for your company, as follows, to ensure you are well-established.
The most tangible benefit of having certification to the global standard – ISO 13485 Medical Device Quality Management Systems– is market access. In most countries, the lack of this certification means that the company cannot operate in the medical devices industry. The products cannot be marketed for the same reason. That usually forms the most significant barrier to market entry.
If that is not already the most apparent benefit, companies with the ISO 13485 certification can also:
ISO 13485 certification cost varies depending on your scope of works and your desired certification body to work with. Get in touch with us, and we can assist in getting a quotation from them!
1.
Identify the appropriate standard(s) that applies to your company, like the ISO 13485:2016 Quality Management System;
2.
Identify the scope of your ISO 13485 certification, set up appropriate processes and documentation;
3.
Share knowledge on the ISO 13485 certification process;
4.
Ensure medical devices’ design and development work is thorough;
5.
Ensure comprehensive coverage of medical devices’ production and manufacturing activities;
6.
Ensure that distribution channels for the medical devices, while extensive, are well-managed;
7.
Ensure the competency of your team regarding ISO 13485 standards and requirements through the conduct of training courses;
8.
Perform annual internal audit services with your team to ensure the effectiveness of your Quality Management System in preparation of ISO 13485 certification; and
9.
Recommending your team to third-party certification bodies providing ISO 13485 certification audit services.
ISO 13485:2016 Medical Devices Quality Management Systems
Of the many ISO standards to abide by, our consulting team would be able to best advise which applies to your company, to ensure appropriate compliance where necessary. You may find more than one ISO standard applicable to your medical devices and related services, and we can help you effectively integrate them to avoid unnecessary overlaps. For example, for Software as a Medical Device (SaMD) companies sometimes decide to adhere to both ISO 13485 (Medical Devices Quality Management System) and ISO 27001 (Information Security Management System).
Better understand the standards that the variety of our clients have engaged us for:
ISO 13485:2016
Quality Management
Systems (Medical Devices)
ISO 22000:2018
Food Safety Management Systems
ISO 27001:2013
Information Security Management Systems
ISO 22301:2019
Business Continuity Management Systems
SS 620:2016
Good Distribution Practices for Medical Devices(SG)
SS 444:2018
Hazards Analysis and Critical Control Points
EU Medical Devices Regulations (Upcoming)
Our consultants scope your ISO 13485:2016 certification, setting up appropriate processes and documents for your Quality Management Systems
Keeping in mind your current business practices, we work closely with your team to develop a robust Quality Management System (QMS) with minimal disruption to ongoing business activities, keeping in mind your customer requirements. Building on existing processes, we ensure compliance with your ISO 13485 certification requirements through the introduction of additional processes as needed.
Our structured approach to your QMS implementation provides a clear timeline for project milestones to be reached. Enjoy time saved through efficiency as we work closely over our Stendard Solution™ platform, which allows for the smooth assignment of tasks and online collaboration, putting your management at ease by providing a birds’-eye view at all times.
Through years of experience with ISO 13485 certification audits of a variety of medical devices companies owning hardware & software products and services, our consultants will have you prepared for official audits conducted by your appointed ISO 13485 certification bodies.
Our consultants review and confirm that your medical devices’ design & development work is completely in accordance to ISO 13485 requirements
We keep your medical devices’ product registration and business strategies in mind as we put together your Design History Files (part of ISO 13485 requirements) so that your records are comprehensive enough to meet regulatory and customer requirements. This includes technical information as we help identify and highlight the depth of tests required (for example with clinical evaluation, sterility tests, software validation, etc.) for your medical devices.
With that, you can be ready for easy expansion to international markets! Our clients have entered major markets around the world: Singapore HSA, EU (under the new MDR), US FDA, Australia TGA, Canada MDEL, to name a few.
Our consultants ensures that you have comprehensive coverage for your medical devices from production & manufacturing to distribution activities, with compliance to ISO 13485
As we are increasingly well-connected globally, part of your organisation’s medical devices may have been outsourced to various vendors or contract partners, while the core business activities were kept in-house.
These activities may span the spectrum of the entire industry, from manufacturing and assembly to the distribution and installation of medical devices.
Regardless, all processes need to be set up well, and our consultants can provide recommendations on how this may be done, in accordance with ISO 13485. From the evaluation of cleanrooms and factory layouts to quality checks to be performed, software validation to IQ, OQ, PQ tests to be run, you can be assured that our broad experience provides thorough support for the set-up of production and manufacturing processes. We also advise on best practice distribution management to ensure traceability, in order to perform post-market surveillance activities when needed, such as that of customer requirements, feedback, product recalls, and post-market clinical follow-up.
Post-setup of your Quality Management System, internal, supplier, and distributor audits would need to be performed on a regular basis (usually annually) to ensure compliance to regulations and standards. As required, we will walk the ground with you during these audits to ensure that all activities are compliant with your ISO 13485 certification and any other medical devices’ regulations.
Our team ensures the competency of your team regarding ISO 13485 standards and requirements.
We will include a combination of online training courses and in-person training to make sure everyone within your team understands the requirements of the medical devices’ regulations and ISO 13485 standards and the application of your Quality Management System (QMS) processes and documents.
We take great pride in training your team. We believe that management and every team member must understand ISO 13485 and your products and services requirements, down to each clause within the standard. Due to the stringent nature of the industry, we would recommend each of our clients to start with our e-learning training courses before arranging for an in-depth session to explore all questions and unknowns.
Some of the e-learning course that we have created includes:
After that, we will conduct a face-to-face or online discussion session customised to your organisation’s needs for clarifications to be addressed, and an opportunity to brief the management on the readiness towards an audit conducted right after.
Our consultants can assist in annual internal/mock audits.
We understand the pressure to prepare for ISO 13485 audits conducted by external auditors.
Our consultants, experienced with seeing clients through the ISO 13485 certification process, can perform internal audits to support your team. This is done by identifying any issues and rectifying any non-compliance in preparation for your ISO 13485 certification audits.
Conducting internal audits ensures that your ISO 13485 Quality Management System’s effectiveness.
These may be in the form of pre-certification gap analysis or mock audits. These activities help us highlight gaps in your medical device quality management system that may need to be addressed.
Our team ensures the competency of your team regarding ISO 13485 standards and requirements
We include a combination of online training courses and in-person training to make sure everyone within your team understands the requirements of the medical devices’ regulations and ISO 13485 standards, as well as the application of your QMS processes and documents.
Stendard can help your organisation by providing ISO 13485 Medical Device Quality Management Systems consulting services with experienced ISO 13485 consultants. We help individual clients prepare, establish, implement and improve their medical device management system processes, including gap analysis, auditing, training and arranging for certification services from an internationally recognised certification body.
Alternatively, suppose your organisation already has a Quality Management System in place. In that case, you may start speaking to accredited certification bodies to conduct third-party audits to be certified.
ISO 13485 Medical Device Quality Management Systems is not mandatory for medical devices. For regulatory purposes, it is highly recommended for all organisations involved in medical device manufacturing, design and development, and distribution activities.
ISO 13485 also depends highly on your medical devices’ risk classification, according to various country’s regulatory requirements. For example in the United States of America, the Food and Drug Administration (FDA) specifies the need for compliance to the 21 CFR Part 820 Quality Systems instead of ISO 13485. It is highly recommended to have and ISO 13485 Quality Management System in place as it fulfils most of FDA’s 21 CFR Part 820 Quality Systems requirements.
Similarly, the Regulations (EU) 2017/745 – Medical Device Regulations (MDR) have been established under the European Union. Depending on your medical device risk classification, a conformity assessment by a notified body on your medical devices quality management system may be required.
Although ISO 13485 is not mentioned under the MDR, the International Organization for Standardization has published the EN ISO 13485:2016+A11:2021 standard which has comprehensive requirements matched to the Regulations (EU) 2017/745 – Medical Device Regulations for organisations that aim to market their medical devices in the European Union.
Not sure if your organisation requires an ISO 13485 or EN ISO 13485:2016 certification? Feel free to contact us, and we would be happy to assist!
EN ISO 13485:2016 Specifies additional requirements in the Annexes to the European Union’s regulations, while ISO 13485:2016 does not. The main content clauses, however, do not differ.
Companies seeking to market their medical devices in Europe are recommended to comply with the new EN ISO 13485:2016+A11:2021 standard.
The current version of the ISO 13485 Medical Devices Quality Management Systems is ISO 13485:2016.
Partially. To add to the challenge, the most commonly adopted ISO standard — the ISO 9001 standard is also known as a Quality Management System. However, the ISO 9001 standard applies to many other industries, including construction, engineering, manufacturing, hotels & hospitality, to name a few.
Being the number 1 most popular standard being certified to, anyone in this industry would be familiar with the ISO 9001 standard or have worked with an organisation with the ISO 9001 certification. This dramatically impacts the impression that the ISO 13485 standard is very similar, which is far from the truth due to the standard’s differences in structure and framework.
Looking deeper into their differences, the ISO 9001 requirements ensure that your organisation focuses on achieving customer satisfaction. At the same time, ISO 13485 puts a lot more emphasis on patient safety during the usage of medical devices and greater efficacy in the diagnosis results. In addition, ISO 9001 now requires product manufacturers to focus on continuous improvement. In contrast, ISO 13485 requires the company to demonstrate implementation and consistent maintenance of the quality management system.
Therefore, ISO 13485 does not replace ISO 9001. ISO 13485, however, can fulfil partial requirements of ISO 9001 and vice versa.
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