Jan 21, 2020 Ezra Kelderman

Medical Device Quality Management System Template: 5 Powerful Options

A great quality management system (QMS) can give you what you need to get a high-quality device on the market quickly and obtain FDA approval and ISO certification as smoothly as possible.

But building a quality system from the ground up shouldn't be done without some guidance. You don't need to reinvent the wheel.

With the right medical device quality management system template, you can quickly build a quality-driven culture and produce a market-leading device. Here are five templates that could help you get started.

5 Powerful Medical Device Quality Management System Templates

Quality management system templates are one approach to build a foundation at a medical device organization. Templates can form a fast-start baseline to a quality management system that meets the requirements of ISO 13485:2016 and FDA 21 CFR Part 820. They are an alternative to enterprise quality management system software (eQMS). A document-based management system created from templates can sometimes be sufficient to pass an audit.

While a template-based quality management system is one option for medical device startups and scale-ups, it’s not necessarily the best approach. The FDA recommends medical device manufacturers adopt an enterprise QMS software to prevent errors and help with fast growth. A cloud-based QMS like Qualio can provide the structure you need and scale as you grow. However, if you’re not quite ready to consider a QMS software, here are some template alternatives.

1. PharmOut

If you want “DIY” ISO 13485 compliance without an eQMS, Pharmout offers a set of Microsoft Word-based templates to build a complete system of electronic documents. This bundle is priced at $900, and it includes 35 pre-written standard operating procedures (SOPs), 15 form templates, 12 master templates, a register, and a quality manual.

Pharmout is an international consultancy that offers a diverse menu of business services in the life sciences sector. Customer reviews of the ISO 13485 product on the Pharmout website sway positive, including one purchaser who noted he found “the QMS pack for 2016 to be very helpful and easy to use.” New call-to-action

2. 13485 Academy

Advisera is a company that specializes in providing documentation and support for a number of quality and regulatory standards and offers a complete academy for ISO 13485 implementation. Advisera states that using their web tools can net medical device subscribers a “90 percent savings compared to the cost of a consultant.” The Academy offers a number of courses and tools, including ISO 13485 documentation and templates, webinars, and guidebooks to ISO 13485 implementation. The documentation toolkit is priced at $797, and includes a total of 76 mandatory and non-mandatory document templates. In addition, the price covers “unlimited email support,” one hour of dedicated support from a consultant, and one expert document review.

Advisera’s 13485 Academy toolkit can be purchased with extended support options, which offer expert consulting hours and additional document review for an upgrade fee. Prospective customers can test Advisera’s products by downloading a number of free digital resources or attending webinars before making a purchase.

RELATED READING: 13 Bottom Line-Boosting Benefits of a Quality Management System

3. 13485 Store

The 13485 store, a business line of the Standards Stores, offers several template packages for ISO 13485:2016. The core product is a Quality Manual in Microsoft Word format, with editable procedures and format documents. The products include all ISO 13485 document requirements, and in-text instructions written in blue text to provide guidance.

The core ISO 13485 product is priced at $397. Additional price upgrades are available for a medical device quality management system template combination pack with both 13485 and ISO 9001 documents, as well as an upgrade to a $497 “QMS pack” with flowcharts and instructions on meeting FDA requirements. The Standards Store specializes in providing digital products for ISO standards.

RELATED READING: How Much Does eQMS Software Cost?

4. IMSXpress

IMSXpress offers a starter pack of templates for ISO 13485 and FDA CFR Part 820 compliance. This packet includes a total of 42 forms, which include 35 electronic and seven manual documents. According to IMSXpress, “extensive notes, tips and comments” are included within the documents to guide purchasers toward compliance with ISO 13485 and FDA requirements.

IMSXPress is an ISO support organization, which was among the first to provide quality management system templates and document support for ISO organizations. Pricing for IMSXPress products isn’t fully listed online; however, some details are provided for potential customers who want to purchase the template kit with supporting software, such as a SQL or file database. Pricing for IMSXpress products increases if you select the option to purchase risk management, remote access, or additional user access.

5. Quality Works

Quality Works takes a unique approach to ISO 13485 documents and templates. Unlike offerings from other companies featured here, Quality Works templates can be purchased individually. An a la carte quality manual for both ISO 13485 and 9001 is priced at $350, an executive overview costs $450, and a complete set of ISO documents is $850. A 2-day, on-site training course is $4,000. It is worth noting that Quality Work documents are tailored to ISO 13485:2003, not the most recent version of the standard.

Quality Works is an international consultancy that provides digital products and business services to ISO organizations globally. In addition to ISO templates, they offer consulting, training, and audit support. Previews of the documents are available prior to purchase.

Choosing the Best Medical Device Quality Management System

There are multiple ways to meet ISO and FDA requirements for a medical device quality management system. Templates can be among the cheapest and fastest ways to create a QMS, but they’re not the only low-cost way to unlock value quickly.

A cloud-based QMS software like Qualio can remove the risks of document-based quality management system and provide benefits such as data integrity, compliance, and linked processes for quality improvement.

The Qualio platform is built with the needs of medical device manufacturers with 5-500 employees in mind. Our eQMS is easy, fast, and scalable, and pricing starts at less than $1,000 per month. To learn more about Qualio, click here.


We're sharing our secrets with our loyal readers. Subscribe & download it now.

Published by Ezra Kelderman January 21, 2020