quality documents and services

ISO 13485
Quality Management
System Templates

We provide quality management system expertise for medical device companies.

View Templates

QMS Success

Your Partner in Quality

Our mission is to accelerate the development, implementation, and certification of your company’s quality management system and improve the efficiency of your business operations.

We offer a complete set of templates to meet all your business needs. Start-up companies typically need to implement an entire quality management system while established companies may need only specific templates to develop new or improved business processes. Whatever your company needs, using our templates is the quickest, easiest, and most cost-efficient way to develop your medical device quality management system.

Save Time

Developing quality processes and procedures is laborious and time-consuming. This can delay quality system implementation and market clearances.

Cost Effective

Saving time means saving money. Leveraging our templates can lower project costs and keep your budget on-track. This is the quickest, easiest, and most cost-efficient way to develop your quality management system.

Rapid Certification

ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and broaden market opportunities. Achieving certification communicates a commitment to quality to your customers and regulators.

ISO 13485 Compliant

Ensure successful audit outcomes with previously audited robust content and a proven risk-based approach.

Easy Customization

User-friendly templates are professionally designed to make them easy to customize to fit your company’s business needs and to minimize document maintenance.

Customization Guides

Template packages include detailed instructions to facilitate the customization of our templates.

Our Clients

Our Inspiration

Notable Quotes

"There are no secrets to success. It is the result of preparation, hard work, and learning from failure."
Colin Powell
"If you can’t describe what you are doing as a process, you don’t know what you’re doing."
W. Edwards Deming
"Almost all quality improvement comes via simplification of design, manufacturing…layout, processes, and procedures."
Tom Peters
“It is always cheaper to do the job right the first time.”
Philip B. Cosby
“There are four purposes of improvement: easier, better, faster, and cheaper. These four goals appear in the order of priority.”
Shigeo Shingo
“When you’re out of quality, you’re out of business.”
“In the end quality cost less.”
“Nothing is going to change until something changes.”
“Know Quality, Know Business; No Quality, No Business.”
“Quality is everyone’s responsibility.”
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