Document control
Keep the relevant procedures under document control, with ownership, revisions, review actions, and acknowledgments around the released version.
BY STANDARD / ISO 13485
Give your ISO 13485 work a clear home.
Organize the procedures, learning, assigned actions, and records supporting medical-device quality management. Configure Qlutch around the processes and scope your organization defines.
FROM REQUIREMENTS TO ROUTINE
Start with your process.
Begin with the applicable requirements and your own documented processes. Identify what evidence you need, who is responsible for it, and which quality activities would benefit from a repeatable workflow.
Training records
Assign relevant learning and retain completion records. Keep practical assessments and authorization decisions distinct, using the process your organization defines.
Issue follow-up
Configure a FormFlow to capture the issue, assign its review, and record the response. Include the effectiveness or closure decision your procedure calls for.
PICTURE THE PROCESS
A controlled procedure changes after a quality review
A representative starting point. Your team defines the information, responsibilities, and controls.
- 01Define your scope
- 02Organize the evidence
- 03Assign the review
- 04Follow up on gaps
KEEP EXPLORING
The tools behind the work.
GOOD QUESTIONS
A little more clarity.
Does using Qlutch make us certified or compliant?
No. Certification, accreditation, and regulatory compliance depend on your organization’s scope, processes, implementation, and assessment. These examples describe supporting quality work, not a complete requirements mapping or a guarantee. Discuss any validation, security, or electronic-signature requirements explicitly.
How do we choose the right apps?
Map the information and actions in your process. DocControl manages controlled documents; FormFlows coordinates steps; Training supports learning; Lists organizes structured records. BaseCamp brings assigned work into an inbox.
Explore the four apps ↗How is app access priced?
One license is one person’s access to one app. Choose access by responsibility and use the calculator to estimate your plan. Headcount alone does not determine the price.
Build your pricing and ROI estimate ↗LET’S PUT QLUTCH TO WORK
Bring a real process.
Let’s make it clearer.
A procedure, a recurring task, or an issue that takes too much chasing. We’ll start with the work you know.