Regulatory focus
Show that applicable regulatory and customer requirements are addressed throughout the quality system.
Medical device quality management systems
ISO 13485 Certification
Demonstrate a quality management system designed for organizations in the medical device life cycle and focused on applicable regulatory requirements.
ISO13485ISO 13485:2016
Who it is for
Built for organizations that need a system others can trust.
- Medical device designers and manufacturers
- Contract manufacturers and critical suppliers
- Organizations providing installation or servicing activities
- External parties providing products or QMS-related services to medical device organizations
Business value
What certification can help demonstrate.
Certification provides independent evidence that the management system has been assessed against the applicable requirements within its defined scope.
Lifecycle control
Establish documented controls for activities such as design, production, installation and servicing, as applicable.
Traceability and records
Maintain records and traceability suited to the organization’s role, devices and regulatory obligations.
Risk-aware processes
Apply risk-based controls to appropriate quality management system processes and product realization activities.
Audit focus
What the audit examines.
Auditors evaluate objective evidence to determine whether your management system is implemented, maintained and effective within the certification scope.
- Organization role, device categories and certification scope
- Applicable regulatory requirements and QMS documentation
- Design and development controls, when applicable
- Supplier, production, validation and traceability controls
- Complaint handling, reporting and advisory notice processes
- Internal audit, management review and corrective action
Before you apply
Prepare the system—not a performance.
The strongest audit readiness comes from a management system that is used in normal operations and produces reliable evidence.
- 1Define the organization’s role and the medical device activities in scope.
- 2Map applicable regulatory requirements to QMS processes.
- 3Validate required processes and maintain representative records.
- 4Complete internal audit, management review and corrective actions.
Common questions
Before you request a proposal.
Is ISO 13485 the same as ISO 9001?
No. Both address quality management systems, but ISO 13485 is specifically written for the medical device sector and emphasizes applicable regulatory requirements.
Who can use ISO 13485?
It can be used by organizations involved in design, production, installation, servicing and related services, as well as suppliers and external parties supporting medical device organizations.
Does ISO 13485 certification approve a medical device?
No. It certifies the quality management system within the approved scope. Product registration, authorization or clearance is handled under the applicable regulatory framework.
Next step
Let’s define your scope.
Tell us about your organization, locations, activities and target standard. We will identify the information needed to prepare a proposal.
Request a Quote