Legal name, sites, scope of activities, headcount and shift pattern, outsourced processes, any existing certificate, and whether you received consultancy on the system and from whom.
GLOBAL
Loading
Global Energy Up is an independent certification body for management systems and a validation and verification body for greenhouse-gas information. We audit and decide; we do not consult.
ISO 13485:2016
Medical devices quality management
A device is only as safe as the process that made it.
ISO 13485 certification demonstrates that an organization involved in the life cycle of medical devices consistently meets customer and applicable regulatory requirements.
Who it is for. Medical device designers, manufacturers, distributors, sterilisation providers, component suppliers and service providers.
- Regulatory requirements and the role of the organization
- Design and development controls, including risk management
- Purchasing and supplier controls
- Production, process validation, cleanliness and sterilisation where applicable
- Traceability, complaint handling and regulatory reporting
- Corrective and preventive action and post-market feedback
Each area above is assessed on objective evidence — records, interviews and direct observation of work.
How the audit runs
Audit time is determined under the applicable IAF rules for medical devices (Global ACI / legacy IAF Mandatory Documents), based on effective personnel and device risk. Remote auditing never reduces the required audit time.
01.
Stage 1
Review of documentation, readiness and scope, and planning of Stage 2.
02.
Stage 2
On-site evaluation of implementation and effectiveness; findings are recorded.
03.
Decision & surveillance
An independent decision, then annual surveillance through the three-year cycle.
Why organizations seek it
01
Consistent device quality and patient safety
02
Support for regulatory submissions and market access
03
Controlled suppliers and processes
04
Effective handling of complaints and feedback
Certification gives independent confidence in the system; it does not by itself guarantee any commercial outcome.
Edition and transition
Audits are conducted against ISO 13485:2016, the current edition.
Auditing with other standards
Where the system is integrated with others, the standards can be audited together in one visit; duration is calculated for each standard and then adjusted for the actual degree of integration.
- What do I need to apply?
- Why do you ask about consultancy?Because we do not certify a system on which a body related to us provided consultancy, and every application is screened for conflicts of interest before it is accepted.
- Will the certificate carry an accreditation mark?Not before accreditation is granted. Certificates are currently issued without an accreditation mark.
