Quality Systems & Compliance.
Quality-system assessment, process development, and preparation for audits.
Focus of this practice
Quality requirements, connected to everyday work.
A quality system needs to reflect how an organization designs, manufactures, and supports its devices. Crossroads helps teams understand the system they have and the work needed to develop it.
The scope of support is agreed around your product, priorities, and available information.
Potential areas of support
System assessment
Review existing processes and records, identify gaps, and establish a practical sequence of priorities.
QMSR and ISO 13485
Consider quality-system processes and documentation in relation to the applicable requirements and the organization’s responsibilities.
Implementation and audit preparation
Support process development, documentation, and preparation of teams and records for assessments.
Supplier quality
Review quality responsibilities in the supply chain, including supplier assessment and outsourced manufacturing processes.
When to start
Start with a clear view of the system.
An engagement may begin with a focused assessment or a specific process. Any implementation support is scoped around the organization, available resources, and the requirements involved.
How we work togetherA useful starting point
What to bring
to the first discussion.
- Current quality-system structure
- Relevant audit findings or identified gaps
- Manufacturing and supplier responsibilities
A brief, non-confidential overview is enough to begin. Detailed documents can be discussed once the engagement arrangements are agreed.
Start a conversation
Discuss your regulatory or quality needs.
Tell us about your product, your priorities, and the question ahead. A brief, non-confidential overview is enough to begin.
Contact Crossroads