Quick Answers

We've compiled helpful information to address common questions and concerns.

What We Do

Elevating Quality, Audit by Audit

We specialize in the development, improvement, and implementation of quality management systems.

Gap Analysis
Full Quality Management System Assessments
Internal Compliance Audits
Performance Optimization
Continuous Improvement

FAQs

Frequently Asked Questions

What Audit Services Do You Offer?

We specialize in quality management systems that comply with:

ISO 9001 – Non-Medical Quality Management Systems
ISO 13485 – Medical Device Quality Management Systems
ISO 14971 – Medical Device Risk Management

And the following regulations:

European Union: EU MDR & IVDR
United Kingdom: UK MDR
MDSAP: FDA (USA), Health Canada, TGA (Australia), MHLW (Japan), ANVISA (Brazil)

How Much Time Is Required for an Audit?

The audit timeline depends on the complexity of the project. Audit timelines will vary depending on the organization's scope (including the number of personnel and risk of devices), needs of the organization, regulations, and complexity of processes.

What Affects the Audit Duration?

There are many factors to take into consideration that affect the timeline of an audit, such as:

Audit Standard or Standards Being Assessed
Company Size/Number of Personnel & Number of Locations
Audit Scope & Complexity
Readiness Level (Documentation and Controls Already in Place vs. Gaps)
On-Site vs. Remote
Corrective Actions (i.e., From Previous Audits)

Can We Use Our Own Internal Audit Reports to Document the Internal Audit?

Yes. If your organization prefers, we can review and utilize your existing internal audit reports, provided they meet the applicable standards and requirements.

Can We Tailor Audits to Meet the Time Frames and Needs of the Business?

Yes. We work closely with your organization to tailor audits to your specific needs and timelines, within reasonable and practical constraints.