Frequently asked questions
What is Quality Assurance (QA)?
Quality Assurance ensures that products, services, and processes meet defined standards and customer expectations. It involves systematic activities such as audits, process reviews, and continuous improvement to maintain compliance and enhance efficiency.
How is Quality Assurance different from Quality Control (QC)?
Quality Assurance focuses on preventing defects through process control and system management, while Quality Control identifies defects in production process, and in the final product through inspection and testing. QA is proactive, QC is reactive — both are essential for a robust Quality Management System (QMS).
What industries do you support?
I provide Quality Assurance and Regulatory Compliance services for:
ISO 9001 Certification all industries
Medical device developers and manufacturers (MD Class 1,2,3)
Supplier Management all industries
What Quality Management Standards do you work with?
I support implementation and compliance with:
ISO 9001
ISO 13485
FDA 21 CFR Part 820
EU MDR
TGA
IEC 60601, ISO 14971, ISO 62304, and related standards
Do you offer internal or supplier audits?
Yes. I provide: Internal audits (to prepare for certification or surveillance audits) and Supplier audits (to ensure compliance and performance)
Can you help prepare for an upcoming certification or surveillance audit?
Absolutely. I offer Audit Readiness and Express Audit Services to identify potential nonconformities and develop corrective action plans to ensure a smooth certification outcome.
What is Change Management in QA, and do you support it?
Change Management ensures that any modification to processes, systems, or documentation is properly reviewed, approved, and implemented without compromising compliance or product quality.
I will design and support Change Management frameworks tailored to your QMS and business needs.
Can you help with FDA required V&V protocols?
Yes. I specialise in FDA-compliant Validation and Verification (V&V) methodologies, including IQ, OQ, and PQ design and implementation. You can be confident that your equipment will meet full FDA compliance once I establish and document all required procedures, complete with protocol templates tailored to your specific equipment.
How can you help if we discover nonconformities?
I perform root cause analysis, assist in corrective and preventive actions (CAPA), and provide training to prevent recurrence. My goal is not just to fix the issue — but to strengthen your system for long-term compliance.
Do you offer Quality Management System (QMS) implementation?
Yes. I can develop, implement, or streamline your QMS to align with ISO and regulatory requirements — from initial setup to certification and ongoing maintenance.
What if we already have a QMS but need improvements?
I can perform a QMS Health Check or Gap Analysis to identify inefficiencies, overlaps, or compliance risks. Then, propose practical, compliant solutions to enhance system performance and usability.
Do you provide staff training in QA and compliance?
Yes. I offer customised training on:
Internal auditing
CAPA management
Risk management
Document control
ISO standards and regulatory requirements
How can we get started?
You can start by completing the Request Form or emailing me direct on enquiry@qacconsulting.com.au to discuss your request and scheduling a free consultation. IBased on your immediate needs, I will assess your current system, understand your challenges, and recommend a tailored solution to meet your current compliance and quality goals.
Where are you based, and do you work with international clients?
I am based in Australia and work with both domestic and international clients. Services can be delivered onsite or remotely, depending on your needs.