Services
Audit established QMS
As a Certified Quality Auditor (CQA), I will conduct a comprehensive QMS audit to uncover potential non-conformities—areas where the business strays from its established procedures. If these issues are not addressed, they could lead to failed certification, loss of licenses, operational bottlenecks, and costs. Upon completion, I will provide an Audit Report that outlines all findings.
The typical core components of a QMS audit include:
Reviewing the Document Management System (DMS)
Evaluating Standard Operating Procedures (SOP) and Work Instructions (WI)
Assessing the Change Management System
Analysing the Risk Management System
Reviewing Training Matrices
Examining Validation and Verification procedures (V&V)
Reviewing the Product Development Framework
Assessing DMR, DHF, and DHR (if applicable)
Quality Consulting
Based on Audit Report you will receive comprehensive consulting services to eliminate any potential non-conformaties, improve, develop and implement robust quality strategies to meet industry specific standards and drive continuous quality enhancement in time and within budget.
Building Quality Management Systems
If your QA department is still growing or has limitations, I will develop a Quality Management System (QMS) for your company from the ground up to guarantee adherence to ISO9001 standards and relevant industry regulations. Additionally, I will supply your QA team with vital document templates for the Product Development, Manufacturing, and Supply Management sectors. I can also document all your processes and procedures, providing a fully functional and tailored Quality Management System specifically for your business.
Quality Improvement Strategies (Post Audit activities)
If your Quality Management System (QMS) receives a Non-Conformance Report (NCR) or an Opportunity for Improvement (OM) after a recent audit, I will assist you with Corrective and Preventive Actions (CAPA), Change Notes (CN), PFMEA, and all necessary updates. Additionally, I will create business improvement strategies that utilise industry best practices and technologies to enhance your quality standards and promote continuous improvements, thereby reducing the likelihood of NCRs in future audits.
Regulatory compliance*
Comprehensive assistance with regulatory compliance requirements including FDA, MDR, TGA, ISO, IEC, and related standards for Class I, II, and III medical devices — covering design, manufacturing, and supply chain processes (PPAP).
*Please note: This service is complex and time-intensive, with timelines dependent on specific project requirements and external factors. Details will be reviewed and agreed upon during the initial evaluation session.
Product Development
I will identify the most suitable Product Development model for your business and assist you in selecting of the appropriate XFT structure (Projectorised, Functional, Hybrid) and FDA expected documentation scheme (DMR, DHF, DHR) including:
Design descriptions
Design architecture documentation
Risk analysis/DFMEAs/PFMEAs to ISO 14971
SRS (system requirements specifications)
Verification plans, protocols and reports (IQ OQ PQ for manufacturing)
Design documentation for IEC62304 (medical device software)
Design for IEC60601 (medical device essential safety and performance)
Manufacturing
I will conduct a comprehensive and systematic audit of all manufacturing activities, documentation, processes, and procedures to verify compliance with ISO 13485 and GMP requirements and applicable regulatory standards. The audit will encompass evaluation of process validation (IQ OQ PQ), control measures, traceability systems, training matrix and risk management (PFMEA) integration throughout the manufacturing lifecycle.
In addition, I will provide support in the development and optimisation of the manufacturing process flow, ensuring it is fully documented, validated, and aligned with quality and regulatory requirements. This includes streamlining assembly operations to reduce production costs, improving takt time and process efficiency, and maximising yield while maintaining product quality and regulatory compliance.
Change Management
I offer specialised expertise in developing and managing change control systems aligned with ISO 9001 and FDA requirements. This includes creating or refining procedures for design and process changes (ECN, CN), conducting impact and risk assessments, coordinating cross-functional reviews, and ensuring full traceability through documentation and validation activities. My goal is to help you maintain compliance, mitigate risk, and achieve continuous improvement throughout your product lifecycle.
In preparation for an upcoming surveillance audit on short notice, I will perform an Express Audit (1–2 days) to identify potential nonconformities. Should any issues be detected, I will provide your Quality Assurance team with a detailed corrective action plan and support its rapid implementation to ensure a successful certification outcome.