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ISO 13485 & Record Controls
QMS & Compliance Readiness (New Zealand)
The Sponsor Needs Controls That Work in Practice. New Zealand does not turn WAND notification into a pre-market QMS certification process, but manufacturers and sponsors still need controlled systems capable of supporting safe supply, complaint handling, records, corrective action, changes and recalls.
When This Support Is Needed
Establishing quality management controls and record retention procedures for a New Zealand Sponsor
Aligning quality procedures with ISO 13485 and the Medicines Regulations 1984
Preparing for a Medsafe safety investigation, compliance review, or importer audit
Remediating compliance gaps in distribution traceability, complaint files, or recall procedures
What We Challenge Before Submission
Can the sponsor produce complete distribution records showing where every batch was supplied?
Are customer complaints received in New Zealand systematically investigated and recorded?
Can the organization demonstrate active, controlled implementation through records rather than SOPs alone?
Are changes made by the foreign manufacturer immediately communicated to the NZ Sponsor?
Can personnel comfortably explain recall execution and Medsafe communication procedures during an audit?
Our QMS & Compliance Readiness Scope
Quality-system gap assessment against New Zealand legal requirements and ISO 13485
Document and record-control review (distribution records, complaint logs, technical file access)
Supplier and outsourced-process control interfaces between foreign manufacturer and NZ Sponsor
Risk-management implementation and benefit-risk review under ISO 14971
Validation evidence review (sterilization, packaging, manufacturing processes)
Complaint handling, adverse event evaluation, and Medsafe escalation procedures
Corrective and Preventive Action (CAPA) system effectiveness review
Management of change (MOC) and WAND record update implementation
Distribution and batch traceability records in compliance with New Zealand regulations
Recall procedure readiness and mock recall execution under the NZ Recall Code
Internal audit and executive management review support
Medsafe regulatory inquiry and inspection response planning
Practical Audit Readiness:
Our readiness question is practical: if Medsafe asks the sponsor to demonstrate what was supplied, where it went, what complaint was received, how the manufacturer investigated it and what corrective action followed, can the records tell a complete and controlled story?
Establish Auditable QMS & Record Controls for New Zealand
Our quality system auditors assess ISO 13485 alignment, establish distribution traceability, and prepare sponsors for Medsafe scrutiny.