Case studyIVD

Work Instructions for an IVD Manufacturer: From 12 Audit-Critical Documents to a Unified Structure

IVD diagnostics manufacturer with ISO 13485 certification

A diagnostics manufacturer worked with fragmented, overlapping work instructions that diverged from actual practice and jeopardized audit readiness under ISO 13485 and IVDR.

The challenge

The situation

A diagnostics manufacturer managed fragmented and overlapping work instructions that diverged from actual practice and made audit-critical documents hard to review. That put audit readiness under ISO 13485 and IVDR in question.

Our approach

What we delivered

Consolidation and risk-based prioritization of the work instructions into a single unified set, with duplicates removed

Definition of an ISO 13485- and IVDR-compliant standard template with versioning and document control

Structured interviews with process owners to align documentation with actual practice

The outcome

Results & impact

12 audit-critical documents prioritized

Risk-based prioritization of the most important work instructions for audit readiness.

1 consolidated document set

Fragmented legacy work instructions merged into a single set, with duplicates eliminated.

1 standard template established

ISO 13485- and IVDR-compliant template providing a unified structure for all work instructions.

Deviations reduced

A consistent, audit-ready set of work instructions reduces deviations from actual practice.

In summary

The manufacturer now has a consolidated, audit-ready set of work instructions with a unified ISO 13485- and IVDR-compliant standard template, forming the basis for ongoing audit readiness.

Regulations & standards considered

ISO 13485
IVDR

Related expertise

ISO 13485 Certification →

Building and documenting the quality management system to ISO 13485:2016, through to the certification audit

IVD Consulting & IVDR Readiness →

Technical documentation and transition strategy under IVDR Art. 110

Inspection Readiness →

Readiness assessment, mock inspection and inspection coaching for QA and production

Quality Management →

Setting up the QMS to ISO 13485:2016 and ISO 9001:2015, with CAPA and complaint handling

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Sources

Entourage project experience (anonymized)

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