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 jeopardised 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 limited the ability to audit audit-critical documents. This situation jeopardised audit readiness under ISO 13485 and IVDR and required a structured harmonisation of the work instructions.

Our approach

What we delivered

Consolidation and risk-based prioritisation 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 prioritised

Risk-based prioritisation 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 →

The manufacturer holds ISO 13485 certification, and the new standard template for work instructions was explicitly designed to comply with ISO 13485, supporting the maintenance of that certification.

IVDR Readiness →

Harmonising the work instructions into an IVDR-compliant template and risk-based prioritisation of audit-critical documents directly targeted the diagnostics manufacturer's IVDR audit readiness.

Inspection Readiness →

Fragmented, overlapping work instructions were jeopardising audit readiness; consolidating them into a single, reviewed set of documents provides the basis for ongoing inspection readiness.

Quality Management →

Introducing a standard template with versioning and document control for all work instructions strengthens the documented process foundation of the quality management system.

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Sources

Entourage project experience (anonymised)

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