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ZEISS IQ/OQ Equipment Qualification Service

Accelerate your equipment qualification with OEM expertise
Medical customers that are using CMMs to measure medical device components must perform validation to meet FDA requirements. As a result of our experience, research, and customer relationships, we’ve developed the IQ/OQ Equipment Qualification Service for ZEISS CMMs and CALYPSO Software.
 
We are excited to provide a comprehensive solution for medical customers that want ZEISS support during their CMM’s equipment qualification!

Benefits
  • Save time – complete your CMM equipment qualification in days, not weeks
  • Rely on ZEISS experts – allow a ZEISS applications engineer to perform the qualification activities
  • OEM insight – execute qualification activities tailored by ZEISS to your CMM model
  • Complete documentation – receive a completed protocol with documented evidence of qualification activities




CMM Validation and the FDA

Free eLearning​

There are a number of pervasive myths and misconceptions about if, how, and why metrology software and CMMs should be validated for use within an FDA-regulated environment.

Many manufacturers have questions about what they need to do to fulfill FDA requirements. This eLearning is intended to clarify what the FDA says - and doesn't say - about CMM validation.

This free eLearning covers the following content:
1. What does the FDA say about CMM validation?
2. Industry Best Practices for Measuring Equipment Validation
3. How can ZEISS support you: The IQ/OQ Equipment Qualification Service
4. Bonus content: V-Model of Validation

What Does the IQ/OQ Equipment Qualification Service Include?​

The IQ/OQ Equipment Qualification Service provides a comprehensive protocol script, formatted and aligned to industry standards, for the Installation Qualification (IQ) and Operational Qualification (OQ) for one ZEISS CMM equipped with ZEISS CALYPSO metrology software.

Installation Qualification includes:

• Supporting documentation, provided by ZEISS

• Verification that all purchased components are present and complete

• Confirmation that all components are in good working condition

• Verification of the CMM system environment and workstation specifications

• Verification that the system is installed according to ZEISS recommendations for that CMM model


Operational Qualification includes:

• Supporting documentation, provided by ZEISS

• Operational tests of the CMM, CMM drives, and probe head, according to our “Health Check” procedure and artifact

• Operational tests of CALYPSO’s algorithms, according to NIST protocols

• Tests of safety-related hardware and software functionality• Test of key user access functionalities

IQ/OQ Equipment Qualification Service Options

There are two options available for the IQ/OQ equipment qualification service:

In-person option (Recommended)
A ZEISS applications engineer comes to your facility and performs the activities of the IQ / OQ Protocol.

Completed within a 2-day onsite visit.

Remote option
ZEISS supports your personnel remotely to perform the activities of the IQ / OQ Protocol. A ZEISS applications engineer (remote) will guide the CMM system owner (onsite) to conduct the protocol activities.

Completed within 1 week (typically requiring 2 – 4 hours of commitment per day).

Contact us: info.metrology.us@zeiss.com

ZEISS guides manufacturers to FDA validation of coordinate measuring machines​

Fill out the form to download our whitepaper to understand industry standards​, identify challenges in validation​ and find best solutions​.

Whitepaper

  • Understand industry standards​
  • Identify challenges in validation​
  • Find best solutions

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