CLSI AUTO10 A : 1ED 2006
Current
The latest, up-to-date edition.
Hardcopy , PDF
English
10-31-2006
Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Definitions
4 Design of Algorithms
4.1 Data Elements
4.2 Algorithm-Based Decisions
4.3 Reporting of Results
4.4 Selective Suppression of Autoverification
5 Regulatory Compliance
5.1 Statutory Obligation
6 Validation of Algorithms
6.1 Logic
6.2 Independent Data Observations/Collection (monitoring
of data in/data out)
6.3 Algorithm Updates
6.4 Software Updates
6.5 Validation Tools
6.6 Periodic Revalidation
References
Additional References
Summary of Comments and Subcommittee Responses
The Quality System Approach
Related CLSI/NCCLS Publication
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