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ISO guide 25 section 10.

7 Software is documented and adequate for use

Practical Guide
There are three types of software products in computer systems or automated equipment
systems used for the capture, processing, manipulation, recording, reporting, storage, or
retrieval of accredited laboratory calibration / test data.
COTS Commercial off the shelf
MOTS Modified off the Shelf
CUSTOM
These three types of software can reside on local hard drives, network hard drives,
embedded on integrated circuits (IC, ROM, EPROM), or removable disks. Products are
considered each piece of uniquely configurable software. Systems are considered the
hardware that uses the software.
COTS software is code that is purchased without modification and either, cannot, or will
not, be modified by the lab. An example of this would be Microsoft Word or Excel. This
software can be considered adequate by the mass market and used as is. The lab should
have evidence that any math used in these tools has objective evidence that the formula
strings written by the lab work as expected. They should also show that the cells are
locked and that file versions are controlled.
Embedded IC software inside of instruments or automated equipment can be assumed
tested by the manufacturer and confirmed adequate during the calibration process. Any
loadable parameters should be considered a data transfer and be checked. No further
action is necessary.
MOTS software is code that is purchased and modified, or configured, for specific
applications. Examples include Lab Windows, Lab Tech Notebook, Tile EMC, HP-Vee,
etc. The purchased portion of the software can be considered COTS. The modified or
configured portion is considered CUSTOM.
ISO/IEC 12119 Information Technology Software Packages Quality Requirements
and Testing describes how to test a purchased software product against requirements.
CUSTOM software is code that is lab written or subcontractor written. This software
requires ADAQUATE FOR USE validation evidence. This process is fully described in
IEEE/EIA/ISO/IEC 12207. Minimally there should be evidence of software
requirements, software design, and software testing. Software requirements state, in user
terms, what the software needs to do. Software design states how the software is built,
along with any diagramming showing the architecture. Software testing includes a test
plan of what and how it will be tested, with individual test cases, along with successful
completion, which satisfy the plan, and map directly back to the requirements.
These adequacy processes have to be performed each time there is a change to the
software. This is the reason for calling it a software life cycle.
In all cases, software should be under CM, configuration management, version and
access control. The labs should ensure that they know what versions are current and
control access to them. There should be a check that is performed periodically to

Gregory Gogates (gdg@fasor.com)

Page 1

18 June 1999

ISO guide 25 section 10.7 Software is documented and adequate for use

Practical Guide
ensure this. A good practice is to consider software a piece of calibrated equipment. It
has to be recalibrated each time it is modified.

References:
ISO/IEC/IEA/IEEE 12207 - 1995Information Technology Software Lifecycle
Processes
ISO/IEC 12119 - 1994Information Technology Software Packages Quality
Requirements and Testing
ISO/IEC TR 13233 - 1995 Information Technology Interpretation of Accreditation
Requirements in IEC/ISO Guide 25 Accreditation of Information Technology and
Telecommunications Testing Laboratories for Software and Protocol Testing Services.
NISTIR 6025 1997 Metrology for Information Technology
Draft EA/GA(98)95 EA Guidelines for the use of computers and computer systems in
accredited laboratories
ISO9000-3 Guidelines for the application of ISO9001 to the development, supply, and
maintenance of software
ASTM E919-96 Standard Specification for Software Documentation for a Computerized
System
ASTM E 1579 - 93: Standard Guide for Ensuring Data Integrity in Highly Computerized
Laboratory Operations
ANSI/IEEE Std 1012-1986 IEEE Standard for Software Verification and Validation
Plans
EPA 2185 1995 Good Automated Laboratory Practices

Gregory Gogates (gdg@fasor.com)

Page 2

18 June 1999

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