scope:

1.1 This guide covers documentation for a computer system operating in a clinical laboratory.

1.2 Documentation is defined as the information needed to install, use, maintain, or modify the system. This information shall be in a reusable form, and may exist in other forms as well. These forms may include printed manuals, online help screens, prompts, computer readable text, computer assisted instruction, audio tapes, or equivalent media. As technology and software techniques change, the form of the documentation may also change. It is a central component of the processes by which system life cycles are managed. Hereafter, the term "documentation" shall encompass all such possible forms.

1.2.1 This documentation includes information that explains how the users interact with and operate the system. This may include a terminal operator's guide, training documentation, system operation descriptions, and database and file maintenance instructions.

1.2.2 Documentation also includes reference documents that describe functional and internal characteristics of the system, such as software reference manuals, source code, descriptions of file structures, hardware reference manuals, schematics, and flow charts. Paragraphs and might apply when some of this information is proprietary.

1.2.3 Documentation includes test procedures to establish whether the system is installed correctly and continues to operate properly. The frequency that the tests are to be performed, the test data sets to be used, and whether the results are to be compared to manual methods should be provided.

1.3 The computer systems under consideration are those designed to assist the general work flow of the laboratory. They typically include some or all of the following features: sample tracking, data gathering, report generation, record keeping, quality assurance, management aids, and hospital communications. They may range from very large to small computer systems. Computers dedicated only to a single instrument are not the primary focus.

1.4 This standard does not purport to address the safety problems associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.