Preparation for ISO 15189 Documents for Accreditation in Medical Laboratories

The ISO 15189 Accreditation is the recognition of a competent medical laboratory, testing body or certification body to perform specific functions that are clearly defined and evaluated throughout the ISO 15189 accreditation study. This knowledge of skills is intended to assure clients of accredited bodies, that the delivery of these accredited organizations, under their accreditation, is reliable.

Emphasizes the implementation of a quality plan that incorporates key or minor approaches that can lead to compliance with international quality standards, such as ISO 15189. The ISO 15189 Document and its recommendations related to implementation strategy can be easily used as it stands, or after adaptation to meet ISO 15189 requirements. The Guidance should be read as development recommendations as well implementation of quality standards that can be done by all types of health and health laboratories.

The ISO 15189 - Quality manual should describe the quality management system and its document structure. The quality manual should include or refer to supporting ISO 15189 procedures; including technical processes. It should highlight the textual structure of the quality management system.

ISO 15189 Documentation Requirements

The 15189 Documentation should include:

• quality policy statement;
• quality manual;
• the procedures and records required for the relevant procedures;
• documents and records, determined by the laboratory to ensure good order, the operation and control of its processes; and
• copies of relevant local and international regulations, laws and standards ordinary texts.

The laboratory must regulate the documentation required by the quality management system and ensure that the unintentional use of any outdated ISO 15189 document is prohibited.

The laboratory must ensure that:

• All documents, including computer-generated, are issued as part of the quality management system is periodically updated and approved by authorized personnel prior to dismissal;
• only current, authorized types of active documents available locally for use;
• altering changes in the text;
• texts are readable;
• documents are periodically updated and updated periodically that they are always ready for the purpose; any changes to the document need to be permanent re-authorization;
• Be careful. The duration of the document review should be defined by the lab according to its requirements,
• The records are kept for a specified period in the laboratory
• storage policy and compliance with privacy requirements.
• obsolete documents dated and marked as obsolete;
• archiving and tracking records; and
• The authorization to obtain documents is clearly defined and in writing.

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