5.1 General
The forensic science laboratory shall establish, implement and maintain an effective quality management system appropriate to the type, range and volume of forensic science activities it undertakes. The quality system shall include policies and procedures addressing all the criteriadetailed in these accreditation requirements.
5.2 Documentation
5.2.1 Quality Manual
All elements of the laboratory's quality system shall be documented. This will include all policies, systems, programme, procedures, instructions etc. where the absence of documentation would adversely affect the test or examination results. Documentation of the quality system will be in a Quality Manual with cross-referencing to related operations documentation, where relevant. The Quality Manual and, where relevant, the associated
operational documentation, shall be kept up-to-date under the authority and responsibility of the Quality Manager. Documentation of the laboratory's quality system must include, where appropriate, the protocol(s) permitting departures from the documented policies and procedures.
Quality system documentation shall be readily available to all the personnel. Forensic science in administration of Criminal justice requires that intensive measures be undertaken to ensure the overall quality of scientific findings. To accomplish this, a quality system is required to provide laboratory management with continuing confidence that results and conclusions are accurate, impartial and relevant. Forensic science laboratories must, therefore, establish and maintain a quality system that is appropriate for the range of forensic disciplines as well as the types and numbers of examinations that are conducted. The success of the quality system
depends on the commitment of the management and active participation of each member of the laboratory staff. To ensure that everyone fully understands what are the expectations, all
elements of the quality system must be clearly articulated in the Quality Manual.
5.2.2 Document and Information Control
The laboratory shall establish and maintain documented procedures to control all documents and information that relate to its quality system. (Document is any medium used to record information or instructions. Documents include manuals, work books, work sheets, charts, posters, notices, memoranda, drawings, plans software, Standard Operating Procedures etc. Documents maintained in computerised systems must also be
considered. It may also include documents of external origin such as standards, regulations, manufacturer's manuals etc).
All documents which form part of the quality management system shall be reviewed and approved for use by the authorised personnel prior to issue. A master list or equivalent document control procedure identifying the current revision status of documents in the quality system shall be established and be easily available to preclude the use of obsolete documents. The procedures shall also ensure that:
preservation purposes are suitably identified.All documents shall be uniquely identified, such identification to include the date of issue and/or the revision number, the total number of pages or a mark to signify the end of the document and the authority for issue.Changes to documents shall be reviewed and approved by the same personnel that performed
the original review and approval, unless specifically decided
otherwise. The designated personnel shall have access to pertinent background information upon which they base their review and approval. Amendments included in documents shall be clearly marked. If the laboratory's documentation control system allows for the temporary amendment of documents by hand, pending their re-issue, the procedures and authorities for such amendments shall be
defined and shall ensure that amendments are initialed and
dated. Documents amended by hand shall be formally re-issued as soon as practicable.
The forensic science laboratory shall establish, implement and maintain an effective quality management system appropriate to the type, range and volume of forensic science activities it undertakes. The quality system shall include policies and procedures addressing all the criteriadetailed in these accreditation requirements.
5.2 Documentation
5.2.1 Quality Manual
All elements of the laboratory's quality system shall be documented. This will include all policies, systems, programme, procedures, instructions etc. where the absence of documentation would adversely affect the test or examination results. Documentation of the quality system will be in a Quality Manual with cross-referencing to related operations documentation, where relevant. The Quality Manual and, where relevant, the associated
operational documentation, shall be kept up-to-date under the authority and responsibility of the Quality Manager. Documentation of the laboratory's quality system must include, where appropriate, the protocol(s) permitting departures from the documented policies and procedures.
Quality system documentation shall be readily available to all the personnel. Forensic science in administration of Criminal justice requires that intensive measures be undertaken to ensure the overall quality of scientific findings. To accomplish this, a quality system is required to provide laboratory management with continuing confidence that results and conclusions are accurate, impartial and relevant. Forensic science laboratories must, therefore, establish and maintain a quality system that is appropriate for the range of forensic disciplines as well as the types and numbers of examinations that are conducted. The success of the quality system
depends on the commitment of the management and active participation of each member of the laboratory staff. To ensure that everyone fully understands what are the expectations, all
elements of the quality system must be clearly articulated in the Quality Manual.
5.2.2 Document and Information Control
The laboratory shall establish and maintain documented procedures to control all documents and information that relate to its quality system. (Document is any medium used to record information or instructions. Documents include manuals, work books, work sheets, charts, posters, notices, memoranda, drawings, plans software, Standard Operating Procedures etc. Documents maintained in computerised systems must also be
considered. It may also include documents of external origin such as standards, regulations, manufacturer's manuals etc).
All documents which form part of the quality management system shall be reviewed and approved for use by the authorised personnel prior to issue. A master list or equivalent document control procedure identifying the current revision status of documents in the quality system shall be established and be easily available to preclude the use of obsolete documents. The procedures shall also ensure that:
- The authorized issues of appropriate documents are
available at all locations where operations essential to the effective functioning of the quality system
are performed.
- Documents are periodically reviewed and, where
necessary, revised to ensure continuing suitability and compliance with applicable requirements.
- Obsolete documents are deleted from the master list and
promptly removed from all points of issue or use, or otherwise, assured against unintended use.
preservation purposes are suitably identified.All documents shall be uniquely identified, such identification to include the date of issue and/or the revision number, the total number of pages or a mark to signify the end of the document and the authority for issue.Changes to documents shall be reviewed and approved by the same personnel that performed
the original review and approval, unless specifically decided
otherwise. The designated personnel shall have access to pertinent background information upon which they base their review and approval. Amendments included in documents shall be clearly marked. If the laboratory's documentation control system allows for the temporary amendment of documents by hand, pending their re-issue, the procedures and authorities for such amendments shall be
defined and shall ensure that amendments are initialed and
dated. Documents amended by hand shall be formally re-issued as soon as practicable.
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