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ISO9001, ISO17025 & Forensic Science FAD (Terminology (Process: a set…
ISO9001, ISO17025 & Forensic Science FAD
International Organisation for Standardisation (ISO)
Develops standards
Updates standards
Terminology
Process
: a set of interacting activities which transforms into outputs
Product
: the results of a process
Service
: the result of an activity or interaction between a service supplier and a customer
Customer/Client
: Receives the product/service
Supplier
: provides a product or service
Requirement
: is mandatory, SHALL/MUST
Recommendation
:strongly recommended, SHOULD
Advisory
: suggestions, MAY/MIGHT
Benefits of Standards
IS017025/ 17025 FAD
Confidence in results, international recognition, effective marketing tool, benchmark of performance
ISO9001
Competitive advantage, improves business performance, enhances brand reputation, saves money, streamlines operations and reduces waste, raises morale and increases customer satisfaction.
Document Management
Quality Policy:
definition of quality, objectives of the management system, commitment that personnel will follow policies, that management will commit to improve quality system.
Quality Records:
internal audit reports, management reviews, corrective and preventive actions.
Technical Records:
original observations, derived data, calculations, calibration records and certificates, staff records, reports, validation data & certificate of analysis.
Forensic FAD:
must be contemporaneous, time & date, item description and condition, test/technique, equipment/instrumentation used, analyst identification, examination room, environmental conditions.
Corrective/Preventive action
Corrective Action:
Steps taken to remove the causes of a nonconformance of undesirable situation, REACTIVE, must have a procedure.
Preventive Action:
identify opportunities for improvement, PROACTIVE, the FFAD encourages a system where all staff contributes to the improvement of the laboratory's management system. Internal Audits: gather evidence to make a judgement about the effectiveness & efficiency of the laboratory/process being assessed.
Activities Reviewed:
Suitability of policies, SOP's, reports for supervisory, audit findings, corrective and preventive actions, changes in volume & type of work, recommendations for improvement, results of proficiency tests,