3 - Documentation

What are documents

• Written policies, procedures, process descriptions, ISO standards, templates, software, textbooks

• Must be approved by an authorised person and communicated to all concerned

Storage of documents

• 6.3.3 storage facilities

• Conditions must ensure the integrity of documents and records ie prevent damage, deterioration, loss or unauthorised access

What are records

• Evidence of a task being complete e.g. activity, transaction, decision

• Must be legible but can be in any format e.g. paper, electronic, audio

• Stored in cabinet, disk, desktop, email

• Retained as per policies and regulations

• Cannot be edited

Examples of records

• Staff training and competency records

• Requests for examination, results and reports

• QC and reagent records

• Non conformance reports and corrective action

• Audits, meeting minutes

Guidelines for records

• Permanent - books bound, pages numberes, permanent ink, control storage

• Secure - maintain confidentiality, limit access, protect from environmental hazards

• Traceable - dated and signed

• Also under MS code of conduct under performance - maintain accurate records

ÌSO 8.4.3

• Retention of records

•Procedures for identification, protection from unauthorised access and chnage, storage, retention time, disposal of records

• All records need to be accessible and legible during specified retention time

Q pulse

• Electronic quality management system

• Conatains documents and automates the process of information retrieval like audits, corrective action, SOP’s, risk assesments, training records, equipment lists

ISO 8.3.2 control of documents

• Laboratory should ensure that all documents are uniquely identified

• Are periodically reviewed and updated as necessary

• Relevant options available at points of use

• Documents are protected from unauthorised change, deletion and access

• At least one copy of each obsolete document retained for a set period