Dr. W. Huisman Cairo, november 19th 2012

ISO 15189:2007 clauses 5.1 Personnel 5.2 Accommodation and environmental conditions 5.3 Laboratory equipment 4.6 External services and supplies [Management of information systems]

 Organisational schema, job descriptions, qualification required  Records to show qualifications and competence  Which data are needed?  Laboratory director  What are the responsibilities  Where are the required competences  Adequate number of staff  Continuing education  How can you show this

 organisation plan, policies, job descriptions  records of relevant education and professional qualifications, training, experience and competence of all personell  competence of laboratory director  summary of responsibilities of laboratory director (in 3 e edition )  adequte number of staff ( in 3 e edition part of quality management under )  continuous education for staff of all levels. Of course it must be recorded

 Space adequate for quality of the work, safety of personnel and patient care (when relevant)  Primary sample collections ◦ Which items  Quality of the work ◦ Which items  Safety of personnel ◦ Which items  Storage facilities

 space adequate  space efficienct and safe  primary sample collection adequate (admission possible for disabled patients)  space adequate to warrant quality of the work  control, monitoring and recording of environmental conditions takes place (sterility, dust, radiation, humidity, electrical supply, temperature and sound). Dependent on type of tests, for instance tuberculosis or molecular biology more stringent.See also 5.2.6

 effective separation between sections with incompatible activities. This also holds true for storage space  access  communication system within laboratory  storage space adequate  clean and well maintained

 Requirements for selection connected to required performance  Adequate function after installation and validation of this function  Standard operating procedure  Records of its functioning –which aspects important  Operation by competent personnel (see under personnel)  How to handle defective incidents  Computing system – see laboratory information system

 Policies for selection of equipment  Record of suppliers  Policies for placing in service  Inventory of supplies  Chapter 5.3 strongly connected to this 4.6

 Not jus an annex also a requirement of  Protection of data  Validation of software  Access  Back up