FOCAL Quality Manual

FOCAL SoftwareFOCAL Software

FOCAL Quality ManualFOCAL Quality Manual


FOCAL Software – Corporate ProfileFOCAL Software – Corporate Profile

FOCAL Software has extensive experience in developing and implementing electronic Quality Management systems for health services and life science since 1993.

Owners:– Founders (32%)– TM Software (32%)– Nyherji – IBM Iceland (24%)– KB-Bank of Iceland (12%)



• Has installed over 20 000 user licences• Started working in quality mangement in

1993 • Started working in health care industry

in 1996• Has 90% market share in quality

management systems in Iceland• Has 100% market share in quality

systems for the health care sector


A few referencesA few references• SWEDAC – Sweden• Electrolux/Husqvarna – Sweden, Finland• Norchip – Norway• GlaxoSmithKline• Reykjavik University Hospital• Össur – Iceland, Holland, USA, Sweden• Medicines Control Agency• Reykjavik Bloodbank• Lýf - biopharmaceutical • ...


• StandardsStandards• ProcessesProcesses• HandbookHandbook• ProjectsProjects• Security manualSecurity manual• Internal AuditsInternal Audits• External AuditsExternal Audits• CertificationCertification• ISO 9001:2000ISO 9001:2000

FOCAL QualityFOCAL Quality

3 databases,Manual, Published documents and Templates

Less paper Better document control Easier distribution of quality

documents Faster response time Easier maintenance of quality

system Easier access to correct

documents Better overview of status and

responsibility

MonitorMonitorMonitorMonitor

Supplier Supplier evaluationevaluationSupplier Supplier

evaluationevaluation

AuditsAuditsAuditsAudits

Non ConformitiesNon ConformitiesComplaintsComplaints

Non ConformitiesNon ConformitiesComplaintsComplaints

ProjectsProjectsProjectsProjects

AssetsAssetsAssetsAssets


Register/DistributionRegister/Distribution

DigitalDigitalDigitalDigital



SignsSigns

PublishingPublishing

• StandardsStandards• ProcessesProcesses• HandbookHandbook• ProjectsProjects• Security manualSecurity manual• Internal AuditsInternal Audits• External AuditsExternal Audits• CertificationCertification• ISO 9001:2000ISO 9001:2000

FOCAL SoftwareFOCAL SoftwareFOCAL GroupwareFOCAL Groupware


FOCAL Qualty Manual SystemFOCAL Qualty Manual System

Document database for quality documents, contaings processes for editing, approving and publishing Document database for quality documents, contaings processes for editing, approving and publishing documents with hyperlinks, process charts, electronic signatures e.t.c.documents with hyperlinks, process charts, electronic signatures e.t.c.

FOCAL SoftwareFOCAL SoftwareFOCAL SoftwareFOCAL Software


Quality documents can be edited using popular word processing systems, or the built-in editor.Quality documents can be edited using popular word processing systems, or the built-in editor.

Documents can include hyperlinks to other documents, URL’s or direct references to standards or other Documents can include hyperlinks to other documents, URL’s or direct references to standards or other requirements..requirements..



Links to other documents

Signs by pressing grey button. Closed system for signing and a password is required.



Work flow diagrams can be created with popular MS Visio or any other application and included, with Work flow diagrams can be created with popular MS Visio or any other application and included, with hyperlinks. Click on one box and jump directly to another documnent.hyperlinks. Click on one box and jump directly to another documnent.

FOCAL SoftwareFOCAL SoftwareFOCAL GroupwareFOCAL Groupware


Documents can be published internally or externally and be read with a Lotus Notes client or Internet Documents can be published internally or externally and be read with a Lotus Notes client or Internet Browser . Hyperlinks work both ways.Browser . Hyperlinks work both ways.