quality management handbook - scanco medical: micro … · quality management handbook ... the...

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SCANCO Medical AG F a b r i k w e g 2 CH-8306 Brüttisellen w w w . s c a n c o . c h

Directive Quality Management Handbook

4 Content

1 Foreword....................................................................................................................................................................2 2 Goals .........................................................................................................................................................................2 3 Scope.........................................................................................................................................................................2 4 Content ......................................................................................................................................................................3 5 Our Quality Management System .............................................................................................................................4 6 Origin .........................................................................................................................................................................4 7 Focus .........................................................................................................................................................................4 8 Research Projects .....................................................................................................................................................4 9 Market........................................................................................................................................................................4 10 Mission Statement .................................................................................................................................................4 11 Corporate Policy.....................................................................................................................................................5

11.1 Our Products ................................................................................................................................................... 5 11.2 Our Customers................................................................................................................................................ 5 11.3 Our Employees ............................................................................................................................................... 5 11.4 Our Partners.................................................................................................................................................... 5

12 Our Processes .......................................................................................................................................................5 12.1 Process Diagram............................................................................................................................................. 6 12.2 Process Tree................................................................................................................................................... 6

Appendix I .........................................................................................................................................................................7 Appendix II ........................................................................................................................................................................8 Appendix III .......................................................................................................................................................................9

Document: AN-300, Revision: 1.4 Seite 3/9 SCANCO Medical AG, CH-8306 Bruettisellen


5 Our Quality Management System The Company utilizes a process oriented management system. The management system reflects the com-pany’s three operative activities (management, resources, and implementation) and fulfills the following re-quirements:

- ISO 9001:2008 (First certified 2001-11-29), see Appendix I for Certificate - ISO 13485:2003 (First certified 2004-03-16), see Appendix I for Certificate - ISO 13485:2003 CMDCAS (First certified 2005-11-22), see Appendix II for Certificate - Annex II.3 of the Medical Device Directive (MDD) 93/42/EEC (First certified 2004-09-15),

see Appendix III for Certificate - Medical Devices Ordinance MepV SR 812.213 - EKAS directives concerning occupational health and safety

6 Origin SCANCO Medical AG was founded in Mai 1988 as a spin-off of the Swiss Federal Institute of Technology, Zurich (ETH Zurich). The company is a privately held corporation under Swiss law.

7 Focus SCANCO Medical AG develops, manufactures, and distributes high tech products (instruments and software) for scientific investigation and diagnosis of bone (structure, density, etc.) and materials sciences and engineer-ing. With close ties to universities and medical institutions, SCANCO Medical AG demands the best of its em-ployees and the applied technologies and methods.

8 Research Projects Nurturing tight cooperation with research centers allows the utilization of synergies formed with fields such as materials sciences, aero-space engineering, and medicine. The goal of these collaborations is to be involved in leading research and to have access to cutting edge technology for our products and applications. The use of SCANCO Medical AG instrumentation in research and aero-space stimulates to new fields of activity and revo-lutionary applications for us to explore and develop for our customers.

9 Market The efforts of SCANCO Medical AG are primarily directed towards medical (bone) and non-destructive material testing.

10 Mission Statement The mission statement is phrased in guidelines promoting a quality focused philosophy amongst the employ-ees. These guidelines are developed together with the employees. − If you don’t go forwards, you go backwards. This is why invariably applying the management system

helps to improve processes, products, and services. − Perpetual contact with our clients allows us to understand their needs and include appropriate solutions in

our products and services. − Our customers can rely on us to bring high quality to them. − The management system is binding for all employees of SCANCO Medical AG. − The management system encompasses all areas of operation and obliges employees of every level to

take responsibility in respecting the guidelines and achieving the set goals. − The employees of SCANCO Medical AG, independent of their function, shape the company by their per-

formance, knowledge, and skill. − All employees identify themselves with the enterprise and contribute to the success.



11 Corporate Policy

11.1 Our Products SCANCO Medical AG aims to develop and produce high tech instrumentation including services and software for high resolution computer tomography. These products should manifest the technological state-of-art and their function shall set the trends of the industry. Medical devices shall represent a significant contribution to health when applied diagnostically or in follow-ups to therapeutic intervention. Mature and optimized solutions guarantee safe and reliable operation of our products at all times. Software and instruments are intuitive and easy to operate in spite of the advanced science they are based on. SCANCO Medical AG does not produce any sterile devices or active implantable medical devices.

11.2 Our Customers SCANCO Medical AG serves their clients throughout the world with expertise. Optimized workflow allows us to react to customers needs with speed and well-targeted purpose. Competent training provides our clients with the means to safely and securely operate the instruments after minimal instruction and practice. A number of different means are available to the client to contact our support services when technical questions arise.

11.3 Our Employees

By careful selection of highly qualified employees – usually with scientific backgrounds – SCANCO Medical AG is able to secure long term and high level potential for further development. Thanks to an ergonomic work envi-ronment a creative and motivated attitude to work is promoted and cultivated. The use of modern and appropri-ate tools supports the proactive and visionary development of new technologies within required times. The health of its employees matters to SCANCO Medical AG. Thus, required measures are specified to assure oc-cupational safety. These measures are regularly checked for their effectiveness.

11.4 Our Partners

Taking good care of our relationships with our suppliers promotes partnerships of high value for all parties in-volved. Reliability and understanding for each others needs creates the trust that guarantees frictionless pro-duction and development. Sound business operations guarantee that SCANCO Medical AG remains, over many years, a fair partner for clients and suppliers and can offer secure employment to its motivated personnel.

12 Our Processes The operations of SCANCO Medical AG are subdivided in to three groups: “Management”, “Resources”, and “Realization”. SCANCO Medical AG has no outsourced processes. None of the processes require validation. The individual processes are means to fulfill the whishes of our customers. The diagram “FO-012, Process-Tree” clearly identifies the person in charge of each process. Each process is described in a directive “AN-XXX”. The process flow is described in a flow chart “PR-XXX”. The documents are managed by the software package “IQ-Soft”. When requiring detailed information about processes, employees can access the instructions, flow-charts, and supplementary documentation via “IQ-Soft” in their currently valid version.



12.1 Process Diagram The process diagram (Fig. 1) shows the correlation between the processes. The chart is derived from the man-aged form ‘FO-053’ and was translated from German into English for this handbook.

Process Group Realization

Customer Service

Customer Satisfaction

Cus

tom

er, P

rodu

ct P

erfo

rman

ce

Cus

tom

er, P

rodu

ct P

erfo

rman

ce

Needs

Requirements Continuous Improvement, Medical Device Vigilance / MDR

Order Processing

Development, Validation, Risk Management

Process Group Resources

Employees Occupational Safety Infrastructure

Process Group Management

Planning, Objectives &Communication Document Management Data Backup Audit

Needs

Feedback

Customer Satisfaction

Goa

ls

Info

rmat

ions

Info

rmat

ions

Scan Service

Inspection ofAcquired MaterialsAcquisition Service &

MaintenanceProduction Installation &Training

Fig. 1: Process Diagram, Chart from Form ’FO-053’ (Release 2.0)

12.2 Process Tree The process tree (Fig. 2) clearly identifies the person in charge of each process. The chart is derived from the managed form ‘FO-012’ and was translated from German into English for this handbook.

2.0 Process Group Resources 3.0 Process Group Realization

2.1 Employees PER BK

a = Process Numberb = Process Namec = Abbr. Process Named = Process Ownere = Substitution of Process Owner

Legende:

1.4 Audit AUD MBBK

2.3 Infrastructure IFS MHMB

1.2 DocumentManagement DOK SM

MB

1.3 Data Backup DAS BKMB

2.2 OccupationalSafety ASI JN**

MB

3.1 Development ENT SHJN

3.3 Order Processing ABA BKLF

3.5 Installation &Training INS MZ

BR

3.7 ContinuousImprovement CZV

3.8 Acquisition BES DVMH

3.6 Service &Maintenance SVC BR

IH

3.4 Production PRD DVMH

3.1.1 Validation VAL SHMB

a b c de

3.1.2 Medical DeviceVigilance / MDR MDR SH

BK3.2 Risk Management RIM SHBK

* General Manager, Quality Manager** Representative Occupational Safety

1.0 Process Group Management

1.1Planning,

Objectives &Communication

PZK BK*SH

3.8.1 Inspection ofAcquired Materials WEP DV

MH

1.2.1 RevisionManagement AND SM

MB

2.3.2 Quality AssuranceTools PMI MH

MB

3.9 Scan Service SSV MBLF

BRIH

Fig. 2: Process Tree, Chart from Form ’FO-012’ (Release 2.2)



Appendix I

Fig. 3: Certificate regarding ISO 9001:2008 / ISO 13485:2003



Appendix II

Fig. 4: Certificate regarding ISO 13485:2003 CMDCAS



Appendix III

Fig. 5: Certificate regarding Annex II.3 of Directive 93/42/EEC


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