Living in conformity with EN ISO 13485

Transcription

1 Living in conformity with EN ISO Best practice examples IHK Lübeck 2013 Summer Academy on Medical Technology Client logo Dr. Martin Peters

2 vita Dr. Martin Peters Dr. Martin Peters * , Remscheid / Germany, married, 2 children Studying / mechanical engineering , RWTH Aachen & Ecole Centrale, Paris Development engineer MPG Klasse III Disposables , Spiegelberg KG, Hamburg Graduating / Dr. Ing (PhD) Laserwelding of polymers 2002, Fraunhofer Institut of Lasertechnology, Aachen Contact: Dr. Martin Peters martin.peters@olympus-oste.eu +49(40) Head of manufacturing Endoscope-component workshop , Olympus Surgical, Hamburg General Manager Quality & Regulatory today, Olympus Surgical, Hamburg Q-Representative for all Olympus Surgical sites September 26, 2013 OLYMPUS SURGICAL TECHNOLOGIES EUROPE, Dr. Martin Peters Page 2

3 Olympus Surgical Technologies Europe OSTE HEADQUARTERS R&D, Production Upstream Marketing Sales, Service, RA,Training Surgery, Energy Imaging, OR Integration Reprocessing 756 Employees CARDIFF HAMBURG BERLIN R&D Production Energy 80 Employees PREROV R&D Production Energy, Surgery 240 Employees TUTTLINGEN Production Energy 151 Employees Sourcing ENT 15 Employees Global competence center and regional headquarter for the development and production of over 3,000 medical devices within the Olympus Group. September 26, 2013 OLYMPUS SURGICAL TECHNOLOGIES EUROPE, Dr. Martin Peters Page 3

4 OSTE - Business fields & product / service overview Flexible Scopes Olympus Pillars of Medical Business Optics / Telescopes Video Rigidscopes Imaging / Therapy CDS / ETD Systems Integration Mechanical Instruments Energy / Therapy customer Hand Instruments HF-Surgery, RFITT, ET & Ultrasonic Surgery System Integration Service Business September 26, 2013 OLYMPUS SURGICAL TECHNOLOGIES EUROPE, Dr. Martin Peters Page 4

5 Living in conformity with ISO 13485: Best practice examples AGENDA Setting the Stage Key topics of EN ISO Process relationship within EN ISO Risk based approach Risk from a customer / patient / product point of view -> ISO Risk from a business point of view -> Pareto Examples / Case Studies Closing Discussion September 26, 2013 OLYMPUS SURGICAL TECHNOLOGIES EUROPE, Dr. Martin Peters Page 5

6 CE / Europe Medical Device Directive 93/42/EEC (MDD) European guideline / law describes application and ist prerequisits of CE mark requires the fulfillment of Essential Requirements statutory presumption: State of the art is ensured by harmonized standards (ISO,EN etc.) e.g. fulfillment of standard (e.g. IEC Electrical safety) allows presumtion, that product fulfills essential requirement for electrical safety MPG ISO translation of EU guideline into German law Harmonized standard containing applicable requirements for a QMS for medical device manufacturer part of the list of harmonized standards September 26, 2013 OLYMPUS SURGICAL TECHNOLOGIES EUROPE, Dr. Martin Peters Page 6

7 EN ISO 13485, ToC ISO 13485:2010 -> LINK Blocked due to licensing restriction September 26, 2013 OLYMPUS SURGICAL TECHNOLOGIES EUROPE, Dr. Martin Peters Page 7

8 EN ISO 13485, process model approach Your triggerpoint September 26, 2013 OLYMPUS SURGICAL TECHNOLOGIES EUROPE, Dr. Martin Peters Page 8

9 Living in conformity with ISO 13485: Best practice examples AGENDA Setting the Stage Key topics of EN ISO Process relationship within EN ISO Risk based approach Risk from a customer / patient / product point of view -> ISO Risk from a business point of view -> Pareto Examples / Case Studies Closing Discussion September 26, 2013 OLYMPUS SURGICAL TECHNOLOGIES EUROPE, Dr. Martin Peters Page 9

10 Risk from a customer / patient product / point of view RISIKGRAPH Severity (Schadensausmaß) S-1 S-2 S-3 S-4 S-5 occurrence level / likelihood W-5 W-4 W-3 W-2 W-1 a typical risk graph acc. to ISO Risk High Mid Low Description Not acceptable area ALARP area (as low as reasonably posible) Acceptable area September 26, 2013 OLYMPUS SURGICAL TECHNOLOGIES EUROPE, Dr. Martin Peters Page 10

11 A basic consideration Turn your attention towards the ceiling; The probability of a harm is not a function of the sharpness of the sword Much more it lies within the thickness of the thread" [acc. to Erich Kästner, sword of Damocles] September 26, 2013 OLYMPUS SURGICAL TECHNOLOGIES EUROPE, Dr. Martin Peters Page 11

12 Risk from a business point of view -> Pareto Vilfredo Pareto is your friend! September 26, 2013 OLYMPUS SURGICAL TECHNOLOGIES EUROPE, Dr. Martin Peters Page 13

13 Living in conformity with ISO 13485: Best practice examples AGENDA Setting the Stage Key topics of EN ISO Process relationship within EN ISO Risk based approach Risk from a customer / patient / product point of view -> ISO Risk from a business point of view -> Pareto Examples / Case Studies Closing Discussion September 26, 2013 OLYMPUS SURGICAL TECHNOLOGIES EUROPE, Dr. Martin Peters Page 14

14 Case Study 1 The requirement: Blocked due to licensing restriction Best practice Have a quality manual available! September 26, 2013 OLYMPUS SURGICAL TECHNOLOGIES EUROPE, Dr. Martin Peters Page 15

15 Case Study 2 The requirement: Blocked due to licensing restriction Best practice Describe your system using the ISO language Most improvements have also a quality aspect, use it! September 26, 2013 OLYMPUS SURGICAL TECHNOLOGIES EUROPE, Dr. Martin Peters Page 16

16 Case Study 3 The requirement: Blocked due to licensing restriction Best practice Use your NC / CAPA / PMS data to show the effectivenes of your training September 26, 2013 OLYMPUS SURGICAL TECHNOLOGIES EUROPE, Dr. Martin Peters Page 17

17 Living in conformity with ISO 13485: Best practice examples AGENDA Setting the Stage Key topics of EN ISO Process relationship within EN ISO Risk based approach Risk from a customer / patient / product point of view -> ISO Risk from a business point of view -> Pareto Examples / Case Studies Closing Discussion September 26, 2013 OLYMPUS SURGICAL TECHNOLOGIES EUROPE, Dr. Martin Peters Page 18

18 Case Study 4 The (hidden) requirement: GMP Cost 1)USA 15-20% of company employees QA/RA oriented 2)Australia, Canada, UK 3)EU, Japan 10% of company employees QA/RA oriented 4)EU mediterranean, Brazil, Saudi Arabia August 8, 2013 OLYMPUS SURGICAL TECHNOLOGIES EUROPE, Dr. Martin Peters Page 224 Best practice Don t try to cheat, or pay too less attention to quality management. Don t try to build up a shadow system. Use the Quality language as your living language September 26, 2013 OLYMPUS SURGICAL TECHNOLOGIES EUROPE, Dr. Martin Peters Page 19

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20 Backup September 26, 2013 OLYMPUS SURGICAL TECHNOLOGIES EUROPE, Dr. Martin Peters Page 21