+ All Categories
Home > Documents > dqs-med folder iso-13485 gb rev02 Layout 1€¦ · Requirements of ISO 13485 as compared to ISO...

dqs-med folder iso-13485 gb rev02 Layout 1€¦ · Requirements of ISO 13485 as compared to ISO...

Date post: 17-Apr-2020
Category:
Upload: others
View: 32 times
Download: 1 times
Share this document with a friend
2
DIN EN ISO 13485 Medical Devices Quality Management What else we can do for you Certifications and accreditations on the basis of n ISO 13485 CMDCAS With a CMDCAS certificate evidencing conformity to ISO 13485 recognized by the Canadian authorities, manufacturers of medical devices of classes II, III and IV according to the Canadian Medical Devices Regulations (CMDR) can obtain the license for the Canadian Market. Rele- vant for: Manufacturers of medical devices oriented towards the Canadian market. n ISO 9001 Standard applied and recognized world- wide to ensure the quality of processes and results in order to improve the competitive factor. Relevant for: Every enterprise. The standard enjoys a high level of recognition in healthcare and related social systems. n Medical Device Directive 93/42/EEC of the Euro- pean Council: Prerequisite for placing medical devices on the market in the European Union. Relevant for: Manufacturers of higher than class I medical devices. n ISO 15378 is based on ISO 9001 and additionally comprises all GMP (Good Manufacturing Practices) requirements relevant for primary packaging mate- rials. Relevant for: Manufacturers of primary packa- ging materials for drugs and manufacturers with a special focus on hygiene. Further certifications and registrations in close cooperation with the DQS Group n i.a. ISO 14001, ISO 50001, TS 16949, BS OHSAS 18001, SCC/SCP; AZAV Pre-submission meeting Training, seminars, workshops DQS-MED ERFA-Club medical devices Process audit Contact us or visit our homepage About us DQS Medizinprodukte GmbH n Independent and competent management partner for companies of all sizes and in all industries. n In 1995, established as the DQS center of excellence for medical devices and designated as a notified body for directive 93/42/EEC. n Founded in 2008 as a wholly owned subsidiary of DQS Holding GmbH. n Currently supervising more than 1200 customers with 100 auditors and experts. n Operating in the areas of medical device approvals and certification of management system in the health care markets for 20 years. DQS Gruppe n More than 80 offices in over 60 countries, n Approx. 20,000 customers currently representing approximately 47,000 certified sites in over 100 countries in almost all industries n Worldwide, approximately 2,800 employees, including about 2,300 auditors and experts n Today it counts to one of the world's largest certification bodies n Other German subsidiaries of DQS Holding GmbH, headquartered in Frankfurt am Main ¨ DQS GmbH ¨ DQS Food Safety Solutions GmbH DQS Medizinprodukte GmbH August-Schanz-Straße 21 D 60433 Frankfurt am Main Phone +49 69 95427-300 Fax +49 69 95427-388 [email protected] www.dqs-med.de Rev.: 02 Office Tuttlingen Königstraße 13 D 78532 Tuttlingen Tel. +49 7461 1617460
Transcript
Page 1: dqs-med folder iso-13485 gb rev02 Layout 1€¦ · Requirements of ISO 13485 as compared to ISO 9001 ISO 13485 requires significantly more documented pro-cedures and records than

DIN EN ISO 13485Medical DevicesQuality Management

What else we can do for you

Certifications and accreditations on the basis of

n ISO 13485 CMDCAS With a CMDCAS certificate evidencing conformity to ISO 13485 recognized by the Canadian authorities, manufacturers of medical devices of classes II, III and IV according to theCanadian Medical Devices Regulations (CMDR) can obtain the license for the Canadian Market. Rele-vant for: Manufacturers of medical devices oriented towards the Canadian market.

n ISO 9001 Standard applied and recognized world-wide to ensure the quality of processes and results in order to improve the competitive factor. Relevant for: Every enterprise. The standard enjoys a high level of recognition in healthcare and related social systems.

n Medical Device Directive 93/42/EEC of the Euro-pean Council: Prerequisite for placing medical devices on the market in the European Union. Relevant for: Manufacturers of higher than class I medical devices.

n ISO 15378 is based on ISO 9001 and additionally comprises all GMP (Good Manufacturing Practices) requirements relevant for primary packaging mate-rials. Relevant for: Manufacturers of primary packa-ging materials for drugs and manufacturers with a special focus on hygiene.

Further certifications and registrations in close cooperation with the DQS Group

n i.a. ISO 14001, ISO 50001, TS 16949,

BS OHSAS 18001, SCC/SCP; AZAV

Pre-submission meeting

Training, seminars, workshops

DQS-MED ERFA-Club medical devices

Process audit

Contact usor visit our homepage

About us

DQS Medizinprodukte GmbH

n Independent and competent management partner for companies of all sizes and in all industries.

n In 1995, established as the DQS center of excellence for medical devices and designated as a notified body for directive 93/42/EEC.

n Founded in 2008 as a wholly owned subsidiary of DQS Holding GmbH.

n Currently supervising more than 1200 customers with 100 auditors and experts.

n Operating in the areas of medical device approvals and certification of management system in the health care markets for 20 years.

DQS Gruppe

n More than 80 offices in over 60 countries,

n Approx. 20,000 customers currently representing approximately 47,000 certified sites in over 100 countries in almost all industries

n Worldwide, approximately 2,800 employees, includingabout 2,300 auditors and experts

n Today it counts to one of the world's largest certificationbodies

n Other German subsidiaries of DQS Holding GmbH, headquartered in Frankfurt am Main

¨ DQS GmbH

¨ DQS Food Safety Solutions GmbH

DQS Medizinprodukte GmbH

August-Schanz-Straße 21D 60433 Frankfurt am MainPhone +49 69 95427-300Fax +49 69 [email protected] Rev.: 02

Office Tuttlingen

Königstraße 13D 78532 TuttlingenTel. +49 7461 1617460

dqs-med_folder_iso-13485_gb_rev02:Layout 1 05.10.2015 15:32 Seite 1

Page 2: dqs-med folder iso-13485 gb rev02 Layout 1€¦ · Requirements of ISO 13485 as compared to ISO 9001 ISO 13485 requires significantly more documented pro-cedures and records than

DIN EN ISO 13485 – for whom?

This standard is addressed to medical device manu-facturers as well as suppliers and service providers whohave to comply not only with international, European ornational legal requirements, but also with correspondingrequirements of customers. Examples are the Canadian,US or Japanese requirements as well as the Europeandirectives concerning medical devices and in vitro diag-nostic devices. With a certificate of conformity to ISO13485 such enterprises document that their manage-ment system satisfies the requirements of that standard.

Examples:n Manufacturers of medical devices of risk classes II

to IV according to the Canadian Medical Devices Regulations (CMDR) who want to sell their products on the Canadian market.

n Enterprises that want to develop and manufacture medical devices and place them on the market.

n Service providers and other suppliers within the value-added chain.

DQS Medizinprodukte GmbH has been accredited forISO 13485 not only by the German National Accredita-tion Body (DAkkS) but also by the Standards Council ofCanada (SCC) and is one of the few certification bodiesworldwide authorised to issue certificates of conformityto ISO 13485 in accordance with the requirements ofthe Canadian Medical Devices Conformity AssessmentSystem.

An enterprise holding a certificate of conformity to ISO 13485n proves compliance with legal requirements,

n minimizes and controls risks,

n contributes to product safety for patients and users,

n emphasizes the competence of the enterprise,

n prevents errors instead of correcting them,

n improves the quality of performance,

n improves customer and employee satisfaction,

n provides transparency and clarity of internal processes, and

n saves time and costs.

The DIN EN ISO 13485 Certification Procedure

Principles and Significance

Small and medium-sized enterprises in particular have thechance not only to occupy a market segment, but to posi-tion themselves more broadly. Apart from the automotiveindustry, mechanical engineering or instrument enginee-ring, the medical devices market has come into focus inrecent years – not least because of recommendations ofthe respective associations. Many manufacturers refrainfrom utilising the potential of this market segment becauseof the supposedly high legal and normative requirements.

Requirements of ISO 13485 as compared to ISO 9001

ISO 13485 requires significantly more documented pro-cedures and records than ISO 9001 and focusses on pa-tient and user safety.

Specific features of national law, such as the German Me-dical Devices Act, have to be taken into account.

A safety representative and, if applicable, a medical devi-ces consultant have to be named.

Requirements are established concerning preventivemaintenance, personal/ambient hygiene, management ofspecial ambient conditions.

A risk management procedure according to ISO 14971 hasto be introduced.

Clinical assessments and/or results of clinical tests aretaken into consideration in the validation of the develop-ment process.

Validations are also required for production and testing soft-ware, if such software has an influence on product quality.

The rule of thumb is:DIN EN ISO 9001– requirement of continuous improvement– requirement of customer satisfaction + specific requirements concerning medical devices

(hygiene, validation, traceability, product safety)+ risk management (ISO 14971)----------------------------------------------------------------------------------------= DIN EN ISO 13485

The objective is not to improve the management system ofan organization or to verify customer satisfaction, but to en-sure product safety and the well-being of patients and users.

PROCEDURAL CYCLEtakes 3 years

dqs-med_folder_iso-13485_gb_rev02:Layout 1 05.10.2015 15:32 Seite 2


Recommended