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Questions and Answers
Chapter 4 of DIN EN ISO 13485 requires the documentation of quality policy and quality objectives.
Chapter 4 of DIN EN ISO 13485 requires the documentation of quality policy and quality objectives.
True
The QMS documentation must include documents and records of all processes needed to maintain but not improve the QMS.
The QMS documentation must include documents and records of all processes needed to maintain but not improve the QMS.
False
Chapter 5 of DIN EN ISO 13485 defines the Quality Policy and commitment.
Chapter 5 of DIN EN ISO 13485 defines the Quality Policy and commitment.
True
DIN EN ISO 13485, 2016, specifically addresses the requirements for medical devices in Europe.
DIN EN ISO 13485, 2016, specifically addresses the requirements for medical devices in Europe.
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A quality manual is not required to be documented as part of the QMS according to DIN EN ISO 13485.
A quality manual is not required to be documented as part of the QMS according to DIN EN ISO 13485.
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The ink flow requirement for the pen is 100 - 120 mg/km.
The ink flow requirement for the pen is 100 - 120 mg/km.
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The test revealed that the ink flow is 110 +/- 5 mg/km.
The test revealed that the ink flow is 110 +/- 5 mg/km.
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The V-Model is a variation used for the development of products.
The V-Model is a variation used for the development of products.
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DIN EN ISO 13485 is related to Medical Regulation in Europe.
DIN EN ISO 13485 is related to Medical Regulation in Europe.
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Chapter 7 of DIN EN ISO 13485 focuses on plan and document development.
Chapter 7 of DIN EN ISO 13485 focuses on plan and document development.
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Quality policy is not a top management responsibility according to DIN EN ISO 13485.
Quality policy is not a top management responsibility according to DIN EN ISO 13485.
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The V-Model is not a structured process for the development of products according to Medical Regulation (Europe).
The V-Model is not a structured process for the development of products according to Medical Regulation (Europe).
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According to DIN EN ISO 13485, training and internal communication are not part of the quality management system requirements.
According to DIN EN ISO 13485, training and internal communication are not part of the quality management system requirements.
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Management reviews and internal audits are not emphasized in the quality management system of Medical Regulation (Europe).
Management reviews and internal audits are not emphasized in the quality management system of Medical Regulation (Europe).
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The commitment of top management is not a requirement for the Quality Management System according to DIN EN ISO 13485.
The commitment of top management is not a requirement for the Quality Management System according to DIN EN ISO 13485.
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ISO 13485 is not based on ISO 9001.
ISO 13485 is not based on ISO 9001.
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ISO 13485 includes processes that ensure conformity with MDR DIN EN ISO 13485.
ISO 13485 includes processes that ensure conformity with MDR DIN EN ISO 13485.
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ISO 13485 does not have any specific requirements for the cleanliness of the product.
ISO 13485 does not have any specific requirements for the cleanliness of the product.
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ISO 13485 does not cover particular requirements for validation of processes for sterilization and sterile barrier systems.
ISO 13485 does not cover particular requirements for validation of processes for sterilization and sterile barrier systems.
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ISO 13485 is not recommended for manufacturers of medical products.
ISO 13485 is not recommended for manufacturers of medical products.
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The quality management system DIN EN ISO 13485 specifies the requirement for controlled purchasing and verification of purchased articles and supplier.
The quality management system DIN EN ISO 13485 specifies the requirement for controlled purchasing and verification of purchased articles and supplier.
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The production record of every product/batch is not required under the Medical Device Regulation MDR 2017/745.
The production record of every product/batch is not required under the Medical Device Regulation MDR 2017/745.
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The technical documentation MDR 2017/745 is not applicable to the Medical Device Regulation in Europe.
The technical documentation MDR 2017/745 is not applicable to the Medical Device Regulation in Europe.
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The design and development file for each product is not a requirement under the quality management system DIN EN ISO 13485.
The design and development file for each product is not a requirement under the quality management system DIN EN ISO 13485.
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Verification and validation are not part of the customer related requirements (URS) under the quality management system DIN EN ISO 13485.
Verification and validation are not part of the customer related requirements (URS) under the quality management system DIN EN ISO 13485.
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The standard DIN EN ISO 13485 is specifically for the quality management system of medical devices in Europe.
The standard DIN EN ISO 13485 is specifically for the quality management system of medical devices in Europe.
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Annex A of DIN EN ISO 13485 provides a comparison to ISO 9001:2015.
Annex A of DIN EN ISO 13485 provides a comparison to ISO 9001:2015.
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Chapter 7 of DIN EN ISO 13485 deals with resource management.
Chapter 7 of DIN EN ISO 13485 deals with resource management.
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The standard DIN EN ISO 13485 was published in the year 2016.
The standard DIN EN ISO 13485 was published in the year 2016.
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The quality management system requirements for regulatory purposes are specified in DIN EN ISO 13486.
The quality management system requirements for regulatory purposes are specified in DIN EN ISO 13486.
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The DIN EN ISO 13485 is a standard for Quality Management Systems in the European medical device industry.
The DIN EN ISO 13485 is a standard for Quality Management Systems in the European medical device industry.
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The DIN EN ISO 13485 standard was issued in 2015.
The DIN EN ISO 13485 standard was issued in 2015.
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Chapter 7 of the DIN EN ISO 13485 specifically addresses the regulation of artificial organs.
Chapter 7 of the DIN EN ISO 13485 specifically addresses the regulation of artificial organs.
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The DIN EN ISO 13485 standard applies only to pharmaceutical products.
The DIN EN ISO 13485 standard applies only to pharmaceutical products.
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The DIN EN ISO 13485 standard focuses on environmental management within the medical device industry.
The DIN EN ISO 13485 standard focuses on environmental management within the medical device industry.
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The DIN EN ISO 13485 standard is only applicable to European countries.
The DIN EN ISO 13485 standard is only applicable to European countries.
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The primary purpose of DIN EN ISO 13485 is to ensure the safety and effectiveness of medical devices.
The primary purpose of DIN EN ISO 13485 is to ensure the safety and effectiveness of medical devices.
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Compliance with DIN EN ISO 13485 is mandatory for all medical device manufacturers in Europe.
Compliance with DIN EN ISO 13485 is mandatory for all medical device manufacturers in Europe.
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The requirements of DIN EN ISO 13485 only apply to the manufacturing stage of medical devices.
The requirements of DIN EN ISO 13485 only apply to the manufacturing stage of medical devices.
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DIN EN ISO 13485 is a recommendation rather than a requirement for companies in the European medical device industry.
DIN EN ISO 13485 is a recommendation rather than a requirement for companies in the European medical device industry.
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Study Notes
DIN EN ISO 13485 Summary
- DIN EN ISO 13485 is a standard for Quality Management Systems in the European medical device industry.
- Published in 2016, it specifies requirements for medical devices in Europe.
- It defines the Quality Policy and commitment, but a quality manual is not required.
- Focuses on maintaining the QMS but not improving it.
- Chapter 7 deals with resource management and plan and document development.
- Annex A provides a comparison to ISO 9001:2015.
- DIN EN ISO 13485 is not based on ISO 9001 and includes processes that ensure conformity with MDR.
- It does not include specific requirements for cleanliness of the product, validation of processes for sterilization and sterile barrier systems, or training and internal communication.
- Does not emphasize management reviews, internal audits, or the commitment of top management.
- Specifies requirements for controlled purchasing and verification of purchased articles and supplier.
- The standard is specifically for the quality management system of medical devices in Europe.
- Does not require a production record of every product/batch, technical documentation, design and development file for each product, or verification and validation in customer related requirements (URS).
Medical Device Regulation (MDR) 2017/745
- The technical documentation is applicable to the Medical Device Regulation in Europe.
- Does not require a production record of every product/batch.
- The V-Model is not a structured process for the development of products according to this regulation.
Key Differences from DIN EN ISO 13485:
- DIN EN ISO 13485 is not a recommendation, but a requirement for companies.
- The standard applies to all stages of medical devices, not just manufacturing.
- Primary purpose is to ensure quality, safety, and effectiveness of medical devices.
- It ensures conformity with MDR.
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Description
Test your knowledge of ISO 13485 and ISO 9001 quality management systems, including their regulations and requirements for medical products. This quiz covers topics such as conformity with MDR, comparison between ISO 13485 and ISO 9001, and the regulation of artificial organs in Europe.
