40 Questions
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.
False
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.
True
A quality manual is not required to be documented as part of the QMS according to DIN EN ISO 13485.
False
The ink flow requirement for the pen is 100 - 120 mg/km.
True
The test revealed that the ink flow is 110 +/- 5 mg/km.
False
The V-Model is a variation used for the development of products.
True
DIN EN ISO 13485 is related to Medical Regulation in Europe.
True
Chapter 7 of DIN EN ISO 13485 focuses on plan and document development.
True
Quality policy is not a top management responsibility according to DIN EN ISO 13485.
False
The V-Model is not a structured process for the development of products according to Medical Regulation (Europe).
False
According to DIN EN ISO 13485, training and internal communication are not part of the quality management system requirements.
False
Management reviews and internal audits are not emphasized in the quality management system of Medical Regulation (Europe).
False
The commitment of top management is not a requirement for the Quality Management System according to DIN EN ISO 13485.
False
ISO 13485 is not based on ISO 9001.
False
ISO 13485 includes processes that ensure conformity with MDR DIN EN ISO 13485.
True
ISO 13485 does not have any specific requirements for the cleanliness of the product.
False
ISO 13485 does not cover particular requirements for validation of processes for sterilization and sterile barrier systems.
False
ISO 13485 is not recommended for manufacturers of medical products.
False
The quality management system DIN EN ISO 13485 specifies the requirement for controlled purchasing and verification of purchased articles and supplier.
True
The production record of every product/batch is not required under the Medical Device Regulation MDR 2017/745.
False
The technical documentation MDR 2017/745 is not applicable to the Medical Device Regulation in Europe.
False
The design and development file for each product is not a requirement under the quality management system DIN EN ISO 13485.
False
Verification and validation are not part of the customer related requirements (URS) under the quality management system DIN EN ISO 13485.
False
The standard DIN EN ISO 13485 is specifically for the quality management system of medical devices in Europe.
True
Annex A of DIN EN ISO 13485 provides a comparison to ISO 9001:2015.
False
Chapter 7 of DIN EN ISO 13485 deals with resource management.
False
The standard DIN EN ISO 13485 was published in the year 2016.
True
The quality management system requirements for regulatory purposes are specified in DIN EN ISO 13486.
False
The DIN EN ISO 13485 is a standard for Quality Management Systems in the European medical device industry.
True
The DIN EN ISO 13485 standard was issued in 2015.
False
Chapter 7 of the DIN EN ISO 13485 specifically addresses the regulation of artificial organs.
True
The DIN EN ISO 13485 standard applies only to pharmaceutical products.
False
The DIN EN ISO 13485 standard focuses on environmental management within the medical device industry.
False
The DIN EN ISO 13485 standard is only applicable to European countries.
False
The primary purpose of DIN EN ISO 13485 is to ensure the safety and effectiveness of medical devices.
True
Compliance with DIN EN ISO 13485 is mandatory for all medical device manufacturers in Europe.
False
The requirements of DIN EN ISO 13485 only apply to the manufacturing stage of medical devices.
False
DIN EN ISO 13485 is a recommendation rather than a requirement for companies in the European medical device industry.
False
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.
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