ISO 13485:2016 – Test your knowledge Welcome to 'Test your knowledge of the ISO 9001: 2015' quiz.This quiz contains 10 relevant questions regarding requirements from different areas of the ISO 9001: 2015 standard. The questions are pulled randomly from our extended ISO 9001:2015 questions bank.To take the quiz, we ask you to approve our privacy policy and fill in the fields below as well as sign up for our newsletter. The newsletter is sent out a maximum of once a month and you can unsubscribe again at any time.Feel free to give your feedback in the comments section at the end of the quiz.Enjoy ... *What is your name? *What is your email address? What is the name of the company you work in? *I hereby accept the pricacy policy *Yes, sign me up for your monthly newsletter I work with quality management7.5 Documented information 2The extent of documented information for a quality management system can differ from oneorganization to another due to? The competence of the employees The type of activities, processes, products and services The annual turnover of the organization A.6 Documented informationAccording to the ISO 9001:2015 does the organization then need to prepare a quality manual? Yes, a quality manual is where you store all the documented information for the organization No, a quality manual is not required 7.5.3 Control of documented informationIs it required to prepare a documented procedure on how to control the documented information of the organization? No, you only need to document the procedure if you determine it is neccesary to ensure effective control Yes, it is one of the procedures you need to prepare 7.5.3 Control of documented informationWhat are the requirements for the control of the documented information? The documented information is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity). The documented information shall be available and suitable for use, where and when it is needed 4 Context of the organizationWhat should the company basically do to meet the requirements of ISO 9001? The organization shall determine the inputs required and the outputs expected from these processes The organization shall document all critical development and production processes, to ensure the fulfilment of customer requirements The organization shall determine the sequence and interaction of these processes The organization shall determine the processes needed for the quality management system and their application throughout the organization The organization shall assign the responsibilities and authorities for these processes 2 Normative referencesWhich standard contains normative references such as terms and definitions used in ISO 9001:2015? ISO 9000 ISO 9003 ISO 9004 ISO 9002 1 ScopeIs the ISO 13485:2016 standard intended to be applicable for all types of organizations? Yes, only organizations with a dedicated Quality Management department can use the ISO 9001:2015 No, it's only medical device manufactures that should use this standard No, this standard is intended to be used by companies who are involved in one or more stages of a medical devices lifecycle 1 Scope, 3 Terms and definitionsWhat is the definition of the word 'product' when used in ISO 9001:2015? The word 'product' means a physical product and not a service which is the reason why ISO 9001 can not be used by service organizations The word 'product' is limited to the physical raw materials used internally to produce a given output 172/5000 The word 'product' means the output that contains what the customer has ordered. This can be in the form of a physical product, a service, knowledge or other form of service/delivery 9.2 Internal auditShould a documented procedure be prepared for internal audits? No, but you need to retain documented information as evidence for the implementation of the audit programme and the results Yes, a documented procedure for Internal Audits is a requirement 7.5 Documented information 1The extent of documented information for a quality management system can differ from oneorganization to another due to? The type of activities, processes, products and services The complexity of processes and their interactions The size of the organization The area in which they are located The competence of the employees Time is Up! Time's upBy Jonatan M. Vinterbaek|2020-09-12T11:39:58-05:0009/12/2020|Comments Off on ISO 13485:2016 – Test your knowledgeShare This Story, Choose Your Platform!FacebookTwitterLinkedIn About the Author: Jonatan M. Vinterbaek
