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 management1 ScopeIs the ISO 13485:2016 standard intended to be applicable for all types of organizations? No, this standard is intended to be used by companies who are involved in one or more stages of a medical devices lifecycle No, it's only medical device manufactures that should use this standard Yes, only organizations with a dedicated Quality Management department can use the ISO 9001:2015 A.6 Documented informationAccording to the ISO 9001:2015 does the organization then need to prepare a quality manual? No, a quality manual is not required Yes, a quality manual is where you store all the documented information for the organization 2 Normative referencesWhich standard contains normative references such as terms and definitions used in ISO 9001:2015? ISO 9000 ISO 9004 ISO 9002 ISO 9003 1 Scope, 3 Terms and definitionsWhat is the definition of the word 'product' when used in ISO 9001:2015? The word 'product' is limited to the physical raw materials used internally to produce a given output 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 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 7.5 Documented information 1The extent of documented information for a quality management system can differ from oneorganization to another due to? The area in which they are located The size of the organization The type of activities, processes, products and services The complexity of processes and their interactions The competence of the employees 9.2 Internal auditShould a documented procedure be prepared for internal audits? Yes, a documented procedure for Internal Audits is a requirement No, but you need to retain documented information as evidence for the implementation of the audit programme and the results 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 Documented information 2The extent of documented information for a quality management system can differ from oneorganization to another due to? The annual turnover of the organization The type of activities, processes, products and services The competence of the employees 5.1 Leadership and commitment 1Is it a requirement that the top management must demonstrate leadership and commitment in respect to the Quality Management System? Yes, the top management shall demonstrate this No, it is the reaponsible quality manager that needs to demonstrate this 4 Context of the organizationWhat should the company basically do to meet the requirements of ISO 9001? The organization shall determine the processes needed for the quality management system and their application throughout the organization 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 assign the responsibilities and authorities for these processes The organization shall determine the sequence and interaction of these processes Time is Up! Time's upBy jmv-admin|2020-09-12T11:39:58+01:0009/12/2020|Comments Off on ISO 13485:2016 – Test your knowledgeShare This Story, Choose Your Platform!FacebookTwitterLinkedIn About the Author: jmv-admin
