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 management 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 output172/5000 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/deliveryThe word 'product' means a physical product and not a service which is the reason why ISO 9001 can not be used by service organizations1 ScopeIs the ISO 13485:2016 standard intended to be applicable for all types of organizations?No, it's only medical device manufactures that should use this standardNo, this standard is intended to be used by companies who are involved in one or more stages of a medical devices lifecycleYes, 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? Yes, a quality manual is where you store all the documented information for the organizationNo, a quality manual is not required7.5 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 locatedThe size of the organizationThe complexity of processes and their interactionsThe type of activities, processes, products and servicesThe competence of the employees 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 needed5.1 Leadership and commitment 2Who in the management shall demonstrate their commitment to the quality management system?The Management RepresentativeTop ManagementThe Quality Manager7.5 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 organizationThe competence of the employeesThe type of activities, processes, products and services5.1 Leadership and commitment 1Is it a requirement that the top management must demonstrate leadership and commitment in respect to the Quality Management System?No, it is the reaponsible quality manager that needs to demonstrate thisYes, the top management shall demonstrate this9.2 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 resultsYes, a documented procedure for Internal Audits is a requirement2 Normative referencesWhich standard contains normative references such as terms and definitions used in ISO 9001:2015?ISO 9003ISO 9002ISO 9000ISO 9004Time is Up! By jmv-admin|2020-09-12T11:39:58-05:00September 12, 2020|Comments Off on ISO 13485:2016 – Test your knowledge Share This Story, Choose Your Platform! FacebookTwitterRedditLinkedInWhatsAppTumblrPinterestVkXingEmail About the Author: jmv-admin
