b'Documented Information Planning for ChangeControl and ManagementWant to change something in your department or within the organization? When the organization determines the What is documented information? In ISO 9001:2015need for changes to the quality management system, standards, documented information is a record required tothe change shall be carried out in a planned manner. ISO be controlled and maintained. 9001:2015 6.3Two types of documented information are maintainedPlanning for any change within Nicklaus Childrens and retained. requires change to be carried out in a controlled manner. Maintained Documented Information - LivingA structured approach ensures that the person requesting document/information that is subject to change (usedthe change consider several items such as who will be for decision-making or performing tasks) (i.e., PEDS/ impacted, the resources involved, the results of making Cerner, Policies, Procedures, Blank Checklists, etc.) the change, etc. This ensures that quality decision making and management for the change are properly met. Items Retained Documented Information - Refers to a recordto consider when planning for change include:(historical proof of having done something). What did we do last week, last month, or last year? Not subjectDiscover the change required and define the factors of to change because you cannot change what alreadythe change.happened. Consider the aspects to make the change:Essentials that must be identified in documented-the point of the changes and probable risk or information include: consequencesDocument Name/Time -the availability of resourcesSource (Internal/External) -the allocation of responsibilities and authorities.Date -Integrity of the Quality Management SystemAuthor When evaluating the plan seek the approval from your leadership for change development and Documented Number/Reference Number/Version Control implementationDo you know your sources of documented information?Create a plan and identify missions, resources, and responsibilities.Here are some examples of how you use documentedEstablish a communication plan and identify impacted information in your daily operations. internal and external stakeholders that may be Cerner/PEDS charting & documentation impacted; notify the department leadership of your plans.Forms/Downtime Forms Showcase the planned changes with leaders once Policies & Procedures or Standard Operatingcompleted for final approval. Procedures Ensure extensive training staff and leadership affected Standard Work by the change you want to implement.Clinical Pathways/Protocols Execute the change effectively.GuidelinesManage and monitor the change to evaluate its success.Checklists/LogsSpecific Binders Patient Education material (handouts/booklets)Marketing materialMeeting Agenda, Minutes, Attendance Sheet Figure 2. Source 6.3 Corrective and Preventive Action Plans (CAPA) Planning for Change Annual budget & monthly expense reports (iso9001help.co.uk)18 Nicklaus Childrens Health System'