[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-173436-105":53,"doc-detail-173436-en":126},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":119,"head_meta":121,"extra_data":123,"updated_unix":125},105,"en","master-sop-development-procedure-framework","Master SOP - Development Procedure Framework","","Master SOP defines how standard operating procedures, forms, and annexes are developed, controlled, and updated across the laboratory. It sets objectives and scope for all employees, establishes roles for authors, verifiers, and authorization by the LM, and requires consistent coding and document header management. The process covers initiation, drafting using defined annex frameworks, verification for practical compliance and quality-standard compliance, approval, printing and signature controls, storage location placement, and secure distribution for comment and finalization.",{"@graph":63,"@context":118},[64,80,101],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":11,"@type":70,"position":76},"https://docshare.wps.com/template/presentations/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/master-sop-development-procedure-framework/173436/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/master-sop-development-procedure-framework/173436.png","ImageObject",442,249,{"name":88,"@type":89},"Anda","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-10-19","2026-09-01",true,{"@type":98,"interactionType":99,"userInteractionCount":8},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"Who is responsible for developing and authoring an SOP under this Master SOP?","Question",{"text":108,"@type":109},"Any employee may take the initiative to write an SOP. In discussion with the LM, verifiers are determined, and the author writes the SOP using the applicable framework.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"How are SOPs verified and authorized?",{"text":113,"@type":109},"Verification is performed by at least one user for compliance with practice and by the QO for compliance with the quality standard. Authorization is done by the LM.",{"name":115,"@type":106,"acceptedAnswer":116},"How is a unique code assigned and kept for different quality documents?",{"text":117,"@type":109},"Each SOP receives a unique code in the header of each page, and codes are not changed after assignment. Coding follows document-type rules for the Quality Manual, Procedure SOPs, Equipment SOPs, Analysis SOPs, Forms, and Annexes.","https://schema.org",{"og:url":78,"og:type":120,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":122,"canonical":78},"index,follow",{"doc_id":124,"site_id":56},173436,1791299944,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":8,"category_name":11,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":8,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":135,"language":136,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":61,"update_tm":140,"read_time":47},962075006959,"https://ap-avatar.wpscdn.com/avatar/e0002397efbe92a78e?_k=1776741047341049297","1. Master SOP\n2. Objectives & Scope\nThis SOP describes the development of SOPs, forms and annexes.\nThis SOP is applicable to all employees of the laboratory. Uniformly  developing, changing and controlling SOPs, forms and annexes will lead to clarity and recognition.\n3. Abbreviations and definitions\nFor general abbreviations, definitions and terms refer to quality manual chapter 1 “General”.\nSOP\tStandard Operating Procedure\nQM\tQuality Manual\nUser:\tPerson who uses the quality document\n4. Tasks, responsibilities and accountabilities\n5. Procedure\n5.1 SOPs\nThe laboratory uses three types of SOPs:\nAnalysis SOPs\nEquipment SOPs\nProcedure SOPs\nThere is a specific framework for developing each type of SOP (see annex 1 to 3).\n5.2 Developing quality documents\nEvery employee can take the initiative in writing SOPs. In discussion with the LM and the QO verifiers are determined. The author writes the SOP. This person should have the appropriate knowledge and expertise regarding the procedure for which an SOP is written.\nVerification of quality documents is done by:\nAt least one user of the quality document for compliance with practice\nThe QO for compliance with the quality standard.\nAuthorization of quality documents is done by the LM.\nAuthor:\nThe author makes him/herself known to the QO with the wish to write a new SOP.\nQO makes a unique code for the new SOP and proposes (when not yet known) who the verifiers are and the authorizer.\nThe QO fills-out the header of the draft SOP and sends it to the author.\nThe author writes the SOP; use the appropriate framework for developing the document (see annex 1 to 4).\nSave the SOP on the computer with the code and title, the year and month of developing the quality document and your initials as filename (for example: P15.Recording.2013.08.MG.docx).\nSend the draft SOP via email to the verifiers, authorizer and possible other users for commenting.\nDiscuss the comments with the verifiers, authorizer and users, for example during a weekly staff meeting.\nProcess the comments into an improved version of the SOP.\nSend the final SOP via email to the QO.\nSubsequently:\nThe QO ensures that the SOP is printed and signed by the author, verifiers and authorizer.\nThe author, verifiers and authorizers sign the SOP with blue pen. The authorizer also places his/her signature in the header of each page. The last person who signs the SOP gives the SOP back to the QO.\nThe QO places the signed SOP at the appropriate location.\n5.3 Coding of quality documents\nEach SOP gets a unique code in the header of each page. Codes will not be changed after they have been assigned to a specific document.\nCoding is done as shown below:\nQuality Manual:\t\tQM + chapter number\nProcedure SOP:\t\tP + index number\nEquipment SOP:\tE + index number\nAnalysis SOP:\t\tA + index number\nForms:\t\t\tCode of SOP or QM chapter + F + index number\nAnnexes:\t\tCode of SOP or QM chapter + A + index number\nFor example:\nAnnex to the Master SOP: SOP P1A1.\n6. Related Documents\nQM1 “General”\nAuthorization Matrix\n7. Related Forms\nN/A\n8. References\nISO 15189 Medical Laboratory – Requirements to quality and competence. International Organization for Standardization. Geneva 2012.\n9. Attachments\nAnnex 1: Framework for developing Procedure SOPs\nAnnex 2: Framework for developing Equipment SOPs\nAnnex 3: Framework for developing Analysis SOPs\nAnnex 4: Framework for developing Annexes and Forms\n1. [Annex 1: Framework for developing Procedure SOPs]\n[Change the above title into the title of the Procedure SOP that is going to be written]\n2. Objectives & Scope\n[Describe briefly the objective of the SOP, the scope and to whom this SOP is applicable]\n3. Abbreviations and definitions\n[List the abbreviations and terms that are present in this SOP and give their definition. For abbreviations that are general and used in all the quality documents, refer to the first chapter of the quality manual that lists all the frequently used abbreviations]\n4. Tasks, responsibilities and accountabilities\n","cbCaiufcANybxd3t","https://ap.wps.com/l/cbCaiufcANybxd3t","docx",80178,13,"English","# Objectives & Scope\n# Abbreviations and definitions\n# Tasks, responsibilities and accountabilities\n# Procedure\n## SOPs\n## Developing quality documents\n## Coding of quality documents\n# Related Documents\n# Related Forms\n# References\n# Attachments\n## Annex 1-4: Frameworks","[{\"question\":\"Who is responsible for developing and authoring an SOP under this Master SOP?\",\"answer\":\"Any employee may take the initiative to write an SOP. In discussion with the LM, verifiers are determined, and the author writes the SOP using the applicable framework.\"},{\"question\":\"How are SOPs verified and authorized?\",\"answer\":\"Verification is performed by at least one user for compliance with practice and by the QO for compliance with the quality standard. Authorization is done by the LM.\"},{\"question\":\"How is a unique code assigned and kept for different quality documents?\",\"answer\":\"Each SOP receives a unique code in the header of each page, and codes are not changed after assignment. Coding follows document-type rules for the Quality Manual, Procedure SOPs, Equipment SOPs, Analysis SOPs, Forms, and Annexes.\"}]","Master SOP - Development Procedure Framework | DOCX",1788303231]