1. PURPOSE



1. PURPOSEThese procedures is meant for describing the process for drafting, reviewing, approving new and revised documents and making them available for personnel during points of use. It is also meant for describing the process of preventing unintended use of obsolete documents.2. SCOPEThis procedure is written to comply with ISO 13485: 2016, US FDA 21 CFR 820 etc requirements and is applicable to all Quality Management System (QMS) documentation such as Quality Manual, Standard Operating Procedures, Work Instructions, Forms and External Documents (e.g. ISO standards or documents received from suppliers and/or customers). 3. RESPONSIBILITYThe QA/ RA Manager takes up the QMS Management Representative (MR) role. He or she is responsible for the effective implementation of the document control system and ensures that documents are controlled, kept up-to-date and made accessible. Any new, revised or documents to obsolete will go through the document change process described below.4. REFERENCE DOCUMENTSISO 13485: 201621 CFR 820 etcTraining SOP5. DEFINITIONSMedical Device File/Device Master Record: The file that consists of all the relevant records pertaining to the product that is developed.Design and Development Files/Design History File: The file consists of all relevant records specific to the design history of the product developed.6. PROCEDURE6.1. Document StructureThe documents are structured into 4 different levels:Level One - Quality Manual, which describes the policy and references procedures applicable to each section of the manual.Level Two - Standard Operating Procedures (SOPs), which describe the basic requirements of the systems and references work instructions and forms applicable to the procedures.Level Three - Most documents generated other than SOPs generally fall under this category. These include work instructions (WIs), drawings and documents such as protocols, reports and manuals.Level Four – These are forms that are often filled up on a day-to-day basis. Once the details are finalized and approved, they are kept as records. The purpose is to provide evidence of meeting the standards/legal requirements.6.2. Document Creation and ApprovalDocuments are created to describe new or changes to certain processes within the organization. These changes are often triggered by activities such as, but not limited to internal/external audit, management reviews, corrective and preventive action (CAPA).A minimum of two signatures is generally required for the approval and release of a document - the person who prepares the document and the other signature(s) for reviews and approvals.The approval process is as follows:Level 1 Document (Quality Manual) – drafted by QA/ RA Manager, reviewed by CEO and approved by CEO.Level 2 Documents (SOPs) and corresponding Level 4 Documents (Forms) – drafted by department engineers, reviewed by Head of department and approved by QA Manager.Level 3 Documents (WIs) and corresponding Level 4 Documents (Forms) – drafted by department engineers, reviewed by Head of department and approved by QA Manager.When documents are signed off and maintained in hard copies, they are kept in the cabinet/cupboard and can only be accessed by staff with the keys to prevent deterioration or loss of the documents, as well as maintain its confidentiality.6.4. Control of Documents by Electronic MeansAfter the documents have been approved, the QA Engineer uploads the documents into the organization’s shared database. They are accessible to staff based on user access rights.6.5. Retention TimeThe QA Engineer will separately keep at least one copy of the obsolete document?throughout the lifetime of the company. An “Obsolete” or equivalent stamp can be marked on these obsolete documents, and filed in a separate “Obsolete” folder. 6.6. Document Change ProcessAny documents that are 1) new, 2) for revision or 3) to be made obsolete have to be initiated by the author. The author will begin the cycle by amending the current document content with “tracked changes” or handwriting amendments. This copy is circulated within the team to collect all feedback and changes required. Once ready, the drafter proceeds to fill up the Document Change Request Form. Information can include the proposed changes, as well as the rationale of making the changes. The names of all the staff that needs to be trained/ briefed (if applicable) due to the changes are to be provided. Refer to Training SOP. Once completed, the drafter, trainer and respective approvals will sign and handover the set of documents to QA RA Manager for checking and QA RA Engineer for filing.?The Document Change Request Form?has a checklist available and the QA RA MANAGER will make sure that all items are available before implementing the new document.?The updated information is logged into the Document List Form. The QM, SOPs, WIs and forms are checked for their validity by QA RA Manager during the Management Review meeting.6.7. External DocumentsExternal documents such as documents received from contract manufacturers, customers, ISO standards and/or any law/regulations documents that are relevant to Manufacturer name, are to?be kept and logged into the organization’s QMS, following the same document change process. Once the Document Change Request Form?has been approved, the drafter will had it over to?QA Engineer for filing.These external documents are checked for their validity by?QA RA manager during the management review meetings.7. ATTACHMENTSDocument Change Request FormDocument List FormThis is the end of the document.Author: QA Engineer representing QA department.DCR No.Version No.AuthorReviewerApproverImplementation DateDescription of Change01QA/ RA EngineerQA/ RA ManagerQA/ RA ManagerInitial Release ................
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