QOP 42 01 Control of Documents IMSXpress ISO 9001

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QOP 42 01 Control of Documents Rev A Pg 2 of 9, categories for which they have explicit viewing permission set up from the Doc Control. 1 3 Documents have automatically generated headers and footers with information about their. revision level effective date issuing authority and approval status This information is. picked up directly from the document control record maintained in the Document Control. module ensuring that it is always accurate and up to date. 1 4 The Document Control module is for creating and managing documents to include. Creating new documents and document revisions,Organizing documents in a folder tree. Approving and releasing documents and, Controlling document viewing and editing permissions. 2 Other document control systems, 2 1 Some categories of documents are controlled locally by the departments that establish and or. use the documents and are not entered in the ISOXpress system This specifically applies to. Engineering design documents specifications and drawings. If you decide to exclude engineering documents form ISOXpress which would be. appropriate in some cases the engineering department must then have their own document. management system that complies with ISO 13485 and general requirements of this. procedure They would also need to have a separate procedure or work instruction defining. their system, Various confidential documents regarding legal financing personnel contracts and other.
such confidential documents and records, Edit this list of excluded the types of documents as applicable in your company. 3 Categories of controlled documents, 3 1 Quality System Records QSR Documents defining the quality management system in. particular the quality manual operational procedures and work instructions that are not. specific to any particular device or its manufacturing process are referred to as Quality. System Record QSR QSR documents are established and controlled following the same. rules that generally apply to all controlled documents e g as defined in this document. control procedure,Documents in this category include. Quality System Manual QM This top level document defines the company s quality. policies and quality objectives defines the scope of the quality system including details. and justification for any exclusions refer to QM Section 1 4 describes the overall quality. system its processes and their sequence and interaction and references applicable. operational procedures, Quality System Operational Procedures QOP These are second level documents. defining specific quality system processes Operational procedures explain the what. when who and how for a process and define what records must be established to. QOP 42 01 Control of Documents Rev A Pg 3 of 9, document the results Operational procedures are code numbered QOP SS NN QOP.
stands for Quality Operational Procedure SS is the section in the quality manual to which. the procedure pertains and NN is the consecutive number of a procedure pertaining to the. same section For example QOP 75 03 is the third operational procedure pertaining to. QM Section 7 5, Quality Forms QF These are usually one page manual forms providing a blank. template for establishing a record Forms are code numbered QF SS NN M QF stands for. Quality Form SS NN is the code number of the procedure to which the form pertains and. M is the consecutive number of a form pertaining to the same procedure to distinguish. between different forms associated with the same procedure For example QF 82 01 2 is. the second form associated with procedure QOP 82 01. Forms are established as separate documents but are associated with specific procedures. through the numbering system, 3 2 Device Master Records DMR Documents that define the device manufacturing process. and quality assurance specifications are organized into a file and or are referenced in an. index called a Device Master Record DMR Operational Procedure QOP 42 02 Device. Master Record defines how DMRs are established and maintained DMR documents are. established and controlled following the same rules that generally apply to all controlled. documents e g as defined in this document control procedure. Although the concepts of DMR and QSR are defined in CFR 820 181 and 820 186 ISO. 13485 also requires the same types of documents The difference is in how the documents. need to be organized rather than what controlled documents are actually required. Documents in this category include, Product specifications These documents include component subassembly assembly. packaging and labeling drawings and specifications bills of materials or lists of. ingredients compositions formulations wiring and piping diagrams software. specifications user manual packaging artwork and other such documents defining the. product and its packaging For some contracts these documents may be of external origin. i e supplied by customers, Refer to these documents as is customary in your industry and company For example in. your industry specifications may be called data sheets and there may be no drawings but. diagrams If labeling or packaging specifications are not applicable delete these references. accordingly Whatever the format and names this clause refers to documents defining your. product If you never receive such documents from your customers delete the last sentence. Manufacturing specifications Documents under this category include process flow. charts diagrams of process assembly lines specifications for equipment tools and molds. setup procedures operator instructions machine maintenance procedures blank work. orders job travelers nonconforming product process forms and other reporting forms. and other such documents defining the manufacturing processes and the manner of. production, As written now this clause mentions too many things This is intentional to give you.
examples of what types of documents to include You must edit this clause to include only the. types of documents that exist and are actually used in your company For example don t. mention molds if you don t use molds and don t include setup procedures if they are not. QOP 42 01 Control of Documents Rev A Pg 4 of 9, Quality control procedures and specifications Documents in this category include. process control specifications charts control plans instructions and acceptance criteria for. incoming in process and finished product inspection and testing procedures and. acceptance criteria for the verification of packaging labeling installation and servicing. activities blank forms for inspection testing reports and other quality records release. document review list and other such documents defining how products and. manufacturing processes are controlled and verified. Delete items that are not applicable For example if you don t use SPC delete references to. process control if you don t do labeling installation or servicing delete references to these. activities if you don t use control plans don t reference them etc. Work Instructions WI The purpose of work instructions is to guide personnel in. performing specific tasks such as carrying out and controlling a production processes. process operator instructions handling products calibrating measuring equipment. conducting tests or inspections etc,Give examples that are relevant in your company. Standards and codes These are international national and local regulations standards. and codes that define operational quality and product requirements. If you don t use any standards and codes you can delete this whole clause remember to coordinate. with Part II Application and with Clause 4 2 1 1 in the Quality Manual If you are using only one. or two you could reference them here directly If there are many different standards you can just. leave this clause as is and list the actual standards to be controlled in the document control. master list,4 Document Identification, 4 1 In the ISOXpress control system documents are identified by. Document ID,Revision level,Issuing authority,Effective date. Review Approval authority, 4 2 ISOXpress system automatically generates a header with document control information ref.
to 4 1 above and merges the header with the document. 4 3 In other document control systems documents are at a minimum identified by. These are generic requirements that apply to all types of controlled documents For specific. types of documents such as engineering drawings for example your internal identification. requirements may be much more comprehensive It is usually better to cover such special. requirements in separate procedures or work instructions rather than complicating this. general document control procedure,Unique title and or code number. QOP 42 01 Control of Documents Rev A Pg 5 of 9,Effective date and or revision level and. Identification of the issuing approving authority, The specific format and method for applying the identification depend on the type of. document and whether the document is in paper or electronic medium. 4 4 At a minimum all controlled documents are identified with respect to their revision level by. the effective date In addition alphanumerical identification of revision level is applied for. some types of documents to facilitate their management. The purpose of this clause is to establish the principle that when there is no numerical or. alphanumerical revision level identified on a document the date is considered to be the. revision level Edit this clause to accurately define how revision level of engineering. drawings and specifications is identified,5 Initiating new documents and revisions. 5 1 Personnel on all levels are encouraged to identify the need for and propose development of. new procedures work instructions workmanship standards and additional product related. documents Personnel are also encouraged to critically evaluate the documents they use and. request revisions to correct errors and inconsistencies. 5 2 Anyone in the company may request the issue of a new document or a revision of an. existing document The person wishing to initiate a document or a revision submits a draft of. the proposed document to the manager or supervisor responsible for issuing this type of. documents or if revision to the author of the original document The manager responsible. for approving and issuing the document may revise or reject the draft Regardless of who. initiates a document the responsibility to review approve and issue the document always. rests with the manager authorized to issue the particular type of documents. If you already have an established process for initiating documents and requesting. revisions rewrite this clause to accurately describe your process Larger companies often. have special forms for requesting new documents and changes but this is not necessary in a. small company,6 Initial issue, 6 1 Prior to issue and release documents are reviewed for adequacy correctness and conformity.
with company policies, 6 2 Approved and released documents are identified with the name or initials of the issuing. and where appropriate approving authority and the effective date In the ISOXpress system. this information is entered into the Document Control Record and can be seen in the. document header, 6 3 In paper hard copy documents hand written or wet approval signatures on documents are. not required although they may be used for particular types of documents usually for. external communication, Edit if you disagree with this statement but remember that requirement for wet or even. for electronic signatures makes it more difficult to control and distribute documents. electronically You should not require signatures when there are no real security. QOP 42 01 Control of Documents Rev A Pg 6 of 9,considerations that warrant it. 7 Revisions, 7 1 Changes to documents are reviewed and approved by the same function that approved the.
initial document unless specifically designated otherwise The issuing of revisions follows. the same procedure that applies to the issuing of initial documents. 7 2 Revised documents are formally issued when the issuing approving authority and the new. effective date are identified in the document as well as the new alphanumerical revision. level where applicable, This defines how draft documents are distinguished from approved and released documents. Edit to accurately reflect how this is done in your company. 7 3 When paper hard copy documents are changed by handwritten corrections without the. document being re issued on a higher revision level the changes are signed and dated When. multiple controlled copies of a document are distributed to different locations all copies are. changed Paper printouts of documents that are distributed electronically e g are available. on the network may not be changed by handwritten corrections. This pertains to the so called redline corrections If such corrections are not allowed in. your company a good idea change this clause to simply state that correcting and altering. documents by hand is not permitted Otherwise edit to accurately describe how handwritten. redline corrections are controlled in your company. 8 Distribution of initial issues and revisions, Your company may have a much more elaborate system for distribution of paper hard copy. documents For example you may have a system of transmittal letters or cover sheets that. QOP 42 01 Control of Documents Issued by Quality Assurance Effective Date 6 6 2011 Rev A Pg 1 of 9 Approved 6 6 2011 5 48 PM Alan Halko Quality Manager categories for which they have explicit viewing permission set up from the Doc Control module 1 3 Documents have automatically generated headers and footers with information about their revision level effective date issuing

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