Iso 9001 software


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Iso 9001 software

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Iso 9001 software

  1. 1. Iso 9001 softwareEver happened to you that your employee used the wrong document and caused a mass?Ever happened to you that a classified information reach the wrong hands andembarrassed you? Ever happened to you that you lost an important document and knewthat your boss would get angry? For no reason? If do, please pay attention!Using Document Control Software usually meets the ISO 9001 Standard DocumentControl Requirements. The document control requirements is one of the key elements ofthe ISO 9001 Standard requirements for achieving an effective quality managementsystem. Without reliable control of procedures and records, a companys QMS integritywill fail - as a practical business matter and as an auditable compliant system.There are many solutions today for Documents control both manual and digital. In thisarticle I will examine how one can achieve the requirements with digital solutions. Payattention, we didnt write software but a digital solution. Digital solution must not be adocument control softwareThere are two kinds of documentations in organizations. The first is the ISO 9001documentation requirements. For The second, (other than is required) the organizationmust identify and document "needed" processes (activities with inputs and outputs). Ofcourse documentation should be appropriate for the size and type of the organization, thecomplexity and interaction of processes, and the competence of personnel. In otherwords, dont go over your heads, you would regret it in the future. The purpose is not toturn the organization to be a secretary for the ISO 9001 Standard.The first level of digital documents controlThe first level of digital documents control over organizations is laid with itsmanagement systems. Management systems are software designed to support some of theworking processes. The system can be an ERP system, a CRM system or any othersystem. As long that it documents the working processes. Within the system forms areimplemented (screens). The system guides you to fill the correct information at thecorrect location. Eventually, the information is at the right place and time, organized andbeing controlled. Even distribution of the information is managed. This is whatdocuments control is all about. So, when you are documenting your QMS and prepareyourself for the terrifying audit, any process that is included within the QMS and isdocumented via the management system - is covered. But you will have to mention it inthe procedure. Dont say I didnt tell you.Basic electronic systems
  2. 2. The most common digital way today is still using the local computer network and emailsystems for documents control. The Documents management is usually being realizedwhen folders or directories are established and usually it is done locally (a department ora division). The documents are saved on the server for use. Sometimes the systemadministrator or maybe the quality manager requires that the document would beprotected by any changes - the "read only" possibility. The types of documents arevarying from forms, procedures, records, plans, work instruction, diagrams etc.As for routing documents, the email as become the main communication channel. Peoplesend as attachments documents for review or for use.Now, you may think that this is a digital documents control but in fact you only getdigital documentation but no control what so ever! Why? First, when you save adocument on the server it is actually a manual management and not a digitalmanagement. It is correct, the document is digital but the management is manually. Theemployee saves it in the folder and names the document. He has full control over it. Godknows what he is capable of doing with it. Digital document management requires thatthe document would be submitted via the documents control management system. Thisway, the system is registering the document and then begins managing his lifecycle.Now, no employee of yours registers any document that he saves on the local net. Correctme if I am wrong.Second, when you send an email with an attachment it is like exporting a document outof his system and into an individual independent lifecycle. The person who receives thisattachment would probably save the massage with the document and whenever he wouldneed it, he would brows through his mails the get the document. Everybody does it. Hecould make changes and you wouldnt know anything about it. Tracking thosedocuments, comments made by reviewers, and the final approval history are notautomatically accessible in a manual email routing system (which are the common ones).Even if documents are sent through email, system administrators must manually track,update, and communicate the review they receive. To make it more clearly, it is an openloop system. Not to mention the ineffective storage results.With digital document management system you wont send the document but a link orany other trigger to access the document via the documents control management system.Third, even when you save a document and you characterize it as "read only" - thatprevents no one from saving the document on his computer, edit it and spread itthroughout the organization. Again you are back to an open loop system. Sorry. O.K.Even with the strongest most sophisticated digital documents control managementsystems you can never, really, prevent that. No matter what anyone tells you. You aredepending on your employee and his willing to follow ground rules to ensure regulatorycompliance. At the end of the day, we are stuck with the human factor.So with manual (as if - digital) document control we achieve three things: an open loopmethod for document management, a document exporting out of the loop and an
  3. 3. independent lifecycle for documents. The three things the ISO 9001 Standard is trying toavoid.Solutions SolutionsThe first solution that we offer you is to maintain the present situation (the manual, socalled "digital", management). You must have to support it with documented procedurethat describes how one must handle documentation (that is the ISO 9001 Standardrequirement) and maintain close control aspects. That would hold against the ISO 9001Standard but I recommend to overview the requirements just to be sure that you obtainthe requirements.The second solution that I can think of is documents control via the management system.What I mean is that all documentation would be concentrated at one location. Documentsare a part of a processes. Some of the processes is documented within the managementsystems (such as ERP or CRM) and some of it manually (with manually forms). In mostsystems (the ones that I know) the next module exists. It is a less used module. It isusually called "Titles Management". The basic idea is to link documents to the process ora record connected with the process within the system. This way you educate theemployees to download the documents from one location only. No more documentsemailing, no more saving documents on personal computers. This solution requires thatall documents would be registered within the system (what a whole a lot of work!). Formore details, access your system administrator. This solution is not the perfect one but itwould hold against the ISO 9001 Standard requirements. Dont forget to document themethod in a procedure.If you are willing to invest more of your resources you might consider implementingdocuments control management software.Documents control management systemNow, this is the optimal solution. Every quality manager would sleep better at night if heknew that all documents are controlled by a robot (without any feelings and wills otherthen what is programmed into him). Lets review the advantages of implementingdocument management software:d Control- this is the most important thing (by the way this is what the ISO 9001Standard is all about, well, most of it). What do you control?S Organization - all documents of all kinds (forms, procedures, plans, diagram andcharts - whatever you are using) would be organized, categorized, saved and ready foryou to retrieve and use.y Distribution - to whom the documents are to be used.y Compliance - with your regulatory frameworks.y Access information - now, you may think that you have access to most of informationin your organization but you would be surprised. With documents control managementsoftware you would have the information you need accurately and you would be able to
  4. 4. track all documents-related activities to improve quality, accountability and productivity -that means that all information is accessible when ever.t Location - the system will manage the location of all documents. No more spreadingdocuments all over the local net.d Security - document management software improves security of documents.Electronic document control software programs often use a secure, access-controlleddatabase to store files as opposed to hard-copy storage or network directories.d Storage - you would be able to save storage by eliminating multiple documentssavings (well, we know that today digital storage is not such a big deal) but Physicalstorage and retrieval of hard copy documents becomes increasingly problematic aspractices grow. And you know it!p More?This solution costs. It costs money and human resources - have no doubts about that! Butwe truly believe that in the long term it pays itself by adding values to the workingprocesses. All of the advantages above are possible to achieve manually by youremployees but they are time consuming. And time is money.Today there are two possibilities of digital documents control systems: web-based andindependently installed.The web based solution is simply subscribing to a web site that provides you documentscontrol service. That means that the entire above are provided via the internet. Soundsgreat isnt it? As an Internet service, there is no software or hardware to buy, install,maintain, or upgrade. And if the service is not satisfying, just unsubscribe. Thats it. Youmay access from wherever you are and provide workspaces for people working fromhome.The independently installation is where you purchase a software and install it no yournetwork. You may want it to integrate with your other systems. Now, that will be greatfor a working process! Today they are usually easy to implement and easy to use andwith prices that wont get your boss upset (too much).SummeryS Using Document Control Software usually Meet ISO 9001 Standard Requirements.As for more documentation (other than what is required by the ISO 9001 Standard) theorganization must identify and document "needed" processes.o The first level of digital documents control over organizations is laid with itsmanagement systems. Eventually, the information is at the right place and time organizedand being controlled. Even distribution of the information is managed.a Saving documents on the local net is not considered a digital documents controlmanagement. It is a manual management.m Emailing documents for use is exporting documents out of the system and out ofcontrol.
  5. 5. With manual (as if - digital) document control we achieve three things: an open loopmethod for document management, a document exporting out of the loop and anindependent document lifecycle.i First solution is to maintain the present situation (the manual management). You mustdocument the procedure and maintain close control aspects.d Second solution is documents control via the management system with a module suchas "Titles management". This solution requires that all documents would be registeredwithin the system. You must document the procedure.w Third solution is implementing a digital documents control management system. Thissolution requires a lot of resources (both financial and human) but it bears a lot ofadvantages.a The first type of a digital documents control management system is an independentlyinstallation - you purchase the software and install it on your organizations systems. Itmay integrate with your other systems.m The second type of a digital documents control management system is a web basedprogram - you buy a service for managing your documents via the net.If you want to download over free 50 ebook for iso 9001 standard, you can visit:http://iso9001ebooks.infoBest regards