Digital Documents Control to Achieve the ISO 9001 Standard Requirements

Ever 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 and embarrassed you? Ever happened to you that you lost an important document and knew that your boss would get angry? For no reason? If do, please pay attention!

Using Document Control Software usually meets the ISO 9001 Standard Document Control Requirements. The document control requirements is one of the key elements of the ISO 9001 Standard requirements for achieving an effective quality management system. Without reliable control of procedures and records, a company’s QMS integrity will 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 this article I will examine how one can achieve the requirements with digital solutions. Pay attention, we didn’t write software but a digital solution. Digital solution must not be a document control software

There are two kinds of documentations in organizations. The first is the ISO 9001 documentation requirements. For The second, (other than is required) the organization must identify and document “needed” processes (activities with inputs and outputs). Of course documentation should be appropriate for the size and type of the organization, the complexity and interaction of processes, and the competence of personnel. In other words, don’t go over your heads, you would regret it in the future. The purpose is not to turn the organization to be a secretary for the ISO 9001 Standard.

The first level of digital documents control

The first level of digital documents control over organizations is laid with its management systems. Management systems are software designed to support some of the working processes. The system can be an ERP system, a CRM system or any other system. As long that it documents the working processes. Within the system forms are implemented (screens). The system guides you to fill the correct information at the correct location. Eventually, the information is at the right place and time, organized and being controlled. Even distribution of the information is managed. This is what documents control is all about. So, when you are documenting your QMS and prepare yourself for the terrifying audit, any process that is included within the QMS and is documented via the management system – is covered. But you will have to mention it in the procedure. Don’t say I didn’t tell you.

Basic electronic systems

The most common digital way today is still using the local computer network and email systems for documents control. The Documents management is usually being realized when folders or directories are established and usually it is done locally (a department or a division). The documents are saved on the server for use. Sometimes the system administrator or maybe the quality manager requires that the document would be protected by any changes – the “read only” possibility. The types of documents are varying from forms, procedures, records, plans, work instruction, diagrams etc.

As for routing documents, the email as become the main communication channel. People send as attachments documents for review or for use.

Now, you may think that this is a digital documents control but in fact you only get digital documentation but no control what so ever! Why? First, when you save a document on the server it is actually a manual management and not a digital management. It is correct, the document is digital but the management is manually. The employee saves it in the folder and names the document. He has full control over it. God knows what he is capable of doing with it. Digital document management requires that the document would be submitted via the documents control management system. This way, 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. Correct me if I am wrong.

Second, when you send an email with an attachment it is like exporting a document out of his system and into an individual independent lifecycle. The person who receives this attachment would probably save the massage with the document and whenever he would need it, he would brows through his mails the get the document. Everybody does it. He could make changes and you wouldn’t know anything about it. Tracking those documents, comments made by reviewers, and the final approval history are not automatically 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 open loop system. Not to mention the ineffective storage results.

With digital document management system you won’t send the document but a link or any 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” – that prevents no one from saving the document on his computer, edit it and spread it throughout the organization. Again you are back to an open loop system. Sorry. O.K. Even with the strongest most sophisticated digital documents control management systems you can never, really, prevent that. No matter what anyone tells you. You are depending on your employee and his willing to follow ground rules to ensure regulatory compliance. 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 loop method for document management, a document exporting out of the loop and an independent lifecycle for documents. The three things the ISO 9001 Standard is trying to avoid.

Solutions Solutions

The first solution that we offer you is to maintain the present situation (the manual, so called “digital”, management). You must have to support it with documented procedure that describes how one must handle documentation (that is the ISO 9001 Standard requirement) and maintain close control aspects. That would hold against the ISO 9001 Standard but I recommend to overview the requirements just to be sure that you obtain the 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. Documents are a part of a processes. Some of the processes is documented within the management systems (such as ERP or CRM) and some of it manually (with manually forms). In most systems (the ones that I know) the next module exists. It is a less used module. It is usually called “Titles Management”. The basic idea is to link documents to the process or a record connected with the process within the system. This way you educate the employees to download the documents from one location only. No more documents emailing, no more saving documents on personal computers. This solution requires that all documents would be registered within the system (what a whole a lot of work!). For more details, access your system administrator. This solution is not the perfect one but it would hold against the ISO 9001 Standard requirements. Don’t forget to document the method in a procedure.

If you are willing to invest more of your resources you might consider implementing documents control management software.

Documents control management system

Now, this is the optimal solution. Every quality manager would sleep better at night if he knew that all documents are controlled by a robot (without any feelings and wills other then what is programmed into him). Let’s review the advantages of implementing document management software:

  • Control- this is the most important thing (by the way this is what the ISO 9001 Standard is all about, well, most of it). What do you control?
  • Organization – all documents of all kinds (forms, procedures, plans, diagram and charts – whatever you are using) would be organized, categorized, saved and ready for you to retrieve and use.
  • Distribution – to whom the documents are to be used.
  • Compliance – with your regulatory frameworks.
  • Access information – now, you may think that you have access to most of information in your organization but you would be surprised. With documents control management software you would have the information you need accurately and you would be able to track all documents-related activities to improve quality, accountability and productivity – that means that all information is accessible when ever.
  • Location – the system will manage the location of all documents. No more spreading documents all over the local net.
  • Security – document management software improves security of documents. Electronic document control software programs often use a secure, access-controlled database to store files as opposed to hard-copy storage or network directories.
  • Storage – you would be able to save storage by eliminating multiple documents savings (well, we know that today digital storage is not such a big deal) but Physical storage and retrieval of hard copy documents becomes increasingly problematic as practices grow. And you know it!
  • More?
  • This solution costs. It costs money and human resources – have no doubts about that! But we truly believe that in the long term it pays itself by adding values to the working processes. All of the advantages above are possible to achieve manually by your employees but they are time consuming. And time is money.

    Today there are two possibilities of digital documents control systems: web-based and independently installed.

    The web based solution is simply subscribing to a web site that provides you documents control service. That means that the entire above are provided via the internet. Sounds great isn’t 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. That’s it. You may access from wherever you are and provide workspaces for people working from home.

    The independently installation is where you purchase a software and install it no your network. You may want it to integrate with your other systems. Now, that will be great for a working process! Today they are usually easy to implement and easy to use and with prices that won’t get your boss upset (too much).

    Summery

  • Using Document Control Software usually Meet ISO 9001 Standard Requirements.
    As for more documentation (other than what is required by the ISO 9001 Standard) the organization must identify and document “needed” processes.
  • The first level of digital documents control over organizations is laid with its management systems. Eventually, the information is at the right place and time organized and being controlled. Even distribution of the information is managed.
  • Saving documents on the local net is not considered a digital documents control management. It is a manual management.
  • Emailing documents for use is exporting documents out of the system and out of control.
  • With manual (as if – digital) document control we achieve three things: an open loop method for document management, a document exporting out of the loop and an independent document lifecycle.
  • First solution is to maintain the present situation (the manual management). You must document the procedure and maintain close control aspects.
  • Second solution is documents control via the management system with a module such as “Titles management”. This solution requires that all documents would be registered within the system. You must document the procedure.
  • Third solution is implementing a digital documents control management system. This solution requires a lot of resources (both financial and human) but it bears a lot of advantages.
  • The first type of a digital documents control management system is an independently installation – you purchase the software and install it on your organizations systems. It may integrate with your other systems.
  • The second type of a digital documents control management system is a web based program – you buy a service for managing your documents via the net.
  • Keys To Success – Business Networking

    One of the primary reasons to invest time and effort into business networking is to get more business. Yet, for many the outcome of greater business remains elusive.

    Business Networking – How To Get More Business

    As a personal business coach one of the first things I ask a potential client, whether it be a self – employed small business owner or a corporate manager or executive, is if they are doing any business networking. Most of them will tell me that they do some business networking.

    The main reason they do business networking is to get more business. When I ask how successful it has been the answers range from very successful to virtually no success at all.

    How come one person has great success and another doesn’t. Is one’s product or service in greater demand? Possibly, but very often it has nothing to do with that.

    Business Networking – Success Is About How You Fish

    For a moment visualize a business networking event as a big pond with many fish. You have come together with a group of other people and all of you are fishing in the same pond. Some of you will catch fish, prospects, referrals and customers. And most of you will put your bait on a hook and come up with nothing.

    What’s causing the difference in results? It could be the pond you are in. Maybe the fish you are swimming with aren’t ideal for you or your business. But, more often than not it is not the fish in the pond that is the problem.

    The problem is how you are choosing to fish in that pond. Especially for small business owners seeking more small business growth and success how you fish is a critical determinant in your results.

    Running a small business is a big enough challenge to your time and energy without engaging in business networking that is not producing positive results. So if the pond of your business networking is not yielding the results you desire, yet appears to be a good pond, then you must change the way you fish in the pond.

    Business Networking – It’s About The Human Being And Not The Human Doing

    How do you catch a fish? It’s easy. You give him some bait where he wants to bite on your hook. The best hook you have is you. It’s not your business. It’s not your service. It is who you are. Most people when you engage them do not need your product or service.

    The key is that they certainly may need it at some point in time in the future. The goal is to start building a relationship with them based on who you are, not what you do. In the end they will do business with someone they know, like and trust.

    The key to successful business networking is to get beyond the human doing, your business, and let others get to know the human being. Focus on learning about who someone else is. Reveal to them more about yourself. It will give you and them many more reasons to build a solid relationship.

    Focus on the human being, not getting business. And, the last part is the most important. If you have business networking functions every month attend them regularly. Even if business is good and you feel too busy attend them regularly.

    Great relationships aren’t built with intensity but with regular contact over a period of time. Be consistent in showing up and persistent in building your relationships. When you approach business networking as an essential marketing activity focusing on human beings instead of human doings you will start catching a lot more fish in your pond and even greater small business, large business and personal success.

    Small Successful Businesses: 3 Tips To Successful Home Businesses

    Did you know that small successful businesses are on the increase? Many new home businesses are increasing every day. Why? Because now they can, since they discovered the crucial secret to a owning a home business.

    Every day people enter into the world of small businesses by starting a kitchen table business expecting to rake in the cash, even while they sleep, and almost overnight.

    Then reality sinks in. No immediate success and no overnight money.

    Feeling disappointed they purchase one product after the next, in the hope that each product will give them the answer for owning a few small successful businesses from the comfort of their home. Soon after, they give up on their dream with no hope of living the lifestyle that they want.

    If you can relate to this, relax. Here you will find 3 tips to owning a number of small successful businesses:

    1. The role of your mind: your mind plays a vital role in the success of your businesses. It is your mind, or more specifically your subconscious mind, who brings about success or failure in your business endeavours.

    When you have the right success mindset, you will automatically be propelled to take action, and you will attract opportunities and success to you with very little effort.

    2. Decisions, decisions, decisions: now that you realise the vital role your mind plays in your home businesses, your next step is to make the decision that you will be committed to be successful. And your primary decision is now for you to decide to work on your subconscious mind; to programme it for success, to engage and align it in the direction of success.

    It goes beyond than simply having wishful thoughts of having several small successful businesses: you will need to instill a successful mindset.

    3. Set realistic goals: far too many people skip this step and they wonder why they have not been successful. Your subconscious mind is a goal-seeking mechanism. Without goals, it works on default, manifesting exactly what you’re aligned to receive – which is why you’re still stuck where you are at. Your subconscious mind must have a goal to work towards.

    Rather than working on a few ideas you want to turn into small successful businesses, make it your goal to focus all your efforts on turning one small business into a success, and once you have fully initiated the successful mindset, you can move on to your second small business, and then your third.

    Having a number of small successful businesses can be achieved, once you have programmed your mind for success.

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