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.
  • Top Time Management Tips For Busy Entrepreneurs

    I don’t think I’ve ever met a business owner who wasn’t busy. Managing your time is one of the hardest things you’ll need to do as an entrepreneur. There’s always too much to do, so you’ll need to manage your time well in order to get everything done. Here are my top time management tips:

    1. Find out what you’re doing with your time.

    One of the first things to do is to actually find out what you are doing with your time. Try monitoring your time for a week and see what’s going on. Use colour coding if it makes things easier i.e. yellow for administrative tasks; blue for marketing; green for client work and so on. At the end of the week, you’ll be able to see what you’re spending too much time on and adjust your time accordingly.

    2. Get organised

    The more organised you get yourself, the more you’ll be able to handle all the tasks you need to do. Tidy your desk; set up filing systems; and have procedures to deal with the work that comes in. I know it’s hard, but try to deal with each thing only once so that you get it out of the way.

    3. Practise the “Do it now” philosophy

    As soon as a new task comes in, try to “do it now”. You’ll be amazed at how many tasks you can get rid of. Things very rarely take as long as you think they will once you get cracking.

    4. Do things in short bursts

    If you’re really not looking forward to doing a task, make yourself do it for 5 minutes only. If you know you’re only going to be doing it for 5 minutes, it doesn’t look as daunting. And once you’ve got started on the task, you’ll probably find you’ll continue on it once the 5 minutes is up.

    5. Ask yourself “what’s stopping you?”

    Lack of time is often used as an excuse for not doing something. If you find yourself putting something off because you “don’t have the time”, ask yourself what’s going on. Questioning what’s stopping you completing tasks can often really help you decide whether or not to do them.

    6. Don’t be afraid to drop a task

    Look, if you haven’t completed a task; you’ve asked yourself “what’s stopping you”; and you’ve reached the conclusion that you really don’t want to do it, don’t be afraid to drop the task altogether. We often agree to things that don’t actually benefit us and if a task falls into this category, make the decision that you have the choice to drop the task.

    7. You have a choice

    As entrepreneurs, we start each day with a blank piece of paper and choose how to fill our time. You don’t have to agree to everything unless you want to do it or it helps you to achieve your goals.

    8. Set goals

    Setting goals will help keep you motivated and focused. Decide on three personal goals that you’d love to complete over the next year and three business ones. The goals must be things that you really want to do. Your time should then be spent on tasks and activities that help you complete these goals.

    9. Accept that it’s impossible to get everything done

    There’s only so much time in a day. Even if you’re the most efficient person ever, if you have too many tasks you won’t get them all completed. Accept this and don’t feel too guilty if you miss out on a few.

    10. Have fun

    Finally, remember as an entrepreneur to have some fun. Running a business isn’t all about working – take some time off too. If you develop a hobby or an interest that takes your mind off the business, you’ll be much more productive as a result.

    There’s no one solution to managing your time. The trick is to find things that work for you, Try different things, have fun and do the things that help you to achieve your goals for what you want from your business.

    The Key Elements of Building a Successful Business

    If you are like most new entrepreneurs, you will most certainly make many mistakes in the process of building a successful business. You are human…and you will falter. Be ready to humble yourself, accept that you will fumble and fall, learn from your failures, pick yourself up, brush the dirt off your back, and continue to look in the only direction that will bring you success…Forward.

    “Failure is the tuition you pay for success” ~ Walter Brunell

    In the last 4 years I have surrounded myself with many successful small business owners. I have taken notes, asked questions, investigated their tactics, picked their brain, silently watched and have done everything humanly possible to follow in their footsteps. In the process I have discovered the key ingredients of creating a business that can, and will survive in any economy…online or offline.

    Putting People First

    Putting your needs aside and putting people first is the foundation of any successful business. Building concrete relationships with your customers will create trust. Once your customer trusts you, they will refer you to others, buy your products and continue using your services. Without trust and customer loyalty..businesses don’t have a fighting chance.

    In the Internet Marketing arena, thanking people may be as simple as retweeting an article, commenting on a comrades blog, or sharing their post on Facebook.

    Zig Ziglar said it best when he said:

    “You will get all you want in life, if you help enough other people get what they want.”

    Market Yourself, Not Your Business

    Spamming and slamming everyone you encounter with a sales pitch about your new product or business is not only unattractive…it’s completely ineffective. People can smell the desperation all over you. Cold calling strangers, neighbors or old friends, and pitching your network marketing business opportunity to them in the first few sentences of a conversation, is not only self serving…it’s downright annoying. You may not realize this…not only are you wasting your time, you are also wasting their valuable time too.

    The great leaders of the most successful businesses today didn’t get where they are by jamming the phone lines and filling people’s inboxes with useless and self serving sales pitches.

    Remember what we all learned from our parents as a small child?

    “You only get one chance to make a first impression” ~ Mom and Dad.

    Learn the simple principles of Attraction Marketing. Not only will you see positive results in your business, but you will begin to see a difference in yourself as well.

    Do Business With A Conscience

    Your reputation as a person will become the fuel and driving force behind your business’s success. Be honest and forthright. If you lose the trust of one associate or customer, it can only take a few minutes, a few phone calls, or a few quick conversations…to lose them all.

    One of my community’s most prominent and successful business owners has this sign in all of his stores.

    “It can take weeks and months to gain a customer…but only seconds to lose them”

    Self Education

    Self education is inarguably one of the most effective tools in creating a successful business. Becoming a business owner puts you in the driver’s seat. You no longer have anyone leading the way. It’s up to you to seek out all of the quality information you can get your hands on to implement your business plan. Invest in yourself. It will prove to be the best investment you will ever make.

    “Formal education will make you a living, self-education will make you a fortune” ~ Jim Rohn

    In A Nutshell

    The holy grail of running a successful business doesn’t lie in the product you are Marketing or the service you offer. Implementing these key elements and tweaking them as you go along, is what most successful business owners focus on.

    Surround yourself with leaders, listen to leaders…and learn from leaders.

    And at the end of the day, after you’ve learned how to implement these basic business building principles, chances are…

    You will be able to sell pet rocks to the President…or ice to an Eskimo.

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