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.
  • Why Jim Rohn’s Legacy Matters To Home Business Entrepreneurs

    “I wish for you a life of wealth, health and happiness; a life in which you give yourself the gift of patience, the virtue of reason, the value of knowledge, and the influence of faith in your ability to dream about and achieve worthy rewards…Jim Rohn

    Network marketing has always held a special aspiration for people who look beyond conformity and the status quo, the driftwood of today to the horizons of tomorrow. From the beginning, this networking foundation has offered the opportunity for every day people to start a home business with minimal capital and potential of maximum profits. The business concepts are based on the tried and true principles of leverage, duplication of a simple marketing plan and residual income.

    There is a new enterprise now that has opened this opportunity to even greater dimensions and created more advantages with major trends in internet marketing, shopping and advertising.

    Being a networker is about setting standards of excellence and inspirations to live our dreams. We purposely plan our futures to be bright and fulfilling because we focus on today’s challenges and responsibilities to be the best we can be.

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    My choice is to take pride in being a networker and in some way at a personal level continue planting these Jim Rohn seeds of wisdom.

    My main wish is to return to basics with 3 concepts that make network marketing a fair and democratic home business opportunity even though individual backgrounds may be vastly different. The hardest challenge through trial and error is to find that one business program with a simple System for Success based on 3 Steps. Every mother, father, spouse, boss, teacher, nurse, executive, janitor, truck driver, or college student needs to check out one webinar that explains how this simple system sets up home-based profits enough even for your children and grandchildren.

    It’s time for you to look in the mirror and decide, once and for all, you are done playing games, or standing by idly on the sideline while other people, possibly less talented, live in nicer homes and enjoy a better quality of life. It’s time for you to honestly make the decision to get serious about your life, to stop blaming others, and investigate the 3 Steps Plan to become the best that you can possibly be. It’s a simple yes or no answer, one that is clearly demonstrated by your actions as behavior never lies.

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    “We all have two choices: We can make a living or we can design a life.”

    Valuable Lessons You May Glean From Successful Business Entrepreneurs

    Ever wondered what factors contribute to catapulting a business firm to success? Success, as many people who are starting their business or have experienced the birth pains of a business venture can attest, does not happen overnight. Successful business people who have blazed trails and expanded into the global market share that foremost among the factors that contributed to their success is having incredible focus. Hard work and determination are also part of the equation for success. Then of course, the way business heads or company founders adopted to he changing business environment also played a vital role in their stories of survival and growth. The business entrepreneur’s mindset or positive outlook is likewise an instrument to success.

    Fashion designer Anna Sui is perfect example of a famous business personality who, through her own efforts, attained a measure of success. There were moments, she once said in an interview, when she did not have money, but she did what she can, and even took extra design jobs, to keep her company going. She’s an entrepreneur who’s alert to opportunities, and that helped in a big way, too. Today, her fashion business is hugely successful and her creations are snapped up by satisfied clientele worldwide. Sam Walton, the founder of Walmart, started out in the retail business armed with nothing more than a dream. He put up a small shop, adopted a hands-on approach, and through perseverance, resilience and a far-thinking mind, steered his retail shop to success. There are many business entrepreneurs who have fumbled & lost their direction. The more courageous, however, hang on to their passion, plan again, and rely on faith and gumption to overcome obstacles and create a successful business.

    Other established firms employ their own tactics and techniques to sustain the momentum of business success. Some companies, like Disney for example, use a tradition of legendary service and whimsical touches at every turn. Yet even highly successful firms need leaders that can breathe fresh air into their corporate culture. Leaders with strategic goals that can revamp the business, even use tools to be up-to-date with market trends and ways of doing business in the digital world in order to create new revenue streams are highly desired nowadays.

    It can be noted that the tasks & challenges to ensure business success in the modern age are not as simple anymore as they may have been decades ago. Today, most companies need to concentrate on maintaining great customer experiences. Firms nowadays also need to show corporate social responsibility and environmental responsibility. In fact, many companies are getting a pat on the back – from both stockholders and the public-at-large – for their impressive eco efforts. Indeed, a focused approach to business; cultivating continuous efforts to improve it coupled with the ability to spot and seize opportunities & come up with out-of-the-box solutions to problems; being tenacious in pursuing goals; bouncing back from setbacks; and above all, having faith can lead to a successful business. So whether you’re an online entrepreneur who’s passionate about your products & services, or an employee who’s still honing skills, you can create a positive vibe with your prospective clients by embodying the traits and gleaning useful insights from the experiences of successful business entrepreneurs & leaders.

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