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.
  • 10 Extremely Important Tips for a Successful Business Launch

    What’s Your Passion? If you are thinking about starting a business, it should be something you enjoy. Since a lot of time and energy goes into running a business, it is smart to look at your hobby or professional experience as a potential business idea. For example, if you are good at sewing, consider a tailoring shop; or an accountant could look at bookkeeping or tax service. Now, imagine what your life would be like if you spent the majority of your day actually doing what you love. Do you have what it takes to be an entrepreneur? To improve your chances, here are 10 Extremely Important Tips for a Successful Business Launch.

    Tip 1: The Name Game

    Now that you’ve narrowed it down to ONE ‘business idea,’ you’ve got to figure out a name. A major challenge in starting a business is the process of searching and choosing the right business name. Choosing the right business name can mean success while a poorly thought out name could doom your business from the start. Three smart business name tips:

    1. A smart business name must be unforgettable. It is imperative that potential clients be able to remember your business name. I’m sure most people have heard of Nike, Walmart, Target, Home Depot and McDonalds. Like these household names, your name should be easy to pronounce and memorable.
    2. A smart business name must describe what your business does. When you create your business name, potential clients should be able to understand what products or services your company offers. For example in ‘ Browder Consulting Group,’ the word “Consulting’ is a clue that I provide specialized advice; or as in Lynn’s Styles & Cuts,’ the words ‘Styles & Cuts is a clue that this is a beauty salon.
    3. A smart business name should be as short and sweet as possible. As you advertise your business, it is important that your name display well on your marketing material, such as business cards, ad campaigns, domain name and email. As potential clients search for you on the internet, you want it to be an easy spelled and searchable name.

    Tip 2: On a Mission

    A mission statement is an important tool that tells others who you are, what you do, how you do it and why you are superior than your competition.

    • It identifies and clarifies the business’ vision, purpose and direction.
    • It provides the path and focus needed for making and implementing decisions.
    • It helps define to your future employees what they are doing, why they are doing it and where they are going.

    Tip 3: Make it Legal

    Be diligent in choosing the best Legal Form for your business. This is one of the first important decisions that you will have to make. This decision can have long-term implications, so here are a few things to consider when deciding which business structure is best for your business:

    • Scope of business you plan to attain
    • Size of your business
    • Business’s vulnerability to lawsuits
    • Tax implications based on the different ownership structures
    • Level of control do you wish to have
    • Expected profit/loss of the business

    Tip 4: Surround yourself with a Progressive Team

    Who do you need to know or collaborate with as a part of your external team? Having the right people on your team will allow you to focus on your business and help you to avoid costly mistakes. For example, you might need the following:

    • Certified Public Accountant: best form of ownership, establish bookkeeping, record keeping procedures and tax planning, etc.
    • Business Attorney: reviewing lease contracts, determining the right business structure, etc.
    • Computer Information Technician: set up systems, repair issues, etc.
    • Human Resource Management Consultant: assess your current HR processes for compliance, navigate through delicate labor issues, set up hiring processes, compensation and benefits and create employee manuals, job description and Standard Operation Procedural manuals.

    Tip 5: Research Licenses & Permits Needed for Your Industry

    As you can see, there are many steps involved in starting a business. With the daunting task of figuring it all out, it’s easy to overlook the important legal requirements associated with permits, licenses and registrations. Here’s a list that your business might need:

    • State Requirements: Business licensing requirements may vary from state to state.
    • Business Licenses: Depending on your state, county and city, a business license may be required for tax purposes and to conduct other basic business functions.
    • Occupations and Professions: Depending on your profession, state licenses may be required for occupations such as, appraisers, accountants, barbers, building contractors, cosmetologists, funeral directors, physicians, private investigators, private security guards and real estate agents.
    • Tax Registration: Some states carry a state income tax. If you establish your business in a state that does, you’ll have to register and obtain an employer identification number. If your business engages in retail sales, you will need to obtain a sales tax license.
    • Trade Name Registration: If you plan to run your business in your local community only, registering with the state may be adequate.
    • Employer Registrations: Are you planning to hire employees? If so, you’ll probably be required to make unemployment insurance contributions.

    Tip 6: Know Your Clients

    A common mistake that I encounter with new business owners is that they don’t know who their customer is… possessing a poorly defined target market. Most want to sell their products or services to ‘everybody’ instead of narrowing their targeted customer base to a manageable size. You must do your homework… i.e., market research. I’ve created a business resource guide to assist you, Resource Guide for Women.

    Tip 7: Got Marketing?

    In business, marketing plays a key role in getting the word out to your prospective clients. You must create an image and be consistent! It’s important to mold and hone your business image to successfully appeal to your prospects and customers. By choosing a relevant company name, answering your phone professionally, creating a professional and clear elevator pitch, investing in professional business cards, logos and brochures, etc… all are key in marketing your business.

    Tip 8: Don’t forget Uncle Sam

    Understanding tax obligations is one of the most important issues facing small businesses. The local, county, state and federal agencies does not care that you didn’t know or you forgot to pay your taxes. You will be subject to penalties for not paying on time. Here are some resources to assist you:

    • For a list of state agencies: business.gov/states/
    • For a SBA resource guide by state: smallbusiness3.com/magazine
    • For IRS business information: irs.gov/businesses/index.html

    Tip 9: Don’t forget the ‘B’ Word… Budget!

    Create a start up budget. Because businesses are different, each will have its own specific cash needs at various stages of development, so estimating your start-up costs may vary. Some businesses can be started on a shoestring budget, while others may require considerable investment in inventory or equipment. It is imperative to know that you will have enough money to launch your business venture.

    A few ways to prepare:

    • Create a list of anticipated expenses for your first three years
    • Projections are fine, be realistic

    Have a tracking system

    QuickBooks, Quicken, Ledger, Excel spreadsheets, I don’t care which you use…. It’s important to put a system in place that works for you. Personally, I use QuickBooks. I can send files to my CPA, easy to work with. In addition, as the treasurer on the board of a non-profit organization, I also use Quick books to reconcile the organization’s bank statements and to bill our member’s annual dues.

    Open a business checking account. The worst thing you can do is run your business from your personal account… it is an accountants nightmare. Open up a business account so that you can separate the two… plus it tells others that you are serious and professional.

    Tip 10: Put it all together… in a plan!

    Last but not least, you must write your business plan. By failing to plan, you are planning to fail. If you can’t take the time needed to plan for the success of your business, then don’t waste your time starting one. Statistics show that 8 out of 10 businesses fail within the first three years. This is staggering but true! Invest your time in researching and writing a business plan. Many prospective entrepreneurs think that a business plan is very hard and tedious. The truth is it’s a powerful tool that can help you plan and achieve business success.

    So, what is this thing called a business plan? Well, a business plan is your blue print or what I tell many of my clients, it’s your bible! A business plan defines your business, identifies your goals, and serves as your company’s resume. It will help you arrange strategic alliances, obtain financing and attract key personnel. By planning for success, you will be able to overcome many hurdles that may arise.

    A closer look at why a business plan is important:

    • To secure funding, your lender will request your business plan with completed financials. DO NOT approach a lender without having a completed business plan. In his/her eyes, you will look unprepared and too risky. By being prepared, you will have a better chance at securing funding for operations or expansion of your business.
    • It is a great way to test the feasibility of your business idea. By the time you complete your market or competitive analysis, you will have a clear picture of the viability of your idea.

    As you can see, there is a lot of work involved before starting a business. To ensure success, it is important to research thoroughly, take advantage of the resources available to you and learn as much as you can. Preparation is key to a successful start!

    Sylvia Browder is Founder of National Association Women on the Rise, a virtual membership community for aspiring and established women entrepreneurs. For more about NAWR or resources and information for women entrepreneurs, visit us at http://www.nawomenrise.com.

    Here is a Quick Way to Build a Successful Business on eBay

    Millions of people are trying to build a successful business on eBay. But the sad truth is that only a very small percentage succeed. To become successful on eBay or any business venture is knowledge. Do you remember the old saying, ” knowledge is power”? Well, that is exactly the truth. I want to share some success tips with you, so you can go forward in your business venture. When trying to run a successful eBay business, there are 10 primary steps that you should follow.

    1. Do What Works
    There are many different ways to build a business and make money on eBay. There are virtually millions of products to sell and thousands of niches to sell in. but what it all comes down to, is what works for you. The main goal here is to produce results. No one can tell you what product to sell or niche to sell in. You must learn this on your own.

    Don’t be afraid to try different ideas and methods. The only way you are going to find out what is working for you, is to put them to the test. And at the end of the the day our main goal here is to make a profit.

    2. Not Failure Only Results
    The only way to get the results you want, is to take action. As long as you keep plugging away at your business, you are not failing, you are producing results. You must come to realize that you are simply testing the waters here. What doesn’t work for you the first time, make an adjustment for the next time around.

    Everyone makes mistakes, and you will to. The trick is to keep learning and keep taking action towards your business. When you do this, failure is not a option.

    3. Be Flexible
    A person that believes in doing things one way, will not be successful on eBay. You must be open to different products, niches, ideas, and so on. Be flexible in all of your endeavors and mindset. In time, you will start to reach different levels in your business. By being flexible, you will take the necessary steps to ensure success every step of the way.

    4. Do Not Chase “The Hot Product ”
    Yes be flexible, but don’t find yourself chasing ” the hot product. ” You must understand the difference between test marketing products or ideas, and studying the results. You cannot just simply keep switching gears and selling something different every other week. Give your product or niche some time to develop.

    5. Conformity
    When you are sitting around trying to come up with ideas or products to sell, look to see what other successful entrepreneurs are doing. Don’t copy them, modify what they do and come up with your own style of business. You don’t have to reinvent the wheel, just learn what other successful people are doing in their business and apply what you learn to yours.

    6. Consistency Is Key
    You must be prepared to work your business on a ongoing basis. By taking action, you will become consistent and successful in your daily business routine. Remember this, if you treat your business like a hobby, it will pay you like a hobby. Get up and take action NOW.

    7. Surround Yourself With Mentors
    Make sure that you choose your friends and colleagues wisely. Your attitude will reflect the people around you. If your family and friends question your dreams and goals, they will inflict negativity towards you and your business. Do not let people drain your energy of becoming a successful entrepreneur.

    8. Be The Best You Can
    Success isn’t beating someone else in business. You cannot compare yourself to other successful business owners and get frustrated because your not where they are in your business. Remember that everyone is one a different level. Take your time to be the best you can be towards life and your business, and success will follow.

    9. Step Out Of Your Comfort Zone
    No successful entrepreneur ever achieved true success by staying inside the box. As human beings, it’s easy to get comfortable with our business and play it safe. The truth is you need to step out of your comfort zone, again and again. This will insure you take the proper steps needed to go forward within your business.

    10. Balance Stress And Work
    Many people believe that stress is simply bad. This may be true in certain situations, but stress is essential for growth and advancement. Continued stress however, can lead to a work breakdown. You must learn to balance your stress and your work properly. It’s OK to take a step back every now and then. You want to keep your mind sharp and your ideas fresh. Sit back, take your time, and your best work will come through.

    Believe and use the information I have provided for you here. Take time to learn and grasp these steps towards building your business on eBay or any other business venture.

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