ISO Certification



             


Monday, March 3, 2008

A Definition and a Comparison Copyright 2004, Michael La

The purpose of this article is to consider Print-On-Demand publishing as an alternative for the aspiring author. It has its strengths and its weaknesses. You may wonder as you begin reading this, but in the end I'm going to say some good things about it.

To a large extent, the title explains the technology. The way that literature has traditionally been printed involves running many copies simultaneously in order to bring the price per copy down. Smaller print runs, such as advertising brochures or concert programs, cost more per copy because they are small print runs. Until recently, printing a single book was all but unthinkable.

In the case of novels, the traditional print publisher begins by publishing several thousand copies. His goal is to run off the smallest number of copies he can while getting the best possible price per copy.

These books are then sent to bookstores, which tend to prefer something along the lines of what has succeeded before. The remainder sits in a warehouse somewhere. Perhaps to be shipped as the orders come in, perhaps to be joined by any "remaindered" copies the bookstores couldn't move.

This represents an investment on the part of that publisher, hence his paranoia about experimenting with new formats or (more importantly) new authors.

Print-On-Demand (POD), as the name implies, uses a completely different process. The end result is, the price per copy on a small run is much lower. How small of a run? Try one book. Zero inventory. The book is economically produced when the reader orders it, not before.

This technology was probably invented for sales literature. Then someone realized it might be a pretty cool way to get ARCs (Advance Review Copies) out to the book reviewers before the book was actually available. Finally, someone decided to get it into the publishing mainstream.

Why is it so much cheaper to publish a single book via POD? The reasons really aren't relevant to this article, besides which they'd probably bore you. But if you care, the first link below spells it all out.

http://www.jdwrite.com/writing/pod_01.htm http://www.jdwrite.com/writing/pod_02.htm http://www.jdwrite.com/writing/pod_03.htm http://www.jdwrite.com/writing/pod_04.htm http://www.jdwrite.com/writing/pod_05.htm

I recommend reading (or at least skimming) all five of those, by the way. It's quite a comprehensive analysis of how. Then come back to this article to determine why. Or if.

Have you ever heard of the author who self-published and wound up with a best-seller? They do exist!

Now look at all the self-published authors who couldn't do that. They're the vast majority. The author who uses POD could be facing similar long shot odds.

(Keep reading. I'll say good things about POD eventually.)

POD has a definite advantage over self-publishing, in that you don't wind up with a few hundred (or more?) copies of a book in your basement because you can't sell them. Thus, it's cheaper, with no difference in quality unless you hook up with losers.

But neither option will bring you the readership that you'll get from a successful book with a traditional print publisher.

I have self published. I went to a local print shop back in the pre-POD days, ran off 80 copies at $3 a copy, and sold them to local bookstores for $6 a copy. Lots of fun, and lots of learning, but I didn't get rich. My wage per hour stunk, but that was fine with me because I honestly didn't care. I broke even and gave away the rest. A pleasant way to spend lunch hours during the work week.

Most of us, though, just don't have that kind of time. And even if we do, why bother? Take the money you'd have invested and buy some Microsoft stock, then take the time you'd have invested and write more books. You'll be happier and you'll make more money.

Having said all that, why am I recommending POD at all? In my case, it's because I've written some books that no print publisher will ever pick up. That's my honest appraisal.

If I were a mercenary type, I'd follow that up with something like "Why'd you even write those books then?" But if you are a REAL writer, you know the answer.

It's always about writing first, marketing second. Two different hats. I'm assuming you already did the writing and now are wondering what the heck to do with it.

As an example, my EPPIE 2002 finalist is too short. I wrote it back when print publishers wanted 40,000 words. Now they want 50,000. But it doesn't take 50,000 words to tell that particular story, and I'm not padding it. Even if I were willing, it'd stink and nobody would buy it. Give the publishers some credit. They know padding when they see it. The same goes for the readers.

As another example, consider my short story collection. Critically acclaimed and selling moderately well, but no traditional publisher wants short story collections from unknown authors. It's just that simple.

So, I simultaneously published these books in e-book form and POD form. E-books are cheaper and more environmentally friendly, but the paperback option is still there for those who can't or won't ever read an e-book.

(Daddy is in that group, by the way. How about your family?)

Places who publish only POD began by accepting anything sent their way. Pay your money, and do your own editing and marketing. This gave POD a credibility problem. There are POD outfits who don't operate this way, but the credibility problem will take time to heal.

As an author, your goal is to write what's in your heart, find people who like to read what you like to write, and get it out to them. (That's my goal, anyway.) If your name happens to be Tom Clancy, that equals many readers. But that's simply luck of the draw.

Many of us don't have such mass appeal. Possibly you're the sort of writer who knows exactly where you stand in that respect. But many don't, and they're flooding the POD market with stuff that most readers just plain don't want. Add to that the badly edited stuff, and the credibility problem with POD is understandable.

Ideally, what you want is for your e-publisher to simultaneously release your book in both formats without charging a POD setup fee. That way, you can direct all your promotional efforts to that single URL. However, these e-publishers have a real problem with backlog now, so if you want to travel the road I did, you'll need much more patience than I did.

Taking advantage of a free POD option with your e-book will also help your promotional efforts. Many reviewers just plain won't touch an e-book. If you've done the POD bit, in addition to being able to tell all your friends and family, "Look at this, I'm a real author because here's the paperback," you'll be able to send review copies via POD to those book reviewers.

(I told my friends and family to kiss my butt, but I'm just a crochety old cuss.)

If you find yourself with an e-publisher who doesn't offer free POD, you may wish to shop around for a POD publisher. As you do this, remember the business model. If a publisher makes all its money from writers, it doesn't need to sell a single book to a single reader to stay in business.

No matter how much praise they send your way, that's the bottom line. Writing is a calling, but publishing is a business. Those authors who can't distinguish between the two are what keep the opportunists in business. (I was such an author for most of my life.)

Some POD places are no more than thinly veiled vanity (or subsidy) presses. They have a valuable role to serve, but let's be honest. Most do no editing, and they don't care. They may not be making a massive profit from your setup fees, but they're certainly making enough to stay in business. Even if you don't sell any books to anyone except your Gramma.

(A few new POD places help with marketing and charge no fees of any kind. I've been told http://www.bewrite.net is such a place, but have yet to visit it.)

Earlier, I recommended e-publishing before print publishing for the free editing you'll receive. If you're going with POD, consider it mandatory. Either that, or pay an editor. The author who can write a mistake-free manuscript does not exist.

Still interested in POD publishing? I've done it, by the way, and it worked out well. Here are the questions you should ask yourself when you select a POD publisher:

A) Sale price of each book
1) Who decides what it is?
2) Will readers pay that much for your book?

B) Profit per sale vs. your setup cost 1) How many copies must you sell to break even? 2) Can you do it?
3) If not, do you care? How big of a financial hit are you willing to take just to see your name in print?

As a rule, US$100 or less setup cost is good and US$1000 is very bad. The latter, no matter how much publicity they promise you, is only a thinly disguised vanity publisher. You will not sell enough books to recoup that $1000 unless you are a real marketing machine. Even then you shouldn't pay the $1000 up front. Pay $100 or less and then sell all those books. $1000 or more won't get you anything that $100 or less won't.

A comprehensive list of POD publishers, along with descriptions, can be found on-line at http://dehanna.com/database.htm

The site mentioned fails to mention Booksurge (http://www.booksurge.com), also known as Digitz (http://www.digitz.net), and Publish America (http://www.publishamerica.com). The first charges US$99 and the second is free.

Another that isn't mentioned is Digital Print Australia at http://www.digitalprintaustralia.com. I've used them before. My setup cost was AUD$35 (roughly US$18), which compares rather favorably to those listed.

Their price per copy is also excellent. The quality is at least as good as what you'll find in the bookstores. If you've ever bought a paperback from Writers Exchange E-Publishing, you've seen it already. If not, Digital Print will send you a free sample. They sent mine to China.

Two problems you may have with them, though, are shipping charges from Australia if that's not where your readers are located, and the fact that they don't offer a way to sell the books on their site.

For selling the books, I used the Book Store feature on Authors Den (http://www.authorsden.com) back when it was free. It offers a secure server. I know some authors who I trusted enough to send money to without a secure server. But I suspect that most of your prospective readers won't know you that well. In fact, they won't know you at all.

Another option is the shopping cart feature at PayPal (https://www.paypal.com/refer/pal=BH2CTDYDK8RPW), which I haven't researched. But take a look. You oughta have PayPal anyway, because it lets people send you money or vice versa through email, absolutely free. They'll give you $5 just for signing up.

If the POD place only prints "trade paperbacks," which are the larger ones, your cost per book (and sale price per book) will be higher than if you can print "mass-market paperbacks." The choice is yours, but whatever you decide, visit the local bookstores and price similar-sized books. If you write like Stephen King but charge twice as much per book, readers are going to buy the author they've heard of, and that's probably not you. Yet...

Michael LaRocca's website at http://freereads.topcities.com was chosen by WRITER'S DIGEST as one of The 101 Best Websites For Writers in 2001 and 2002. He published two novels in 2002 and has two more scheduled for publication in 2004. He also works as an editor for an e-publisher. He teaches English at a university in Shaoxing, Zhejiang Province, China, and publishes the free weekly newsletter Mad About Books.

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Friday, February 1, 2008

ISO 9001: A Brief Explanation on ISO 9001 Quality Procedure

When our company intend to implement Quality Management System (ISO 9001:2000), we should prepare quality management system documentation that includes documented statement of quality policy and quality objectives, a quality manual, quality procedures and workplace references or work instructions to ensure the effective planning, operation, and control of company processes.

In regard with quality procedure, it should be established, documented, implemented and maintained. The documented ISO 9001:2000 procedure may be different from one company to another because of the size of company and type of activities, the complexity of processes and their interactions and the competence of their personnel.

In practice, format of ISO 9001:2000 quality procedures may also differ from one company to another. For a company that is trying to make their own ISO 9001: 2000 quality procedures for the first time, using ISO 9001:2000 procedure examples can be very helpful. It does not mean duplicating the ISO 9001:2000 procedure example for the company own use.

An ISO 9001:2000 quality procedure may consist of cover sheet, flow diagram, and procedure in detail. The cover sheet contains Company name, title of ISO 9001:2000 procedure, sheet number, document number and revision record (revision number, description of revision, date of revision and signature of the person in charge.

The flow diagram explains step by step from the beginning how the ISO 9001:2000 procedure flows. And the procedure its self should at least have an objective, scope, general explanation, definitions used in the procedure, content of the procedure, records used, related documents and important attachments. The contents of ISO 9001:2000 procedure is a text description of the work flow or instructions based on its flow diagram. The description is started with the persons in charge and followed by explanation of their tasks or jobs as specified in the flow diagram.

Lukman is the webmaster of Free Ebooks Downloads Directory- http://www.hot-free-ebooks-maps.com Communicate with him at http://inside-chemical-plant.blogspot.com

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Saturday, January 19, 2008

Understanding Film Types and ISO Ratings - Beginning Photography Basics

Beginning photographers are usually so wrapped up in learning about exposure, depth of field, and creative composition - they tend to overlook the importance of what they are recording the image onto. Whether it be film or a digital sensor - what takes place when the image hits it has a huge determining factor of what it will look like, and most especially will determine how much work you have to do in the darkroom or on the PC.

It should be noted that while I will be mentioning popular film brands, I am not promoting them. I'm not sponsored, nor am I a film sales affiliate. These are the brands I am accustomed to working with. You will need to decide for yourself and hopefully these guidelines will help you.

In my beginning years as a film photographer if you were to dig through my backpack you would find a dozen different film types and way too many rolls per type. "Afterall," I would mutter under the extra weight, "never know what I will encounter!" To a certain extent that is true, but having 10 rolls of 100 ISO color print film of varying brands is a bit extreme!

A simple guideline to follow that you can test for yourself starts with choosing the right ISO rating for the film you work with. As a matter of fact, these ISO principals are the same for digital cameras as well!

Quite simply, the ISO rating is that number on the film box. If you purchased it at the local grocery store it's usually a 200, 400, or 800. That number is the film's rating of how sensitive it is to light. The higher the number the more sensitive - the lower, the less. The mistake many beginning photographers make is the assumption that the higher the number the better because they can shoot in lower light and not use flash, and still use faster shutter speeds. This is fine if you are CSI photographer at a crime scene at night...not so fine if you are shooting a gorgeous landscape with the last of the day's light on the horizon.

Basically - the higher the ISO number the worse the quality of the image - especially if you will enlarge prints. The lower the ISO (particularly where landscapes and nature are concerned) the better the image quality. With print film - color or black & white, when you get up into the 800 and higher range you will see an increase of grain in the printed image. This becomes even more visible as you enlarge the photo. While some artsy photos are quite appealing with this grain, it is extremely unappealing in fine art landscapes or nature. Of course the higher ISO rated films have their place in photography: sports and, well, CSI night photography!

In the 125 ISO or lower range these films are extremely fine grain and generally reproduce fantastic colors! They are excellent for enlargements. Black and white film in this ISO range will have superb contrast and an incredibly smooth tonal range (the transition from white to black).

As a starting point I recommend the following ISO ratings:

50 - 125: Landscapes and scenics
125 - 160: Portraits, people photography where flattering skin reproduction is important
200 or higher: Sports

In case you are wondering, you will not find these high quality films at your local convenience store! You will need to find a camera shop or buy from a professional supplier.

Now, with a general understanding of ISO, this leads to the next part: which film types? For the sake of simplifying education I am focusing on Daylight film, which is usually what you are handed over the counter. But should you shoot with print film or slide film? (also referred to as transparency or chrome film) This will depend on what you are shooting and what will be the end result.

Color Landscapes

Most serious film photographers will agree that slide film in the 100 ISO or lower range is what they work with exclusively. Along with many other photographers, if I am working in color film for landscapes you will only find Fuji Velvia (50 ISO) or Fuji Provia (100 ISO) slide film in my bag. They enlarge prints extremely well, have unsurpassed sharp resolution, and reproduce fantastic shadows and realistic colors. If you have any aspirations of submitting your work to publishers, you will need to learn to work with slide film. Most only accept transparencies or digital files.

The disadvantages with these slide films is they are just that - transparencies. You will have to spend a few more bucks to have prints made from them, and unless you are working with a highly skilled printer the results can be sometimes be disappointing compared to the original transparency. If you want to make a digital file out of it you will need to buy a high end film and transparency scanner. Slide film is also very easy to over expose during the shoot. So until you are accomplished at right-on exposures, you may think I'm an idiot recommending these slide films.

If you are a serious landscape photographer my personal recommendation is to avoid color print films. I switched to the high-end slide films because I never found a color print film that satisfied me. However, I have no doubt there are photographers who have something to say about that.

Black and white landscapes are entirely different. There are many excellent black and white print films available, but after much testing you will only find Ilford PanF (50 ISO) and FP4 (125 ISO) in my film bag. In my bold opinion - black and white print film for landscapes and scenics does not get any better than these.

Portrait and People Photography

Until you become highly skilled with exposure, and you are working with models that have flawless skin - stick to print films. The most important factor with color portrait photography is skin tones. Using films with ISO ratings lower than 160 will bring out the red pigments in a person's skin more than if you stick to the 160 range. Go below 100 and your model will look like they have a nasty rash! I speak from experience.

Kodak makes a wonderful color portrait film called Portra 160. In my opinion it reproduces the most pleasant skin tones and the contrast is perfect. Just as important, it enlarges very well. If you want to try black and white portraits I also recommend giving Ilford FP4 a try. You will see some of the smoothest facial tones imaginable with this film!

One of the advantages with color and black & white print film is the exposure tolerance (or film lattitude) is excellent. This means that if your exposure is just slightly off, the image will still most likely come out looking very nice.

I recommend these as starting points to find what works best for your photography. It is important for you to learn for yourself what works well, and what does not. However, applying these principals will give you a significant step up towards perfecting your photographic work.

Chip Clark is a San Diego based professional photographer, with over 20 years experience in landscape photography, wildlife photography, sports photography, and portraiture.

Chip Clark's photography tutorials are available at http://www.chipclarkphotography.com/advanced-techniques-for-beginning-photographers.htm

Publishing and reprint rights are granted solely according to the guidelines set forth by Ezinearticles.com.

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Sunday, January 6, 2008

How Can ISO 9001:2000 be Applied to Healthcare?

Definition of ISO:

 

  • ISO means “all sides being equal”. To date, more than ½ a million organizations in 149 countries have implemented the ISO Standards.
  • ISO 9001:2000 is a fundamental quality management system standard that requires an organization to identify, define, document, implement (follow), monitor/measure, and continually improve the effectiveness of its processes. It is a self-directed system that requires the organization to identify and address all imposed requirements; as well as improve its organizational performance by modifying systemic issues (e.g. those traditionally associated with the “hand-offs”).

 

Application of ISO in Healthcare:

Using the ISO Family of Standards, the organization can establish a comprehensive Quality / Business Management System which:

  • Provides a solid basis for compliance with all imposed requirements (e.g., JCAHO, AABB, Federal & State regulations). Makes all other certification & accreditation processes easier and less costly.
  • Facilitates improved understanding of roles & responsibilities among employees; and enhanced communication/coordination between departments.
  • Requires the establishment of measurable improvement objectives and accountability to those objectives through monitoring/measuring and reporting.
  • Results in improved systems, processes, and outcomes.

 

Structure of the ISO 9001:2000 Standard:

The ISO:9001 2000 Standard is comprised of 8 Clauses. The 1st 3 are introductory in nature. The subsequent 5 clauses include the requirements the organization must address. They are:

 

  • Clause 4 – Quality Management System
      Process Management, Documentation Requirements, Records Control
  • Clause 5 – Management Responsibility
      Customer/Patient Focus, Policy, Objectives, Planning, Responsibility & Authority
  • Clause 6 – Resource Management
      Human Resources, Infrastructure, Work Environment
  • Clause 7 – Product / Service Realization
      Planning of New Products & Services, Customer Interface/ Communication, Design, Purchasing/Supplier Management, Production/ Service Operations, Calibration
  • Clause 8 – Measurement, Analysis, and Improvement

     

    Internal Audits, Customer/Patient Satisfaction, Monitoring/Measurement of Products/Services and Processes, Handling Nonconformances, Corrective & Preventive Action, Continual Improvement

 

Process / Methodology

While the standard does not prescribe the approach or methodology to be utilized by an organization, the following is recommended.

 

      Obtain Management commitment to support, understanding, involvement, provision of resources
      Educate Management & Staff about the ISO 9001:2000 Standard, Scope of Work, Organizational impact
      Define Key Improvement Objectives
      Identify and Map Organizational Processes, key as well as support. Address all imposed requirements.
      Develop the organization’s Quality Policy and Quality Manual
      Establish approach to document control and access.
      Develop, review/revise, and incorporate all required support documentation (e.g. Department Policies/Procedures, forms).
      Educate Staff on QMS documentation
      Establish and implement monitoring/measurement for each process
      Train internal auditors. Implement an Internal Audit Process.
      Conduct a Management Review of the QMS.
      Undergo a Pre-Assessment or “Mock Survey” to assess system implementation, readiness
      Make required corrections
      Submit Document Review to Registrar (Quality Manual, Processes)
      Undergo the Certification Audit

 

Sample Key Improvement Objectives

 

  • Improve Patient Satisfaction
      Goal: Improve to 70th Percentile
      Department Goal: Reduce Wait time for Outpatient Registration to < 4 minutes
  • Improve Patient Safety
      Goal: Reduce Medication Error Rate to < .3%
      Goal: Reduce fall rate to < 2.6 per 1,000 patient days

 

Sample Process Interaction Diagram
See =>http://www.iqsconsulting.net/applications-of-iso9001-to-healthcare.html

Sample Quality Policy

We will strive to be the leading provider of healthcare services in Southern Ohio. We will accomplish this through

 

  • Consistent compliance with all imposed requirements;
  • Our focus on Patient Safety and Satisfaction; and
  • Continual improvement of our products, services, and processes.

    Innovative Quality Solutions Company is a full service training and consulting firm focused on total customer satisfaction, performance improvement and achievement of organizational objectives. Innovative Quality Solutions provides all aspects of support to organizations seeking certification and compliance to the ISO 9001, ISO 14001, AS 9100 and ISO/TS 16949 (TS 16949) Standards. Since 1995, the firm has lead more than 250 organizations to successful first time certification/registration.

    Innovative Quality Solutions is located in Akron, Youngstown, Cleveland and Columbus. Renee Mallett, Vice President, Healthcare Division, may be contacted at 614-855-0008 or email: reneem@iqsconsulting.net

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Wednesday, December 12, 2007

ISO 9001 and Total Quality Management

Total Quality Management

Total Quality Management, or TQM, has become one of the most frequently discussed topics in current business literature. Because of the competitive pressures created by Japanese companies, quality became a competitive weapon in the 1980s in most industries. Its role in economic life seems to be attaining a new level in the 1990s; in some industries, such as the automotive industry, quality no longer seems to be a competitive weapon, but rather a prerequisite to survival.

Competitive pressures of the 1980s and 1990s have been felt most strongly in the major industries that are dominated by very large firms. Large U.S. corporations were the first to feel the impact of international competition and suffer its devastating effects. Thus, it is natural that almost all discussions of quality and related issues have focused on large corporations. Small firms seem all but forgotten. This article attempts to attract attention to this neglect and propose a conceptual framework for implementing TQM in the small business environment. Specifically, its emphasis is on small firms in the United States.

The main assumption is that quality is as important for small businesses as it is for large corporations. One reason is that some small companies have been competing directly with foreign firms for a long time; some have suffered the same consequences as large companies, while others have prospered in the competition. A second reason is that many large firms rely on a number of small companies for parts and services they use in producing their products. Quality-conscious corporations are demanding continuously higher quality in the goods and services they buy from small businesses; at the same time, they are reducing considerably the number of vendors. Criteria used in deciding which company to keep as a vendor are based almost entirely on cost and quality. Third, competition in the American economy seems to be intensifying, and new conditions emerge to which small firms have to adapt. Quality and productivity seem to be the indispensable main ingredients in a small firm's struggle for survival in these new conditions.

SMALL BUSINESS DEFINED

A challenging issue one must deal with when writing about small business--an issue that has not yet been settled in a generally accepted manner--is to define what small business is and distinguish it from big business. Most of the attempts at defining small business have to rely on some quantifiable characteristic, such as the number of employees, sales volume, or worth of assets. One classification scheme defines a small business as a firm with fewer than 500 employees. A more detailed classification divides this range further into subcategories: very small (1-19); small (20-99); and medium (100-499). Any company with more than 500 employees is considered to be a big business.

But there are other, qualitative approaches that offer valuable insight into understanding small business. According to The Small Business Act of 1953, a small business is independently owned and operated and not dominant in its field of operation. The Committee for Economic Development, as reported in Broom and Longenecker (1993), proposed identifying a small business as a firm that is characterized by at least two of the following:

Management is independent; usually the manager is also the owner.

Capital is supplied and ownership is held by an individual or a small group.

The area of operations is mainly local; workers and owners tend to be in one home community, although the markets need not be.

The business is small compared to the biggest units in its field.

Clearly, these are all useful definitions of small business, with some more appropriate for certain purposes than others. The classification that divides small businesses into three sub-categories (very small, small, and medium) with respect to the number of employees will be used in the rest of the discussion in this paper--not as rigid groups that are clearly distinguishable from others, but as reference points along a continuum of small businesses of different sizes.

The main reason for this approach is that the number of people a firm employs is usually proportional to the magnitude of its financial and human resources. Consequently, the number of employees is a proxy for the resources a firm may possess. The resources at the disposal of a company play an important role in the implementation of TQM. Therefore, the position of small firms along the size continuum (from 1 to 499 employees) will indicate the level of resources they possess.

THE NATURE OF SMALL BUSINESS

Many believe that a small business is more than just a "scaled-down" version of a big business. What makes it different may be discussed in four categories: (a) ownership, management, and organizational structure; (b) capital and resources; (c) objectives; and (d) markets and customers. In the following paragraphs, characteristics in each category will be described briefly. Later they will be referred to as they relate to applying TQM in the small business environment.

Ownership, Management, and Organizational Structure

Almost all small businesses start small and stay that way. Usually they are started by an entrepreneur who has a bright idea about a service or has developed a new product that fills a niche. A majority of small firms are privately owned; only about 40,000 of them are publicly traded. In most cases the business is owned by the entrepreneur, or jointly by close family members. The management is independent; usually the owner is the manager and reports to no one, or to other members of the family if they are also owners. Absentee ownership is very rare.

Although owners/entrepreneurs are generally experts in the product or service they produce, they usually have neither the education nor the skills required to manage a business. Many small business owners, who do not understand the intricacies of running a business and being proud craftsmen, may think those duties are beneath them. Yet they end up making most of the decisions--at least all the critical ones. Often they do not know how to delegate authority and responsibility, or the organization lacks qualified people to assume some of the authority and responsibility. Consequently, an owner has to make decisions in areas such as inventory or finance that are usually the responsibility of expert professionals in large firms.

Organization structure in a small firm is usually very simple, with few layers. Sometimes management positions are filled by family members, making it a truly family business. Employees usually perform a variety of tasks, often giving the business greater flexibility than larger businesses have. In general, organizational complexity and the number of levels increase as one moves from companies with a few employees to the higher end of the size continuum.

Capital and Resources

Because of the nature of ownership, typical small business firms often suffer from a shortage of capital. Originally, capital is supplied by the owner or the owner's family. Additional capital for growth, or Short-term credit for weathering bad times, is very difficult to raise. The main reason for the difficulty in obtaining long-term financing is that a large proportion of a typical small firm's assets includes short-lived equipment and fixtures, leaving insufficient long-term assets to qualify for long-term loans. Many small businesses do not even have sufficient record keeping to provide the necessary documents for bank loans. Insufficient capital is usually the main reason why most small businesses are service companies.

In addition to sparse. physical resources, small businesses are also severely limited in human resources, and so cannot attract highly qualified and experienced managers or professionals. Again, this weakness disappears as the firm grows in size and sales. Many small companies, however, provide some employees with a rich learning experience because of their focus on craftsmanship and the multitude of tasks required of them.

Objectives

Many small businesses are established as a means of self-employment. As long as the owner receives a satisfactory income, there may be no desire to expand the business. In some cases, the motive for profit may take a back seat to other motives, such as pride and craftsmanship. Some may become small business owners because they prefer a more relaxed and less competitive environment. Some have the objective of maintaining ownership and control of the business. Thus, growth is not an objective for many owners. According to Solomon (1986), most small firms fall into this category.

Driso provide ISO 9001 2000 consultancy, auditing, software, and training Services. They also supply Easy ISO 9001 2000® software for initially setting up an ISO 9001 2000 compliant Quality Management System or improving upon an existing one.

To contact Driso Consultancy Services visit the web site below and see what they can do for you and your business. Contact: http://www.driso.co.uk for more details.

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Friday, December 7, 2007

ISO 9001 What Records Does My Business Need To Keep?

Which documents must I keep for ISO 9001?

In addition to the legislative requirement for your business to keep certain records ISO 9001 2000 requires your business to retain other records to demonstrate compliance with its various clauses.

From an ISO 9001 2000 viewpoint records are documents generated whilst operating your Quality Management System. Typical examples are records of management reviews, purchase orders, sales orders, test results and internal quality system audits.

An ISO 9001 2000 consultant can be very helpful to your business in deciding which records are required and those that are not.

The standard is not specific about how long your business must retain each record but in order not to fall foul of your own Quality Management System, or the law, you might like to consider the following.

If your business offers a period of (x) years guarantee with its product you must keep associated records for at least (x) years.

If your business sells products that have legislative requirements for product testing you must keep associated records for the life of the product and sometimes longer.

Any legislative requirement for you to keep records associated with your product or service.

Records can be in many formats including computer generated records such as those maintained by the Easy ISO 9001 2000® software package.

It would be wise to remember when keeping computer based records for long periods (say 10 - 30 years) the medium upon which the data is stored will deteriorate and therefore you must periodically validate its integrity. Another factor to consider with long term data storage is will a device still be available in 30 years time to read the media upon which the data is stored? I still have computer programs on punch tape but I no longer have a punch tape reader! If you do not know what I am talking about here take it as validation of this advice. (Punch tape was a medium for storing computer programs and data in the 1960's and 1970's)

The following table identifies the specific records required by ISO 9001 2000. The list does not include records that your business might choose to retain voluntarily or those required by legislative requirements for your product or service.

Clause Document to retain, (Record)

5.6.1 Minutes from your Quality Management Review meetings, including any actions raised.

6.2.2 Education, training, skills and experience.(Sub clause-e)

7.1 Evidence that the realization processes and resulting product fulfill requirements. (Sub clause-d)

7.2.2 Results of the review of the requirements relating to the product and actions arising from the review.

7.3.2 Design and development inputs.

7.3.4 Results of design and development reviews and any necessary action.

7.3.5 Results of design and development verification and any necessary action.

7.3.6 Results of design and development validation and any necessary action.

7.3.7 Results of the review of design and development changes and any necessary action.

7.4.1 Results of supplier evaluations and actions arising from evaluations.

7.5.2 As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring and measurement. (Sub clause-d)

7.5.3 The unique identification of the product, where traceability is a requirement.

7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use.

7.6 Standards used for calibration or verification of measuring equipment where no international or national measurement standards exist. (Sub clause-a)

7.6 Validity of previous results when measuring equipment is found not to conform with its requirements.

7.6 Results of calibration or verification of measuring equipment.

8.2.2 Internal audit results.

8.2.4 Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the release of the product.

8.3 Nature of the product non-conformities and any subsequent actions taken, including concessions obtained.

8.5.2 Results of corrective actions.

8.5.3 Results of preventive actions.

Driso provide ISO 9001 2000 consultancy, auditing, software, and training Services. They also supply Easy ISO 9001 2000® software for initially setting up an ISO 9001 2000 compliant Quality Management System or improving upon an existing one. To contact Driso Consultancy Services visit the web site below and see what they can do for you and your business. Contact: http://www.driso.co.uk for more details.

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