ISO 9000 FAQs

ISO 9000 is a set of standards internationally accepted by businesses and consumers. It allows organizations to establish and monitor quality management systems. ISO 9000 standards are considered to be generic standards since they can apply to any business, product or service irrespective of the industry. They have been developed and are maintained by the International Organization for Standardization (ISO).

1. What is the ISO 9000 family?

The ISO 9000 family consists of three quality assurance and quality management standards, namely, ISO 9000: 2000, ISO 9001:2000, and ISO 9004:2000. The ISO 9000:2000 and ISO 9004:2000 present guidelines for performance improvement, while the ISO 9001:2000 presents requirements. These standards are implemented by individual businesses, corporations, and government organizations.

2. What are the benefits of ISO 9000?

Major benefits include increased marketability, reduced operational expenses, better management control, improved internal communication, reduction of product-liability risks, and improved customer service.

3. What are the main phases involved in obtaining ISO 9000 certification?

There are two major phases - documentation and certification. Documentation process is done in-house or by the help of an ISO 9000 consultant. Most businesses seek the services of an experienced consultant to create the quality system. An agency accredited in this regard does the certification. The certification process includes documentation review and compliance audit. Documentation review is done with or without visits to the organization. Compliance audit is generally conducted on the site.

4. Is a consultant must for implementing ISO 9000?

The manuals of standards and certification are written in such a way that most of us can hardly understand what they are saying. Only an experienced consultant can help you understand and effectively administer new and existing quality systems.

5. How much does it cost to become ISO 9000 certified?

Unfortunately, there is no simple answer to this question. The cost depends on a lot of factors such as complexity of operations, number of locations of plants, willingness of owners, and type of standards to be implemented.

6. How long does it take to attain ISO 9000 certification?

Depending upon the commitment of the owner and/or managers, the time taken could be 3 months to a whole year. ISO certification is granted initially for a period of three years.

ISO 9000 provides detailed information on ISO 9000, ISO 9000 Standards, ISO 9000 Software, ISO 9000 Consulting and more. ISO 9000 is affiliated with Home Inspections.

ISO 9000 AND SEI-CMM PROCESSES AND STANDARDS FOR OUTSOURCING

Companies seeking international outsourcing are increasingly expecting providers who can offer high quality services and work products, as defined by formal compliance with international standards such as ISO 9000 and SEI-CMM. Providers who offer high quality work but do not adhere to recognized ISO or SEI-CMM standards will surely lose out to those who do.

In fact, a growing number of companies who will use outsourcing already use ISO standards, which define the rules for selecting outsourcing providers. In this case, these companies MUST select outsourcing companies that use the same or similar standards. For example, Clause 7.4, "Purchasing," of the ISO handbook, "ISO 9001 for Small Businesses," deals in detail with the complex area of contracting out processes, products or services which is commonly referred to as " outsourcing " or " subcontracting ". It covers who is responsible, the relationship between outsourcing, the organization and customers, how to ensure that you get what is expected, plus how to select companies with the necessary capability to meet requirements.

About the Standards :

ISO 9000

- The International Organization for Standards (ISO 9000 series).
- International set of documents on quality assurance. Written by members of a worldwide delegation.
- 3 core quality systems documents.
- Models of quality assurance.

SEI-CMM Model

- SEI (Software Engineering Institute) established in 1984.
- The CMM (Capability Maturity Model) of SEI is a framework that describes the key elements of an effective software outsourcing process.
- CMM - composed of 5 maturity levels.
- Each level facilitates a layer in the foundation for continuous process improvement.

Achieving each level of the model institutionalizes a different component in the software process, resulting in an overall increase in the process capability of the organization.

For outsourcing providers, it is therefore critically necessary that you understand ISO 9000 and SEI-CMM processes and standards not only for your own purposes, but also so that you can better understand the requirements of the companies who will be your clients. Having certification in these standards will greatly improve your business profile and increase your potential for doing business in an increasingly quality-conscious world.

For further information on software outsourcing , offshore outsourcing and offshore software development , please visit http://www.a1technology.com .

ISO 9001 - The Three Components of the Implementation Process

The three components to implementing an ISO 9001 quality management system are: 1) documentation, 2) information management, and 3) operational changes.

Documentation

On the surface it may seem like developing the ISO 9001 documentation shouldn’t be that difficult. You must have a manual that includes a policy, objectives, scope, and the interaction of the processes; and you must have written instructions for:

 

1. Managing the quality system documents
2. Managing the quality system records
3. Conducting internal audits
4. Controlling nonconforming product
5. Implementing corrective action
6. Implementing preventive action

 

The standard also hints at the need for additional instructions, e.g., referring to the work instructions, section 7.1 states “shall determine the following, as appropriate,” but technically, aside from the manual and these six instructions, anything more is optional.

The reality, however, is that in order to get the most out of a quality management system a significant amount of additional documentation is required. A primary function of the system is to establish consistency and eliminate misunderstandings, which is best facilitated with clear and unambiguous written instructions. Policies, which are a pervasive part of any system, have absolutely no value if they're not in writing, and enforcing accountability is extremely difficult if the responsibilities are not spelled out.

The ISO 9001 system documentation is normally organized into four sections, including:

 

1. The Manual, which provides background information and explains how the system works;
2. The Administrative Procedures, which include the procedures and policies that define how the company complies with the requirements of the standard and how it manages the processes that are unique to its operation;
3. The Operating Instructions, which are the detailed instructions used to control manufacturing and service activities; and
4. The Reference Documentation, which are documents like industry standards, equipment maintenance manuals, corporate auditing guidelines, employee policies, etc. that define practices, procedures, or performance criteria not covered by the other documents. These can either be externally or internally generated.

 

No two organizations have the same goals and objectives or do things exactly the same way, which means there are always some differences between the procedures and policies of different organizations. It also means that completely documented “off-the-shelf” systems don’t exist and some document development is inevitable. The challenge is to minimize the effort without sacrificing value.

The Manual – The administrative procedures are usually the more difficult and time-consuming of the four sections to develop. The manual, on the other hand, is relatively straightforward and probably the easiest part to develop. The standard suggests what should be included, and an example of a “well written” manual can provide the format for organizing the material. Most of the work is in converting the ideas of the example into documents that describe your situation. Goals and objectives have to be established, processes defined, responsibilities established, the interaction of the processes explained, and the system parameters established.

Administrative Procedures – The secret to developing administrative procedures is 1) using a format that creates readable documents, 2) finding examples of procedures that offer solutions that apply to your needs, and 3) organizing the documentation based a process list.

The “process approach” is the system structure recommended by the authors of the standard and the process list is the starting point of the process approach.

Think of processes as objectives, i.e., maximizing employee output, making sure new products comply with customer requirements, or making sure working conditions adequately support the production objectives. A set of procedures that constitute a means for meeting an objective is what the standard refers to as an “activity group”. Employee vetting, performance reviews, and training procedures is an examples of an activity group that maximizes employee output. The objectives are the outputs of the “process approach” and the procedures (the activity groups) the inputs. Example:

 

Input = Policies and procedures for making sure employees are motivated, informed, and capable of performing the assigned responsibilities

 

 

Output = Maximum employee output

 

 

The process list is simply a list of those objectives that best represent the needs of your organization. They can be different for every organization and are rarely in sync with the outline of the standard.

 

The format used for developing the procedures, to a large extent, determines whether employees will embrace the system. It can be the difference between documents that are easy to read and ones that are not. The better formats include a clear propose, policies that are relevant to the purpose, and an explanation why things are done the way they are done. A good format also leaves no doubt as to who is accountable for the actions of the procedures.

Examples of procedures from other systems provide ideas on how to develop new procedures and how to improve existing procedures. The same examples can also provide formatting ideas. Don’t fall into the trap of thinking that there must be a procedure of every requirement of the standard, or that the documentation has to follow the outline of the standard. The authors of the standard have made it clear that this is not the case. You are encouraged to use a process approach, which is inherently unique to your operation, and to include processes that are important to you but may not included in the standard.

While individual examples can be helpful, continuous system templates that lock into the outline of the standard tend to complicate the implementation process. They depersonalize the system, limit the system to the scope of the standard, and make the process of writing procedures more difficult. Also, don’t go overboard on process mapping and flowcharting. Procedures should be clear to everybody, not just the primary users. A fundamental covenant of the system is continual improvement and some of best improvement ideas come from employees with unrelated responsibilities.

Operating Procedures – The trick to developing operating procedures is in understanding the balance between training and documentation requirements, and in knowing how much information is needed. Too many companies develop too much unnecessary detail.

The standard requires employers to provide employees with the information needed to correctly perform their assigned responsibilities. Proof is either documentation showing that they have been provided the necessary instructions, or training records, which also verifies that they have been provided the necessary instructions. The value of written operating instructions is that they make it easier to hold employees accountable for their actions. From this standpoint, it is only necessary to document those aspects of an operation that are subject to misinterpretation or misunderstanding, which normally doesn’t require a great deal of detail.

Information Management

Managing information is a big part of the standard. The standard states that records shall be maintained in the case of management review meeting minutes (5.6.1); education, training, skills and experience (6.2.2); product validation and verification (7.1.d); inputs for product design and development (7.3.2); and calibration records (7.6). In addition, the standard also requires “evidence of conformity”, which is either physical evidence or documented records, and in many cases records are preferable and sometimes the only alternative.

Records provide a means of confirming that the quality system is controlled, customer requirements are understood, audits are conducted, customers are heard, problems are found and corrected, non-conforming goods are managed, purchasing information is correct, products are traceable, and incoming goods are inspected.

The method of managing information is generally some combination of 1) a file management program, 2) database files such as Microsoft Access, or 3) hard copy files, i.e., binders, file cabinets and manila folders, all of which have advantages and disadvantages.

File Management Programs – File management programs are typically tamper-proof and capable of handling a large volume of information. They’re designed to be paperless systems. Assignments, authorization levels, and additions and revisions to records are keyed into the program, which, under certain conditions, trigger action commands that are communicated via email. There are a few programs tailored to manage primarily ISO 9000 records, but most are universal in nature and designed to manage all types of records. The user is normally responsible for developing the forms and reports needed to manage specific types of records.

The programs are expensive; they come with annual and sometimes monthly maintenance fees; and there are usually costs associated with installation, the number of users, data migration, and training. Many have their own programming language, which makes the user dependent on people with that language skill. And some are web based, which means the program is running on someone else’s server. Generally, they are best suited for companies with a lot of people dealing with a large volume of information.

Database Files – Database files are less expensive, more flexible, and easier to manage. You can either develop your own files or purchase files that have been programmed to deal with specific types of records.

The majority use Microsoft Access and run on a Microsoft Windows operating system. The cost is the cost of the files plus the cost of the Microsoft programs. (The 9000 Advisers offer individual Access files for all the ISO 9001 record keeping requirements.) The files are placed on a server and secured by whatever means is used to secure the server files. Changes and enhancements can be made by anyone who understands Microsoft Access. In most cases there are no user fees or reoccurring maintenance fees, and existing database files can be transferred into the files with the migration functions of the Access program.

Hard Copy Records – Almost everyone ends up with some hard copy records: documents that can’t be scanned, documents with signatures, and documents that are available to all employees. However, building a record keeping policy completely around this approach is risky, even for small companies. It is too easy to misplace documents that move from one person to the next; and it is difficult to manage information that is located in various files, in different offices, and assigned to different people. Responsibilities change and individuals tend to change the way information is gathered and filed. Manual record keeping frequently results in unnecessary duplication, e.g., sales using a different customer list than the person keeping track of the customer complaints. It is also difficult to gather, analyze, and disseminate information. File cabinets are not as accessible as computers and don’t have the sorting, reporting, linking and analytical capabilities of database files.

Operational Changes

The final component of the implementation process is the operational changes, which are the changes needed in order to meet the procedural requirements of a system. They include both the things that are done in order to ensure that the products and services comply with the requirements specified by the customer, as well as the measure taken to in order to improve products and services and the processes used to produce the products and services.

Some of the more common ones include:

 

Administration – 1) Conduct at least one management review meeting. 2) Communicate system developments to all employees. 3) Demonstrate that the key performance indicators are measured, evaluated, and communicated.

 

ISO Representative – 1) Make sure that the auditors are adequately trained. 2) Develop an audit schedule and conduct audits on all of the system procedures. 3) Demonstrate that the corrective and preventive action processes are working. 4) Make system procedures and forms available to employees.

Human Resources –1) Verify that all employees have a basic understanding of the ISO 9000 system. 2) Prove that all employees are capable of performing their respective work assignments, including the top-level executives. 2) Establish a training program for developing employee skills.

Purchasing – 1) Demonstrate that all of the primary vendors are qualified and that their performance is routinely evaluated. 2) Prove that material specifications are verified before they are released to vendors.

Sales/Customer Service – 1) Demonstrate that customer feedback is gathered and analyzed, including records of complaints. 2) Prove that processing capabilities are reviewed before orders for new products are confirmed.

Engineering – 1) Demonstrate that the information released to production is current, accurate, and complies with customer requirements. 2) Demonstrate that product changes affecting form, fit, or function are not implemented without customer approval.

Production – 1) Establish a calibration program that complies with the requirements of the standard. 2) Demonstrate that machinery capabilities have been validated. 3) Prove that nonconforming materials are not mixed in with satisfactory materials. 4) Prove that that shipments comply with the customer requirements. 5) Prove that incoming materials comply with purchase specifications. 6) Prove that operators are provided with the information required to produce products that conform to customer requirements. 7) Demonstrate how materials with shelf life are managed.

 

System documentation and information management are the paperwork part of the system. The operational changes are the action part and represent the part of the implementation process that makes the system work

John is founder and president of http://9000advisers.com/ : a consulting firm specializing in implementing ISO quality management systems. He has over thirty years of manufacturing management experience in the metalworking industry and another six years of consulting experience implementing quality and costing systems. He has a BS in Metallurgical Engineering and an MBA.

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ASA - ISO Ambient Light Rule

If you have been taking photographs for years or just now starting there is one quick rule of thumb that is key to understanding how cameras work. I call it the Ambient Light Rule. There are two standard agencies that regulate camera speeds; in the old days film used ASA (American Standards Association) now film cameras and digital cameras use ISO (International Standards Organization) with both the higher the ASA or ISO number the faster the film or computer chip will accept light therefore allowing the camera to manipulate shutter speed and aperture opening.

Ambient Light Rule is quickly this, the faster the shutter speed (stop motion) the lower the aperture opening (depth of field). This can be changed by using a higher or lower ASA or ISO. This all depends on what kind of picture you want to take. Automatic cameras make it easy to take pictures they will adjust the shutter speed and aperture without you needing to know the Ambient Light Rule.

However sometimes it is necessary to go off automatic mode for the shot you want to take. For example, say you go to a Nascar race and you want a picture of your favorite Nascar Driver going over 200 miles per hour. In this case you may want to take your film or digital camera off auto and go with shutter preferred and choose a fast stutter speed probably at least 1/500th of a second. The faster the better, but this setting does effect how clear the items are in the foreground and background.

Another situation is when you want to take a close up and want as clear of shot that is possible. Here you may want to go with aperture preferred. In this case the higher the aperture (means the smaller the light source kind of like squinting your eyes to see better) means that you will get a sharper photograph. But the higher the aperture the slower the shutter speed. You either need more light or you may want to use a tripod.

Today with all the advancements in computers photography has been made quite a bit simpler. Adobe Photoshop CS2 is a photographer’s dream program. It has made darkroom manipulations obsolete. You can now lighten, darken, sharpen, unsharpen, as well as erase or add to your photos with easy. If you are serious about photography I would definitely suggest purchasing Adobe Photoshop. Plus I would recommend that you take courses on the program. Two that I have used in the past are from Lynda.com and Total Training both are excellent!

For more information www.bestdigicamsite.com

Bob has been a photograher since the 1960's from a Kodak Instamatic to Minolta, Canon, Nikon, and now a Fuji Digital Camera.

Photography A - Z the Easy Way: I - ISO Setting

Do you know what ISO is? Perhaps not. And, in fact, you don’t need to know what it is – just how to use it. In very simple terms, the ISO setting is a measure of how sensitive your camera sensor is to light. A low ISO (e.g. 100) will not be very sensitive to light whereas a high setting (e.g. 1600) will be very sensitive.

How does this affect you?

It’s simple, and don’t let others tell you otherwise. If you have plenty of light around – say on a sunny day or if it is bright but overcast, use ISO setting 100 or 200. In fact, keep it at that setting for most of your shots. Then just take your pictures as normal.

If however, you are in low light levels, you may wish to use flash (keep the same ISO setting) OR use a higher ISO without flash.

Here is an example of practical use:

You want to take a picture of your friend. Normally, on a normal bright day, you would use programme mode or a semi-automatic mode which will select an aperture of 5.6 and shutter speed of 1/250. No problem.

But if the light is fading and you don’t want to use flash, then the shutter speed for the same aperture might reduce to 1/30 or 1/15. At slow speeds like this you will find your shots are not as sharp due to camera shake. Here, you can switch to a higher ISO setting – for every doubling of the ISO you can halve the shutter speed. Therefore you will be able to use a faster shutter speed in low light conditions with a higher ISO.

That’s it really.

There are two drawbacks. First, you will get a “noisier” image at a higher ISO setting (more grainy – but this can often create a nice effect) and secondly you must remember to switch back to your usual ISO after the shots have been taken (so that your usual images have the optimum ISO setting).

Eric Hartwell runs the photography resource site http://www.theshutter.co.uk and the associated discussion forums as well as the regular weblog at http://thephotographysite.blogspot.com.

ISO 4217 in Forex Trading

ISO 4217 is an international standard describing three letter codes to define the names of currencies established by the International Organization for Standardization (ISO).

The first two letters of the code are the two letters of ISO 3166-1 alpha-2 country codes (which are similar to those used for national top-level domains on the internet) and the third is usually the initial of the currency itself. So Japan's currency code becomes JPY—JP for Japan and Y for yen. This eliminates the problem caused by the names dollar, franc and pound being used in dozens of different countries, all with wildly differing values.

The standard also defines the relationship between the major currency unit and any minor currency unit. Often, the minor currency unit has a value that is 1/100 of the major unit, but 1/10 or 1/1000 are also common. Some currencies do not have any minor currency unit at all. Mauritania does not use a decimal division of units, setting 1 ouguiya (UM) = 5 khoums, and Madagascar has 1 ariary = 5 iraimbilanja.

ISO 4217 includes codes for not only currencies, but also codes for precious metals (gold, silver, palladium and platinum; normally measured in troy ounces) and certain other entities used in international finance, e.g. Special Drawing Rights. There are also special codes allocated for testing purposes (XTS), and to indicate no currency transactions (XXX). These codes all begin with the letter "X". ISO 3166 never assigns country codes beginning with "X", so ISO 4217 can use "X" codes for non-country-specific currencies without risk of clashing with future country codes.

Supranational currencies, such as the East Caribbean dollar, the CFP franc, the CFA franc BEAC and the CFA franc BCEAO are normally also represented by codes beginning with an "X". However, the Euro is represented by the code EUR; although EU is not an ISO 3166-1 country code, it was used anyway, and in order to do so EU was added to the ISO 3166-1 reserved codes list to represent the European Union. The predecessor to the Euro, the European Currency Unit, had the code XEU.

More detail about ISO 4217 can be found on wikipedia.org

The author blog: Marketiva Forex

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.

ISO 9001 the Process Approach to Quality Assurance

What is the Process Approach to Quality?

The ISO 9001 2000 standard is designed to manage and improve organizations processes. There is a great deal of misunderstanding and misinterpretation of the meaning of the process approach to Quality.

If you have at all been involved with quality assurance I am sure that you will at least heard of the "process approach" to Quality Assurance even if you are not fully aware of its meaning. The process approach to Quality Assurance is based on the idea that an organization is a system of interlinked processes.

If an organization does not define how its individual activities work together and the order in which the activities are performed it cannot deliver a quality product to its customers.

The process approach to quality involves analysing and then documenting the actual activities and links between those activities within an organization using simple process flowcharts. This technique is typically used by an auditor when conducting a gap analysis on a business. If you are unsure about your ability to identify your processes then you can employ a consultant to assist you.

Once the process and their interactions have been identified a framework of procedures and work instructions can be built around them.

It can often be the case that the output from one process in an organization is the input for another process within the same organization. As can be seen in the diagram below where the output for activity one is the input for activity two and similarly the output of activity two is the input for activity three.

When analysing the processes within your organization it should be remembered that processes may link to processes outside of your organization. A typical example of this might be the product design interface between you and your customer.

Your organization sends a design concept to the customer (the Process input).

The customer approves the design (the Process activity).

You receive back the approved concept design (Process output)

In many organizations it may be possible to break down each process still further into their individual sub-process components, (please forgive the simplistic example).

For example: The posting of a letter might be broken down into.

Process 1: Selection of the envelope type. E.g. Padded, anti static, brown, white, anti-static.

Process 2: Selection of postal method. E.g. Courier, air-freight, secure, insecure.

Process 3: Selection of first or second class postage, same day, seven day.

Each of these processes can then be broken down into sub-processes. E.g. The closure of the envelope. Should it be the type you lick, self adhesive, secured with sticky tape, security fastener or wax seal?

One always has to look at the common sense approach as to how far you should break each process down into sub-processes. For example: If the customer does not specify the method of envelope seal to be used then any type of seal may be used as long as it is fit for purpose. However, if the customer specifies a particular type of seal for certain products the process becomes more important to both you and your customer and therefore the process is worthy of documentation.

If you have difficulty documenting your processes, especially regarding the amount of detail required then it may be worth employing a consultant to guide you through the process. If your procedures are too prescriptive you will end up with unmanageable documents which serve no real purpose. A consultant will be able to minimise your documentation while ensuring compliance with ISO 9001 2000.

Many organizations already have documented instructions in the form of standard operating procedures (SOP's) and work instructions (WI's) that define how individual activities are performed. However, it is often the case that the interfaces between these instructions are misaligned. In some cases the interfaces are not even considered let alone documented. Misaligned process interfaces within an organisaton often leads to process fragmentation and eventually to break down of the organizations processes.

The ISO 9001 2000 standard has adopted the process approach to Quality management systems which is designed to improve an organizations processes.

The following rules may be used to implement a process approach to your Organizations Quality Management System.

Identify your Organizations key processes.

Define Quality Assurance levels for those processes.

Decide how process quality will be measured.

Document your approach to achieving the desired quality.

Evaluate your quality level and continuously improve it.

The following example will help guide you through the methology of identifying process inputs, activities and outputs.

As an example, let us consider the Purchasing Process:

1. The Input to the Purchasing process is a requirement to purchase materials, components or services.

2. The Purchasing Activity involves selecting a supplier from our approved supplier list and preparing a purchase order. We will interact with - The supplier: to place the order. - Receiving: to notify them of the material ordered. We may interact with - Engineering: if Purchasing specifications are needed. - Quality Assurance: if Receiving inspection is needed and to disposition the product if it is non-conforming when received.

3. The Output of the purchasing process is an approved purchase order released to the supplier.

A typical manufacturing company will have the following product realization processes:

Customer Enquiry.

Review and Quote.

Receive Order

Prepare Process Control Documentation

Purchase Materials

Receive Materials

Production

Pack

Label and Ship

In addition, we have the following support processes:

Management Review

Training

Document Control

Internal Auditing

Corrective and Preventive Action

Summary: As you develop your quality system, you must define the sequence and interaction of your processes in your quality manual as required in Section 4.2.2 of the new standard.

As you define your processes and prepare the accompanying documentation, be sure that the inputs, activities, interactions and outputs are fully defined so your quality system is effective.

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