ISO Certification



             


Monday, January 28, 2008

Six Sigma Vs ISO 9000

The debate over whether or not to choose Six Sigma over ISO 9000 is getting more interesting with each passing day. In an attempt to determine which of these is the better of the two, it is highly pertinent to discuss that in the context of applicability of them to industries. And there exists a huge amount of difference between the approaches of these two methodologies in tackling the issues.

Six Sigma - A Critical View

Six Sigma utilizes a multi-faceted approach to doing business with total improvement of the end product being the goal. In doing so, Six Sigma defines and analyzes the processes critically almost always focusing on process improvements. The statistical tools used in Six Sigma help not just in the adoption of processes but are also critical tools of Six Sigma implementation.

Process Development Stages

Let us examine the above statement as applicable to a process for easier understanding. While working on process improvement, the Black Belts break up the original sequence of different events that comprise the entire process and each event is further subdivided internally. This enables the "belts" to take an entirely different view of the process via the entire process as a whole. The powerful statistical tools employed at this stage of evaluation make the picture clearer and help the "belts" to arrive at decisions about the value additions those made to the process by different events.

This principle obviously goes beyond standardizing the processes and setting the pathway for being vigilant about adherence to the Six Sigma methodology. Useless values which have lost meaning make way for more meaningful events and eventually more robust and comprehensive processes. In a Six Sigma environment, customer demands will assume a key role in driving the processes towards aligning all activities with the vision of the leader of the company. The approach is "how to" rather than "what to" deliver.

The ISO 9000 Approach

The ISO approach towards quality management concentrates on standardization of the activities of production. The eight quality principles of ISO 9000, along with its twenty-four requirements outline business processes. The emphasis here is on the control of events in each aspect of doing business by documenting evidence and reports. The eight principles of ISO 9000 include prioritizing customer data, purchasing and quality systems, among other critical aspects. ISO 9000 recognizes each process, whose end goals are the same, as an independent entity. Documented quality requirements typically decide, based on set rules, whether or not a particular process adhered to that standard.

Document and Process Control

Maintenance of quality is achieved by adhering to key process and document control. Operating procedures and process control documents restrict deviations outside the concepts of what you should be doing in every process. What-you-should-be-doing is given emphasis under standard conditions rather than dealing with process improvement.

Stalwarts in industry are examining the possibility of merging the best practices of the two. Several industry leaders have already acknowledged the benefits of using both methodologies to compliment each other. Another view is that, as Six Sigma implementation is what you do within your company (unlike the certification in ISO) the company does not get recognition for achieving successful Six Sigma implementation. However, as long as the culmination of a business activity is defined by both methodologies as retaining and improving the customer base along with maximizing the bottom line, rejection of one in favor of other will be hard to justify.

Tony Jacowski is a quality analyst for The MBA Journal. Aveta Solution's Six Sigma Online offers online six sigma training and certification classes for lean six sigma, black belts, green belts, and yellow belts

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Friday, January 25, 2008

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 .

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Thursday, January 17, 2008

Mapping ISO 9001 - 2000 With CMMI

This article is an effort to create a mapping between the one of the most common standard and one of the most common models.

In this section different clauses of the ISO 9001:2000 standard is compared with the GP’s of CMMI:

(ISO: Clause 4) – Quality Management System
• Organization process focus
• Organization process definition
• Project planning
• Process and product quality assurance
• Configuration management
• Supplier agreement management

CMMI

Generic Practices – 2.1, 2.2, 2.3, 2.6, 2.7, 2.8, 2.9, 3.1, 3.2

(ISO: Clause 5) – Management Responsibility
• Organization process focus
• Organization process definition
• Requirement development
• Project monitoring and control
• Organizational process performance
• Quantitative project management

CMMI

Generic Practices – 2.1, 2.2, 2.3, 2.4, 2.6, 2.7, 2.10, 3.1,

(ISO: Clause 6) – Resource management

• Project planning
• Organization training
• Organizational environment for integration

CMMI

Generic Practices – 2.3, 2.5,

(ISO: Clause 7) – Product Realization
• Requirement management
• Requirement development
• Technical solution
• Product integration
• Measurement and analysis
• Quantitative project management
• Verification
• Validation
• Organization process definition
• Project planning
• Project monitoring and control
• Integrated project management
• Configuration management
• Supplier agreement management

CMMI

Generic Practices – 2.1, 2.2, 2.3, 2.4, 2.6, 2.7, 2.8, 2.9, 2.10, 3.1

(ISO: Clause 8) - Measurement Analysis & Improvement

• Project monitoring and control
• Process and product quality assurance
• Measurement and analysis
• Configuration management
• Requirement management
• Requirement development
• Supplier agreement management
• Organization process focus
• Verification
• Validation
• Organizational innovation and development
• Organizational process performance
• Quantitative project management
• Casual analysis and resolution

CMMI

Generic Practices – 2.1, 2.2, 2.4, 2.6, 2.8, 2.9, 3.2

In ISO 9001:2000 there are six mandatory procedures which have to be fulfilled. This section brings to light where these mandatory procedures are covered in CMMI.

Mapping with six mandatory procedures based on ISO 9001:2000 to CMMI

4.2.2 – Control of Documents

• Configuration management (Generic practices 2.6)

4.2.4 – Control of records

• Configuration management (Generic practices 2.6, 2.2)

8.2.2 – Internal Audit

• Organization process focus (Specific practices 1.1, 1.2, 2.1, 2.2)
• Process and product quality assurance (Generic practices 2.4, 2.6)
• Measurement and analysis (Specific practices 2.4, 2.6, 2.9)

8.3 – Control of non-conforming Product

• Configuration management (All generic practices)
• Project monitoring and control (Specific practices 2.1, 2.2, 2.3)

8.5.2 – Corrective Action

• Organization process focus (Specific practices 2.1, 2.2, 2.3)
• Project monitoring and control (2.1, 2.2, 2.3)

8.5.3 – Preventive Action

• Organization process focus (Specific practices 2.4)
• Causal analysis and resolution (Specific practices 1.1, 1.2 2.1, 2.2, 2.3)

Whenever we do any project/activity all of us knowingly or unknowingly follow the cycle which is known as PDCA i.e. Plan, Do, Check, Act. This section shows how PDCA is covered in both ISO 9001:2000 and CMMI

Mapping with PDCA based on ISO 9001:2000 to CMMI

P – Plan

ISO
• Clause 4 Quality Management System
• Clause 5 Management Responsibility
• Clause 6 Resource management

CMMI
• Organization process focus
• Organization process definition
• Project planning
• Process and product quality assurance
• Configuration management
• Supplier agreement management
• Organization training
• Organizational environment for integration
• Requirement development
• Project monitoring and control
• Quantitative project management

D – DO

ISO • Clause 7 Product Realization

CMMI
• Requirement development
• Technical solution
• Product integration
• Measurement and analysis
• Quantitative project management
• Verification
• Validation
• Organization process definition
• Project planning
• Project monitoring and control
• Integrated project management
• Configuration management
• Supplier agreement management

C – Check

ISO
• Measurement analysis & Improvement

CMMI
• Project monitoring and control
• Process and product quality assurance
• Measurement and analysis
• Configuration management
• Requirement management
• Requirement development
• Supplier agreement management
• Organization process focus
• Verification
• Validation
• Organizational innovation and development
• Organizational process performance
• Quantitative project management
• Casual analysis and resolution

A – Act

ISO
• Measurement analysis & Improvement

CMMI
• Requirement development
• Technical solution
• Product integration
• Measurement and analysis
• Quantitative project management
• Verification
• Validation
• Organization process definition
• Project planning
• Project monitoring and control
• Integrated project management
• Configuration management
• Supplier agreement management

Tariq Kamal is working as a Process Consultant in New Delhi. He provides consultancy in the Quality field in software. Visit his website http://www.gate2quality.com

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Sunday, January 13, 2008

How to Formulate your Quality Policy Statement and Quality Objectives in your ISO Quality Manual

When embarking on a new quality management system and writing a new quality manual for your organization, one of the most important decisions to make is how your quality policy statement should read. A quality policy statement is a requirement of an ISO9001:2000 quality management system, and can be regarded as the general guiding philosophy of your company or organization.

If you compare guiding a company to steering a ship, the nautical equivalent of a quality policy statement might be something like "We are going to sail to New York". This is a general statement of the overall goal. In your company's quality manual, you might say something like "Our goals are to achieve 100 percent customer satisfaction, constantly innovate in our products, and continually improve in all our activities". How can you steer the ship if you don't know where you want to go?

The quality objectives you choose to include in your quality manual, on the other hand, are the nuts-and-bolts, day-to-day objectives that will show how you are doing in regards to your overall goal. Quality objectives are also a requirement of an ISO9001:2000 quality management system, and must be included in your quality manual.

Depending on the size and complexity of your organization, I recommend that you have from 3 to 7 quality objectives in your quality manual. Any less than three is probably inadequate to accurately measure the improvement in your quality. Any more than 7 is probably too difficult to keep track of, and may start to become redundant.

Quality objectives must be measurable based on objective, numerical data. A vague statement in your quality manual such as "create the best product" is not measurable. The word "best" is a subjective evaluation, and can not be measured accurately. Your quality objectives should most likely contain some sort of numerical reference. Here are some examples:

 

  • Customer Satisfaction Rating -- 97 percent or better.
  • Customer Returns -- less than 10 per month
  • Customer Returns -- less than .5 percent of sales.
  • Final Inspection Rejection Rate -- less than .5 percent of units produced.
You must keep records of your organization's performance. You must keep track of how you do with respect to each of your quality objectives. These records will be reviewed by your third party auditor in the event you are audited to the ISO9001:2000 standard.

 

Whether or not you are ISO certified, it is definitely in your best interest to keep track of where you are in relation to where you want to be. In order to steer the ship accurately, not only do you need to know where you want to go, but you also need to know where you are currently.

I recommend that you compile statistics on your quality objective performance at least twice a year. Your performance measurements should be one of the inputs for your management review meeting, but you are free to compile and examine the statistics as often as you feel would be helpful.

Whether it be during the course of your management review, or at any other time, an analysis of your quality objective performance can be quite revealing. It can validate that you are on the right track, or can point out deficiencies. Hopefully a regular analysis of your quality objectives will keep you on track, and keep pointing you in right direction, in your quest for continually improving your quality system and your whole organization.

I always recommend that people keep their ISO quality manual as simple as possible, while covering the necessary requirements of ISO9001:2000. Keep your quality policy statement simple, but meaningful. Keep your quality objectives simple, meaningful, and measurable.

Timothy Macenroe
ISO Consultant and Quality Manager

My Blog about ISO Certification and Quality Manuals - QualityManualChat.com

ISO Quality Manual Sample and Templates - ISO-Quality-Manual.com
 

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Friday, December 21, 2007

ISO 9000 Certification and Consulting

The process of becoming ISO 9000 certified can be intimidating. The manuals regarding standards and certification are written in such a way that most of us can barely comprehend what they are saying. Fortunately, several specialists are available to assist in the process. These specialists are experts in providing ISO 9000 consulting.

ISO 9000 consultants can help you to understand and effectively manage new and existing standards. By enlisting the help of a qualified professional, you can be assured that you are correctly implementing the processes. Consultants can also help you to utilize your ISO 9000 software program to document and implement your new program.

Even if you have been ISO 9000 certified for many years, a consultant can help keep you abreast the new issues and standards. An ISO 9000 consultant can help your company to achieve maximum performance and benefits from your quality control standards.

Many ISO 9000 consulting firms offer individual and comprehensive packages. The comprehensive packages include training for the implementation of ISO 9000 standards, training for internal auditors, training for documentation and training for lead auditors. When implementing these standards it is important to know that your management team is on board with the changes and fully understand the importance and implications.

Other ISO 9000 consultants offer training for individual areas. Your company can choose between on-site training or attending an overview class. For those considering taking the ISO 9000 plunge, an overview class on standards, regulations and certifications is an excellent place to start. You can gain a vast amount of knowledge by attending the courses and get a good idea of what the process entails.

When choosing a consulting firm you should begin by identifying your company’s particular needs. Some firms specialize in creating individual training programs specific to your company. They can get an idea of what you need and develop a comprehensive plan to meet those goals. Other firms only offer generic or pre-packaged training and advice. For some industries, pre-packaged training programs may be suitable and for others it may not. Perhaps a company should begin by asking for references from the consultants and find out exactly what they can do to help your company in the ISO 9000 process.

ISO 9000 Info provides detailed information about ISO 9000 standards, software, consulting, help, and solutions. ISO 9000 Info is affiliated with Business Plans by Growthink.

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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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Wednesday, December 5, 2007

ISO 9001 2000, Getting Started on The Route To Registration

 

ISO 9001 2000, Getting started

Before starting the ISO 9001 2000 route to registration you will need to have the top management on board. This can be achieved by highlighting to top management the cost benefits to the business of ISO 9001 2000 registration.

If you feel unable to sell the benefits of ISO 9001 registration to your business or that you are unqualified to do this then it will be worth you contacting a consultant to assist you with this process. The consultant will have all the necessary tools and examples to hand.

Next you will need to consider what your business is trying to achieve, most businesses want to make money but as with all things there are many ways of achieving the same goal. Some businesses are very good at what they do but I have never yet encountered the perfect business.

If you feel there is no room for improvement in you business you may need to see your doctor about delusional thoughts.

(If you genuinely think you have the perfect business, be it ISO 9001 2000 related or otherwise please contact me at [admindriso.co.uk] and invite me to audit your business. Yes I do charge, albeit the normal daily rate.)

Okay, so you now know what your business is trying to achieve. I'm sure it will be something like:

"We aim to provide our customers with the best value (Widgets or service) on time, every time etc.

Well done, you have just written your companies Quality Management System Policy.

Next we have to look at how your business is going to work towards and then achieve its new Policy. A good starting point is to identify the objectives each department need to set in order to meet the requirements of your policy. Some typical examples for a Sales order process might be:

Reply to customer enquiries within 1 hours of receipt.

Update sales database with customer details before order acknowledgment.

After sales database entry send order acknowledgement on the same day as order received.

Send product catalogue to new customer on day of order receipt.

Run credit check on new customers before loading order to production schedule.

The process objectives can be documented in text format or as flow simple flow diagram. Many businesses now opt for a simple flow diagram because it dictates pictorially how a process works.

Great, you have now documented your first process. Next we need to consider what records to keep so that you can demonstrate the process objectives have been met. In the above example all the necessary records are kept on the sales database. The database automatically records the time between order entry, reply to customer, completion of customer details, acknowledgment sent, product catalogue sent, completion of credit check and loading of order to production schedule. The database will only allow things to be completed in a certain order; for example it will not allow the order to be loaded to the production schedule prior to an acceptable credit check being received. To ensure that only authorised people access the sales database it is password protected and it records the computer users ID against each sales database entry.

At the end of each week the sales manager runs an exception report to identify which targets have or have not been met, this gives him the opportunity to implement corrective action if the process is not being operated as planned. The corrective action may simply involve the re-allocation resources or additional employee training. You can of course run this process without a computer system by using a check-sheet where the process checkpoints are recorded. Using a paper-based system relies heavily on your business not entering into a blame culture, otherwise your employees may decide to falsify results rather than report a process failure. A business that operates a blame culture will never be successful, as there is no incentive for employees to report process errors and more importantly the business does not know where its processes are breaking down.

Excellent, you have documented a Quality Management System policy for your business, set departmental objectives needed to meet that policy and generated records which can be used for business process improvement.

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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