Implementing ISO 9001 Standards

Implementing ISO 9001 standards

If you have your own business and now you are looking for ISO 9001 certification for quality standards for business to make your business products more reliable to the customers. To be in the market for any business, it needs quality and for quality any business needs to follow quality standards, so ISO 9001 Standards developed many quality standards as per different -different business areas.

ISO 9001 Standards is a generic quality standard and can be applied to any organization but before applying it, a process starts with pre-assessment audits and passes through on-going maintenance. The process of implementing ISO 9001 includes identifying, collecting and organizing the information required for certification.

For implementing ISO 9001 standards, any organization needs to hire a consultant because detailed knowledge of ISO standards is essential before successfully applying it. A consultant will analyze your organization structure, your products and their standards and will make a complete plan as per ISO standards for your organization.To hire a consultant is easiest way because they have complete knowledge of ISO standards and they perform various activities like provides class room training to your business employee about ISO 9000 standards

An ISO consultant performs the various activities and explains the course objectives :

• understand the purpose of ISO 9000: 2005, ISO 9001: 2008, ISO 9004: 2000, ISO 19011: 2002 etc. standards and their interrelationship

• describe the purpose of Quality Management Systems and 8 Quality Management Principles

• Interpret the ISO 9001: 2008 in the context of audit

•Plan and conduct an audit in accordance with guidelines as per ISO 19011: 2002, gather objective evidence via various methods and determine conformity to the requirements of Quality Management Systems

• Develop understanding of Roles & Responsibilities of Lead Auditors

Hiring a Consultant is a better and easiest way to implement ISO in your organization

How To Meet Quality Standards With ISO 9001 Standards

In today’s hectic business environment, it is vital that we are all on the same page, right? But how do we know if we meet those standards? Business owners and executives can avoid the uncertainty, and that’s where ISO 9001 certification comes in.

Standardizing Quality Systems

The ISO, or International Organization for Standardization, was established in 1947 to develop international standards for
everything from electronics to management systems. Having over 13,000 standards currently in place, ISO has created the auditing and certification process known as ISO 9001. This began the drive toward quality standards.

Improving Customer Satisfaction

Companies choose to implement ISO 9001 and get certified because many customers and industries require it. By keeping customers happy, they can increase sales and profitability for their business. And if an area of the company’s program appears to be too bureaucratic and non-value-adding, then it might also be an area for continuous improvement efforts.

Enhancing Company Performance

Both customers and industries alike use ISO certification as a way to evaluate and audit their suppliers and products. Through an independent verification process, customers can gain assurance of their suppliers’ products. And as a supplier becomes certified, the testing requirement is waved, which saves the company both
time and money.

Developing Best Practices

Employed as a “Best Practices” model, ISO 9001 utilizes the philosophy of the “Plan-Do-Check-Act” continuous improvement cycle to achieve requirements. This process approach centers around eight quality management principles used by management as a guide toward improving performance and identifying the main elements
needed in a good quality system:

1. Customer Focus
2. Leadership
3. Involvement of People
4. Process Approach
5. Systems Approach to Management
6. Continuous improvement
7. Factual Approach to Decision-Making
8. Mutually Beneficial Supplier Relationship

Building Stable Processes

ISO 9001 policies, procedures and forms can provide employers, managers and employees with a systematic and consistent approach to implementing policies, plans, procedures and work routines. Instead of building their own policies and procedures from scratch, some companies prefer to hire professional writers that have already prepared a set of written policies and procedures to help on the way to certification.

Auditing a Company System

In the certification process, an independent registrar will perform an on-site audit of a company’s operations to verify that it complies with the ISO standard. If the business complies, then that company will be registered as ISO 9001 compliant.

Meeting Company and Customer Needs

On the way to certification, a business can meet its ISO needs by:

= Using well-defined processes and procedures to build stable processes
= Training in the audit and certification process
= Continuously improving with ISO 9001 standards

Noticing the Difference

With complete procedures manuals for ISO 9001 Quality Management System, required HR procedures, and an ISO training class, a template like an ISO 9001 Quality Manager Procedures Manual Series can help a business on its way to ISO 9001 certification.
Sometimes the effort can be very great, but companies typically notice a remarkable difference in efficiency and effectiveness after the first year.

ISO 9000 Training DVD

ISO 9000 Training DVD

ISO 9000 Training DVD

The major reasons that company leadership or management decides to seek ISO 9000 certification are to gain continued or increased business and to maintain effective operations.

A company can maintain a relationship with customers, as well as get increased business through complying to the ISO 900 standards or becoming certified. This comes from satisfying customer demands, the desire for European business, and to advertise.

The “Introduction to ISO 9001:2008” DVD covers 3 major areas, which will help companies in the process of implementing ISO 9000 Standards. It consists of:

First, to describe some basic information on ISO 9000 Standards. It will specifically refer to ISO 9001:2008 Standards. The video will explained on topic like what is ISO 9000 Standards, The origin, history & evolution, Series of ISO 9000, version & certification in ISO 9000 Standards.

Then, the DVD will go into the introduction on quality management. It will explained on topics like what is quality, quality characteristic, quality management, Quality Management Principles, ISO 9000 vs. Quality, what is Quality Management System & etc.

Finally, the DVD will technically highlight the requirement of Quality Management System in ISO 9001:2008. It also going through in details the steps in implementing Quality Management System in ISO 9001:2008.

ISO 14001:2004 Training DVD

ISO 14001:2004 Training DVD

ISO 14001:2004 Training DVD

Global warming, ozone depletion, pollution and extinction of numerous species of animals. These are just a few of the environmental issues that the world faces, in the name of development. As responsible corporate citizens, companies can play their part in preserving our natural environment for our next generation by implementing ISO 14001:2004 Standards – Environmental Management System.

So, what is ISO 14001:2004 Standards – Environmental Management System? What is the requirement of the ISO 14001 standards? What is the content of Environmental Management System? What are the steps in implementing ISO 14001:204 Standards – Environmental Management System? You will find the answers in this “ISO 14001:2004 Standards – Environmental Management System” DVD.

The “ISO 14001:2004 Standards – Environmental Management System” DVD will elaborate in details on:

1. Introduction to ISO 14001:2004 Standards – Environmental Management System.
2. The history & origin of the standards.
3. Requirement of ISO 14001:2004 Standards.
4. Contents Of ISO 14001:2004 Standards.
5. ISO 14001:2004 Implementation Steps & Checklist.

No matter how simple or complex the business, each can benefit from the implementation of a management system based on ISO 14001:2004. This international standard has as its focus the prevention of pollution, accomplished by a teamwork approach to identifying those aspects of the organizations processes that have the potential for harming the environment and the development of ways to reduce or prevent this harm.

In the process, many organizations have found ways to reduce costs by elimination of scrap, changes to their waste disposal processes or reduced use of natural resources. It is the application of the system approach that has proven to be successful. And, once the system is in place, it is logical and beneficial to have that system certified and registered. This provides added assurance that the management system remains effective and also provides public recognition to numerous stakeholders that your organization is committed to the prevention of pollution.

What Is ISO 14000 Environmental Management System

ISO 14000 is primarily concerned with Environmental Management. In plain language, this means what the organization does to minimize harmful effects on the environment caused by its activities.

Improving the environmental performance of corporations is one way of limiting environmental damage. Environmental management systems (EMS’s), such as ISO 14001, provide a framework for organizations that wish to effectively manage their environmental affairs. Implementing an EMS that conforms to the ISO 14001 standard may help businesses integrate environmental values into their operations.

An EMS can be described as a program of continuous environmental improvement that follows a defined sequence of steps drawn from established project management practice and routinely applied in business management. In simple terms these steps are as follows:
• Review the environmental consequences of the operations.
• Define a set of policies and objectives for environmental performance.
• Establish an action plan to achieve the objectives.
• Monitor performance against these objectives.
• Report the results appropriately.
• Review the system and the outcomes and strive for continuous improvement.
Not every system will present these steps in exactly the same way, but the basic principles are clear and easily understandable.

The ISO 14000 series is a series of standards for different aspects of environmental management. A number of these standards relating to environmental management systems have been adopted formally by the members of the ISO, while others are in different stages of preparation.

ISO 14000 is a group of standards covering the following areas:
•Environmental Management Systems (14001,14002, 14004)
•Environmental Auditing (14010, 14011, 14012)
•Evaluation of Environmental Performance (14031)
•Environmental Labeling (14020, 14021, 14022, 14023, 14024, 14025)
•Life-Cycle Assessment (14040, 14041,14042, 14043)

Read more on ISO 14000 Environmental Management System at http://www.e-wia.com

ISO 14001 Certification

ISO 14001 certification is primarily concerned with the approach of Environmental Management System. Keeping in mind the growing worldwide concerns regarding the living environment, we have come up with expertise in providing certification services.Certification to the internationally recognised EMS standard, ISO 14001 from an accredited and reputable provider is becoming a preferred choice for organisations looking to demonstrate their environmental credentials.

What is ISO 14001?

ISO 14001 is the internationally recognised standard for the environmental management of businesses. It prescribes controls for those activities that have an effect on the environment. These include the use of natural resources, handling and treatment of waste and energy consumption.

Implementing an Environmental Management System is a systematic way to discover and control the effects your company has on the environment. Cost savings can be made through improved efficiency and productivity. These are achieved by detecting ways to minimise waste and dispose of it more effectively and by learning how to use energy more efficiently. It verifies compliance with current legislation and makes insurance cover more accessible.

Advantages of ISO 14001 certification:

* Environmental legal liability.
* Improved corporate image; strategic investment; improved regulatory relations.
* Improving the quality of the environment.
* Assuring commitment to manage and improve environment
* Reducing incidents that may be detrimental to working in the long run and causing liability
* Conserve natural resources and energy and help in getting the required legal consent
* Sharing environmental solutions and improving industry and government relationship
* Evaluates system performance through management review and correct management system deficiencies.

The ISO 14001 certification provided by OSS, offers quality control system defines the organisation, responsibilities, objectives and procedures used to assure quality and reliability of products and services. The policies of the ISO 9001:2008 quality control program should be implemented and maintained at all levels of the business operation and be accessible to all employees.

The ISO 14000 standardization series establishes standards, guidelines, and policies governing correct environmental management by certified organizations. ISO 14001 is, thus far, the most recognized of the ISO 14000 series, as well as the sole ISO standard that can be certified. In an era of environmental consciousness, this certification is crucial for a business or corporate entity to remain competitive in not only a national market, but the international market.

Wide acceptance- ISO certification is recognised in more than 120 countries and is the logical choice for any organisation involved in international business or committed to quality.

The certification process is undertaken by a third party uninvolved in any way with the organization seeking certification. A sizable number of certification organizations, known as auditors, will provide materials, mentoring, and monitoring to ensure that organizations recognize and comply with the various management guidelines. Once the standards have been met, the auditing organization will certify the applicant organization as ISO 14001-compliant.

OSS is considered as a professional organisation which holds some of the highly qualified individuals in the pool, serving for a wide range of areas by providing customer preferred and efficient certification services. The company toils for rendering a complete suite of consulting services and training in the field of Quality Management and Environmental Management to the organisation across all the industries verticals for building a progressing and profitable organisation by creating competitive advantage in the market.

ISO 14001 Standards – Control Of Forms

ISO 14001:2004, element 4.4.5, instructs an organization to control documents required by the EMS and the standard. While some companies often try to justify not controlled forms, let’s find out if forms are the same as “documents” and if they also should be controlled.

Organizations use forms and tables within their environmental, quality, H&S and other management systems. Often, instead of preparing a traditional instruction or a procedure with all the sections, such as scope, purpose and process description, a simple form can provide this information. Frequently registrars issue companies non-conformities for their not controlled forms of their EMS.

Repeatedly I discuss this issue with my clients. Regularly I hear the same answer “Why do I need control a form?” Honestly, I do not understand this! Why should a form be treated differently from any other document? How would one know that we need a form if it is not referenced in our ISO 14001 management system? If forms are not managed by your documentation system, and you decide to modify them, how can you be confident that you make changes to the latest revision? Anyway, what is a form? A short review will help answering this question. If we have a list of directions telling us to:

1 – prepare 2-column table

2 – note your organization’s name in the first column

3 – put your business’s URL into the 2-nd column

There is no doubt; most of us would call this three-line direction a procedure or an instruction. So, if this is an instruction, it shall be controlled per ISO 14001 Standard.

Now, what if we were given a two-column table where the first column was titled “You enterprise name” and the second column “Internet address”. We were asked to complete the form. Easy to imagine, we would enter our company’s name and our URL in the table. It means that we interpreted this table as an “instruction”. If it walks like duck it is a duck! OK, most like a duck

This example demonstrate that our first three-line instruction in English (that obviously needs to be controlled), serves the same function, producing the same result, as our form. Therefore, the form as an instruction and “shall” be controlled as well.

I suspect that the confusion regarding forms used in ISO 14001 environmental management systems is based on the fact that forms serve two purposes. Blank forms are brief instructions written in tabular language. The same form, after being completed, becomes a record. Since records are not required to have a number, I presume this transposes on the source document – our blank table. Let’s remember this and treat our blank forms as instructions letting the documentation control process govern them. There are a couple of easy tests you may take when you are tempted to use a form that has not been identified:

- If you created a form for ISO 14001:2004 EMS and found it was changed, would you like to know who did it and why?

- If you revised one of your ISO 14001 forms, would you like your users use the latest revision?

- If you are in Brazil on a business trip, would you like other employees to know where to find your form in your EMS?

If you answered, “yes” at least once, your form is a definite candidate for being a part of your formal ISO 14001 documentation management system.

ISO 9001 Standards For Small Medium Enterprise

There are some companies out there as small as two people that are ISO 9000 certified. In terms of size, companies range from the very small, to under 100 employees, to between 200 ? 300 employees. In terms of revenue, companies can range from one hundred thousand to multi-million dollar companies. They provide a variety of products or services including testing and assembly, manufacturing metal stampings, electronic components, paper products, printing, or different kinds of machinery. Other companies include banks, food industries, and chemical plants. There are also service companies that do recruitment, consulting, and engineering. Any industry in the world can be ISO 9000 registered, and it doesn’t matter what size they are or what they do.

ISO certification can help small business by slimming down your business operation system and make it more effective. Basically, when you first build your ISO 9000 system, it looks like a paper giant to you. In actuality, once it’s done, you’ve completed your audit, and are now running your system, you are able to more effectively utilize the people you work with.

You could have four different processes that you actually could work into one. Now one person can handle completing a particular process instead of four different ones. You’ve been able to consolidate multiple actions/processes into one. This will save time, which is money in the long run. Corrective and preventive actions help you as well. If you catch a product defect prior to its being completed or shipped, you save yourself money and an impact on your company’s reputation. There are a lot of cost effective ways that employee input can also help being ISO registered.

This process will save your business money down the road, even if you may not see it in the front end. You’ve got to run the system. Then as it is running and you are using it, you start consolidating areas of your business that are inefficient or are contributing to loss of materials, labor, etc?. The money isn’t always cash coming back all the time. You will get some cash in some workplaces if you’re getting a lot of scrap and re-work, but YOU ARE going to see it come back in savings of time, and we all know TIME is MONEY.

Obviously where people are working more efficiently, they are making more product in less time, so you are saving money and making money at the same time. In the long run it will balance out, and you’ll help your company into the next level. Also, you can put the ISO on your website. You can use it for your marketing because suppliers recognize it, not only in the United States, but around the world. You’ll probably get more calls, because of your ISO registration.

Many companies look to see if potential suppliers are ISO registered prior to contacting them. Potential customers will know that through effective and efficient management of your system you are assuring them that they get a quality product. It’s going to open up more doors for potential customers because they are going to understand what you’re doing. Some companies will not even look at clients or other companies unless they are ISO registered. It’s similar to the idea that, in the job market, a lot of companies won’t look at a candidate unless they have a college degree. In this case your ISO certificate is your degree.

Another way that ISO registration can save small businesses money is by eliminating the need for vendor audits. In the past, companies would conduct these audits to verify the quality of potential suppliers? products, or they would purchase the product and hope that it was what they wanted. Now you can verify just by asking for a copy of their certificate and verifying with the registrar. You would not have to send someone in to do a vendor audit. This is an extremely strong benefit.

Committing to becoming ISO certified is not a small decision. It takes time, dedication, and it can be expensive. However, the benefits for small businesses far outweigh these costs. Becoming ISO certified can help you small business grow!

ISO 9000 AND THE CONSTRUCTION INDUSTRY

A formal quality management system has the potential to change attitudes, cultures, and work procedures at any construction firm in a way the organization has never experienced before. In most cases, in order to set up a

formal quality management system at a construction firm, there has to be direct demands from their customers, whose requirement for quality is essential for doing business. Most of the construction organizations will not enter into the cost and allocation of resources to implement a quality management system unless they will be compensated. There is a general movement towards making implementation of a quality management system a contractual requirement. Small to medium sized organizations can always argue that they ‘operate to a quality system’ although this is not formalized. However, since the existence of such ‘informal’ quality systems are

difficult to justify, the International Standards Organization, (ISO) has come up with ISO 9001 series of standards that are applicable to all organizations irrespective of size or nature of business.

ISO 9000 refers to a set of quality management standards. Standards present an opportunity for an organization to develop a quality management system that meets the requirements specified by ISO 9001:2000, which are

recognized internationally, making the organization competitive. ISO 9001 family of standards is undeniably the most prolific of all formal standards. This could be due to the worldwide applicability standardization and

flexibility with which the standards are associated, even though there are some experts that still question the standards’ applicability in the construction industry. It is important to note that ISO 9001:2000 has replaced ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994, while the old ISO 9002 and ISO 9003 standards have been discontinued.

A formal quality management system has the potential to change attitudes, cultures, and work procedures at any construction firm in a way the organization has never experienced before. In most cases, in order to set up aformal quality management system at a construction firm, there has to be direct demands from their customers,whose requirement for quality is essential for doing business. Most of the construction organizations will not enterinto the cost and allocation of resources to implement a quality management system unless they will becompensated. There is a general movement towards making implementation of a quality management system acontractual requirement. Small to medium sized organizations can always argue that they ‘operate to a qualitysystem’ although this is not formalized.

However, since the existence of such ‘informal’ quality systems aredifficult to justify, the International Standards Organization, (ISO) has come up with ISO 9001 series of standardsthat are applicable to all organizations irrespective of size or nature of business. ISO 9000 refers to a set of quality management standards. Standards present an opportunity for an organization todevelop a quality management system that meets the requirements specified by ISO 9001:2000, which arerecognized internationally, making the organization competitive. ISO 9001 family of standards is undeniably themost prolific of all formal standards. This could be due to the worldwide applicability standardization andflexibility with which the standards are associated, even though there are some experts that still question thestandards’ applicability in the construction industry. It is important to note that ISO 9001:2000 has replaced ISO9001:1994, ISO 9002:1994 and ISO 9003:1994, while the old ISO 9002 and ISO 9003 standards have been discontinued.

Review In ISO 9000 Standards

If you have your own business and now you are looking for ISO 9000 certification for quality standards for business to make your business products more reliable to the customers. To be in the market for any business, it needs quality and for quality any business needs to follow quality standards, so ISO 9000 Standards developed many quality standards as per different -different business areas.
ISO 9000 Standards is a generic quality standard and can be applied to any organization but before applying it, a process starts with pre-assessment audits and passes through on-going maintenance. The process of implementing ISO 9001 includes identifying, collecting and organizing the information required for certification.
For implementing ISO 9000 standards, any organization needs to hire a consultant because detailed knowledge of ISO standards is essential before successfully applying it. A consultant will analyze your organization structure, your products and their standards and will make a complete plan as per ISO standards for your organization.To hire a consultant is easiest way because they have complete knowledge of ISO 9000 standards and they perform various activities like provides class room training to your business employee about ISO 9000 standards
An ISO consultant performs the various activities and explains the course objectives :
• understand the purpose of ISO 9000: 2005, ISO 9001: 2008, ISO 9004: 2000, ISO 19011: 2002 etc. standards and their interrelationship
• describe the purpose of Quality Management Systems and 8 Quality Management Principles
• Interpret the ISO 9001: 2008 in the context of audit
•Plan and conduct an audit in accordance with guidelines as per ISO 19011: 2002, gather objective evidence via various methods and determine conformity to the requirements of Quality Management Systems
• Develop understanding of Roles & Responsibilities of Lead Auditors
Hiring a Consultant is a better and easiest way to implement ISO 9000 in your organization.

How To Prepare ISO 9001 Standards Audit Check List

How To Prepare ISO 9001 Standards Audit Check List

There are a few steps to prepare ISO 9001 Standards Check List, namely:

1. Apply the concept of Plan Do Check Act (PDCA). This PDCA concept is applied at the Quality Management System and the process levels.

2. Convert the question to requirement raised by QMR or the QMS Committee which derived from theISO 9001 standards. In this case, several questions can lead to one single requirement.

3. To edit those questions to suit the process that is to be audited. For example, you are going to audit the Purchasing/Procurement Department and you’re sitting down with the Audit Team trying to come up with relevant questions.

The main objective in auditing any process is to extract adequate information and evidence in order to verify that the process is conformant to the ISO 9001 requirements and that, it is effective in achieving its objectives. As an auditor, you need to be able to investigate, assess and verify the conformity and effectiveness of a given process, in terms of its planning, implementation, monitoring & measurement and improvement. As a Lead Auditor, preparing your Audit Team for the actual audit is crucial in ensuring success of the audit excercise. There is no better way to do that than by developing the audit questions with them.

Review In ISO 9000 Standards

If you have your own business and now you are looking for ISO 9000 certification for quality standards for business to make your business products more reliable to the customers. To be in the market for any business, it needs quality and for quality any business needs to follow quality standards, so ISO 9000 Standards developed many quality standards as per different -different business areas.
ISO 9000 Standards is a generic quality standard and can be applied to any organization but before applying it, a process starts with pre-assessment audits and passes through on-going maintenance. The process of implementing ISO 9001 includes identifying, collecting and organizing the information required for certification.
For implementing ISO 9000 standards, any organization needs to hire a consultant because detailed knowledge of ISO standards is essential before successfully applying it. A consultant will analyze your organization structure, your products and their standards and will make a complete plan as per ISO standards for your organization.To hire a consultant is easiest way because they have complete knowledge of ISO 9000 standards and they perform various activities like provides class room training to your business employee about ISO 9000 standards
An ISO consultant performs the various activities and explains the course objectives :
• understand the purpose of ISO 9000: 2005, ISO 9001: 2008, ISO 9004: 2000, ISO 19011: 2002 etc. standards and their interrelationship
• describe the purpose of Quality Management Systems and 8 Quality Management Principles
• Interpret the ISO 9001: 2008 in the context of audit
•Plan and conduct an audit in accordance with guidelines as per ISO 19011: 2002, gather objective evidence via various methods and determine conformity to the requirements of Quality Management Systems
• Develop understanding of Roles & Responsibilities of Lead Auditors
Hiring a Consultant is a better and easiest way to implement ISO 9000 in your organization.

ISO 9000 Document Management Software System

Today’s manufacturing companies that seek ISO 9001 compliance-(regardless of their motivation to do so) probably don’t find it that difficult to create intelligent documentation. After all, a few days with a good consultant or a quality manager can take care of document creation. The problem lies in the gap between what employees are doing and what employees are supposed to be doing (in terms of adhering to documentation) and the gap between the manner in which processes are being implemented and the manner in which they should be implemented ( in accordance with documentation). In other words, the problem lies in the way processes are strategized and applied and in the way employees commit to standards when compared against existing documentation. How can a company overcome these issues? The answers may be simpler than you think.

Automation is the Answer for ISO Control
If your underlying processes are poorly strategized then an automated document management software system won’t be of much use. However, once the processes have been effectively planned (and applied) a document management software system can speed process-to-process management by leaps and bounds. Companies that automate not only to comply with ISO standards but to generate more revenue by performing less administrative labor save weeks and even years worth of time just by automating their processes and documentation control with a document management software system.

Making Amends
The right document management software system and ISO document control would also allow companies to find deviations and nonconformance events faster and move those events to resolution phases in a small fraction of the time they were originally routed—if they were routed at all. Some ISO 9000 document management software systems may even be combined with a CAPA QMS solution. This is especially valuable when determining the root cause of major to minor deviations.

A Document Management Software System and Employee Training
ISO standards do not require any type of automation but ISO standards lend themselves to automation in a way that’s quite remarkable. Take for instance the following document management requirements from the official ISO 9001 International Standard.

ISO 9001 Section 4.2.3
ISO standards make it clear that ISO 9001 “approved” companies must define (i.e., document) how they will approve documentation, how they will identify documentation changes, how they will update/reapprove revised documentation, how external documentation will be managed and how assurance will be provided that documentation will be available when it is required. 1 And that’s only a shadow of things to come! A document management software system designed for strict compliance can automate the approval of documentation, the identification of document changes, updates and reapproval notifications, external documentation management and high-level document security. Some solutions also integrate training and online exams as well.

How Much Could You Save?
Chances are high that automation will save you thousands, tens of thousands or even hundreds of thousands of dollars annually depending on the size of your company. Just foregoing a typical document routing process (a manual process) can save many employees fruitless trips back and forth from one office to another. Who wouldn’t want to avoid those time consuming searches through 3-ring binders and lost documentation due to employee absence or neglect?

Conclusion
Regulation and control are the future for manufacturing. Gone are the days of free experimentation and a blind eye toward material waste. Today is the day of premeditated design, quality assurance and web-based automation. If your company plans to be, or already is, compliant with ISO 9001 standards why not consider automating those ISO 9001 controls with a document management software system.

ISO/FDIS 9001:2008 Overview

ISO/FDIS 9001, the final draft of the upcoming ISO 9001:2008 standard, has been published and is available for purchase from both ANSI and the American Society for Quality (ASQ). Pending formal approval of the draft by the ISO membership, publication of the ISO 9001:2008 standard is expected in October or November of this year. According to a June 17th press release from the International Organization for Standardization (ISO), “The proposed ISO 9001:2008 does not introduce additional requirements compared to the last edition in 2000 and does not change the intent of ISO 9001:2000.” ISO’s process does not allow for changes to documents in the FDIS stage.

The ISO membership either votes to approve and publish it, or votes against publication, so no further changes are expected between the FDIS and the ISO 9001:2008 standard.

While the clause numbering has not changed, and no new requirements have been added, there are numerous clarifications to the requirements. While many of the clarifications are only rearrangements of existing text and punctuation, others involve additional notes and text. It is possible that a previous misunderstanding of a requirement, or a partial fulfillment of a requirement, will be identified during an audit to the new standard.

Companies’ management and/or management representatives should review ISO 9001:2008, and ensure that their quality management system effectively addresses the clarified requirements. In addition, internal audits should be conducted to ISO 9001:2008.

In mid-August of 2008, ISO stated that it “is now working on implementation guidance for ISO 9001:2008, a reference table comparing and contrasting ISO 9001:2000 and ISO 9001:2008 and answers to Frequently Asked Questions.”