Inside The ISO Certification Process

Considering certification? Here are answers to your most basic questions, as well as a case study from someone who's been there.

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Avon Gear Company commenced operations in 1974. The company started as a gear manufacturer in a 10,000 square-foot facility in Rochester, Michigan. Today, under the leadership of company President Aaron Remsing, Avon Gear is located in a 60,000 square-foot facility, also in Rochester. Its product line includes high-precision gears, AGMA Class-10–sun, spur, helical, and high-contact ratio gears–shafts, splines, housings, pulleys, covers, and other powertrain components. Figure 1

In 1998, Avon Gear became ISO 9002 certified, with QS 9000 registered, and maintains this accreditation today. Avon Gear credits its current and continued growth to its skilled workforce, experienced management team, and state of the art equipment, with its primary emphasis on total customer satisfaction. The company has the support of its parent company, Okubo Gear, in maintaining its reputation as a world-class, quality supplier to major original equipment manufacturers. Figure 2

Figure 3 Earlier this year, Avon Gear's management team recognized the need to become ISO 14001 compliant. As a result, a cross-functional core team sat down and outlined its concerns, asking themselves the question "Could we implement ISO 14001 and, if so, what are some of the constraints?" Their concerns included:
 

  • A tight schedule, with limited human resources
  • Discovery and understanding of all applicable environmental laws
  • Educating and training of employees
  • Cost benefit analysis
  • Whether or not to hire a consultant
  • Verification and documentation
  • How to format the system and include internal and external communications as a key component

Based upon this list of questions, Avon Gear determined that it needed an ISO 14001 Environmental Management System Model. This model had to evolve around continuous improvement, and include management's commitment, an environmental policy, planning, implementation, operational issues, auditing, corrective and preventive actions, training and awareness, and management review. The company also determined that the system could be developed and implemented without hiring a consultant, provided that the program administrator had a comprehensive understanding of how to conduct research, disseminate information, develop and communicate a plan, and write workable policies, procedures, and work instructions that could be integrated into the company's current operating system. In essence, the company decided that it needed a documented environmental system to ensure that it did not contribute to or violate laws that protect against the loss of species, habitat destruction, global warming, and groundwater, land, air, or noise pollution. Having established a foundation, the company then used the following outline in its "plan, implement, check and act" cycle:

  • Establish your company policy: Every company policy should include the continuous improvement objective as the fundamental core of its environmental policy. It is recommended that you include your commitment to meet all applicable laws in the prevention of pollution. In addition, establishing key objectives, based upon the nature of the business, will assist you in determining the aspects or features of an environmental system and how it is impacted.
  • Conduct benchmarking: This is one of the most critical and important aspects of an environmental management system. Avon Gear developed a relationship with a company of comparable size and standard industrial code and freely exchanges information on successes as well as failures.
  • Conduct a Gap Analysis: We made the mistake of using a gap analysis as an environmental review and a means of tracking and quantifying our progress. Avoid this pitfall by using a gap analysis as a comparison of your current system and controls and comparing them with the requirements of ISO 14001. If your company has the elements of a quality system such as ISO or QS 9000, then most of the elements are in place and understood, thus they should only require slight modification. It is highly recommended that the ISO 14001 and ISO 19011 standards be compared to ISO 9000 and QS 9000 and, when applicable, the similarities be denoted.
  • Define legal requirements and aspects, while identifying internal and external resources. Environmental aspects, features, or characteristics are defined as "any element, activity, project or operation that may result in an impact upon the environment." There are many free publications and Internet resources that will assist any company in determining those laws that pertain to them.
  • Visit your local city or township offices and request maps that outline the stormwater system, as well as hydrology within a half to one-mile radius of your facility. Oftentimes these files may be available in PDF format, so don't forget to ask. This will assist you in determining how you could potentially impact the environment.
  • Conduct an in-depth, in-house environmental assessment. Look for the obvious, such as cutting fluids, oils, acids, and cleaning fluids. Evaluate solid waste, metal chips, scrap, and sludge, as well as your safety and housekeeping programs. Also look for the not so obvious, such as noise pollution, wastewater discharge, air emissions, and floor drain locations. Brainstorm ways to reduce or control energy usage. Bear in mind that if your company employs 5S, lean manufacturing, or six-sigma methods, then ISO 14001 lends itself well to the process.
  • Determine your key indices: Every system needs key indicators, some with an economic as well as an operational impact. This list could include the cost and/or consumption of items such as packaging materials, cutting fluids, electricity, water, natural gas, propane, and scrap, just to name a few.
  • Communication: Internal and external communication are vital aspects of training and awareness. Medias such as newsletters, e-mail, bulletin boards, and training syllabuses are all part of a company's communication methods and should be controlled through a policy and procedure. In addition, these are excellent venues for communicating your continuous improvement efforts.
  • Root Cause Analysis: Determine the root causes of any actual or potential environmental effects by using the Ishikawa Fishbone Diagram method. Include items such as use of fossil fuels, carbon dioxide releases, electricity, heating systems, new buildings or developments, toxic releases, landfills, discharge, fertilizer and inherited historical activities as potential root causes of pollution.

Having completed this list, you should be prepared to establish your environmental policies, procedures, and work instructions. Areas in your quality system that may be affected include:

  • 4.6 purchasing, whereas you may require all subcontractors to be ISO 14001 compliant, or to be aware of your environmental requirements
  • 4.11 inspection and test equipment, whereas any measuring or test device that is used for environmental evaluations should be included in your gage control and calibration programs

If your company has a recognized quality system, then you should be able to integrate ISO 14001 smoothly into your programs. We recommend that you establish a matrix, with the elements of your quality system in the "Y" axes, and the elements of ISO 14001 along the "X" axes, and then determine where the similarities exist. Once this is completed, your management representative or quality personnel who are familiar with "think, plan, do" methods probably have the capabilities necessary to make ISO 14001 work for your company.

We hope that you have found this article to be educational and informative, and we welcome any feedback you'd care to provide. For contact information, visit our Web site at [www.agcoga.com].

 

 

Questions—and Answers—on ISO 9000 Registration

Why should your company consider becoming ISO 9000 registered? What type of investment will it take? How much time? What do you stand to gain? Important questions… here are the answers.

By Dave Hornstein

There comes a time in any manufacturing company’s development when its principals start to wonder what it would take to step up to the next level and become a national, and even a global, presence. One way might be to consider working toward attaining ISO 9000 registration. In association with Dave Hornstein, managing editor at Perry Johnson, Inc.—the world leader in ISO 9000 and ISO 14000 consulting and training—Gear Solutions developed the following feature to provide readers with a basic understanding of the ISO 9000 registration process and related issues.

Gear Solutions: What is the ISO, and what does it do?

Dave Hornstein: This question requires two answers: one applying to ISO itself, and the other to ISO 9000.

First of all, the International Organization for Standardization (ISO) is a non-governmental worldwide federation of 132 national standards bodies based in Geneva, Switzerland. The American National Standards Institute (ANSI) is the member body representing the United States. 

Established in 1947, ISO’s mission is to promote the development of standardization and related activities in order to facilitate the international exchange of goods. ISO is derived from the Greek word isos, defined as “equal.”

ISO operates through working groups and technical committees to produce international agreements that are published as standards. Standards are documented agreements containing technical and other precise criteria to ensure that materials, products, and services are fit for their purpose. ISO issues and revises more than 800 standards a year.

Secondly, ISO 9000 is a series of quality management systems standards created by ISO. The ISO 9000 quality management standards are not specific to products or services, but apply to the processes that create them. The standards are generic in nature so that they can be used by manufacturing and service industries all over the world. First released in 1987, and revised in a limited manner in 1994, they underwent a major overhaul in 2000.

ISO 9000 is intended to establish, document, and maintain a system for ensuring the output quality of a process. It consists of a group of commonsense and generally well-known precepts laid out in an organized fashion. 

The most important ISO 9000 standard is ISO 9001:2000, Quality Management Systems-Requirements. It addresses an organization’s quality management requirements in order to demonstrate its capability to meet customer requirements, and it applies to all generic product categories such as hardware, software, processed materials, and services.  ISO 9001:2000 is the standard to which organizations may become registered or certified.

At what point should a business consider becoming ISO 9000 registered?

The most common reason for a company to seek ISO 9001:2000 registration is a customer registration mandate. A growing number of firms are requiring their suppliers to be ISO 9000 registered, making it a necessity for keeping major customers.

Other reasons for considering ISO 9000 registration include gaining a competitive advantage in the marketplace, improving the quality of products or services, making processes run more efficiently, increasing customer satisfaction, and getting better access to the European market.

What does a business stand to gain by doing so?

When implemented correctly, ISO 9001:2000 can offer a company several advantages. It will guide it to build quality into products or services; help to reduce time-consuming and expensive supplier audits, inspections, warranty costs, and rework; and provide a competitive edge over companies that are not registered to ISO 9001:2000.

Facilities which operate ISO 9000 quality management systems tend to exhibit a philosophy of prevention rather than detection; continual review of critical process points; corrective actions and outcomes; consistent communication within the process, and among facility, suppliers, and customers; thorough record keeping and efficient control of critical documents; total quality awareness by all employees; and a high level of executive management confidence and support.

These attributes lead to informed and competent management decision-making, dependable process input, control of quality costs, increased productivity, and reduced waste. A well-designed and implemented ISO 9000 quality management system creates a process that tends to be lean, sensitive to customer needs, highly reactive, efficient, and positioned at the leading edge of its marketplace.

What’s the difference between ISO 9000 and 14000?

While ISO 9000 is a series of quality management systems standards, ISO 14000 is a series of environmental management systems standards. The ISO 14000 standards aim to provide effective, efficient, and economical means for organizations to implement sound environmental management practices, such as waste minimization; recycling; controlling the discharge of wastes into the air, water or land; and using energy-saving measures.

The most important ISO 14000 standard is ISO 14001:1996, Environmental Management Systems-Specification with Guidance for Use, to which organizations may become registered or certified. ISO 14001 helps organizations identify environmental aspects (activities, products, and services that can interact with the environment), and to find ways to manage their impacts through the implementation and operation of an environmental management system.

In implementing an effective ISO 14001 environmental management system, top management establishes an environmental policy and defines roles, responsibilities, and authorities to ensure that system requirements are established, implemented, and maintained. An organization is then better able to control the environmental impact of its activities and prevent pollution, while reducing remediation and regulatory compliance costs. 

How does a business begin the registration process—who are the contacts, or what resources exist?

A company seeking ISO 9001:2000 registration would need to contact a consulting firm to prepare it for registration and a registrar to perform the registration audit and issue the registration certificate.

A good source of contacts is Quality Systems Update, available online at www.qsuonline.com. This publication lists major registrars, along with consulting firms offering ISO 9000 training courses.

Is there any way to determine how much money this will cost? Also, what additional resources—training, consultants, etc.—will be required?

The cost of ISO 9000 registration depends on several factors. The most important are the size of the organization and the state of its quality management system, if any. An organization with a good quality management system may only need to document what it already does.

Training employees will depend on how well they are already trained and how much of the implementation is carried out by the organization or a consultant. At a minimum, at least one employee, preferably the management representative, who is responsible for quality management system operation, should receive ISO 9000 lead auditor training. Other employees would need to be trained as internal auditors. If the organization decides to implement the quality management system, some employees would need implementation training. Otherwise, it would pay a consultant for implementation services.

How long does the process usually take?

This also depends on the size of the organization and the state of its quality management system, if any. An organization with a good quality management system would take a short time to implement ISO 9000. The minimum period to achieve registration is six months, allowing three months for full implementation and a three-month paper trail of documentation for the registration audit.

A company starting from scratch could take as long as two years to achieve registration, with this time period reduced by a strong management commitment to implementing the quality management system.

Once registration has been achieved, what will be required to maintain it in the future?

Registration certificates are for three years. An ISO 9000 quality management system uses a continual improvement process, with regularly scheduled internal audits, followed by management review. In addition, the registrar conducts regular surveillance audits to make sure the quality management system is being maintained.

Does ISO 9000 have industry sector-specific derivatives?

Several industry sector-specific ISO 9000 derivatives have been developed, and more are on the way. These derivatives combine ISO 9001:2000 with additional industry sector-specific requirements.

The greatest amount of activity has occurred in the automotive industry, where four derivatives of the 1994 ISO 9000 standards were developed. There was the Big Three’s QS-9000, the German VDA 6.1, the French EAQF, and the Italian AVSQ. International automotive suppliers faced multiple registrations to these standards, which had overlapping sector-specific requirements. As a result, an international automotive quality standard, ISO/TS 16949, was developed. After the ISO 9000 standards were revised in 2000, only ISO/TS 16949 was revised to align with ISO 9001:2000. It is replacing all the other automotive quality standards, none of which were revised, with this process to be completed in 2006.

Other major industry sector-specific ISO 9000 derivatives are AS9100 for aerospace, TL 9000 for telecommunications, and ISO 13485 for medical devices.

 

About the author: Dave Hornstein has been involved in ISO 9000 for seven years. He was a major contributor to the Perry Johnson books, ISO 9000: The Year 2000 and Beyond, Third Edition (McGraw-Hill, 2000) and ISO/QS-9000 Yearbook: 1998 (McGraw-Hill, 1998). He can be reached at (800) 800-0450 ext. 223, or via e-mail at dhornstein@pji.com. Visit the Perry Johnson, Inc., Web site at [www.pji.com].