ISO 9001:2000 Certification
CSC can help your company upgrade your current quality system to the new ISO 9001:2000 revisions. For more information please contact us.
Why Should we become ISO 9001 Certified?
ISO 9001 is recognized as the quality management standard by more than 130 countries worldwide (more than are in the United Nations!). The US Department of Economic Development has forecast that by 2006 there will be 1,000,000 organizations registered to ISO 9001 word-wide. In the USA, today there are approximately 50,000. But what are the reasons you should be implementing the standard?
Organization - The first step to improving a process is to gain complete control over it. When you have control, you have a baseline from which to work. Effective use of ISO 9001 achieves this control by understanding exactly what is supposed to happen and knowing if it works. An additional advantage of the ISO 9000 process is that it provides specific targets for employees to meet. These targets motivate employees to achieve, therefore maximizing their productivity.
Ease of Training - The importance of properly defined training cannot be overstated. Using the documented procedures laid down by the standard, new employees can grasp the requirements of each task from the beginning. In this regard, training is made easier and can be focused toward more specific roles.
New Markets - With the technological advances made in the last two decades, the business world has truly become a global marketplace. The potential to increase your market by exporting is massive. ISO 9000 certification is your passport to international markets.
Competitive Advantage - As an internationally recognized symbol of consistent and dependable quality, ISO 9000 provides a substantial competitive advantage. It stands to reason that registered firms would receive preferential consideration. Large corporations and Government departments have already begun to specify ISO 9000 as a prerequisite to contract bidding. Look at your industry. Are your competitors already certified or working toward ISO 9000?
Legal Liability - With product liability becoming an increasingly important consideration, demonstrating "Good Practice" is advisable. ISO 9000 provides: external evidence of control over all processes, traceability of product, complete records of production and efficient mechanisms for product recall. In addition, if your company has ISO 9001 its design process for new products will also be fully documented.
Cost - The most important factor in considering ISO 9000 is this: companies who have implemented ISO 9000 standards have shown savings averaging from 10-15% per annum. These savings result from better work practices, more efficient time management and the reduction of direct quality costs such as remakes. There will also be hidden cost savings such as the time and energy currently invested in external audits conducted by customers and suppliers. In addition, by determining these customers and suppliers' individual specifications, you will impress upon them the importance of their needs to your company.
A recent ISO 9000 press release from the International Organization for Standardization provides the following information:
* At the end of 1998, more than 270,000 ISO 9000 certificates were issued; an increase of 48,500 over 1997.
* 143 countries had ISO 9000 certificates issued, up from 128 at the end of 1997.
* The USA and Italy showed the highest growth rate in 1998, with 6,406 and 5,961 certificates issued respectively.
* Europe accounted for 83% of certificates issued for ISO 9000.
* The Far East, which accounted for 2% of all certificates in 1997, is now at 14%.
Key Benefits of ISO 9000 Certification
Many experts believe that the driving factor to become "Quality Certified" is market pressure. Very simply, organizations that can demonstrate higher quality will out-perform those that cannot, or will not.
The reason is obvious: quality, in products, services, practices, and procedures is a competitive asset; and a variety of private and public sector facilities are actively developing formal quality programs.
Organizations that become Quality Certified are able to:
- Improve business efficiency
- Ensure quality and repeatability of results
- Ensure timely, accurate, accessible information
- Develop "best practices" and eliminate costly surprises
- Save administrative costs
- Facilitate the organization's ability to obtain contracts
- Enter new markets that may have been previously closed
- Enhance credibility for procurements requiring teaming
- Enhance credentials for professional publications and research
- Facilitate patent filings
Why should we choose CSC as our partner?
CSC has developed a proven implementation method that will document your system, train key personnel to manage it and prepare you for your registration assessment. Whether your company is large or small, manufacturing or providing a service, we can help you implement an ISO 9001 based Quality Management System. Many of CSC's customers are small companies (2-30 employees) where resources are limited but who need an ISO 9001 registration. Our contribution involves our experience as specialists trained in the ISO 9000 philosophy, and our background in business management. We also possess experience in guiding other firms through the same process.
To take the time to train your staff for this level of specialist knowledge would be counter-productive for most. As with attorneys and accountants, it is often advisable to trust the experts to get you through the process. Could you do the same thing yourself? Perhaps, but at what cost ultimately? Your staff is hired to operate and manage your business enterprise, not to learn how to prepare for a registrar’s audit.
CSC offers comprehensive services that will help you achieve your Quality goals. We can:
- Help you select a Registrar that has experience in your industry
- Conduct an initial company review
- Help you establish policies and objectives
- Identify documentation requirements
- Prepare documentation
- Manage implementation schedules, training and follow-up actions
- Conduct training on Internal Auditing, SPC, Gage R&Rs, FMEAs, etc.
- Identify and implement electronic tools to better manage these systems
- Conduct internal audits
- Complete corrective actions
- Conduct vendor and supplier audits
- Help you maintain your quality program
As part of our normal approach we complete a full assessment prior to the registration audit. All members of our team are trained Lead Auditors, so assessments are carried out in the same way, and to the same standard, as the Registrar.
For more information on ISO 9000 certification programs please contact us.
Interested in Training your Internal Auditors?
Internal Auditor Training
Internal Auditing is one of the elements assessed in the Quality System audit. The better your audit team the better your system. CSC has developed an internal auditing course for companies going through registration, as well as for registered companies who want to expand their audit team.
We customize each program to fit your needs. If you have an existing documented system, we can integrate your own procedures and audit forms into the program so that the training will be conducted on processes and procedures familiar to those being trained.
Courses for new auditors are generally 2-3 days, depending on the complexity of your business and are provided at a location of the customer's choice.
Auditor improvement courses can be provided in as little as 1/2 day, minimizing the impact on your operations.
Each participant receives a comprehensive internal auditor training package that includes detailed interpretations of the ISO 9001 standard as well as auditing tips for each ISO requirement and standard audit forms.
Finally, what makes our course so effective is that we can include an optional supervised internal audit on the final day of the course so that the participants get some immediate hands-on training.
Interested in Training?
Additional Training Courses
CSC offers several different quality management training programs specifically directed to ISO 9001, TS 16949, QS 9000, ISO/IEC 17025, and ISO 9000-3 / TickIT certification. We provide quality system awareness training for organizations thinking about developing an approved quality management system. We also provide staff and management-level training for firms that have already begun the process to become certified.
We also possess many attributes above and beyond the implementation of Quality Management Systems. Here are some examples of programs we can provide:
- Electronic Document and Forms Management
- Statistical Process Control
- Measurement System Analysis/Gage R&R
- Failure Modes and Effects Analysis
- Cost of Quality Measurement
Other programs have been customized to the clients' requirements. If you have a quality management related problem and are not sure how to handle it, we will give you an honest answer.
For more information on these training programs please contact us.
Frequently Asked Questions ISO 9000
The International Organization for Standardization (ISO) is the international agency for standardization. At present, it comprises the national standards bodies of 91 countries. The American National Standards Institute (ANSI) is the member body representing the United States. ISO is made up of approximately 180 Technical Committees. Each Technical Committee is responsible for one of many areas of specialization ranging from asbestos to zinc. The purpose of ISO is to promote the development of standardization and related world activities to facilitate the international exchange of goods and services, and to develop cooperation in intellectual, scientific, technological, and economic activity. The results of ISO technical work are published as international standards. The standards discussed here are a result of this process.
The ISO 9000 series is a set of 3 individual, but related documents on the concepts of quality management systems. They are generic, not specific to any particular products or organizations. They can be used by manufacturing and service industries alike. These standards were developed to effectively develop, implement and improve an organization's quality management system. The ISO 9000 Series of standards do not themselves specify how you have to do anything, just what you have to consider.
There are several benefits to implementing this series in your company. For example, it will guide you to build quality into your product or service and avoid costly, after-the-fact inspections, warranty costs, and rework. In addition, you may also be able to reduce the number of audits customers perform on your operation. Increasingly, customers are accepting supplier quality system registration from an accredited third-party assessment based on these standards.
ISO 9000 as a stand alone document provides definitions and terminology for use with IS 9001. ISO 9001 is "The "Standard" which organizations get certified / registered to. ISO 9001 was originally developed for use in contractual situations such as those between a customer and a supplier. ISO 9004 provides guidelines for improving the performance of your quality management system to meet business needs and take advantage of opportunities.
Yes. The United States adopted verbatim the ISO 9000 series as the ANSI/ASQ Q9000 series.
Everyone!!! Organizations around the globe have built and continue to build their quality management systems around these standards. Both large and small companies with international businesses perceive the ISO 9000 series as a route to open markets and improved competitiveness. You don't have to be a multinational corporation or have business overseas to benefit from implementing these standards in your company.
The answer to this question is simple: you can't hope to meet the expectations of any of these programs if you aren't already implementing the ISO 9000 standards in your company. These standards provide the foundation on which you can build your quality management and quality assurance systems so you may ultimately achieve a high level of success. Moreover, the ISO 9000 series is the only system accepted internationally.
Yes. ISO 9004-2 was prepared as a guideline for service industries and ISO 9000-3 deals with software. In addition, there is the ISO 19011 standard on various aspects of auditing quality management systems. There are also documents on guidelines for implementing ISO 9001; project management; process industries; configuration management; quality plans; quality manuals; economics of quality; and continuous improvement. Of course, there is the vocabulary document ISO 8402 (ANSI/ASQ A8402) that defines the terminology contained in the ISO 9000 series.
The standards were designed to be user-friendly. They are generic in nature and follow a logical, easily understood format. However, each company is unique and there may be wide differences in companies' readiness to implement the standards.
Unfortunately there is no set answer. Each company is different. The answer really depends on how developed your present system is and the implementation strategy you adopt.
Of all the questions about the ISO 9000 series, this is probably the one that causes the most concern. Increasingly, European and other foreign customers expect U.S. companies to have their quality systems registered to ISO 9001. This generally involves having an accredited independent third party conduct an on-site audit of your company's operations against the requirements of the standard. Upon successful completion of this audit, your company will receive a registration certificate that identifies your quality management system as being in compliance with ISO 9001. Your company will also be listed in a register maintained by the accredited third-party registration organization. You may publicize your registration and use the third-party registrar's certification mark and the accreditation body's mark on your advertising, letterheads, and other publicity materials (but not on your products).
Certification times vary. Companies have been certified in as little as 3 months or in as many as 3 years. On average though, you can plan on 9 to 18 months from the time you decide to get certified until your registration assessment, depending on the resources that you dedicate to these efforts.
How hard your implementation will be depends completely on what your current system is like. If you have a fairly good system (you review most of what you do; you control most of what you do; you document much of what you do and you do what you document), then implementation will be fairly easy. Unfortunately, most organizations don't review or control as well as they should - hence the standards.
ISO 9000 registration is not a legal requirement for access to foreign markets, but it can be beneficial. In the European Union (EU) for many regulated products, ISO 9000 registration is an alternative for product certification, not an absolute requirement. In fact, as cited in most EU legislation, quality system registration is neither mandatory--there are other paths to product certification--nor is it a stand-alone procedure.
Manufacturer compliance with either EN 29002 or 29003 is usually combined with product type testing at the design stage for full certification to EU legal requirements. Manufacturers interested in the European markets need to review relevant EU product safety directives available from the U.S. Department of Commerce for specifics applicable to their product area.
Outside of regulated product areas, the importance of ISO 9000 registration as a competitive market tool varies from sector to sector. For instance, in some sectors, European companies may require suppliers to attest that they have an approved quality system in place as a condition for purchase. This could be specified in any business contract. ISO 9000 registration may also serve as a means of differentiating "classes" of suppliers, particularly in high-tech areas, where high product reliability is crucial. In other words, if two suppliers are competing for the same contract, the one with ISO 9000 registration may have a competitive edge with some buyers. Sector and product areas where purchasers are more likely to generate pressure for ISO 9000 registration include aerospace, autos, electronic components, measuring and testing instruments, and so on. ISO 9000 registration may also be a competitive factor in product areas where safety or liability are concerns.
The accredited third-party registrar will perform periodic surveillance to assure that your quality system is being maintained. Registrars are also required to perform a full re-audit after a specified time (typically three or four years). If you fail to maintain your quality system, the registrar will suspend or cancel your registration.
Yes, but to eliminate debate, make sure that the third-party registrar includes both the ISO number and date and the ANSI/ASQ number and date on your registration certificate and in the registrar's published directory of registered suppliers (for example, "ISO 9001-2000; ANSI/ASQ Q9001-2000").
There are many factors that will affect your choice of a registrar, such as: what is their mutual recognition status, are they knowledgeable in my industry as well as in auditing quality systems, how many similar firms have they registered, what is re-audit schedule and does it complement our business cycle, and, most important, are they accredited. Your selection of an accredited registrar won't automatically guarantee access to all global markets, but it is the best way to ensure that you have a competent registrar whose methods of operation and qualifications have been subjected to intense scrutiny, with the full weight of the ANSI due process system behind it. It can give you assurance that the dollars you invest in this decision are spent wisely. The Registrar Accreditation Board and the American National Standards Institute work continuously on behalf of U.S. industry so that registrars accredited in the United States will be recognized internationally.
QS-9000 is the shorthand name for "Quality System Requirements QS-9000." It is the common supplier quality standard for Chrysler Corporation, Ford Motor Company, and General Motors Corporation. QS-9000 is based on the 1994 edition of ISO 9001, but it contains additional requirements that are particular to the automotive industry. These additions are considered automotive "interpretations" by the ISO community of accreditation bodies and registrars. QS-9000 applies to suppliers of production materials, production and service parts, heat treating, painting and plating and other finishing services. It does not, therefore, apply to all suppliers of the Big Three. For more information see the QS 9000 FAQs.
ISO 9000 Faces Complete Restructuring Under 2000 Revisions
The ISO 9000 quality management systems (QMS) standards are set to take on a completely different look under revisions slated for release in November or December of 2000. The International Organization for Standardization (ISO) requires all of its standards to be reviewed every five years to determine whether they should be confirmed, revised or withdrawn. ISO 9000, first released in 1987, underwent limited revisions in 1994. A more thorough revision was begun by ISO Technical Committee (TC) 176, Quality Management and Quality Assurance, in 1996, with Subcommittee (SC) 2, Quality Systems, developing revision drafts. The First Committee Draft (CD1) of the ISO 9000: 2000 standards was released in July 1998, with the Second Committee Draft (CD2) published in February 1999 and the Draft International Standard (DIS) released in November 1999. These drafts consist of four primary standards, replacing more than 20 standards and documents.
The four primary standards are:
ISO 9000: Quality Management Systems - Fundamentals and Vocabulary, replacing ISO 9000-1 and 8402
ISO 9001: Quality Management Systems - Requirements, replacing ISO 9001, 9002 and 9003
ISO 9004: Quality Management Systems - Guidelines for Performance Improvement, replacing ISO 9004-1
ISO 19011: Guidelines on Auditing Quality and Environmental Management Systems, replacing ISO 10011-1, 10011-2 and 10011-3, as well as the ISO 14010, 14011 and 14012 environmental auditing standards
Other old ISO 9000 standards and documents are being reviewed by ISO/TC 176 for incorporation into the new standards, withdrawal or reissue as technical reports. The new standards, particularly ISO 9001, are being designed to be more generic, to follow a process-based structure, to be more compatible with the ISO 14000 series of environmental management systems (EMS) standards, and allow for integrated management systems. Under the 2000 revisions, ISO 9001 becomes more generic through the new option of being tailored to omit requirements that don't apply to an organization or limit the scope of application under Section 1.2, Permissible Exclusions. This eliminates the need for the less comprehensive ISO 9002 and 9003 standards. In addition, there are no QMS documentation layout or structure requirements.
The new process-based structure, similar to that used in ISO 14001, creates a completely different look for ISO 9001. The 20 elements have been replaced by five clauses containing 23 elements. The two standards are more compatible under this approach, making it easier to integrate management systems and combine documentation.
ISO 9004, Section 4.3 and ISO 9000, Section 0.2. set forth eight quality management principles, which have been identified to facilitate the achievement of quality objectives. These principles are the basis of ISO 9001. They are:
- Customer Focus
- Leadership
- Involvement of People
- Process Approach
- System Approach to Management
- Continual Improvement
- Factual Approach to Decision Making
- Mutually Beneficial Supplier Relationships
Major clauses of ISO 9001: 2000 are:
Quality Management System (2 elements), which briefly states general requirements, including such documentation as procedures and work instructions. It sets the general framework to establish a quality management system, which defines and manages processes in order to produce a good product or service and allow for continual improvement.
Management Responsibility (6 elements), under which management defines policy, objectives, planning and quality management system requirements, while providing for feedback through management review for change authorization and initiation of improvement. It addresses management's responsibility to establish a system that continually meets customer needs and expectations, even in times of organizational change. This responsibility includes quality objectives at each organizational function and level.
Resource Management (4 elements), where necessary resources, such as human resources and facilities, are determined and applied. Theses resources, which include new elements covering facilities and work environment, are required to implement and maintain the quality management system.
Product Realization (6 elements), under which processes, such as customer-related processes, design, purchasing, and production and service operations, are established and implemented. These processes are needed to manufacture product and/or deliver services from receipt to delivery. Organizations must define and describe their unique business processes, but are not obliged to use the standard's structure.
Measurement, Analysis and Improvement (5 elements), where results are measured, analyzed and improved through internal audits, nonconformity control and continual improvement. Organizations are required to measure and monitor processes, and product and/or service conformity. Collected data must be analyzed to initiate corrective and preventive action for continual improvement.
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ISO 9000 Certification
CSC can help your company upgrade your current quality system to the new ISO 9000: 2000 revisions. For more information please
Why Should we become ISO 9000 Certified?
ISO 9000 is recognized as the quality management standard by 130 countries worldwide (that's more than are in the United Nations!). The US Department of Economic Development has forecast that by 2006 there will be 1,000,000 registered to ISO 9000 in the USA, today there are approximately 30,000. But what are the reasons you should be implementing the standard?
Organization - The first step to improving a process is to gain complete control over it. When you have control, you have a baseline from which to work. ISO 9000 achieves this control by documenting exactly what is supposed to happen. An additional advantage of the ISO 9000 process is that it provides specific targets for employees to meet. These targets motivate employees to achieve, therefore maximizing their productivity.
Ease of Training - The importance of properly defined training cannot be overstated. Using the documented procedures laid down by the standard, new employees can grasp the requirements of each task from the beginning. In this regard, training is made easier and can be focused toward more specific roles.
New Markets - With the technological advances made in the last two decades, the business world has truly become a global marketplace. The potential to increase your market by exporting is massive. ISO 9000 certification is your passport to international markets.
Competitive Advantage - As an internationally recognized symbol of consistent and dependable quality, ISO 9000 provides a substantial competitive advantage. It stands to reason that registered firms would receive preferential consideration. Large corporations and Government departments have already begun to specify ISO 9000 as a prerequisite to contract bidding. Look at your industry. Are your competitors already certified or working toward ISO 9000?
Legal Liability - With product liability becoming an increasingly important consideration, demonstrating "Good Practice" is advisable. ISO 9000 provides: external evidence of control over all processes, traceability of product, complete records of production and efficient mechanisms for product recall. In addition, if your company has ISO 9001 its design process for new products will also be fully documented.
Cost -The most important factor in considering ISO 9000 is this: companies who have implemented ISO 9000 standards have shown savings averaging from 10-15% per annum. These savings result from better work practices, more efficient time management and the reduction of direct quality costs such as remakes. There will also be hidden cost savings such as the time and energy currently invested in external audits conducted by customers and suppliers. In addition, by determining these customers and suppliers' individual specifications, you will impress upon them the importance of their needs to your company.
A recent ISO 9000 press release from the International Organization for Standardization provides the following information:
* At the end of 1998, more than 270,000 ISO 9000 certificates were issued; an increase of 48,500 over 1997.
* 143 countries had ISO 9000 certificates issued, up from 128 at the end of 1997.
* The USA and Italy showed the highest growth rate in 1998, with 6,406 and 5,961 certificates issued respectively.
* Europe accounted for 83% of certificates issued for ISO 9000.
* The Far East, which accounted for 2% of all certificates in 1997, is now at 14%.
Key Benefits of ISO 9000 Certification
Many experts believe that the driving factor to become "Quality Certified" is market pressure. Very simply, organizations that can demonstrate higher quality will out-perform those that cannot, or will not.
The reason is obvious: quality, in products, services, practices, and procedures is a competitive asset; and a variety of private and public sector facilities are actively developing formal quality programs.
Organizations that become Quality Certified are able to:
- Improve business efficiency
- Ensure quality and repeatability of results
- Ensure timely, accurate, accessible information
- Develop "best practices" and eliminate costly surprises
- Save administrative costs
- Facilitate the organization's ability to obtain contracts
- Enter new markets that may have been previously closed
- Enhance credibility for procurements requiring teaming
- Enhance credentials for professional publications and research
- Facilitate patent filings
Why should we choose CSC as our partner?
CSC has developed a proven implementation method that will document your system, train key personnel to manage it and prepare you for your registration assessment. Whether your company is large or small, manufacturing or providing a service, we can help you implement an ISO 9001/2 based Quality Management System. Many of CSC's customers are small companies (2-30 employees) where resources are limited but who need a 9001/2 registration. Our contribution involves our experience as specialists trained in the ISO 9000 philosophy, and our background in business management. We also possess experience in guiding other firms through the same process.
To take the time to train your staff for this level of specialist knowledge would be counter-productive for most. As with attorneys and accountants, it is often advisable to trust the experts to get you through the process. Could you do the same thing yourself? Perhaps, but at what cost ultimately? Your staff is hired to operate and manage your business enterprise, not to learn how to prepare for a registrar’s audit.
CSC offers comprehensive services that will help you achieve your Quality goals. We can:
- Help you select a Registrar that has experience in your industry
- Conduct an initial company review
- Help you establish policies and objectives
- Identify documentation requirements
- Make assignments and prepare MS project plans
- Prepare documentation
- Manage implementation schedules, training and follow-up actions
- Conduct training on Internal Auditing, SPC, Gage R&Rs, FMEAs, etc.
- Identify and implement electronic tools to better manage these systems
- Conduct internal audits
- Complete corrective actions
- Conduct vendor and supplier audits
- Help you maintain your quality program
As part of our normal approach we complete a full assessment prior to the registration audit. All members of our team are trained Lead Auditors, so assessments are carried out in the same way, and to the same standard, as the Registrar.
For more information on ISO 9000 certification programs please contact us.
Why Should we become QS 9000 Certified?
Ideally, for the same reasons that you would become ISO 9000 Certified. But more likely, because your current and/or potential customers are requiring it.
Why should we choose CSC as our partner?
CSC has developed a proven implementation method that will document your system, train key personnel to manage it and prepare you for your QS 9000 registration assessment.
Whether your company is large or small, we can help you implement a QS 9000 based Quality Management System. Many of CSC's customers are small companies (2-30 employees) where resources are limited but who need a QS 9000 registration.
Our contribution involves our experience as specialists trained in the QS 9000 philosophy, and our background in business management. Our consultants are all QS 9000 certified lead auditors as well. We also possess experience in guiding other firms through the same process.
To take the time to train your staff for this level of specialist knowledge would be counter-productive for most. As with attorneys and accountants, it is often advisable to trust the experts to get you through the process. Could you do the same thing yourself? Perhaps, but at what cost ultimately? Your staff is hired to operate and manage your business enterprise, not to learn how to prepare for a registrar’s audit.
CSC offers comprehensive services that will help you achieve your quality goals. We can:
- Help you select a Registrar that has experience in your industry
- Conduct an initial company review
- Help you establish policies and objectives
- Identify documentation requirements
- Make assignments and prepare MS project plans
- Prepare documentation
- Manage implementation schedules, training, follow-up actions
- Conduct training on Internal Auditing, SPC, Gage R&Rs, FMEAs, etc.
- Identify and implement electronic tools to better manage these systems
- Conduct internal audits
- Complete corrective actions
- Conduct vendor and supplier audits
- Help you maintain your quality program
As part of our normal approach we complete a full assessment prior to the registration audit. All of our team are trained Lead Auditors, so assessments are carried out in the same way, and to the same standard, as the Registrar.
What is QS-9000?
QS-9000 is the shorthand name for "Quality System Requirements QS-9000." It is the common supplier quality standard for Daimler-Chrysler Corporation, Ford Motor Company, and General Motors Corporation. QS-9000 is based on the 1994 edition of ISO 9001, but it contains additional requirements that are particular to the automotive industry. These additions are considered automotive "interpretations" by the ISO community of accreditation bodies and registrars.
What is ISO 9000 vs. QS-9000?
ISO9000 is a set of standards created by an international body to help manufacturing companies produce quality products (ISO has since been adapted for the service industry as well). The first version of ISO9000 came out in 1987. QS9000 is a more stringent set of standards developed by the Big Three (Ford, Chrysler, GM) and some truck manufacturers as a set of standards for the tier one suppliers to Ford, GM and Chrysler. QS9000 incorporates ISO9000 and aspects of each of the Big Three's quality systems.
To whom does QS-9000 apply?
QS-9000 applies to suppliers of production materials, production and service parts, heat treating, painting and plating and other finishing services. It does not, therefore, apply to all suppliers of the Big Three.
Have any other organizations adopted QS-9000?
Several heavy truck companies have adopted QS-9000 and are signatories to the document. These companies include Navistar International Transportation Corporation and PACCAR, Inc. Other companies in the automotive industry are also adopting QS-9000 as their supplier quality requirement, and non-automotive industries are watching the implementation of QS-9000. They are considering using it as a model to develop ISO 9001-based requirements for their industries.
Who is responsible for developing and maintaining QS-9000?
The Daimler-Chrysler/Ford/General Motors Supplier Quality Requirements Task Force is the responsible body that oversees QS-9000. It is made up of representatives from each of the Big Three companies, along with several members who are liaisons to relevant organizations. Because QS-9000 was a new approach to the application of the ISO 9001 standard, the Big Three, together with several accreditation bodies and registrars, initiated the International Automotive Sector Group (IASG) early in 1995. This group issues official interpretations of the process connected with third-party registration to QS-9000, as well as revisions, clarifications, and expansions to QS-9000.
What about a document called "TE-9000"?
TE-9000 was an internal shorthand for a supplement to QS-9000. Properly called the "Tooling and Equipment Supplement", this document has been developed and is being implemented. It applies QS-9000 to suppliers of tooling, equipment, and related products. This document replaced the Daimler-Chrysler TESQA (Tooling and Equipment Supplier Quality Assurance) manual after it was released.
Does QS-9000 apply to external suppliers only, or do the Big Three also have to comply with it?
QS-9000 applies to external and internal suppliers of the products and services explained above. An external supplier is a company not owned by the Big Three. This includes most of what is thought of when considering the "supply base." However, many divisions of Big Three companies supply their competitors as well as their own plants. For example, it is not unusual for a Ford plant to sell component products to Ford, Chrysler, and General Motors divisions. In all such cases, these Big Three plants are external suppliers to the other companies and QS-9000 applies to them. In addition, within the Big Three companies, QS-9000 is being required of many of the internal supplying divisions. The timing requirements for internal divisions are the same as for external suppliers.
Is QS-9000 worldwide?
Yes. QS-9000 is truly a worldwide, common supplier quality requirement for Daimler-Chrysler, Ford and General Motors. It has been released throughout North America, in several countries of South America, Europe, Australia, and Asia.
How does a company comply with QS-9000?
For suppliers to Ford, compliance may be demonstrated by internal audits, customer (or second-party) audits, and third-party audits by qualified ISO 9001 registrars. For suppliers to Daimler-Chrysler and General Motors, compliance must be demonstrated through third-party audits by qualified ISO 9001 registrars.
What is a qualified registrar?
Qualified registrars are ISO 9001 registrars recognized by accreditation bodies (such as RAB, RvA, UKAS, etc.) who have agreed to abide by the Code of Practice for QS-9000 registrars and have passed a qualification process administered by a recognized accreditation body. Not all registrars for the ISO 9000 series are qualified to conduct third party audits to QS-9000. Any company seeking certification to QS-9000 must deal with a QS-9000 qualified registrar for the certificate in order to attain official recognition by its customer.
What is a recognized accreditation body?
Just as all registrars are not qualified to conduct audits to QS-9000, not all accreditation bodies are recognized by the Big Three to qualify registrars. QS-9000 contains "Accreditation Body Implementation Requirements."
Looking for a competent calibration laboratory?
You may want to look beyond whether the laboratory is ISO 9000-certified and, instead, ask whether it is ISO/IEC Guide 25 (soon to be ISO 17025) accredited. Accreditation to ISO Guide 25 requires that a laboratory have a quality system similar to ISO 9000. More importantly, it requires that a lab facility have adequate equipment to perform its testing or calibration tasks, as well as laboratory personnel with the competence to perform the testing.
The purposes of ISO/IEC Guide 25 are to:
* aide the assessment of laboratory competence
* set up requirements for laboratory compliance in calibrations or tests
* and assist in laboratory quality system implementation.
The ISO Guide 25 lab-accreditation movement will benefit the clients of testing and calibration labs. Now, manufacturers who require outside testing and calibration services can rely on the accreditation process for assurance that the lab they choose meets minimum standards of competence. In recent years, several factors have contributed to an increasing need for an accreditation program for testing and calibration laboratories. Many manufacturers are getting accreditation for their in-house test and/or calibration labs. The automotive industry is requiring that sub-tier manufacturers calibrate their measurement devices using accredited laboratories. The recent adoption of the Fastener Quality Act has also increased the demand for services from testing laboratories.
In 1998, the 3rd edition of QS-9000 was released with a new requirement that all automotive suppliers must use commercial / independent calibration facilities that are accredited to ISO/IEC Guide 25 or national equivalent. This new requirement took the automotive and metrology industries by surprise. There are currently not enough qualified calibration facilities to meet the demands of the automotive industry. Therefore, achieving ISO/IEC Guide 25 accreditation can lead to significant new business for any calibration or testing facility.
Laboratories in the United States can receive ISO Guide 25 accreditation through either the National Voluntary Laboratory Accreditation Program (NVLAP), or the American Association for Laboratory Accreditation (A2LA). Certain Quality System Registrars are also recognized by the "Big Three" as being competent to perform compliance assessments to ISO Guide 25.
ISO 9000 vs. ISO Guide 25 - What's the Difference?
The ISO 9000 standards provide guidance for the development of an organization's quality management system, irrespective of the company's function. ISO/IEC Guide 25 provides guidance to owners and operators of laboratories on both quality management and technical requirements for proper operation of a testing laboratory. There is a widespread misunderstanding that the ISO 9000 standards assure validity of specific test results at a level equivalent to accreditation to ISO/IEC Guide 25. The purposes of the two standards are very different and certification against them provides different forms of assurance in the quality of the delivered product or service to the recipient of the product or service. In other words, laboratories that attain ISO 9000 certification only may not meet the needs of the end user of the lab's test results.
What is laboratory accreditation?
Laboratory accreditation is a process for the recognition by a third party that the laboratory meets requirements for developing, implementing, and maintaining a quality system, and that it can demonstrate proficiency in conducting laboratory analyses. Recognition is usually in the form of a certificate and listing in a register published by an accrediting body. International recognition is achieved through mutual recognition agreements among accrediting bodies of various countries.
How does a laboratory benefit from being accredited?
The listing in a register provides external third-party recognition to the customer. Internal benefits are many and include the following:
- Clear definition of roles, responsibilities, and authority provide for greater efficiency in operation of the laboratory.
- Audit and assessment activity by laboratory customers can be reduced through third party recognition.
- Increased efficiency will lead to a reduction in operating cost.
- Increased efficiency will result in less re-analysis of samples. This, too, effects the cost of operation in a positive way.
- Increased efficiency and reduction of re-analysis will decrease customer complaints and should contribute to decreased turnaround time for analyses.
- Increased efficiency should also free-up capacity to increase throughput and provide for increased business.
- Strong quality control, qualified processes, and demonstrations of competence will provide a greater degree of data defensibility.
CSC has successfully guided clients through their ISO Guide 25 registration process. Please see the testimonial of the United Radio Metrology Laboratory.
CSC has extensive experience with laboratory quality systems and Guide 25 compliance. For more information please contact us.
Interested in Training your Internal Auditors?
Internal Auditing is one of the elements assessed in the Quality System audit. The better your audit team the better your system. CSC has developed an internal auditing course for companies going through registration, as well as for registered companies who want to expand their audit team.
We customize each program to fit your needs. If you have an existing documented system, we can integrate your own procedures and audit forms into the program so that the training will be conducted on processes and procedures familiar to those being trained.
All courses are generally 3 days and are provided at a location of the customer's choice.
Each participant receives a comprehensive internal auditor training package that includes one of the most detailed interpretations of the ISO 9001 standard ever produced as well as auditing tips for each ISO requirement and standard audit forms.
Finally, what makes our course so effective is that we include a supervised internal audit on the final day of the course so that the participants get some immediate hands-on training.
CSC has performed many auditor training courses. Please see the testimonial from Performance Technologies Inc.
For more information on Internal Auditor Training please contact us.
Interested in outsourcing your Internal Audits?
Internal Audit Management
In recent years many companies have asked us to audit their system. Some companies wanted a final audit of their efforts just prior to their registration audit. Other companies were already registered and wanted a fresh review of their system.
The largest demand for this service has come from small to mid-sized companies who realize the cost of training internal auditors and then taking them away from their normal business functions to conduct audits was too great. These companies also recognized that the skills of their internal auditors were never fully developed by auditing once or twice each year. By contracting an expert to perform their internal audits they actually saw greater improvements and reduced costs.
The reasons companies choose us for this type of assessment are:
- We provide an unbiased opinion on your system.
- We help with suggested corrective actions, something the Registrar is not allowed to do.
- Our audit can be used to meet the ISO 9000 internal audit requirement.
- We actually reduce the costs of maintaining an internal audit program and add value to the system.
For more information on this program please contact us.
Electronic Document Management
- Management Introductions to ISO Standards
- Statistical Process Control
- Measurement System Analysis / Gage R&R
- Failure Modes and Effects Analysis
- Cost of Quality Measurement
- Electronic Document Management
Interested in Training?
CSC offers several different quality management training programs specifically directed to ISO 9001/2, QS 9000, ISO/IEC Guide 25, and ISO 9000-3 certification. We provide quality system awareness training for organizations thinking about developing an approved quality management system. We also provide staff and management-level training for firms that have already begun the process to become quality-certified.
We also possess many attributes above and beyond the implementation of Quality Management Systems. Here are some examples of programs we can provide:
- Electronic Document and Forms Management
- Statistical Process Control
- Measurement System Analysis/Gage
- Failure Modes and Effects Analysis
- Cost of Quality Measurement
Other programs have been customized to the clients' requirements. If you have a quality-related problem and are not sure how to handle it, we will give you an honest answer.
For more information on these training programs please contact us.