The ISO 9001:2008 has been published and the standard is available for purchase through The American Society for Quality Website.

ISO 9001:2008 does not introduce any additional requirements beyond the current ISO 9001:2000.

Although certification is not compulsory, it is estimated that over one million ISO 9001 certificates have been issued to organizations in private and public sectors, in manufacturing and services, and in 170 countries. The new edition, however, will not require any specific reassessment for certification.

ISO 9001:2008 will be the fourth edition of the standard which was first published in 1987. The third edition, published in 2000, represented a thorough revision, including new requirements and a sharpened customer focus, reflecting developments in quality management and experience gained since the publication of the initial version.

Compared to the current 2000 edition, ISO 9001:2008 represents fine-tuning. It introduces clarifications to the requirements in ISO 9001:2000, based on user experience over the last eight years, and changes that are intended to improve further compatibility with the ISO 14001:2004 environmental standard.

To accompany the publication of this new edition, ISO is 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.

With the publication of the revision, companies certified to ISO 9001:2000 will have 24 months to transition to ISO 9001:2008. This transition period provides an opportunity for organizations to review their quality management systems and identify key requirements. While the ISO 9001:2008 is considered a refined version of the 2000 standard, companies can find value in reviewing the 2008 version.

“Quality management systems add great value to an organization,” said Lorri Hunt, deputy task group leader for the international amendment to ISO 9001:2008. “You shouldn’t overlook the 2008 version just because it is an amendment,” concludes Hunt. “The clarifications could help you implement a requirement in an efficient manner or help you understand something your organization has struggled with in the past.”

This reference document aims to compare ISO 9001:2008 and ISO 9001:2000 and to highlight changes. This reference document is not comprehensive, and should never be used as a replacement to the actual ISO9001:2008 Standard.

President George W. Bush named Feigenbaum as a laureate of the National Medal of Technology and Innovation (NMTI).

The medal, which is administered by the Department of Commerce, was presented at a ceremony held at the White House on Sept. 29, when Feigenbaum was recognized for his establishment of the discipline of total quality and its impact on society.

The citation from President Bush reads:

For leadership in the development of the economic relationship of quality costs, productivity improvement and profitability, and for his pioneering application of economics, general systems theory and technology, statistical methods and management principles that define the Total Quality Management approach for achieving performance excellence and global competitiveness.

It’s impossible to create a synopsis of hundreds of articles and a half-dozen books that have been written about a career that spans more than six decades. Instead, the following are just 10 of Feigenbaum’s core ideas based on one interpretation of his quality concepts:

• Quality is a company-wide process-it must touch everyone, with no exceptions.
• Quality is what the customer says it is-the customer votes with money, therefore this is important.
• Quality and cost are a sum, not a difference-cost is a measure of quality, and quality drives lower cost.
• Quality is a way of managing-management is responsible for defining its business control system.
• Quality and innovation are mutually dependent- one without the other will not lead to enduring results.
• Quality requires continuous improvement-without improvement, all systems performance degrades.
• Quality is implemented in a system connected to customers and suppliers-customer intimacy is critical.
• Quality is an ethic, a belief system about what ought to be, a responsible way of working.

Perhaps the most ubiquitous example of Feigenbaum’s contributions over the years is the words of encouragement he has spoken on so many occasions: “When some of us help to make quality better, it makes life better for all of us.”

Jonathan Katz begins his Industry Week article with the statement, “Plant floor machines have so much to say.” He goes on to explain that trapped inside every machine is a wealth of information that can tell maintenance technicians if small hiccups might develop into large problems.

Tapping into this machine information is becoming easier with predictive maintenance tools. Machine maintenance is evolving from prescheduled routine tasks to the use of more precise indicators that increase maintenance efficiency.

Scheduled maintenance is an effective way to reduce machine downtime and prevent costly repairs. However, it doesn’t take into account the ever- changing plant floor environment.

Technologies have been developed that use embedded machine sensors and remote monitoring to identify and prevent maintenance issues. These sensors collect data on variables such as temperature, vibration, and motor current.

With this information, you can gain insight into the rate of machine degradation and historical data can be used to predict future problems. To read the full article, see Maintenance Seers at the Industry Week web site.

The Small Business Administration (www.sba.gov) and Nationwide Mutual Insurance Company have teamed up to launch a disaster planning guide for small business owners.

The 10-page brochure provides information that business owners need to develop an effective plan to protect customers and employees in the event of a disaster. The guide provides key disaster preparedness strategies to help small businesses identify potential hazards, create plans to remain in operation if the office is unusable, and understand the limitations of their insurance coverage.

The most successful recovery efforts are always preceded by good planning. The more preparation that businesses complete before a disaster, the better able they are to rebuild and reopen quickly after a disaster.

Understanding this, the SBA and Nationwide created this guide to help business owners get their arms around the disaster planning process, and convince them to mitigate their risk.

An electronic version of the guide is available at this SBA page.

Performance metrics are a vital part of managing an organization. Many organizations have a tendency to select metrics by copying what competitors measure, what is read in the business press and what benchmarked firms are using.

The best organziational metrics keep the focus on its strategic direction, not the direction in which others are going.

Organizations should:

• Define a competitive vision and a strategy to achieve it.
• Set objectives aligned to the vision and strategy.
• Create processes to deliver on that vision and
• Set metrics that will monitor how well they are doing on the objectives. That will allow those managing the processes to keep them going in the right direction.
• Revise them over time to account for changes that impact their potential value.

A simple but important step in metrics selection is applying the Pareto principle to ensure the critical measures are available while not swamping the organization with a lot of noise.

The types of metrics and the right mix of metrics drives effective outcomes. For example, some metrics should focus on customer needs (externally focused, effectiveness metrics) and some on organizational needs (internally focused, efficiency metrics) so the organization can effectively balance the management of resources used to achieve the market results. An organization with high customer satisfaction and costs that create negative profitability is not going to be a sustainable venture.

Some metrics should be able to evaluate results (outcome or lagging metrics), while others should allow proactive management of the vital factors (process or leading metrics) that create those outcomes. For example, on-time delivery (an outcome) might be significantly impacted by equipment reliability (a leading indicator for delivery performance). However, equipment reliability is an outcome measure for the maintenance management process. As much as possible, metrics should be biased toward business drivers, such as process or leading indicators, instead of outcomes.

Once the desired metrics have been identified, the real work begins. Decisions must be made regarding:

• Who owns the metric.
• Where will the data be acquired and how often.
• How might the raw data be manipulated (normalized) to allow more equivalent comparisons over time.
• How often should the metrics be reported and analyzed for decision making.

Although it might sound simple, creating operational definitions is an important component of metric details. In other words, what is meant by the terms as expressed in mathematical terms (for example, numerator, denominator and time boundaries)? A company might ask, “What is meant by on-time delivery? When it is picked up by the carrier or when it arrives at the target location.

For more information see the Quality Progress article written by Duke Oates.

A case study packet that includes documents used for training Baldrige examiners is available through The Baldrige National Quality Program. The packet also provides documents used in the award evaluation process by illustrating the format for an application, how an applicant might respond to the criteria requirements, and how examiner teams evaluate and score applications.

Also available is the The Baldrige Criteria for Performance Excellence which provides a systems perspective for understanding performance management. They reflect validated, leading-edge management practices against which an organization can measure itself. With their acceptance nationally and internationally as the model for performance excellence, the Criteria represent a common language for communication among organizations for sharing best practices. The Criteria are also the basis for the Malcolm Baldrige National Quality Award process.

This free information is available in PDF format at the National Institiute of Standards and Technology website.

ISO 13485–”Medical devices–Quality management systems–Requirements for regulatory purposes” is the standard for organizations engaged in the manufacture of medical devices. According to the most recent survey by the International Organization for Standardization there were a total of 8,175 current ISO 13485 registrations across 82 countries.

Although being registered does not fulfill the requirements of the various industry regulators, such as the U.S. Food and Drug Administration (FDA), ISO 13485 is now commonly used as the basis of regulatory requirements. The standard is an essential consideration not only for exporters but for the local market, global suppliers, and subcontractors to prove that their products are of the highest quality.

ISO 13485 is based on the ISO 9001 format with additional requirements relating to design, special processes, environmental control, traceability, documentation records, and regulatory actions. This is an outcome of the primary objective for the creation of ISO 13485, which was to facilitate standardized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices but excludes some of the requirements of ISO 9001 that are not appropriate in a regulated environment.

The primary difference between ISO 13485 and ISO 9001 is that ISO 9001 requires the organization to demonstrate continuous improvement, whereas ISO 13485 requires only that the organization demonstrate that the quality system is implemented and maintained. Thus many organizations maintain dual registration against both standards.

According to research by Secure Computing, 80% of IT directors said in a recent survey that insider threats were their biggest security danger. Security problems created by employees are far more serious than the threats posed by external hackers and criminals, the new research reports.

Less than one in five respondents said external threats from hackers are more dangerous. This could be due in part to 37% of respondents saying they have experienced a leak of sensitive information in the past year.

Email was identified by 34 % of respondents as the biggest current security risk to organizations, followed by VoIP (25 %), and browser-related threats (21 %). Despite this apparent confidence, however, four in five respondents feel they could be better prepared for web-borne threats.

Viruses topped the list of external threats for 31 % of respondents, followed by spam (18 %), and data leaks (14 %). When asked to rank their biggest external security concerns, hackers are surprisingly the area of least concern. Less than a quarter of respondents feel that hacking is the biggest threat. Malware appears to be the major headache, with 56 % identifying it as their biggest worry.

• Meet your needs and expectations
• Comply with acceptable regulations

ISO 9001:2000 does not specify requirements for the goods or services you are purchasing. That is up to you to define, by making clear your own needs and expectations for the product. You might, for example, refer to product specifications, drawings, national or international product standards, supplier’s catalogues or other documents as appropriate.

What does “Conformity to ISO 9001:2000″ mean?
This means that your supplier has established a systematic approach to quality management, and is managing its business to ensure that your needs are clearly understood, agreed and fulfilled. A statement of conformity to ISO 9001:2000:2000 should not, however, be considered as a substitute for a declaration or statement of product conformity.

How does ISO 9001:2000 help you in selecting a supplier? ISO 9001:2000 provides some requirements for the purchasing process that include you as the customer. These requirements address the following topics:

• requirements regarding the purchasing information that should be provided so that suppliers clearly understand their customers’ needs
• the ways in which supplied products can be verified as meeting the requirements of the customer

You have an important role to play, by specifying to your supplier what you actually want. You may need to consult with your own internal technical staff (the actual users) in this process. If you don’t do this, you might find that you receive a product that meets all your stated requirements and the applicable regulatory requirements, but which is absolutely wrong for your intended application. So, first of all, you should concentrate on specifying your needs related to the intended use of the product.

To help in this task you may consider the following:

• What is the specific product (goods or service) you are buying?
• What impact does this product have on your own business?
• What are the risks to your business if you experience problems with this product?
• How can you be sure that the product you receive will actually meet your requirements?
• What do you know about the reputation and historical performance of your supplier?
• What level of confidence do you need in your supplier’s ability to provide you with conforming product on a consistent basis?
• If you decide that conformity to ISO 9001:2000 is important, (based on your assessment of the risks associated with the goods and services you are buying) how can you be sure that your supplier does have a QMS that meets ISO 9001:2000 requirements?
• Are the goods and services you require covered by your supplier’s QMS? (You may need to ask for a copy of your supplier’s actual certificate or declaration of conformity to find this out!)

ISO 9001:2000 is a useful basis for organizations to be able to demonstrate that they are managing their business so as to achieve consistent (good!) quality goods and services.

If you are not satisfied with the performance of your supplier, you must provide them with the appropriate feedback. Learning from complaints helps organizations to improve their future performance – that is what ISO 9001:2000 is about.

For More Information

ISO 9001:2008 does not contain any new requirements.

They have recognized that ISO 9001:2008 introduces no new requirements. ISO 9001:2008 only introduces clarifications to the existing requirements of ISO 9001:2000 based on eight years of experience of implementing the standard world wide with about one million certificates issued in 170 countries to date. It also introduces changes intended to improve consistency with ISO14001:2004

Accredited certification to the ISO 9001:2008 shall not be granted until the publication of ISO 9001:2008 as an International Standard.

Certification of conformity to ISO 9001:2008 and/or national equivalents shall only be issued after official publication of ISO 9001:2008 (which should take place before the end of 2008) and after a routine surveillance or recertification audit against ISO 9001:2008.

Validity of certifications to ISO 9001:2000

One year after publication of ISO 9001:2008 all accredited certifications issued (new certifications or recertifications) shall be to ISO 9001:2008. Twenty four months after publication by ISO of ISO 9001:2008, any existing certification issued to ISO 9001:2000 shall not be valid.

Certification to ISO 9001:2008 cannot be issued until after a surveillance or recertification audit based on ISO 9001:2008, and the decision to issue a certification is made following a CB’s normal practice including independent review (ISO/IEC 17021:2006, 9.1.14 and 9.1.15).

Organizations wanting to apply the quality management requirements of ISO 9001:2000 to the acquisition, supply, development, operation and maintenance of IT systems and related support services now have a valuable tool in ISO/IEC TR 90005:2008, Systems engineering – Guidelines for the application of ISO 9001 to system life cycle processes.

ISO/IEC TR 90005 identifies the issues that should be addressed independent of technology, life cycle models, development processes, sequence of activities or organizational structure. It discusses each activity in ISO/IEC 15288 in terms of how it relates to sections of ISO 9001:2000. The tables enable quick comparison of the different treatment of systems in ISO/IEC 15288 and ISO 9001 and explanatory texts help the user to understand why a particular relationship is cited.

The guidelines provided do not in any way add or change the requirements of ISO 9001:2000 and are not intended to be used as assessment criteria in quality management system registration or certification.

ISO/IEC TR 90005:2008 is appropriate to systems that are:

• part of a commercial contract with another organization
• a product available for a market sector
• used to support the processes of an organization
• embedded in a hardware product, or
• related to software services.

The guidance provided by ISO/IEC TR 90005 is intended for software-intensive systems. According to François Coallier, Chair of ISO/IEC JTC1/SC 7, “Most of the systems that our society depends upon are either software-intensive or software-critical, i.e. they cannot work without one or many functional software component(s). Automobile systems, for instance, are now in such a category.”

Further details see iso.org press release

FMEA is one of the Automotive Quality Core Tools developed by representatives of Chrysler, Ford, and General Motors. Point: FMEA’s are not just for automotive industry gains. This tool has been used sucessfully for process improvement by manufacturing and service industries for decades.

Methods described in the new reference manual include those applicable to the DFMEA (product design at the system, subsystem, interface and component level) and to the PFMEA (process control at manufacturing and assembly operations).

Improvements incorporated in the FMEA Reference Manual, Fourth Edition, include:

• New format for improved readability, including an index, visual cues, and icons to indicate key paragraphs
• Additional examples and text to provide a clearer explanation of the steps to develop a robust failure mode analysis
• Reinforcement of the need for management participation in, and support of, the FMEA process
• Clarification of the linkage between DFMEA and PFMEA, as well as, linkages to the other core tools
• Improved clarity in definition of the Severity, Occurrence, and Detection ranking tables
• An introduction to the alternative methods currently being applied in industry
• Clarifications are provided in the use of RPN, including alternative methodologies

An emphasis on problem prevention is included to eliminate the sources of failures. This has many advantages:

• Improved quality, reliability, and safety of a product/process
• Early identification and elimination of potential failure modes
• Reduced system development timing and cost
• Reduced potential for warranty concerns
• Increased customer satisfaction and competitiveness
• Reduced need for inspection

You can order the new FMEA manual at the AIAG website.

Most organizations use IT as a fundamental business tool and few can function without it. IT is also a significant enabler in the future business plans of many organizations. ISO 38500 will help the governing body to evaluate, direct, and monitor the use of IT.

ISO 38500:2008, Corporate Governance of Information Technology, is applicable to organizations of all sizes, including public and private companies, government entities, and not-for-profit organizations. This standard provides a framework for effective governance of IT to assist those at the highest level of organizations to understand and fulfill their legal, regulatory, and ethical obligations in their use of IT.

The framework is comprised of definitions, principles, and a model. It sets out six principles for good corporate governance of IT that express preferred behavior to guide decision making:

• Responsibility
• Strategy
• Acquisition
• Performance
• Conformance
• Human Behavior

The purpose of the standard is to promote effective, efficient, and acceptable use of IT in all organizations by:

• assuring stakeholders that, if the standard is followed, they can have confidence in the corporate governance of IT
• informing and guiding directors in governing the use of IT in their organization
• providing a basis for objective evaluation of the corporate governance of IT

This standard is targeted at the Board of an organization, to assist the Board in delivering the maximum value from IT and information assets across the organization

Has your organization outsourced any processes? Are these processes being properly controlled?

ISO 9001:2000 clause 4.1 states: “Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system.”

What is considered an outsourced process? Document ISO/TC 176/SC 2/N 630R2 at the ISO web site describes an “outsourced process” as a process that has been identified as needed for the quality management system, but one which the organization has chosen to be carried out by an external party.

An outsourced process can be performed by a supplier that is totally independent from the organization, or which is part of the same parent organization. For example, a separate department or division not subject to the same quality management system. The process may be provided within the physical premises or work environment of the organization, or at an independent site. The intent of Clause 4.1 is to emphasize that when an organization chooses to outsource a process (permanently or temporarily) that affects product conformity, it cannot simply ignore this process or exclude it from the quality management system. The organization has to demonstrate it exercises sufficient control to ensure the process is performed according to the relevant ISO 9001:2000 requirements, as well as, the requirements of the quality management system.

The nature of this control will depend on the importance of the outsourced process, the risk involved, and the competence of the supplier. Also, the outsourced process will interact with other processes (either carried out by the organization or outsourced). These interactions must be managed as required by ISO 9001:2000 clauses 4.1.a (process identification) and 4.1.b (sequence and interaction).

The acquisition of an outsourced process will normally be subject to the requirements of both ISO 9001:2000 clause 7.4 (Purchasing) and clause 4.1 (General Requirements). In some situations, the organization might not actually “purchase” the outsourced process. It might receive the service from a corporate office or from another division, without a monetary transaction taking place. Under these circumstances, however, ISO 9001:2000 Clauses 7.4 and 4.1 are still applicable.

There are two situations that frequently must be considered when deciding the appropriate level of control of an outsourced process:

1. When an organization has the competence and ability to carry out a process, but chooses to outsource that process (for commercial or other reasons), the process control criteria should already have been defined and can be transposed into requirements for the supplier, if necessary.

2. When the organization does not have the competence to carry out the process itself, and chooses to outsource it, the organization has to ensure the controls proposed by the supplier of the outsourced process are adequate. In some cases, it may be necessary to involve external specialists in making this evaluation.

It may be convenient, or even necessary, to define some or all of the methods to be used for control of the outsourced processes in a contract between the organization and the supplier. Care should be taken, however, not to inhibit the supplier from proposing innovations to the outsourced process.

In some situations, it might not be possible to verify the output from the outsourced process by subsequent monitoring or measurement. In these cases, the organization must ensure the control over the outsourced process includes process validation in accordance with ISO 9001:2000 clause 7.5.2.

The new ISO/DIS 9001:2008 standard has added two notes under clause 4.1 to further explain outsourced processes. One note says, “An outsourced process is identified as one being needed for the organization’s quality management system, but chosen to be performed by a party external to the organization.”

The other note says, “The type and nature of control to be applied to the outsourced process may be influenced by factors such as,

a) the potential impact of the outsourced process on the organization’s capability to provide product that conforms to requirements;

b) the extent to which the control for the process is shared;

c) the capability of achieving the necessary control through the application of clause 7.4.

Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory, and regulatory requirements.”

To audit the outsourcing of processes, an auditor might ask these questions:

• Have any processes been outsourced?
• What is your criteria for outsourcing?
• How are the suppliers being evaluated?
• Are relevant ISO 9001 requirements assigned?
• What outsourcing controls are in place?
• How is risk considered in the controls?
• How is supplier performance evaluated?
• How are supplier problems handled?

If an organization uses outsourced processes, it is still responsible for conforming to customer and legal requirements. Carefully evaluate the suppliers of outsourced processes according to ISO 9001:2000, clause 7.4.1, as you must for all other suppliers of products and services.

Regardless of size, facilities with the need to calibrate instruments can benefit by implementing calibration software. These software products allow an organization to maintain its calibration records, calibration procedures, instrument location, and instrument history in a secure, readily accessible database. Another advantage of using calibration software is it can alert the operator when an instrument is due for calibration, prevent the use of overdue instruments, and communicate the overall performance of the measurement system.

Automated management trumps the abilities of homegrown software because an Access database or an Excel spreadsheet still relies on someone looking at it periodically to act on what the data is telling them. However, calibration software informs you, ‘This instrument is due.”

The software can send an e-mail to remind operators that a gage is due for calibration, they failed to take action, or the gage is missing. Instrument due-date alerts can escalate through an organization’s hierarchy. For example, if an operator isn’t responding to an alert, the manager can receive e-mail notification that the issue is not being promptly handled.

When an organization is being audited, calibration software can help with both preparation and the audit. With a paper system, locating records can be a daunting task. With a computerized approach, verifying that the system works correctly is the focus, rather than dealing with how the system works. Calibration solutions are typically able to integrate with measurement system assessment activities and inspection software. Other key features to look for include bar code reading, expansive statistical capabilities, automated printing of labels and certificates, grouping of instruments, and visual representations of instruments.

In general, calibration solutions are moving toward the use of centralized databases to allow multiple users and locations to share data. And, because many organizations outsource much of their calibration needs, solutions are available that allow users to interface with their calibration vendors.

Considerations

When considering which calibration software solution fits your needs, thoroughly analyze prospective solutions by asking questions such as:

• Will the software help us meet industry or customer requirements?
• Do we need basic or expansive functionality and features in a solution?
• How many users or locations will need access to the software?

Organizations should also be aware of factors such as whether or not a solution supports a calibration system directly, integrates with other enterprise systems, offers bar code reading, or has the capability to expand to perform future tasks. Beyond the initial purchase cost, find out how often the software is updated, what type of support is offered, and what additional costs may be incurred, e.g., maintenance activities.

Price vs. Capability

Calibration software ranges in price and capability, and your organization’s situation, size, throughput, and resources should dictate the product selection. Low-cost solutions are appropriate for small shops in which calibration data is needed for only one location, few instruments need calibrating, and with minimum requirements for industry compliance. These will be stand-alone solutions that offer basic gage surveillance features, calibration and measurement history, and reporting tools.

Mid- to high-end software is appropriate for organizations looking to implement a large deployment of a common solution. Such software will be feature rich and will have advanced statistical capabilities; furthermore, it will enable multiple users and locations to share data through the use of centralized databases or a web- based architecture.

When multiple computers or manufacturing locations require access to calibration data, a system that allows open database connectivity to a central database is required. In laboratory environments, a hosted web- based solution that automatically collects calibration data from instruments may be the answer.

Also, mid- to high-range software will provide scalability, reliable product support, and a focus on continuous adherence to industry standards, such as, ISO 9001 and ISO 17025; with solutions that satisfy the requirements of 21 CFR Part 11 and 10 CFR 50 tending to be more expensive.

More Inforamtion

Visit Quality Online and type “Calibration Software” into the search engine to find related articles.

Which standard, AS9100, AS9110, or AS9120, is applicable to an organization in the aerospace industry? According to the International Aerospace Quality Group (IAQG), the three quality management system standards are to be applied as follows:

AS9100 – Quality Management Systems – Aerospace – Requirements

AS9100:2004, Revision B, is intended for use by organizations that design, develop, and/or produce aviation, space, and defense products; as well as, by organizations providing post-delivery support, including the provision of maintenance, spare parts, or materials for their own products.

AS9101:2006, Revision C, is the Quality Management System Assessment standard. It defines the content and presentation of the AS9100 Assessment Report.

AS9110 – Quality Management Systems – Aerospace – Requirements for Maintenance Organizations

AS9110:2003 is intended for use by organizations whose primary business is providing maintenance, repair, and overhaul services for aviation sector products. It is tailored for organizations with National Airworthiness Authority (NAA) repair station certification, but is also suitable for non-certificated organizations, including those that provide maintenance, repair, and overhaul services for military aviation products.

The standard is also intended to be used by organizations with maintenance, repair, and overhaul operations that operate autonomously, or that are substantially different from their manufacturing operations.

AS911:2005 is the Quality Management System Assessment standard for Maintenance Organizations.

AS9120 – Quality Management Systems – Aerospace – Requirements for Stockist Distributors

AS9120:2002 is intended for use by organizations that procure parts, materials, and assemblies and sell these products to a customer in the aviation, space, and defense industries. This includes organizations that procure products and split them into smaller quantities. This standard is not intended for organizations that rework or repair products. Organizations that perform work that affects, or could affect, product characteristics or conformity should use AS 9100 or another general quality management system standard.

AS9121:2007, Revision A, is the Quality Management System Assessment standard for Stockist Distributors.

Upcoming AS9100 Revision

AS9100 uses ISO 9001:2000 as its foundation, with additional aerospace requirements highlighted in bold, italic type. The ISO 9001 standard is being amended and its release is expected in October this year. This ISO 9001 revision is driving an update of AS9100.

The first draft of the AS9100 revision was issued November 8, 2007 based on the September 20, 2007 draft of ISO 9001. The publication of the AS9100 revision should be a few months after the issuance of ISO 9001:2008.

The AS9110 (Maintenance Organizations) and AS9120 (Stockist Distributors) standards are undergoing a similar revision process. Since they use AS9100 as the baseline, they are expected to trail the AS9100 revision by about six months.

The AS9101 checklist is being revised as a more process- oriented tool, as well as, to apply across AS9100, AS9110, and AS9120. It will be introduced into the audit process as organizations make the transition to the revised AS9100, AS9110, and AS9120 standards.

AS9100 Training

If you are interested in implementing or auditing an AS9100-based quality management system, see our training courses or for further information contact us on any of these valuable standards.

ISO has approved the creation of a project committee to develop an international standard on energy management. The standard will provide all types of organizations a practical and widely recognized approach to increase energy efficiency, reduce costs, and improve environmental performance. If you are interested in participating in the development of this standard, please see the contact information at the end of this article.

The standard is intended to be broadly applicable to various sectors of national economies, including utility, manufacturing, commercial building, general commerce, and transportation sectors. As a result, the standard could have an influence on as much as 60 percent of the world’s energy demand.

ISO Secretary-General Alan Bryden commented: “The urgency to reduce GHG emissions, the reality of higher prices from reduced availability of fossil fuels, and the need to promote efficiency and the use of renewable energy sources, provide a strong rationale for developing this new standard building on the most advanced good practices and existing national or regional standards”.

Following the successful examples of the ISO 9000 series on quality management and the ISO 14000 series on environmental management, the project committee ISO/PC 242, Energy Management, will consider the development of a standard that provides management system requirements together with guidance for use, implementation, measurement, and metrics. The standard will be based on the continual improvement and Plan-Do-Check-Act approach utilized in ISO 9001 and ISO 14001 to provide compatibility and integration opportunities.

Among the main benefits of the future standard are that it will:

• provide organizations with a well-recognized framework for integrating energy efficiency into their management practices
• offer organizations with operations in more than one country a single, harmonized standard for implementation across the organization
• provide a logical and consistent methodology for identifying and implementing improvements that may contribute to a continual increase in energy efficiency across facilities
• assist organizations to better utilize existing energy consuming assets, thus reducing costs and/or expanding capacity
• offer guidance on benchmarking, measuring, documenting, and reporting energy intensity improvements and their projected impact on reductions in GHG emissions
• create transparency and facilitate communication on the management of energy, promote energy management best practices, thus reinforcing the value of good energy management behaviors
• provide a framework for organizations to encourage suppliers to better manage their energy, thus promoting energy efficiency throughout the supply chain

The secretariat of ISO/PC 242 will be held jointly by the ISO members for the United States (American National Standards Institute: ANSI) and for Brazil (Associação Brasileira de Normas Técnicas: ABNT). ANSI has approved the formation of a United States Technical Advisory Group (US TAG) for ISO PC 242. The TAG is a mechanism for identifying issues and developing national consensus regarding energy management. The TAG’s primary purpose is to develop and transmit to the International Organization for Standardization (ISO), via ANSI, the US position on activities and ballots of their ISO Project Committee.

The US TAG for PC 242 will consist of experts and practitioners in the field of energy management. The selected delegates will participate in the activities of ISO/PC 242, including the development of the ISO standard on energy management and others that will be approved in the future. Participation in the US TAG 242 provides an opportunity for representatives of all affected U.S. constituencies (industry, commerce, NGO, education, government, etc.) to influence the development of international energy standards.

To see the course description, schedule, and on-line registration click on the course title below. Courses are awarded Continuing Education Units.

Understanding & Implementing ISO9001:2000
ISO 9001:2000 Process Based Internal Auditor
Documenting Your Quality Management System

Understanding & Implementing AS9100B:2004
AS9100B: 2004 Process Based Internal Auditor
Documenting Your Quality Management System

Understanding and Implementing ISO/TS16949:2002
ISO/TS16949:2002 Process Based Internal Auditor
Documenting Your Quality Management System

Understanding and Implementing ISO14001:2004
ISO14001:2004 Process Based Internal Auditor

The Five Pillars of a Lean Workplace Organization
Continuous Process Improvement
Lean Six Sigma

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Following the examples of the ISO 9000 series on quality management and the ISO 14000 series on environmental management, the project committee ISO/PC 242-”Energy management,” will consider the development of a standard containing relevant terms and definitions, and providing management system requirements together with guidance for use, implementation, measurement, and metrics.

The standard will be based on the continual improvement and plan-do-check-act approach used in ISO 9001 and ISO 14001 to aid compatibility and integration.

The future standard is expected to:

• Provide public and private organizations and companies with a well-recognized framework for integrating energy efficiency into their management practices
• Assist organizations to better utilize existing energy consuming assets, thus reducing costs and/or expanding capacity
• Create transparency and facilitate communication on the management of energy and promote energy management best practices, thus reinforcing the value of good energy management behaviors
• Facilitate the use of energy management as a component of GHG emission reduction projects.

For more information, visit The International Organization for Standardization.