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 | Applicability to all product and service sectors and to all company sizes |
| Simple to use, clear in language, readily translatable and easily understandable |
| Ability to connect quality management systems to organizational processes |
| Providing a natural stepping stone towards performance improvement |
| Greater orientation toward continual improvement and customer satisfaction |
| Compatibility with other management systems, such as ISO 14000, for Environmental Management |
| Need to provide a consistent basis and address the primary needs and interests of organizations in specific sectors such as aerospace, automotive, medical devices, telecommunications, and others |
A key criticism of previous versions to ISO 9001 has been that management had a minimal role that did not require their involvement beyond maintaining the system, and now must be actively involved in continuous improvement. The new revision is intended to transfer the responsibility for the quality management system from quality assurance to top management. Upper management will now be challenged to demonstrate commitment to more comprehensive quality management system activities, and will need to evaluate how this commitment will be demonstrated to registrar representatives.
It may not be well understood by organizations that a key requirement for implementing the new system is to define the actual operating structure, recognizing or developing procedural methods and processes, then writing procedures required by the standard and to effectively implement the system.
The level of difficulty organizations experience in implementing the new standard revision will be significantly influenced by the maturity of the organization and their quality management system, and their relationships with their customers. Having an effective customer satisfaction measurement system in place, will also be beneficial.
Process approach
The international standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of quality management systems, to enhance customer satisfaction by meeting customer requirements.
For an organization to function effectively, it has to identify and manage numerous linked activities. An activity using resources, and managed in order to enable the transformation of inputs into outputs can be considered as a process. Often the output from one process directly forms the input to the next.
The application of a system of processes within an organization, together with the identification and interactions of these processes and their management can be referred to as the “process approach”. An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.
When used within a quality management system, such an approach emphasizes the importance of:
a)
understanding and meeting requirements,
b) the need to consider processes in terms of added value,
c) obtaining results of process performance and effectiveness, and
d) continual improvement of processes based on objective measurement.
One of the biggest challenges companies will face in meeting the requirements of ISO 9001:2000 will be in reorganizing and rewriting the quality system to comply.
Don't Delay-Transition to ISO 9001 : 2000
Benefit Now!
The three-year window to make the transition from ISO 9000:1994 to ISO 9000:2000 has passed, however not all previously registered organizations have made the transition. "It's not just a matter of avoiding the final registration crush. There are numerous operational benefits in being registered to the revised standards," said Randy Dougherty, RAB’s director of registrar programs.
Smart companies will act now to avoid problems later. Companies transitioning early may also be in a position to gain market advantages. A notable difference in the 2000 revision is a greater focus on continual improvement, customer satisfaction, resource management, and business results. ISO 9001:2000 provides for an evolutionary approach to improved organizational performance. In short, there is real value for organizations making the transition to ISO 9001:2000 as soon as possible.
Because the 2000 revision was a substantial one, organizations need to consider their potential need for education and training prior to making the transition. If your company needs to upgrade its quality system and associated procedural elements, or develop a new quality management system and perform the required training, please click on the Inquiries button above or below to request an estimate for QA services that are tailored to suit your specific needs.
AS9100
Definitions:
Americas Aerospace Quality Group (AAQG) - An SAE Aerospace Council subcommittee (G-14) of prime aerospace Original Equipment Manufacturers (OEMs). This group was formed in 1995 to develop and standardize quality requirements for the aerospace industry, and establish and maintain cooperation between these companies on initiatives to improve quality performance and reduce cost in North, Central, and South America.
The Registrar Management Committee (RMC) - a permanent
AAQG subteam established by SAE document AIR5359A, which addresses requirements
for registering quality systems to AS9100.
The International Aerospace Quality Group (IAQG) was founded in December 1998 by
22 of the industry's leading aircraft companies, engine manufacturers, and prime
suppliers. It has grown to include the key quality executives from 24 European
companies, 20 in the America’s and nine in Asia (Japan, Korea and
China). This organization of the major aerospace companies from around the
world is dedicated to working with themselves, their suppliers, and the
authorities to assure safety through the implementation of effective quality
management systems and practices.
The purpose of the IAQG, as stated in their charter, is "to establish and maintain a dynamic cooperation based upon trust between international aerospace companies on initiatives to make significant improvements in quality and reductions in cost throughout the value stream." Initial focus is to continuously improve the processes used by the supply chain to deliver consistently high quality products, thereby reducing non-value added activities and costs. The IAQG encourages members to share their best practices to improve quality.
The aerospace industry developed the first consensus standard ARD9000, in December 1996 for companies doing business with the DoD and NASA, and it met FAA requirements. This standard became AS9000 as published by the SAE in May 1997, and in December of 1998, along with the Aerospace Division of the American Society for Quality and international aerospace organizations, agreed to manage the new AS 9100 standard, released in November of 1999. That version of the standard had significant changes in a number of areas with additional "shall requirements" beyond ISO 9001/1994, including:
21 for Design Control
19 for Process Control
17 for Purchasing
16 for Inspection and Testing
8 for the Quality System
5 for Product ID & Traceability
Using the ISO 9001/1994 Standard as a baseline, AS9000 had approx 31 more requirements and AS9100 has 129 additional requirements than the basic ISO Standard. This means AS9100 has 98 (129-31) more requirements than AS9000.
ISO 9001 : 2000 Incorporation into AS9100 (AS9100A)
The international aerospace writing team reconvened March 2000 to begin work on ISO 9000:2000 incorporation:
| AS9100 Revision A was completed and released August, 2001 |
| AS9100:1999 and AS9100 Rev. A will co-exist until November, 2003 |
ISO 9001:2000 Revision Impact:
| Aerospace unique requirements are not changed in AS9100A |
| ISO 9000:2000 revision and incorporation results in eliminating some requirements from the AS9100:1999 version |
| Some requirements from ISO 9001:1994 were added back to 9100:2001 version |
| AS9100A contains 80 aerospace unique requirements, and 18 amplifications and notes |
FAA: The FAA has reviewed the AS9100A Standard and determined it to be a comprehensive quality standard containing the basic quality assurance elements required by the current Code of Federal Regulations (CFR), Title 14, Part 2. Additionally, the Airworthiness Certification Office believes the effective implementation of AS9100A will continue to enhance overall company performance.
If your company needs to upgrade its quality system and associated procedural elements, please click on the Inquiries button to request more detailed information or to request QA services and schedule the work.
Implementing the Standards
Most of the global IAQG members have implemented AS9100 internally and are requiring it of their suppliers. Many OEMs will require suppliers to comply with the current version of
AS9100 Revision A, which aligns to ISO 9001:2000.
OASIS
The IAQG has selected the Society of Automotive Engineers Aerospace Division (SAE Aerospace) to establish and maintain the Online Aerospace Supplier Information System (OASIS), a new informational supplier database. This database will allow worldwide suppliers to the aerospace industry to monitor their audited compliance to: AS9100 (for North America), EN9100 (European Union and neighboring countries), JISQ9100 (Japan), and other international quality specifications.
OASIS is expected to reduce the number of different audits the global aerospace industry now requires of its suppliers, resulting in time and cost efficiencies. OASIS is scheduled to begin July 1, 2003.
The IAQG has also developed a global scheme for the use of
assessment results performed by quality certification bodies, based on the
9100-series standards. This system takes into account the schemes already
in use or under development in the various IAQG sectors. This is the core
of the OASIS system, and it will be available to IAQG members. Data on
involved national accreditation bodies, approved certification/registration
bodies and certified/registered suppliers is available to all stakeholders in
the international aerospace community, such as suppliers and regulatory
authorities.
Because of its reputation in the global aerospace marketplace and its technical
expertise, SAE is uniquely positioned to develop and provide the database
management system that has become OASIS.
The aerospace industry established the IAQG with the purpose of achieving significant improvements in quality and reductions in cost throughout the value stream. The IAQG has developed specific requirements for quality systems that are implemented and maintained throughout the supply chain in the manufacture of products used in aviation, aerospace, and related applications worldwide. SAE Aerospace in the USA, AECMA in Europe, and SJAC in Japan publish these requirements simultaneously as 9100-series standards.
Aerospace Quality System Standards
| International Standards 9100 - Quality System for Aerospace Manufacturers 9101 - Checksheet for 9100 9102 - First Article Inspection 9103 - Variation Management of Key Characteristics 9110 - Quality System for Aerospace Repair Stations (EAQG) 9111 - Checksheet for 9110 (EAQG only) 9120 - Quality System for Distributors (EAQG) 9121 - Checksheet for 9120 (EAQG) 9130 - Record Retention (EAQG) 9131 - Nonconformance Documentation |
| AAQG Quality Standards |
AS9003 Inspection and Test Quality System
| Projects in work (Americas only): Advanced Quality Planning Software Quality (Embedded and non-embedded) Internal Auditing Requirements Root Cause Corrective Action Sub-tier Supplier Control Sampling Plans - Proposed |
AS9003 Inspection and Test Quality System
This standard was released in October 2001, and:
| is considered to be less than AS9100 |
| addresses the 20 elements as does the ISO:1994 based AS 9100 Rev. A, Section II |
| retains most of ISO and AS 9100, but is less prescriptive and more generally worded |
| a procedure is required for many elements |
TL 9000
The Quality Excellence for Suppliers of
Telecommunications Leadership Forum ("QUEST Forum") was founded to
foster continued improvements to the quality and reliability of
telecommunications services and products. The founders established a common set of quality system requirements and
metrics by
creating the TL 9000 Quality System Requirements Handbook and the TL 9000
Quality Systems Metrics Handbook. These handbooks are the result of a
cooperative effort among members of the telecommunications industry:
| service providers, |
| suppliers, and |
| registrars. |
The purpose of TL 9000 is to define the telecommunications quality system requirements for the design, development, production, delivery, installation, and maintenance of products: hardware, software or services. The TL 9000 Quality System Metrics Handbook defines a minimum set of performance metrics and reporting requirements, which are cost and performance-based that measure reliability and quality performance of these products. The metrics and indicators are selected to measure progress and evaluate results of quality system implementation.
The TL 9000 requirements promote consistency, efficiency, and will reduce redundancy and improve customer satisfaction. They also enable suppliers to improve quality and reliability, reduce costs, and increase competitiveness. The TL 9000 Quality System Requirements Handbook consists of four major sections with appendices. The requirements are built upon existing industry standards, and is based on and includes ISO 9001.
The goals of TL 9000 include:
Benefits of TL 9000:
Telecommunications service providers, their subscribers and all customers will benefit as a result of implementing TL 9000. These benefits include:
· Continuous improvement of service to subscribers;
· Enhanced customer-supplier relationships;
· Standardization of quality system requirements;
· Efficient management of external audits and site visits;
· Uniform cost and performance-based metrics;
· Overall cost reduction and increased competitiveness;
· Enhanced management and improvement of suppliers' performance; and
· Industry benchmarks for TL 9000 metrics.
Relationship to ISO 9001:1994; ISO 9000:2000 and Other Requirements
TL 9000 Release 2.5, maintains compatibility with other sets of requirements and standards, and provides a telecommunications-specific set of requirements built upon an ISO 9001:1994 framework. See the Bibliography in the TL 9000 Standard for the standards and requirements that were considered during its development.
TL 9000 Release 3, was recently revised to the new ISO 9000:2000 Standard on March 1, 2001.
The Requirements Handbook release 2.5 can be used through March 31, 2002; but submissions of measurement data must be in Release 3 format from September 30, 2001. Although this is 6 months from publication of the new handbook, organizations only have 3 months to transition because the September submission will be the previous 3 months of data.
The main change in Release 3 is the transition to ISO 9000:2000.
The Requirements Handbook has been restructured to follow the new ISO Standard. The additional TL requirements, or "adders", have been mapped into the new structure. Some have been reworded for clarity but their intent is unchanged. A few have been deleted because they duplicate requirements of the new standard, such as the requirement for the skills list.Following is a list of the more significant changes:
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Section 7.2.3.C.2, regarding problem severity, is now assigned by organization only, not customer and supplier (however, section 7.2.3.C.2-Note-1, retains the “jointly determine” wordage from release 2.5). |
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Section 7.2.3.C.4, regarding providing timely feedback to customers on status of problem reports, is new to the standard. |
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“Supplier” becomes “Organization” and “Subcontractor” becomes “Supplier”. |
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Book 1 page 3.3: the TL 9000 logo may be used on flags, buildings, or cars. |
The measurements are as before, except:
| normalization units are simplified (see new product category table) |
| return rates now comprise three measures, not two: initial return rate, one-year return rate, and long term return rate |
| software measures are unchanged, but their application has been clarified |
| the term "metric" has been universally replaced with "measurement" |
Some new product categories have been added- see the QuEST Forum’s website for the latest categories.
Some telecommunications companies are already requiring their suppliers to comply with these requirements and may impose the requirements, including the metrics reporting, contractually. If your company needs to upgrade its quality system and associated procedural elements, please click on the Inquiries button above to request more detailed information or to request QA services and schedule the work.
Other Developments
Auditing
Aerospace Programs for Auditors / Course Providers to Debut Soon
RAB
is playing an important role as the international aerospace industry works to
align its quality management systems standards to ISO 9001:2000. At the request
of the Americas Aerospace Quality Group (AAQG), RAB is developing programs for
certifying aerospace auditors and accreditation of course providers offering
training to aerospace auditors.
RAB provided AAQG with draft criteria for course providers in December 2004, and
expects to finalize criteria for an AS9100 auditor certification program by the
end of March.
The new AS9100 programs could result in substantial new activity for RAB. "There are approximately 100 auditors who can be grandfathered into the program, plus about 1,000 potential auditors in the United States," said Cindy Miller, RAB's director of auditor certification and course accreditation.
The International Aerospace Quality Group has established a procedure for harmonizing these and similar certification and accreditation processes being developed in Europe and the Pacific area. Aerospace companies worldwide can be assured that properly issued certifications will ensure that the processes meet their requirements.
ISO 19011:2002
ISO 19011:2002, Guidelines For Quality And
Environmental Management Systems Auditing.
Key Developments
ISO 19011 was approved as an International Standard in balloting that concluded August 13, 2002, with publication on October 2, 2002. However, the decision to ballot the joint EMS/QMS auditing guidance document as an American National Standard was postponed until a US supplement to ISO 19011 was completed and to publish the standard and supplement together.
This supplemental guidance document is tentatively titled: QE 19011S, Guidelines On Quality And/Or Environmental Management Systems Auditing - US Version With Supplemental Guidance. A Joint Task Group started significant work on QE 19011S during a meeting in March 10-13, 2003, in Dallas. QE 19011S has been published since then. Other countries have reported interest in the guidance supplement as there is a common need for such guidance relative to non-3rd party auditing applications.
ISO 10012
On April 15, 2003, ISO 10012, Measurement Management Systems- Requirements for Measurement Processes and Measuring Equipment, was published as an International Standard. Balloting of the Final Draft International Standard (FDIS) concluded in March 2003 with the US voting to approve the ISO/FDIS 10012, ISO 10012:2003, which essentially represents the last standard to be completed in the core ISO 9000:2000 family.
ISO 10012:2003 replaces two standards: ISO 10012-1:1992, Quality Assurance Requirements For Measuring Equipment-Part 1: Metrological Confirmation System For Measuring Equipment and ISO 10012-2-1997, Quality Assurance for Measuring Equipment-Part 2: Guidelines For Control Of Measurement Processes. There are plans to ballot ISO 10012:2003 as an American National Standard thru ANSI.
Software
ISO/EEC 90003:2004
ISO/EEC 90003:2004, Software Engineering-Guidelines for the application of ISO 9001:2000 to computer software, covers development, supply, acquisition, operation and maintenance of computer software.
This standard is applicable to software that's part of a commercial contract with another organization, products
available for market sectors, those used to support the organizational processes, hardware-embedded applications or those related to software services. ISO/IEC 90003:2004 is not in itself a certification standard,
but is intended to be a useful guide whether or not the organization seeks ISO 9001:2000 registration.
In addition to providing guidance on how to implement the highly successful ISO 9001:2000 approach to software environments, the publication of ISO 90003 is an important event for the software engineering industry sector. It brings unity to what has been an increasingly fragmented approach, considering the number of software engineering standards being developed.
Given the presence of information technology in virtually every business sector, the International Organization for Standardization saw huge potential in applying the ISO 9001:2000 quality management standard to software engineering.
Deliverable vs. Non-Deliverable Software
The aerospace community distinguishes between deliverable non-deliverable software. Deliverable software generally needs a higher caliber of software to meet safety, mission performance, and maintenance objectives. However, some safety focused software regulatory documents, such as RTCA/DO-178B, include all software that can affect operational safety, regardless of whether it is deliverable or not. The AAQG has created two working groups to address these two software sectors.
AAQG Project # 19 is addressing deliverable software, and includes product such as:
•Avionics
& engine controls
•Flight
controls, Displays
•Cabin
temperature/pressure systems
•In-flight
entertainment systems
•Weapons
armament
•Mobile/ground-based
defense systems
•Communication
Navigation Surveillance/Air Traffic Management (CNS/ATM)
•Ground-based
systems-simulators, trainers
AAQG Project # 020 is addressing non-deliverable software. While the direction here is not totally clear, it is currently intended to build on the draft of non-deliverable software created by AIA/GAMA subcommittee, including:
•CAD
sets & SW
•MFG
SW
•Executive
SW (OS)
•Test
SW
•Inspection
SW
•Data
Acquisition SW
•Process
Software
An aerospace international standard for software quality based on AS9100:2001 has been in development. ARP9005--Aerospace Guidance for Nondeliverable Software was developed by the G-14 Americas Aerospace Quality Group (AAQG). ARP9005 standardizes the auditing of non-deliverable software used in manufacturing, specific to the AS-9100B standard and the FAA's Aircraft Certification Systems Evaluation Program. It addresses practices for control during the development, production, release, maintenance, and retirement of nondeliverable software, as well as for software procured from outside manufacturers and incorporated in the production, evaluation, test, acceptance, or calibration of processes