Quality Standards
Home QA Services Quality Standards Inquiries Contact Info Quality Sites

 

 


Quality Standards and Developments


ISO 9001 - 2008

The fourth edition of the of the ISO 901 Standard was published on November 15, 2008.
The intent of the standard did not change.  However, some of the changes from the 2000 version include rewording of some of the text  with no requirements impacted, terminology changes to provide consistency with other standards, and to provide clarification in approach and application.

The new version of the standard still includes and is based on the eight Quality Management Principles on which the revised standards are based, additional requirements, and new concepts and terminology.

    - Customer focused organization
    - Leadership
   
- Involvement of people
   
- Process approach
   
- System approach to management
   
- Continual improvement
   
- Factual approach to decision making
    - Mutually beneficial supplier relationships

The new standard still contains a single quality management requirements standard applicable to all organizations, products and services. The new ISO 9001 standard will be used for the certification of quality management systems, and may also be the basis for contractual agreements.

ISO 9004 is the quality management system guidelines standard designed to go beyond quality management requirements to a holistic approach to quality management in improving organizational performance and benefits to all interested parties through sustained customer satisfaction.

The new ISO 9001 and 9004 are designed to constitute a "consistent pair" of standards. Their structure and sequence are identical in order to facilitate an easy and useful transition between them. Although they will be "stand alone" standards, the new structure promotes enhanced synergy between the two and will aid organizational efficiency and effectiveness.

The primary aim of the "consistent pair" is to relate modern quality management to a company's processes and activities, including promoting continual improvement and achievement of customer satisfaction. It is intended that the ISO 9000 standards have global applicability.  The consistency of the two standards will also support a smooth transition for organizations wishing to go beyond minimum compliance with the ISO 9001 requirements for performance improvement. Thereby, all organizations producing manufactured goods, services, or software, may organize their quality management activities to achieve internal and external benefits.

The new ISO 9000 standards are restructured to facilitate a more user- friendly introduction of quality management systems. The common structure of the two standards follow the typical flow and sequence of the main company processes, and enable aligning the quality management system to operations.

The principles that were driving the revision process, are:

bulletApplicability to all product and service sectors and to all company sizes
bulletSimple to use, clear in language, readily translatable and easily understandable
bulletAbility to connect quality management systems to organizational processes
bulletProviding a natural stepping stone towards performance improvement
bullet Greater orientation toward continual improvement and customer satisfaction
bullet Compatibility with other management systems, such as ISO 14000, for Environmental Management
bullet 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 will be in reorganizing and rewriting the quality system to comply.  


Don't Delay-Transition to ISO 9001- Benefit Now!

ISO 9001 has a greater focus on continual improvement, customer satisfaction, resource management, and business results. ISO 9001 provides for an evolutionary approach to improved organizational performance. In short, there is real value for organizations making the transition to ISO 9001 as soon as possible.

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 9001/2008 Standard as a baseline, AS9100 has 129 additional requirements than the basic ISO Standard.

ISO 9001 : 2008 Incorporation into AS9100B/C

The international aerospace writing team reconvened March 2000 to begin work on ISO 9000:2008 incorporation:

bulletAS9100 Revision A was completed and released August, 2001
bulletAS9100 Revision B was completed and released January 2004
bulletAS9100 Revision C was completed and released January 2009

ISO 9001:200/2008 Revision Impact:

bulletAerospace unique requirements are not changed in AS9100

FAA: The FAA has reviewed the AS9100 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 AS9100 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 C, which aligns to ISO 9001:2008.

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

bulletInternational 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

bulletAAQG Quality Standards

AS9003 Inspection and Test Quality System

bulletProjects 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:

bulletis considered to be less than AS9100 
bulletaddresses the 20 elements as does the ISO:1994 based AS 9100 Rev. A, Section II 
bulletretains most of ISO and AS 9100, but is less prescriptive and more generally worded
bulleta 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:

bulletservice providers,
bulletsuppliers, and
bulletregistrars.

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:

  1. Foster quality systems that effectively and efficiently protect the integrity and use of telecommunications products: hardware, software or services;
  2. Establish and maintain a common set of quality system requirements by reducing the number of telecommunications quality system standards;
  3. Define effective cost and performance-based metrics to guide progress and evaluate results of quality system implementation;
  4. Drive continuous improvement;
  5. Enhance customer-supplier relationships; and
  6. Leverage industry conformity assessment processes.

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 and Other Requirements

TL 9000 Release 2.5, maintained 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 revised to the new ISO 9000:2000 Standard on March 1, 2001. 

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:

bullet

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).

bullet

Section 7.2.3.C.4, regarding providing timely feedback to customers on status of problem reports, is new to the standard.

bullet

“Supplier” becomes “Organization” and “Subcontractor” becomes “Supplier”.

bullet

Book 1 page 3.3: the TL 9000 logo may be used on flags, buildings, or cars.

The measurements are as before, except:  

bulletnormalization units are simplified (see new product category table)
bulletreturn rates now comprise three measures, not two:  initial return rate, one-year return rate, and long term return rate
bulletsoftware measures are unchanged, but their application has been clarified
bulletthe 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

ANAB is playing an important role as the international aerospace industry works to align its quality management systems standards to ISO 9001. At the request of the Americas Aerospace Quality Group (AAQG), ANAB is developing programs for certifying aerospace auditors and accreditation of course providers offering training to aerospace auditors.

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

 

Contact Us


Home QA Services Quality Standards Inquiries Contact Info Quality Sites