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Greetings!
Welcome to the Whittington & Associates e-Newsletter! Visit and bookmark our web site.
Our newsletters provide guidance on ISO 9001, AS9100, ISO 13485, ISO/TS 16949, TL 9000, ISO 14001, ISO 27001, ISO 20000, and related ISO standards, as well as, Six Sigma.
If you have any questions about the articles appearing in this issue, or you want to suggest topics for future issues, please let us know.
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ISO 17021:2006 for Certification Bodies |
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The recently released ISO 17021:2006 standard is expected to increase confidence in management system certification.
Hundreds of thousands of organizations worldwide, their customers, consumers, and regulatory authorities stand to benefit from ISO 17021, Conformity Assessment – Requirements for Bodies Providing Audit and Certification of Management Systems. The new standard places rigorous requirements for competence and impartiality on the bodies that offer audits and certification to standards like ISO 9001:2000 (quality management) and ISO 14001:2004 (environmental management).
ISO 17021 has a huge potential impact since some 888,000 organizations in 161 countries are independently certified to ISO 9001:2000 and/or ISO 14001:2004.
ISO 17021 has been designed as the single source of internationally harmonized requirements for certification bodies and their activities, not only in relation to ISO 9001:2000 and ISO 14001:2004, but also to new management standards for food safety (ISO 22000), information security (ISO 27001), and supply chain security (ISO 28000), as well as, to others that may be developed.
Replacing and improving on two ISO Guides (62 and 66), ISO 17021 distills an international consensus on the latest in good practice. In addition, it incorporates guidance developed by the International Accreditation Forum (IAF), an international association of accreditation bodies.
ISO 17021 represents a new model for the standards that make up ISO’s “tool box” for conformity assessment, which is the evaluation of products, services, systems, processes, and materials against standards, regulations, or other specifications. It innovates in presenting the principles of certification and the performance-based requirements that flow from them.
These certification principles cover impartiality, competence, responsibility, openness, confidentiality, and responsiveness to complaints. The standard underlines the need to ensure the competence of all the personnel of the certification body – not just auditors – in the management system certification process.
Requirements for impartiality include the following: demonstration by the top management of certification bodies of the need to avoid conflicts of interest between certification and consultancy, training and internal auditing services; the marketing of certification services; and the subcontracting of audits.
The certification body is required to set up a committee for safeguarding impartiality. The standard envisages that such a committee could include representatives of clients of the certification body, customers of these clients, trade associations, regulatory bodies, governmental and nongovernmental organizations, and consumer associations.
Additionally, the certification body is required to implement a management system to ensure its conformity to ISO 17021:2006. The new standard is available from the ANSI eStandards Store for $54.00
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TS 16949 Customer Specific Requirements |
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Organizations seeking or maintaining ISO/TS 16949 certification are required to comply with the Customer Specific Requirements (CSR) for all of their customers that subscribe to ISO/TS 16949. A central repository for ISO/TS 16949-related CSR is being set up on the Automotive Industry Action Group (AIAG) web site.
The AIAG web page will be a resource for subscribing organizations to post links to their customer specific requirements for ISO/TS 16949. Using this newly established repository will ensure the current revision is available and communicated to suppliers and auditiors.
To date, Delphi, Visteon, and Timken have established links on the AIAG web site for their ISO/TS 16949 customer specific requirements. To view the repository, go to the Quality web page maintained by AIAG and look at the links within the ISO/TS 16949 section.
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ISO 25062 for Software Usability Test Reports |
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ISO 25062:2006 provides a standard method for reporting software usability test findings. The format is designed for reporting results of formal usability tests in which quantitative measurements were collected, and is particularly appropriate for summative or comparative testing.
The Common Industry Format (CIF) does not indicate how to perform a usability test, but provides guidance on how to report the results of a usability test. The CIF targets two audiences: usability professionals and stakeholders in an organization. Stakeholders can use the usability data to help make informed decisions concerning the release of software products or the procurement of such products.
The format includes the following elements:
- Description of the productGoals of the testTest participantsTasks the users were asked to performExperimental design of the testMethod or process by which the test was conductedUsability measures and data collection methods
- Numerical results
To order ISO 25062:2006, Software Engineering - Software Product Quality Requirements and Evaluation (SQuaRE) - Common Industry Format for Usability Test Reports, go to the ANSI eStandards Store. The standard is $124.00
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Benefits of ISO 9001 for Service Sector |
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A practical method for helping service sector companies implement ISO 9001:2000 quality management systems, particularly in developing countries, has been published by ISO and the International Trade Centre (ITC).
ISO 9001:2000: A Workbook for Service Organizations is designed to make it easier for service providers to achieve the benefits, such as increased efficiency and effectiveness, of implementing ISO 9001:2000.
According to the World Trade Organization (WTO), the value of world trade in commercial services increased in 2004 by 16% to $2.1 trillion. The cross-border trade in services includes business process outsourcing and offshoring, which offers opportunities for developing countries in particular.
One way that organizations in developing countries can increase their market share in such opportunities is by ensuring competitiveness through the implementation of a quality management system based on ISO 9001:2000.
The ISO/ITC workbook targets service organizations with less than 20 employees, such as accountants, architects, engineers, lawyers, and management consultants. Very practical in its approach, it focuses on the discussions, decisions, and steps that make up a program to implement an effective quality management system.
With the aid of questions and checklists, it guides the service company manager through the following stages: 1) making a decision to implement ISO 9001:2000; 2) planning an approach, 3) designing the quality management system, and 4) managing documentation.
For organizations that wish to go further and have their quality management system audited and certified by an independent body, there are also chapters on getting certified and after certification. One of its appendices provides tips on working with external consultants.
Although developed with service enterprises in developing countries in mind, the hands-on approach of the workbook also has something to offer service providers in developed countries. The workbook is available for $51.00 at the ANSI eStandards Store.
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What is an Ethics & Compliance Officer? |
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Ethics are the principles of conduct governing an individual or a group. Although ethical behavior should be the foundation of professionalism, we see executives being brought to trial because of their apparent lack of a moral compass.
To help instill a corporate conscience, some companies are naming Ethics & Compliance Officers to integrate their ethics and values initiatives, compliance activities, and business conduct practices into the decision-making processes at all levels of the organization.
In addition to recommending and implementing strategies that reinforce appropriate business conduct, they also assist employees at all levels of the organization to determine the right course of action in difficult situations.
For more information on the role of an Ethics & Compliance Officer, go to the Ethics & Compliance Officer Association web site.
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Automotive Study on Competition |
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A recent study, "Automotive Competitive Challenges: Going Beyond Lean", provides a snap shot of the key issues impacting the gap between the Detroit Three and Honda, Nissan, and Toyota. It includes a summary describing revenue per vehicle; labor-cost issues; capacity; design, product and manufacturing engineering; yen exchange rate; and future investments.
The North American automotive scene today is marked by a strange dichotomy: surveys show that the three major Detroit-based automakers have dramatically improved their manufacturing performance, particularly in quality and productivity. But, they continue to lose market share amid consistently weak profits.
Many of their major suppliers are bankrupt, and some analysts have raised the alarm that General Motors, Ford, and Chrysler are headed down the same path. Meanwhile, their three major Japan-based rivals are rapidly gaining ground while recording strong and consistent profits.
Profitability in North America for the three Detroit-based firms has deteriorated sharply since peaking in 1999. Today, an average gap of $2,400 per vehicle exists. This imbalance is usually explained by a crushing burden of so-called “legacy costs” – health care and pensions for the Detroit firms’ large group of retired workers. But there’s far more to the story.
This study highlights many reasons why Detroit is failing to defend its home turf, most of them in fundamental aspects of the automotive business where the Detroit-based companies haven’t yet fully addressed structural and cultural barriers to full competitiveness.
GM, Ford and Chrysler remain behind in many key areas – product engineering, manufacturing flexibility, labor practices, supplier relations, steep price discounting, unfavorable currency exchange rates, and high costs of health care and pensions – that still add up to an uncompetitive overall business model.
You can read more about the study at the Harbour-Felax Group web site.
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