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December, 2005

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Newsletter Articles
December 2005

Public Classes
Quality, Environment, Information Security, Medical, Automotive, Aerospace

Click on an article title to jump to the article:

1. Information Security and ISO 27001

2. How to Select and Use a Consultant

3. Suspension of RABQSA Certification Transition

4. Z10 - Occupational Health and Safety Standard

5. ANAB: QMS and EMS Outputs Matter!

6. Classes: December, 2005 - February, 2006

ISO 9001:2000

Understanding ISO 9001:2000
 
Implementing ISO 9001:2000
 
Quality System Documentation

 
ISO 9001:2000 Internal Auditor
 
ISO 9001:2000 Lead Auditor

ISO 14001:2004

Understanding ISO 14001:2004
  
Implementing an EMS
 
ISO 14001:2004 Internal Auditor
 
ISO 14001:2004 Lead Auditor
ISO/TS 16949:2002

ISO/TS 16949:2002 Internal Auditor
 
Understanding and Implementing ISO/TS 16949:2002
AS9100B:2004

AS9100 Internal Auditor
AS9100 Lead Auditor

Books ISO 17799:2005 and ISO 27001:2005

ISO 17799 - Understanding an ISMS
 
ISO 17799 - ISMS Implementation
 
ISO 27001 - ISMS Auditor
ISO 13485:2003

Understanding ISO 13485:2003
 
ISO 13485:2003 Internal Auditor
 
ISO 13485:2003 Lead Auditor

See  ISO 9001, Auditing, and Six Sigma books at:
http://www.whittingtonassociates.com/v2/books.shtml


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Six Sigma

Introduction to Statistics

Green Belt Certification

Black Belt Certification

Atlanta Classes

Enroll and pay for an Atlanta class at least 30 days in advance of the class and receive a 10% discount. Students at previous Atlanta classes receive a 20% discount on future Atlanta classes.

1. Information Security and ISO 27001

Information security flaws can result in escalating financial losses and wreak havoc with business operations. The newly published ISO 27001:2005 standard for information security management systems can help organizations plug existing leaks and prevent future threats.

"The publication of ISO 27001:2005 is a big event in the world of information security and the standard has been eagerly awaited," said Ted Humphreys, Convenor of the working group responsible for managing the development of the standard. "It is a standard that all security-conscious organizations should look to implement."

ISO 27001:2005 can be used by a broad range of organizations – small, medium, and large – in most of the commercial and industrial market sectors: finance and insurance, telecommunications, utilities, retail, and manufacturing sectors, various service industries, transportation sector, governments, and many others.

The implementation of ISO 27001:2005 will reassure customers and suppliers that information security is taken seriously within the organizations they deal with because they have in place state-of-the-art processes to deal with information security threats and issues.

Information is an asset, which, like other important business assets, adds value to an organization and consequently needs to be protected. Information security protects information from a wide range of threats in order to ensure business continuity, minimize business damage and maximize return on investments and business opportunities.

An Information Security Management System (ISMS) is a systematic approach to managing sensitive company information so that it remains secure. It encompasses people, processes and IT systems.

ISO 27001:2005, Information technology – Security techniques – Information security management systems – Requirements, specifies the processes to enable a business to establish, implement, review and monitor, manage and maintain an effective ISMS. It integrates the process-based approach of ISO's management system standards – ISO 9001:2000 and ISO 14001:2004 – including the Plan-Do-Check-Act (PDCA) cycle and requirement for continual improvement.

The new standard forms a complementary pair with the recently published ISO 17799:2005 "code of practice" on information security management. Organizations that so wish can have their information security management systems independently certified as conforming to the requirements of ISO 27001:2005, although certification is not a requirement of the standard. Up to now, organizations that wished to have their ISMS certified have done so in conformity with the British Standard, BS 7799 Part 2. This is now possible against ISO 27001:2005, which is an International Standard.

We offer the following courses on ISO 27001 and ISO 17799:

ISO 17799 / ISO 27001 Understanding an Information Security Management System
Atlanta, GA - February 7-8, 2006

ISO 177799 / ISO 27001 Information Security Management System Implementation
Reston, VA - February 7-9, 2006
Atlanta, GA - April 4-6, 2006

ISO 27001 Information Security Management System Lead Auditor
Atlanta, GA - February 13-17, 2006
Seattle, WA - March 6-10, 2006

2. How to Select and Use a Consultant

Choosing a qualified consultant is no easy task. The importance of taking the time to make a thoughtful selection cannot be underestimated. Your choice could end up affecting the efficiency and effectiveness of your business operations.

1. Understand the reasons for using a consultant
Why do organizations use consultants? An organization may realize it lacks the expertise, time, experience, or objectivity to perform the work without outside assistance.

2. Identify the services you need from consultants
Competent consultants should not only be able to plan the activities, document your processes, and recommend system improvements, but also suggest good practices, teach onsite classes, and conduct internal audits.

3. Decide on the selection criteria
You must agree on the criteria for selecting the right consultant for your organization. Some factors to consider include experience, credentials, skills, availability, accessibility, cost, and references.

4. Find prospective consultants
Now it's time to locate possible candidates. There isn't a single directory of consultants, so we will suggest a variety of ways to identify consultants, e.g., prior use, referrals, associations, consulting guides, advertisements, trainers, registrars, and the Internet.

5. Request a proposal
Ask the consultant candidates to submit proposals for your evaluation. To help them propose the appropriate services, include the following information in your request: scope, timing, methods, fees, and expenses.

6. Choose the consultant
Evaluate the proposals using the agreed selection criteria. Know in advance who will participate in the evaluation and make the recommendation. You want the decision fully supported so the consultant can work effectively with your organization.

7. Negotiate the terms
Confirm the consulting fees and estimated expenses. Although negotiating the terms of the agreement remains to be done, you will make your initial decision based on the available facts. Remember, consultants may reduce their quoted rates to win your business.

8. Prepare the agreement
It is very important to get a written agreement. Make sure everyone has the same understanding and expectations. The agreement could be a legal contract or simply a letter of understanding. The bigger the job, the more formal the agreement.

9. Manage the consultant
Even an expert consultant needs to be managed well. Ensure that the primary contact at your organization fully accepts this coordination role. Any issues or misunderstandings must be promptly resolved.

10. Evaluate the results
When the project completes, evaluate the results. Were the deliverables acceptable? Were they produced on schedule? Did the outcome satisfy the objectives? Assess the consultant’s performance. Did the consultant do a good job of planning? Was the plan followed without significant deviation? Were you kept informed throughout the project? Did the consultant work well with others and foster teamwork?

Summary and Guidance
If thoughtfully selected and wisely used, a consultant can be a valuable partner in setting up or improving your quality management system. However, remember that the system is owned by your organization.

Larry Whittington wrote a white paper on this subject, 10 Tips for the Selection and Use of a Quality Management System Consultant, for BSI Management Systems. Also, ISO 10019:2005, Guidelines for the Selection of Quality Management System Consultants and Use of their Services, is available at (http://qualitypress.asq.org).


3. Suspension of RABQSA Certification Transition

RABQSA has announced the suspension of the Certification Transition Plan requiring auditors to transition to the competency-based certification schemes for QMS, EMS, Food Safety and OH&S. The 31 December 2006 transition deadline has been suspended, to allow auditors more time to choose their certification scheme.

“The message we have received from our customers throughout 2005 is that more time is required to allow auditors to decide on the value of transitioning from the current qualification-based certification schemes to the internationally recognized competencybased schemes”, said Michael Carmody, CEO RABQSA.

RABQSA will continue to offer both its traditional qualification and the new competency-based certification products, including the associated Training Course Certification and TPECS certification products, until our customers have had sufficient time to make an informed choice as to the most appropriate scheme that will serve their needs.

RABQSA will engage industry, and its current certified professionals, to promote the value of being internationally recognized to deliver a professional service and product direct to industry; and providing a career pathway for people seeking competency based, professional certification.

“The future value of personnel certification to industry will be based on the demonstration of your ability, not simply showing your qualifications”, said Carmody; “It’s about confidently showing your customer, you are the right person with the knowledge and skill for the job no matter where you choose to work”.

For more information, go to the RABQSA web site at (http://www.rabqsa.com/news.shtml).

4. Z10 - Occupational Health and Safety Standard


ANSI/AIHA Standard Z10, Occupational Health and Safety Management Systems, has been published. The standard, developed through a consensus process by a committee of experts and stakeholders from industry, labor, business, professional organizations, and government, is a fully recognized American National Standard. The American Industrial Hygiene Association (AIHA) serves as secretariat for the Z10 Committee.

The new standard enables organizations to integrate occupational health and safety (OHS) management into their overall business management systems. It focuses on principles that are broadly applicable to organizations of all sizes and types, not on detailed specifications. It is compatible with relevant OHS, environmental, and quality management standards, as well as, with approaches to OHS management in common use in the United States.

Founded in 1939, the American Industrial Hygiene Association (AIHA) is the premier association of occupational and environmental health and safety professionals. AIHA’s 12,000 members play a crucial role on the front line of worker health and safety every day. Members represent a cross-section of industry, private business, labor, government, and academia. You can order the Z10 standard for $65 at this AIHA web site.

ANAB Accreditation Program for Z10

The ANSI-ASQ National Accreditation Board (ANAB) has developed an accreditation program to support ANSI/AIHA Standard Z10. Because the new standard is compatible with environmental and quality management standards, such as ISO 14001 and ISO 9001, it will allow organizations to integrate occupational health and safety management into their overall business management systems.

“The Z10 standard of management systems and principles is designed to help organizations of all types and sizes improve their occupational health and safety performance,” says Robert H. King Jr., ANAB president. “Our accreditation program is intended to meet the needs of the U.S. market for an accredited certification program for occupational health and safety management systems.”

5. ANAB: QMS and EMS Outputs Matter!

The ANSI-ASQ National Accreditation Board (ANAB) recently issued a notice titled, "Outputs Matter!" Since ANAB is the U.S. accreditation body for ISO 9001 and ISO 14001 registrars (certification bodies), we need to pay attention to their advice.  

The ANAB notice said for clients with a certified Quality Management System (QMS), the expected outputs should be trends of improving:

  • customer satisfaction,
  • product and/or service conformance, and
  • continual improvement.
For clients with a certified Environmental Management System (EMS), the expected outputs should be trends of improving:
  • environmental performance,
  • legal compliance,
  • pollution prevention, and
  • continual improvement. 
The purpose of their notice was to encourage an increased focus by certification bodies (CBs) during audits on the outputs (results) of certified clients. Early in every audit of a client, the audit team should review information regarding the trends of the expected outputs. When the information indicates no improvement or, even worse, a negative trend, the audit team should determine what the client is doing to identify why its management system is failing. 

Users of certified organizations are saying with increasing emphasis that these firms are not delivering the expected outputs. These users are even beginning to question the value of accredited certification. As a result, ANAB accreditation auditors (during their office and witness audits of CBs) will increase their focus on what is being done to ensure the CB auditors have a consistent and appropriate focus on outputs during their audits of certified clients.


The ANAB notice included the EMS and QMS white papers below that
elaborate on the parts of the ISO standards, ISO guides, and IAF guidance that support this focus on system outputs.
 

Outputs matter in EMS Audits

History

When ISO 14001 was introduced in 1996, a key concern of non-governmental organizations and regulators was the lack of performance requirements in the standard. Compliance with law was (and is) not required for registration. Specific performance requirements for air, water, and waste management were also not prescribed.

With the introduction of ISO 9001:2000, the focus shifted from simple conformity to the effectiveness of the management system. The EMS focus also shifted. There is now an expectation that the output of the EMS includes an improved level of compliance with legal requirements and improvement in the level of environmental performance.

Requirements

The expectations of an effectively implemented EMS are stated in the introduction to ISO 14001:2004: “[An EMS] enables an organization to ... take action as needed to improve its performance ...” The standard requires top management to commit to continual improvement, prevention of pollution, and compliance with legal and other requirements (subclause 4.2). The standard also requires an organization to evaluate and prioritize its environmental aspects and impacts, establish objectives and targets, and define and implement the means for their achievement (subclauses 4.3.1 and 4.3.3).

The organization must evaluate its compliance with legal and other requirements (subclause 4.5.2) and take corrective and preventive actions (subclause 4.5.3). The organization must review the results of evaluations of compliance with legal and other requirements, its environmental performance, its progress in meeting objectives and targets, the status of corrective and preventive actions, and opportunities for improvement as part of management reviews (subclause 4.6).

While EMS conformity assessment requirements do not discuss specific EMS performance expectations, the importance of an organization’s demonstrated commitment to compliance and the need to consider the organization’s environmental performance and compliance are underscored in ISO Guide 66 and the associated IAF guidance.

ISO Guide 66 and the IAF guidance provide several performance-focused criteria for the selection and qualification of audit teams (ISO Guide 66 subclauses 4.2.3.2 a, c and d; IAF guidance G.4.2.11 and G.4.2.15). The IAF guidance discusses expectations regarding the information gathered during audits and surveillance that provides a basis for initial and continued certification, including information relating to environmental performance, compliance with legal and other requirements, continual improvement, and overall effectiveness of the organization’s EMS (IAF Guidance G5.3.21, G5.3.22, and G5.6.5 a, d and e).

ISO Guide 66 and the IAF guidance have been careful to avoid the EMS conformity assessment process developing into "compliance" auditing. However, the importance of considering compliance information as a basis for initial and continuing certification is recognized in ISO Guide 66 subclause 4.1.1.5 and IAF guidance G.4.1.6 and G5.6.5 d, which emphasize the need for the CB to verify that a system is in place to assure compliance.

Expectations of CB Audit Teams

CB audit teams are in a position to drive a focus on outputs by a certified organization. The CB audit team should focus on environmental performance measures and compliance at the earliest opportunity during the audit.

The audit team should review environmental performance measures to determine if the organization shows improvement in all the measures based on the objectives and targets of the EMS. If the organization does not show improvement on any of the performance measures, the audit team should investigate to determine what element of the EMS might be allowing this finding to occur. The audit team should use the initial tour of the facility and subsequent tours to look for compliance issues. If any are discovered, the audit team should ensure management is alerted to the non-compliance.

The audit team should, as in the previous situation, investigate to determine where a failure in the EMS might be allowing the non-compliance to occur. The EMS elements to be investigated could include 4.3.2 Legal and Other Requirements; 4.3.3 Objectives, Targets and Programs; 4.4.1 Resources, Roles, Responsibility and Authority; 4.4.2 Competence, Training and Awareness; 4.4.6 Operational Control; 4.5.1 Monitoring and Measurement; 4.5.2 Evaluation of Compliance; 4.5.3 Nonconformity, Corrective Action and Preventive Action; and 4.6 Management Review. The nonconformance should be written against the appropriate requirement of the standard.

Summary

Criteria and guidance for the certification process emphasize the need for the CB to consider an organization’s compliance with legal and other requirements and its environmental performance as factors essential to demonstrating that an EMS is effectively implemented.
 


Outputs Matter in QMS Audits

History

The ISO 9001:2000 revision brought a major shift in emphasis on management commitment to and participation in an organization’s QMS. The revised standard contains specific requirements for establishing objectives and criteria for QMS processes for management activities, provision of resources, product realization, and monitoring and measurement of products, processes, and the QMS itself for achieving customer satisfaction and continual improvement.

If supply chain customers and other interested parties are to rely upon and receive value from the third-party certification system, it is imperative that these QMS processes provide outputs that meet customer, regulatory, and the organization’s own requirements. In plain words, outputs matter! To achieve these outputs, the inputs to processes must be complete and appropriate, and the processes must be robust. Feedback to ANAB, through witness audits, complaints, and their involvement at ISO and IAF indicates the objectives of this shift in emphasis of ISO 9001:2000 have not been consistently achieved.

Requirements

Clauses 4 through 8 of ISO 9001:2000 require top management  to commit to its QMS by communicating to the organization the importance of meeting established requirements, establishing a quality policy and measurable quality objectives, conducting management reviews, allocating sufficient resources, and ensuring that customer requirements are determined and met, with the aim of enhancing customer satisfaction. Responsibilities and authorities are to be defined and communicated within the organization. Resources are to be provided, including competent personnel and a supportive infrastructure and work environment.

Product realization must be planned and carried out effectively and efficiently. Products, processes, the QMS itself, and customer satisfaction must be monitored and measured. Data must be analyzed to demonstrate the suitability and effectiveness of the QMS, including customer satisfaction and product conformity to established requirements. Decisions related to conformity of product and continual improvement of the QMS must be made and actions taken when results are not achieved. The organization is required to conduct internal audits that determine if the QMS is effectively implemented and maintained and conforms to the organization’s planned arrangements and to the ISO 9001 standard.

Expectations of CB Auditors

Top management of a certified organization is ultimately responsible for establishing and sustaining a customer-focused, process-based QMS in conformance with ISO 9001:2000. CB auditors are in an excellent position to instill through their auditing practices a driving focus by the organization on the intent and requirements of ISO 9001:2000 (and the concept of this paper) that output does matter. CB auditors should focus on the suitability and effectiveness of the organization’s QMS by probing the organization’s ability to determine necessary inputs, implement effective processes, and produce outputs that consistently deliver products that meet customer and regulatory requirements.

CB auditors should thoroughly audit the interaction and communication of the QMS processes both within the organization and with customers. Successful implementation of the QMS should lead to the establishment of appropriate planning, realization, and monitoring of processes and products to assure product conformance and continual improvement of the QMS. Where the goals and objectives of the organization and customer and regulatory requirements have not been met or the trends are negative, CB auditors should identify the underlying processes that are deficient. Where requirements of the standard have not been met, nonconformities should be written.

CB auditors should similarly focus on the processes of the organization’s internal audit function, corrective action, and preventive action to maintain the effectiveness of the QMS. While the CB auditor’s periodic surveillance gives an independent assessment of QMS status, it is ultimately the scope and depth of the organization’s ongoing efforts between such audits that assure long-term effectiveness. Internal auditors need to look at process inputs, outputs, and interactions with the same diligence as CB auditors.

CB auditors should probe the effectiveness of root cause analyses and corrective action applied by the organization to internally identified nonconformities of products, processes, and the QMS. Similarly, the effectiveness of handling customer returns and complaints should be probed to validate data on perceived customer satisfaction.

Summary

The consistent application of criteria in auditing an organization’s QMS with regard to achieving customer satisfaction, delivering conforming product, and continually improving the QMS is imperative. This is especially important to the continued reliance of the customer supply chain and other interested parties on the added value of the third-party certification system. To achieve the intended purposes of ISO 9001:2000, certified organizations must be held accountable. Outputs do matter!

6. Class Schedule: December, 2005 - February, 2006

To enroll in these public classes, you can click on the course title, go to Class Schedule at our web site, or call us at 800-404-7585. Enroll and pay for an Atlanta class at least 30 days in advance of the class and receive a 10% discount. Students at previous Atlanta classes receive a 20% discount on future Atlanta classes. Classes taught by Larry Whittington are shown in yellow.

SO 9001:2000 Lead Auditor (RABQSA Certified) - BSI Management Systems
Initial course version developed by Larry Whittington 

December January February
05-09  Chicago, IL 09-13  San Jose, CA 06-10  San Diego, CA
12-16  Atlanta, GA 23-27  Reston, VA 13-17  Atlanta, GA
12-16  Las Vegas, NV 30-03  Houston, TX 13-17  Orlando, FL
  - -
  - - 27-03  St. Louis, MO

ISO 9001:2000 Internal Auditor (RABQSA Certified) - BSI Management Systems
Initial course version developed by an Associate at Whittington & Associates

December January February
06-08  Reston, VA 18-20  San Jose, CA 22-24  San Antonio, TX
  - - 24-26  Atlanta, GA    - -

Implementing ISO 9001:2000
Course developed by Larry Whittington

January February March
10-11  Chicago, IL 09-10  Atlanta, GA 07-08  Reston, VA

Understanding ISO 9001:2000

 
January February March
09 Chicago, IL   - -
06  Reston, VA

Understanding ISO 9001:2000 Requirements (Atlanta Only - $295)
Course developed by Larry Whittington
 
February May
06 Atlanta, GA 01  Atlanta, GA

Quality System Documentation (ISO 9001:2000)
Course developed by Larry Whittington

December January February
01-02  San Diego, CA 12-13  Chicago, IL 07-08  Atlanta, GA

ISO 17799 / ISO 27001 - Understanding an Information Security Management System

December January
February
19-20  Reston, VA   - - 07-08  Atlanta, GA
  - -
  - -
22-23  Newark, NJ

ISO 27001 - Information Security Management System Lead Auditor

December March
05-09 San Jose, CA 06-10  Seattle, WA

ISO 17799 / ISO 27001 - Information Security Management System Implementation

February March
April
07-09  Reston, VA
  - -
04-06  Atlanta, GA

Understanding ISO 14001:2004

January
February
March
30 Atlanta, GA
  - - 27  San Jose, CA

Implementing an Environmental Management System

December January March
13-14  San Diego, CA 17-18  Reston, VA 28-29  San Jose, CA
  - -
31-01  Atlanta, GA
  - -

ISO 14001:2004 Internal Auditor

January February March
19-20  Reston, VA 20-21  Atlanta, GA 30-31  San Jose, CA

ISO 14001:2004 Lead Auditor

January February March
23-27  San Jose, CA 13-17  Houston, TX 20-24  Reston, VA
  - -
  - -
27-31  Atlanta, GA

On-site Courses
The above public courses can be offered on-site at your facility. In addition, we offer these on-site courses:

  • ISO 9001:2000 Auditor Update - The Process Approach (1 Day) - Course developed by Larry Whittington
  • Understanding ISO/TS 16949:2002 Requirements (1 Day) - Course developed by Larry Whittington
  • Internal Quality Auditing (2 Days) - Course developed by Larry Whittington (based on ISO 19011)
  • AS9100B: Requirements Beyond ISO 9001:2000  (1 Day) - Course developed by Larry Whittington
To arrange an economical on-site class, please call us at 800-404-7585.  


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