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Whittington Newsletter )
QMS, EMS, Information Security, and Six Sigma March 2007
In this Issue
  1. How to Audit Customer Communication
  2. New TL 9000 R4.0 Handbooks
  3. Writing Checklist for Documents
  4. ISO 16085 for Risk Management
  5. Information Security Audit Checklist
  6. Want to Comment on ISO 9001:2009?
  7. Class Schedule

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.


How to Audit Customer Communication

An effective customer communication process contributes to the success of any organization’s quality management system, and ultimately, to the success of the organization itself. Conversely, many problems an organization experiences with its customers can be traced back to poor communication.

ISO 9001 Requirements
ISO 9001:2000, clause 7.2.3, Customer Communication, states an organization must determine and implement effective arrangements for communicating with customers in relation to:

a) product information,
b) inquiries, contracts or order handling, including amendments, and
c) customer feedback, including customer complaints.

To understand how to audit the customer communication process, we should first look at other ISO 9001:2000 requirements that relate directly or indirectly to customer communication, including:

5.2 - Top management must ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction.

5.6.2.b - The input to management review must include information on customer feedback.

7.2.1 - The organization must determine the requirements specified by the customer, as well as, any requirements not stated by the customer, but necessary for the specified or intended use, where known.

7.2.2 - The review of requirements must be conducted prior to the organization's commitment to supply a product to the customer.

7.2.2 - Where the customer provides no documented statement of requirement, the customer requirements must be confirmed before acceptance.

7.5.4 - If any customer property is lost, damaged, or otherwise found to be unsuitable for use, this must be reported to the customer and records maintained.

8.2.1 - The organization must monitor information relating to the customer perception as to whether the organization has met customer requirements.

8.2.4 - Product release and service delivery can not proceed until all planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority, and where applicable, by the customer.

8.3.b - One of the ways an organization may deal with nonconforming product is by authorizing its use, release, or acceptance under concession by a relevant authority and, where applicable, by the customer.

8.5.2.a - A documented procedure must be established to define requirements for reviewing nonconformities (including customer complaints).

ISO 9004 Guidance
In addition, ISO 9004:2000, clause 7.2, states that management should ensure the organization has defined mutually acceptable processes for communicating effectively and efficiently with its customers and other interested parties.

ISO 9004 also suggests that organizations implement and maintain such processes to ensure adequate understanding of the needs and expectations of its interested parties, and for translation into requirements for the organization.

Verifying Effectiveness
Verifying the effectiveness of customer communication is a critical component for achieving customer satisfaction. Although there is no specific requirement in ISO 9001:2000 for a documented procedure, depending on the size, complexity, and culture of the organization, it may be necessary to have one in order to ensure effective implementation of the customer communication process.

ISO 9000:2005 defines the term “customer” as the recipient of the product. It also gives examples of customers, including the “end user”.

Many organizations sell their products or services through dealers and retailers and may not be receiving orders directly from end users. It is important for the auditor to verify how the organization also communicates about the quality of its products and services to the end users, and to verify the mechanism for obtaining feedback (besides complaints) from the end users. The needs of the dealers and retailers may at times be different from those of the end users.

Audit Approach
As we’ve seen, customer communication falls in three general categories:

1. An organization’s general communication to existing or potential customers, such as advertisements or marketing information,
2. Specific information relating to a customer inquiry, requirement, or order, and
3. Communication in response to customer feedback and complaints.

General Communication

Where an organization receives orders from dealers and not the end users, the auditor should establish that the product information available to the end users (e.g., pamphlets, brochures, and web sites) describes the products and services adequately and accurately. The auditor should also try to establish how the customer needs have been identified and product specifications arrived at.

The auditor should verify the product information to confirm that it is readily available to customers or potential customers, and provides information that is up-to-date and accurate. The auditor could also query how often advertising material, web sites, and product catalogs are reviewed to reflect the organization’s current product offerings and services, and what measures are taken if a particular product is modified, discontinued, or no longer available.

Specific Communication

Some or all of the following means of an organization’s specific customer communication may be observed by the auditor:

Inquiries, contracts, or order handling, including amendments, e.g.,

• quotations
• order forms
• confirmation of order
• amendment to order
• delivery documentation
• invoices
• credit notes
• e-mail and general correspondence
• visit reports or notes to/from customer

Customer feedback and the complaints management process, e.g.,

• Letters in response to complaints
• Acknowledgments

Other areas where the auditor may observe the organization’s communication with customers are:

• During the ordering process where the customer provides no documented statement of requirement, the organization must have a system in place to obtain or confirm these customer requirements before accepting the order

• During the design and development process there may be considerable communication taking place between the organization and the customer

• During the process of authorizing product release or service delivery (under concession by the customer) prior to satisfactory completion of all planned product testing

• During the process of authorizing the use of nonconforming product by release or acceptance under concession by the customer

• During the process of gathering customer satisfaction data from customers on their perception as to how well products and services are meeting their requirements

The auditor would use normal trace methods to verify the conformity of these activities to the customer communication requirements of ISO 9001, as well as, assessing the effectiveness of communications with customers in the execution of the inquiry, contract, or order.

Note: This article was based one of the Auditing Practices Group papers at the ISO web site. Another paper at that site addresses the customer feedback and customer complaint processes.

New TL 9000 R4.0 Handbooks
TL 9000

TL 9000 was developed by the Quality Excellence for Suppliers of Telecommunications Forum (QuEST Forum) to meet the quality requirements of the worldwide telecommunications industry.

The TL 9000 Requirements Handbook establishes a common set of quality management system requirements (based on ISO 9001:2000) for suppliers of telecommunications products: hardware, software, and/or services.

The TL 9000 Measurements Handbook defines a minimum set of performance measurements that are used to evaluate results and identify improvement opportunities. All certified TL 9000 organizations are required to submit product measurements.

TL 9000 Requirements Handbook, Release 4.0

The new TL 9000 Requirements Handbook, R4.0, consists of all the ISO 9001:2000 requirements and 90 additional Tele-com requirements. All audits completed after July 1, 2007 must be performed to the R4.0 Requirements.

The upgrade to R4.0 may be done during a surveillance audit and does not have to be done during a certification or re-certification audit. Auditors must have delta training before conducting a third party audit to R4.0.

Summary of Changes
The ISO 9001:2000 base remains unchanged.

  • ~30% adders remain unchanged
  • ~30% adders with minor changes
  • ~40% adders with major changes or are new
These new and changed requirements were designed to:
  • Ensure intended results instead of specifying methods of doing
  • Emphasize design process quality measurements
  • Add required testing (regression, document verification, stress, abnormal condition and system), and
  • Broaden scope of certain requirements, e.g., from “software only” to “common” or, “hardware and software”
There was a net gain of 9 adders in TL 9000 for a total of 90 unique Tele-com requirements.

TL 9000 Measurements Handbook (Release 4.0)

All data as of July 2007 or later must be submitted according to this handbook. Auditors must have delta training conducting a third party audit to R4.0.

Summary of Changes
The basic measurements and reporting processing remains unchanged. There were minor modifications and clarifications to the common (NPR, FRT, OFR, and OTD) measurements, as well as, the field returns (FR) measurement.

The system outage (SO, SONE, EIO) measurements were simplified. The software (SFQ, SPR) measurements were considerably changed and shortened. The service quality (SQ) measurement was also simplified, applied to additional product categories, and changed to report defects.

To learn more about TL 9000, go to the Quest Forum web site.

Writing Checklist for Documents
Checklist

When writing a procedure, keep in mind these questions:

• What is the objective of process? Know its purpose before starting.
• Which activities are part of scope? Agree on coverage of activities.
• Who is responsible for these activities? Identify key process players.
• What are inputs and who are suppliers? Identify inputs and providers.
• What are outputs and who are customers? Identify outputs and recipients.
• What is referenced as an information source? Identify related documents.
• What is the logical series of steps? Organize the steps in a logical sequence.
• How are the activities performed? Interview users and observe operations.
• Which departments use the process? Know readers and users of the process.
• What reports or records are generated? Identify records for the process.
• What forms are used? Don’t overlook forms used to collect information.
• When and where is the work performed? Identify timing and location of work.
• What products are covered by the process? Define its applicability.
• What process documentation already exists? See if documents can be adapted.
• What are the requirements of the process? Know user and organization needs.
• What are the quality criteria? Identify the acceptance criteria.
• What are the related procedures? Ensure compatibility with other processes.
• Which tasks have or need instructions? Add or refer to needed instructions.
• How might the process be audited? Be able to demonstrate conformity.

ISO 16085 for Risk Management

ISO 16085:2006, Systems and Software Engineering - Life Cycle Processes - Risk Management, defines a process for managing risk in system and software life cycles.

ISO 16085 can be used with existing set of processes defined by ISO 15288, Systems Engineering - System Life Cycle Processes, and ISO 12207, Information Technology - Software Life Cycle Processes, or it can be used independently.

Risk management is a key discipline for making effective decisions and communicating the results within organizations. The purpose of risk management is to identify potential managerial and technical problems before they occur so that actions can be taken that reduce or eliminate the probability and/or impact of these problems should they occur.

Risk management is a critical tool for continuously determining the feasibility of project plans, for improving the search for and identification of potential problems that can affect life cycle activities and the quality and performance of products, and for improving the active management of projects.

ISO 16085 describes a process for the management of risk during systems or software acquisition, supply, development, operations, and maintenance. The purpose of this standard is to provide suppliers, acquirers, developers, and managers with a single set of process requirements suitable for the management of a broad variety of risks and it is suitable for adoption by an organization for application to all appropriate projects.

ISO 16085:2006 supersedes ISO 16085:2004 and can be ordered from ANSI for $107.00 It has also been issued as IEEE standard 16085-2006 and can be ordered from IEEE for a member price of $85.00

Information Security Audit Checklist
Security

According to the Information Security Forum, security management is “keeping the business risks associated with information systems under control within an enterprise.”

Requirements for security management include clear direction and commitment from the top, the allocation of adequate resources, effective arrangements for promoting good information security practice throughout the enterprise, and the establishment of a secure environment.

An information security program is a critical component of every organization’s risk management effort, providing the means to protect the organization’s information and other critical assets. Therefore, the information security program should be assessed at planned intervals to ensure it is meeting requirements and achieving objectives, as well as, to identify opportunities for security improvements.

The audit team should look for evidence that the information security program is well organized and well managed. The security program must also specifically mitigate risks in satisfying key business objectives, and this traceability must be clear.

The information security audit should confirm that key risks to the organization are being identified, monitored, and controlled; that key controls are operating effectively and consistently; and that management and staff have the ability to recognize and respond to new threats and risks as they arise.

The information security audit’s goals, objectives, scope, and purpose will determine the actual audit procedures and questions that are required. The IT Compliance Institute has published a series of IT Audit Checklists. To see the Information Security Checklist written by Dan Swanson, click here.

Want to Comment on ISO 9001:2009?

The ISO 9000:2000 family of quality management system standards is being updated with an anticipated final release date in 2009. The updated standards (ISO 9001 and ISO 9004) are being released as committee drafts and available for review at the American Society for Quality (ASQ) web site.

Of course, the two documents are not intended to be used for quality system design purposes. As committee drafts, the two standards are offered only for public review and comment.

For ISO 9001, the requirements standard, the plan is to produce minor changes for clarification and compatibility with ISO 14001. Although the changes are expected to be minor, even small changes to the standard may dramatically impact your quality management system.

For ISO 9004, the guidelines document, the plan is to produce a major revision with its focus on providing guidance on organizational sustainability rather than performance improvement.

ASQ and the international standards developers are making these committee drafts available at this early stage in their development in an effort to determine if the direction of the two standards is on target with user needs.

Directions for users to follow in providing comments to the standards developers are included within the electronic document. All public comments need to be submitted before March 31, 2007.

The ISO 9001 draft includes yellow highlighted text to indicate the changed areas. However, the ISO 9004 draft is very different, uses a different clause structure, and does not include any highlighting of its changes.

You can download the free draft standards from the ASQ web site by clicking here.

Class Schedule

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
ISO/TS 16949:2002 Lead Auditor
Understanding and Implementing ISO/TS 16949:2002

AS9100B:2004
AS9100 Internal Auditor
Implementing AS9100
AS9100 Lead Auditor

ISO 17799 / ISO 27001
ISO 17799 - Understanding an ISMS
ISO 17799 - ISMS Implementation
ISO 27001 - ISMS Internal Auditor
ISO 27001 - ISMS Lead Auditor

ISO 13485:2003
Understanding ISO 13485:2003
ISO 13485:2003 Internal Auditor
Implementing ISO 13485:2003
ISO 9001 Lead Auditor - ISO 13485 Emphasis

Six Sigma
Introduction to Statistics
Green Belt Certification
Black Belt Certification

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

Books
See our list of ISO 9001, Auditing, and Six Sigma books. Includes book descriptions and links to Amazon.

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