Next ISO 9001 Edition Delayed to 2009

Performance Improvement Solutions for Your Business Needs

September 2006

In this issue

Auditing Organizational Legal Requirements

Linkage of Business and Quality Objectives

The Academy of Quality Awards

News and Events

Greetings!

Industry Magazine Feature Article
Read how the management team of Ascentec and Sustaining Edge Solutions improved operational and quality performance. “If you pick a good ISO consultant, he or she will pay for themselves ten-fold.” Read on…

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Next ISO 9001 Edition Delayed to 2009

The planned publication date for the next revision of ISO 9001 and ISO 9004 was to be third quarter of 2008. Since the working drafts for these standards were not approved for elevation to committee drafts at the recent ISO/TC 176/SC2 meeting, the new projected date for their publication is mid 2009. The next ISO 9001 is being referred to as an Amendment and the next ISO 9004 as a Revision. Although not formal ISO terms, they are being used to convey the level of expected changes to the standards. The ISO 9001 amendment will be limited to clarifications. The document is expected to retain all the clause numbers and titles from the 2000 edition. The ISO 9004 revision is expected to include more substantive changes to encourage more usage.

Auditing Organizational Legal Requirements

Part of audit planning is determining the audit criteria, in other words, the policies, procedures, and requirements used as the reference for comparing audit evidence. The primary types of requirements are:

Customer, as expressed in orders and contracts;

Company, as found in policies and procedures;

Standard, such as ISO 9001:2000;

Legal, as defined in statutes and regulations.

Unfortunately, legal requirements are often ignored during internal audits. And that omission would be a nonconformity. ISO 9001:2000, clause 7.2.1.c states that organizations must determine statutory and regulatory requirements for their products. In addition, clause 7.3.2.b requires design inputs to include applicable statutory and regulatory requirements.

According to clause 5.1.a, top management must communicate the importance of meeting customer, as well as, statutory and regulatory requirements. The legal requirements in this context are quality and product-related, not health, safety, or environment- related. Auditors must first identify the applicable legal requirements for the area to be audited. Ask the legal staff, contract group, and audited area itself about any process or product legal requirements. According to ISO 9001:2000, the requirements should have been identified.

For the organization to meet the legal requirements, they must have access to the statutes and regulations. Ensure they are available for reference. If the applicable legal requirements have been determined by the organization, see how they monitor for any new or changed legal requirements. Then ask for evidence that the organization is conforming to the requirements. If there is proof legal requirements are not being considered, then issue a nonconformity report. Or, if there is evidence that the organization is in violation of a legal requirement, then issue a nonconformity report.

Linkage of Business and Quality Objectives

QualityInsider surveyed readers on how their company communicates quality objectives. Here are the results:

Bulletin boards 39.2%

Company meetings 29.7%

My company doesn’t publish quality objectives. 15%

Web site 7.2%

E-mail or intranet broadcasts 5.1%

Company newsletter 3.8%

Our clients ask “Is their a difference between quality objectives and business objectives”? How does a company ensure that objectives are relevant, measurable, communicated, and understood by employees? The best organizations understand that the two are fully integrated.