April, 2005

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April Articles

Atlanta Classes

To see a list of recommended ISO 9001, Auditing, and Six Sigma books, click on: http://www.whittingtonassociates.com/v2/books.shtml Click on a title to jump to the article: 1. ANAB Advisory on Conflict of Interest with Consulting 2. ANSI to Accredit Food Safety Auditors 3. ISO to Develop New Food Safety Standard 4. Best Practices for Information Retention and Maintenance 5. Registrar Rankings in United States and by Industry Standards 6. Classes: April, 2005 - June, 2005 Call us at 1-800-404-7585 for these 1-day onsite classes: AS9100B: Requirements Beyond ISO 9001:2000 ISO 9001:2000 Auditor Update - The Process Approach Understanding ISO/TS 16949:2002 Requirements To see previous articles, go to Newsletter Archives. To avoid this newsletter being rejected, or placed in a junk folder, please add <Larry@WhittingtonAssociates.com> to your address book or accepted list.

Students attending a class in Atlanta receive a 20% discount on future Atlanta classes. ISO 9001:2000 Lead Auditor April 18-22, 2005 June 20-24, 2005 ISO 9001:2000 Internal Auditor May 24-26, 2005 July 12-14, 2005 Understanding ISO 9001:2000 Requirements May 16, 2005 Quality System Documentation May 17-18, 2005 Implementing ISO 9001:2000 May 19-20, 2005 Green Belt Certification May 23-25, 2005 Black Belt Certification  Group 15 (3 weeks): April 4-8 + May 2-6 + June 6-10 Training Classes in Other Cities

This article is based on ANAB Advisory 16. To see other Advisories, go to: http://www.anab.org and click on "Advisories".

ANAB Advisories represent positions taken, or policies established, on operational issues related to programs operates by ANAB. One basis of the value of third-party conformance assessment and certification is that the registration process, audits, and certification decision are objective and impartial and not influenced by conflicting interests. This basic premise is unambiguously expressed in ISO Guides 62 and 66 and related IAF Guidance.

The requirements for safeguarding impartiality apply at three levels: the structure and operation of the certification body (CB), personnel (including employees, contractors, and subcontractors), and relationships with other bodies.

There has been satisfactory experience safeguarding impartiality of audits with the historic and longstanding requirement that an auditor for a third-party registration audit cannot have consulted with the client organization being audited for at least two years (IAF Guidance on the Application of ISO Guide 62:1996 Clause G.2.1.30 and IAF Guidance on the Application of ISO Guide 66:1999 Clause G.4.1.29).

There has also been satisfactory experience safeguarding impartiality of audits and registrations for the automotive sector with the following QS-9000 requirement: “Organizations that have provided quality system consulting services in the past two years to a particular client are not acceptable as certification bodies/registrars for that client, nor may they supply auditors. This restriction includes subsidiaries or affiliates of the same parent company” (QS-9000:1998 Appendix B Clause 9).

This successful experience with auditors and the automotive sector led the aerospace sector to establish a similar requirement: “CRBs processes and requirements to obtain an AQMS sector qualification, shall include as a minimum: prohibition against certifying/registering an organization to an AQMS with whom a related body has provided consulting services related to certification/registration of said organization within the past two year. Any individual, who has in the past two years provided consulting services to an organization, shall have no involvement with the certification/registration of that organization. Where there might appear to be a conflict of interest, either through consulting or the offering of training to a potential client, this shall be disclosed to the ABs and RMC prior to performing the registration process to determine if there is a conflict of interest” (SAE AIR5359: 2003 Clause 6.3j).

There is within the United States a very heightened awareness of the conflict of interest when an organization or related organizations provide both auditing and consulting. This heightened awareness led many stakeholders to challenge the safeguards in the third-party certification system for ISO 9001 and ISO 14001 management systems. This challenge was posed directly to the ANAB, as the national accreditation body for the United States.

This led the ANAB Board of Directors to form an ad-hoc Conflict of Interest Task Force. The task force recommended that ANAB implement this requirement now as an Advisory, rather than waiting for the adoption of ISO 17021 (Conformity assessment - Requirements for bodies providing audit and certification of management systems) to improve safeguards that prevent conflicting interests between a CB and a management systems consultancy. ISO/CASCO Working Group 21 has developed what is generally perceived to be a better solution to this issue by focusing on the activity that is of concern rather than relying upon a definition of a related body. Therefore, this Advisory is changed to be consistent with the wording in ISO/DIS 17021.

To understand this Advisory, it is necessary to have a definition for management systems consultancy. The following is the definition from ISO/DIS 17021:

Definition: Management System Consultancy - participation in designing, implementing, or maintaining a management system.

Examples

a. preparing or producing manuals or procedures;
b. giving specific advice, instructions, solutions, or training towards the development and implementation of a management system;
c. conducting internal audits.

Note: Arranging training and participating as a trainer is not considered consultancy, provided that where the course relates to management systems or auditing, the course is confined to providing generic information and advice that is freely available in the public domain, that is, the trainer should not provide company-specific solutions.

Advisory

A CB shall not certify a management system for a client that has received management systems consultancy on the same management system, where the relationship between the consultancy body and the CB poses an unacceptable threat to the impartiality of the certification body.

Note 1: Allowing a minimum period of two years to elapse following the end of the management system consultancy is one way of reducing the threat to impartiality to an acceptable level.

Note 2: A relationship that threatens impartiality between the CB and management systems consultancy body may be based on ownership, governance, management, personnel, shared resources, finances, contracts, marketing, and payment of a sales commission, or other inducement for the referral of new clients, etc.

Note 3: This Advisory is not intended to apply to an individual under the direct contractual control of a CB because other accreditation requirements apply that prohibit any auditor from participating on an audit for a client that the auditor may have consulted or was otherwise employed by the client for at least two years.

The Food Marketing Institute (FMI) has selected the American National Standards Institute (ANSI) to accredit the certification bodies that audit suppliers under FMI’s Safe Quality Food (SQF) Program. This new partnership is designed to help strengthen food safety procedures and improve quality for consumers. ANSI will help ensure the auditing organizations are legal entities, independent and free of conflicts of interest, employ qualified people, have proper oversight, and otherwise comply with the requirements of ISO Guide 65.

“Accreditation provides the necessary additional oversight of the certification and auditing function,” said Paul Ryan, executive director of the SQF Institute, the FMI division that administers the program. “If a food safety certification program is going to have credibility and be internationally recognized, it must have an accreditation component. Through our partnership with ANSI, the U.S. now has a system in place for meeting this requirement. FMI is pleased that ANSI has agreed to provide an accreditation service for its SQF certification bodies.”

“ANSI brings worldwide credibility, a knowledgeable and professional staff and a long history of accreditation activities similar to our new partnership with the SQF Institute,” said Reinaldo Figueiredo, ANSI program director of product certification accreditation. “We look forward to working with FMI to encourage participation by certifiers in this program.” Seven certification bodies already have expressed strong interest in participating in this program.

The SQF Program is a fully integrated food safety and quality management system that enables a food supplier to ensure that its products have been produced, prepared, transported, stored, and handled according to the most rigorous international standards. The program has established standards for both third-party auditing and training.

SQF certification is the most important feature of the program. It ensures that suppliers use the Hazard Analysis and Critical Control Point (HACCP) system, a science-based method used by the food industry worldwide to minimize food safety risks. The SQF Program outlines safety and quality requirements for all food commodities, including raw materials and ingredients, processed and prepared foods and beverages — from grains, produce, and meat to canned goods, fruit juices, and sushi.

Currently 4,000 businesses in 17 countries are certified as complying with SQF standards. For more information, go to: (http://www.sqfi.com).

ISO/FDIS 22000, Food Safety Management Systems - Requirements for Organizations throughout the Food Chain, has been approved for Final Draft status. It combines quality concepts from ISO 9001:2000 with the Hazard Analysis and Critical Control Point (HACCP) system. This standard is intended for use by farmers, ranchers, food processors, wholesalers, distributors, retail stores, and food outlets.

The five key elements of ISO 22000 are 1) interactive communication, 2) system management, 3) process control, 4) HACCP principles, and 5) prerequisite programs, such as good manufacturing practices, good hygienic practices, and good veterinarian practices. This new standard on food safety is planned for publication by the end of 2005.

AMR Research predicts that companies will spend $6.1 billion in 2005 just to comply with the Sarbanes-Oxley Act, which is in addition to the resources already committed to retention and maintenance requirements found in US federal, state, and international law. The rapid growth of regulation, combined with the ambiguity of many of the requirements, has made compliance not only difficult and expensive, but also in some cases impossible.

For example, a financial institution based in the US with offices in the UK is required to comply with both US data regulations and UK data laws. Under US law, companies must retain all records, including customer data, for seven years. In the UK, a company must immediately destroy all customer information when the customer terminates his relationship. No matter what the company does, it will violate one of these laws.

As a result of market conditions, legal concerns, and regulatory requirements, companies, technology vendors, and regulators are facing specific challenges, but there is common ground when it comes to compliance:

• Regulators want to raise the levels of compliance as quickly as possible
• Companies want to minimize the risk of non-compliance
• Technology vendors want to provide solutions that help customers address regulatory requirements

“Global businesses and legislators are working diligently to make universal regulatory compliance a reality,” said David Yockelson, executive vice president, META Group. “Having this broad base of technology vendors working together to help facilitate discussions about compliance and provide advice around best practices is a valuable asset for stakeholders on all sides of the compliance issue.”

The CMEI site will host documentation on best practices for information retention and maintenance regulations, provide counsel and exchange information with various businesses, legislative bodies, and regulatory agencies in various workshops, and publish checklists and summaries of legal and regulatory requirements for interested companies. The working group's intention right now to offer its downloadable items from its web site for free. For more information, please see www.ilpf.org.

Quality Systems Update has unveiled a new global ranking of certification bodies based on its free search engine, WhosRegistered.com. Based on submissions to QSU Publishing as of December 1, 2004, the registration totals for different geographic areas and industries are shown below:

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.

Classes taught by Larry Whittington are shown in yellow.

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

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

Implementing ISO 9001:2000
Course developed by Larry Whittington

Understanding ISO 9001:2000

Understanding ISO 9001:2000 Requirements (Atlanta Only - $295)
Course developed by Larry Whittington

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

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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Whittington & Associates provides training, consulting and auditing services for quality systems based on
ISO 9001, ISO/TS16949, TL9000, AS9100, ISO 13485, as well as, ISO 27001, ISO 20000, ISO 22000, and ISO 14001.