ISO 9001:2008 News

The new edition of ISO 9001 is being submitted for voting as a final draft international standard. Subject to formal approval by the ISO membership, the publication of the revised version is expected to be published this fall.

The proposed ISO 9001:2008 doesn’t introduce additional requirements compared to the last edition in 2000 and doesn’t change the intent of ISO 9001:2000.

The draft international standard was approved at the May 19–23, 2008, meeting of ISO technical committee ISO/TC 176—“Quality management and quality assurance,” held in Novi Sad, Serbia, and hosted by ISS, the Serbian national standards body. ISO 9001 will be circulated in July as a final draft, on which ISO’s national member bodies as a whole may vote.

ISO 9001 provides the requirements for a quality management system (QMS), which is a framework for an organization to control its processes to achieve objectives including customer satisfaction, regulatory compliance, and continual improvement. Organizations that implement the standard can choose to have their QMS independently certified as conforming to the requirements of ISO 9001, as a means of increasing the confidence of their business partners, customers, and regulators in their products and services.

Although certification isn’t compulsory, it’s estimated that more than one million ISO 9001 certificates have been issued to organizations in 170 countries. The new edition will not require any specific reassessment for certification.

ISO 9001:2008 will be the fourth edition of the standard, which was first published in 1987. The third edition, published in 2000, represented a thorough revision, including new requirements and a sharpened customer focus, reflecting developments in quality management and experience gained since the publication of the initial version.

ISO’s rules for the development of standards require their periodic review. Compared to the 2000 revision, ISO 9001:2008 represents fine-tuning, rather than a thorough overhaul. It introduces clarifications to the requirements existing in ISO 9001:2000, based on user experience over the last eight years, and changes that are intended to improve further compatibility with the ISO 14001:2004 standard for environmental management systems.

To accompany the publication of the new versions, ISO is now working on implementation guidance for ISO 9001:2008, a reference table comparing and contrasting ISO 9001:2000 and ISO 9001:2008 and answers to frequently asked questions. ISO is collaborating with the International Accreditation Forum (IAF) concerning accredited certification.

ISO 9001 is one of 17 standards (plus a corrigendum) developed by ISO/TC 176 on quality management supporting tools. These include ISO 9004:2000—“Quality management systems—Guidelines for performance improvements,” which is undergoing revision and expected to be published as a new edition in 2009.

Watch here for our Webinar on the FDIS coming September 10, 2008. www.4iqc.com

To purchase the IQC ISO 9001:2008 ebook use the following link: http://www.4iqc.com/Services/ISO9001_2008.htm

Application of Clause 7.3 - Design and Development

Application of Clause 7.3 - Design and Development

Ever since ISO 9001:2000 replaced the 1994 editions of ISO 9001, ISO 9002, and ISO 9003, it has been a struggle for companies to decide if their quality management system includes design and development. As a result, the International Accreditation Forum (IAF) issued the following guidance:

If an organization has responsibility for, and performs or outsources the design and development of products that are within the scope of its certification, then clause 7.3 of ISO 9001:2000 shall be included in the quality management system.

When assessing the validity of a request to exclude clause 7.3 from the system scope, the IAF points to the ISO 9000:2005 definition of design and development: a set of processes that transforms requirements into specified characteristics or into the specification of a product, process, or system.

If an organization is not provided with the product characteristics needed to plan its product realization processes and has to define those characteristics based on customer (or regulatory) requirements, then this is, by definition, design and development.


An organization may have the responsibility and authority to make changes to the product specification or to the product characteristics, even though it was not responsible for the original design and development process. In this situation, some requirements of clause 7.3 may not be applicable, but clause 7.3 cannot be excluded in its entirety.

An organization may not be responsible for the design and development of all the products within the scope of the quality management system. Clause 4.1 applies if an organization chooses to outsource the design and development process.


Although design and development has traditionally focused on tangible products, it is equally applicable when the product of an organization is a "service".

New ISO 9001:2008 Update Webinar Dates!

Based on the success of the last webinar IQC held on the ISO 9001:2008 Updates, we have released dates for the next webinars:

April 8, 2008 (Tuesday) 1:00PM to 2:30PM EST
September 10, 2008 (Wednesday) - FDIS 1:00PM to 2:30PM EDT
November 13, 2008 (Thursday) - IS 1:00PM to 2:30PM EDT

for more information please go to http://www.4iqc.com/Services/ISO9001_2008.htm

The Five Characteristics of a successful ISO Implementation

Lessons Learned:

After over 1500 successful ISO implementations and transitions, IQC has identified,

The Five Characteristics Of a Successful Implementation:

1. Management leads the project.
Management is vocal and visible-providing real leadership, not just lending their support. Management review is used to check progress and to make any necessary changes to the system.
2. Every department is represented.
Implementation is a strategic cross-functional project with the necessary time and resources given to it.
3. It's a business management system, not a quality add-on.
People learn that it's about the way they do business day-to-day. Reaching certification or compliance is only the beginning.
4. Real people write real documents.
The people who must live with the system use the documentation process to identify best practices and develop work flow improvements.
5. Internal auditing is seen as something that helps make the system better. It has as its main purpose continuous improvement, not policing and inspection.

Outsourced ISO Internal Auditing, Audits

Outsourced ISO Internal Audits, Auditing, Audit
Does your organization struggle keeping required ISO internal audits on schedule and productive?

Typical internal challenges include:

• Your internal auditors lack time and/or experience to make audits value added.
• Auditor training over and over again and auditor turnover.
• Auditors are not independent enough from the process to audit objectively.
• Auditors are not up to speed on the requirements of multiple Standards.
• Auditors do not know how to do a process audit.
• Auditors do not understand “core tools” as required by the automotive and aerospace industries.
• Your audit plans do not focus on customer requirements and satisfaction.
• Your audit results are not viewed as a tool for improvement.
• Your audit review and corrective action plan is ineffective.
• Your registrar has issued Corrective Action Request(s) and/or you are struggling with re-certification.

IQC can put your internal audit program back on track.

IQC’s CEO is on the US TAG to ISO/TC 176, the U.S. committee that drafts ISO 9001:2000 as well as the ISO Interpretations Committee. IQC provides trained and certified auditors who are knowledgeable, objective, and experienced in process audits. Our style of auditing looks at the effectiveness of the process and seeks out opportunities for improvement. IQC provides outsourced auditing to companies of all sizes and in many industries.

IQC offers the industry leading program for internal auditing outsourcing.

You may request a complete internal audit program; a single audit; coach led audits with your team; pre-assessments; or outsource ISO system management. Our auditors can audit and offer consultation at the same time. Take advantage of input on proven approaches, best practices, and benchmarking that your Registrar can not provide. IQC provides every client with a robust on-line audit management and corrective action portal for detailed communication, audit scheduling, documentation and “on demand” information concerning audit results and actions.

Benefits from Outsourcing Internal Audits:

• Professional auditors will provide complete documentation of internal audits for your Registrar or supplier audit.
• Our auditors will ensure that your system stays in conformance with changing requirements.
• Save on training costs.
• Achieve a robust quality and/or environmental management system.
• Reduce your internal audit costs by as much as 50%.... and enjoy superior results!

Please fill out and submit our RFQ page for a free cost/benefit analysis of outsourcing ISO internal audits specific to your organization.

Standards available for outsourced internal auditing include:
ISO 9001:2000
ISO/TS 16949:2002
ISO 14001
ISO 17025
ISO 13485
AS9100
OHSAS 18001