New ISO 9001:2008 requirements

New ISO 9001:2008

Information concerning the transition of the certification to DIN EN ISO 9001:2008

The basis for certification according to the internationally recognized quality standard DIN EN ISO 9001 was revised at the end of 2008.

Based on the implementation plan of ISO (International Organization for Standardization) and the IAF (International Accreditation Forum) all existing accredited certifications, new certifications as well as recertifications shall be transferred to the new DIN EN ISO 9001:2008. Existing certifications will become invalid within the next 2 years after publication of the new standard, which means November 2010 the latest.

The revised standard basically contains no new requirements. It is merely a clarification of the already existing standard. Furthermore, harmonizations concerning the regulations for certification of environmental and occupational health and safety management systems have been included.

We would like to present these specified requirements to you, which will have to be taken care of prior to the transition to the new standard and which will be evaluated during an audit. The carried out adaptation of the documentation will be subjected to an examination in advance.

• Outsourced processes are to be directed and monitored in a way which ensures that customer requirements as well as legal and regulatory requirements are fulfilled. (see 4.1 Notes 2 and 3)
• Detailed provisions have to be initiated for the necessary processes (core and supporting processes), including their interdependency. (see 4.2.1 d)
• A member of the management has to be named, who has the responsibility for safeguarding the standard conformity of the quality management system. This also includes the control of external parties, who are employed for the support of the QM system. (see 5.5.2)
• Employees have to be verifiably competent for the tasks they have been assigned to by the company. Decision competences have to be defined in the specifications of the organization (Organizational diagram, description of tasks and others). (see 5.5.1)
• Evaluation of the necessary regulations and obligations for activities after delivery. Especially the warranty provisions, contractual obligations such as maintenance and additional services, for instance re-use or recycling, as far as applicable or required. (see 7.2.1)
• The product status has to be ensured during the complete product realization process. (see 7.5.3)
• Aside from the intellectual property all personal data are deemed property of the customer. (see 7.5.4)
• Measures resulting form internal audits are now classified as necessary corrections and corrective actions, which have to be addressed without unjustifiable delay for the removal of recognized faults and their causes. (see 8.2.2)
• Appropriate core process indices (cpi) for process measuring have to bee determined and to be reasonably evaluated. These cpi can also be deduced from goals of individual departments of the organization. The effectiveness of the quality management system and fulfilling of product requirements have to be ensured for the determination of the cpi. (see 8.2.3)
• Clarification that aside from the general evaluation also the monitoring of the effectiveness of the initiated corrective and preventive measures has to be carried out. (see. 8.5.2 and 8.5.3)

For all requirements the appropriate objective evidence and records have to be kept.

For manufacturers who have already been certified by the VDE Testing and Certification Institute no basic changes in the audit procedure will result from the application of the revised DIN EN ISO 9001. The expert competence of the VDE auditors for the evaluation of the processes and thus the quality assurance measures of your company are resulting from the production-oriented VDE factory inspection and conformity control and have therefore already been implemented in the auditing of the companies on a regular basis.

For additional information concerning the transition to ISO 9001:2008 or the certification of your management system please contact our audit service at 0049 69 8306 270, via E-mail to audit@vde.com.

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