I’ve covered this topic before, but so many people continue to ask about the differences in the revised standard that I feel compelled to write again.
As most reading this probably know, the ISO9001 quality system standard is revised periodically. There was a version in 1994, another in 2000, and the latest revision came late in 2008. Hence the updated standard is now called ISO9001:2008.
Here are some things to know about the latest revision.
There are no new requirements for 2008. Yay! The bad news is…..well, there isn’t any bad news! The 2008 revision includes additional text to clarify some sections of the standard.
The changes to the quality standard include the following:
Clause 0.2 – Process approach: Text added to emphasize the importance of processes being capable of achieving the desired outputs.
Clause 1.1 – Scope: Clarification that “product” also includes intermediate product. Explanation regarding statutory, regulatory and legal requirements.
Clause 4.1- General Requirements: Additional explanation about outsourcing. Types of control that may be applied to oursourced processes. Relationship to clause 7.4 – Purchasing. Clarification that outsourced processes are the responsibility of the organization and must be included in the quality management system.
Clause 4.2.1 – Documentation: Clarification on needed records. Explanation about combining required documents. Explanation about ISO9001 requirements being covered by more than one procedure.
Clause 4.2.3 – Document Control: Clarification regarding controlling external documents.
Clause 4.2.4 – Records Control: Editorial changes only.
Clause 5.5.2 – Management Representative: Clarification regarding Management Representative being a member of the organization’s own management.
Clause 6.2.1 – Human Resources: Clarification regarding competency requirements for personnel involved in the quality management system.
Clause 6.4 – Work Environment: Clarification regarding working conditions.
Clause 7.2.1- Customer Related Processes: Clarifies post-delivery activities, warranty provisions, contractual obligations, supplemental services.
Clause 7.3.1- Design and Development: Clarification regarding purposes of design and development review, verification and validation. Review, verification and validation may be conducted and recorded separately or in combination as appropriate to the organization.
Clause 7.3.3 – Design and Development Outputs: Clarifies information needed for production and service provision includes preservation of product.
Clause 7.5.3- Customer Property: Explanation regarding intellectual property and personal data.
Clause 7.6- now retitled Control of Monitoring and Measuring Equipment: Explanation regarding use of computer software.
Clause 8.2.1 – Customer Satisfaction: Notes added to explain monitoring of customer perception.
Clause 8.2.3 – Monitoring and Measurement of Processes: Notes added to clarify appropriate methods, and that the organization should consider the impact on conformity to product requirements and on the effectiveness of the quality management system.
One year after the publication of ISO9001:2008 all accredited certifications issued, whether they be new certifications or recertification, will be to the 2008 standard.
Your ISO9001:2000 certification will be valid for 24 months after publication of the ISO9001:2008 standard. After that, it will not be valid.
If you already have ISO9001:2000 certification, you should have no problem getting recertified to the new 2008 standard, as there are effectively no differences.
- Is Design and Development a part of your QMS?
- The 21 records required by ISO9001:2000
- How much can you tailor ISO9001:2008 to your company?
- Information on ISO9001:2008 – its almost here!
- Using outside companies as part of your Production Process in ISO9001:2000