ISO 9001 Compliance

The newest version of the ISO 9001 standard was released in November, 2008. As was the case the last time the standard was revised (2000), all currently certified companies must upgrade their quality management systems to meet the new requirements. The deadline for transitioning your certification to the ISO 9001:2008 is 24 months following the release of the new standard.

Those who went through the previous transition from the 1994 version to ISO 9001:2000 know first-hand the disruption that was caused by the significant changes introduced by the last revision. It was very costly for all certified companies to change over to the new version.

The good news is that the 2008 release does not have the same impact. In fact, the ISO technical committee (TC176) who develops the ISO 9001 series of standards purposely planned the new release as an amendment rather than a formal revision. The difference is that an "amendment" is focused on making changes for clarification purposes only and for better alignment with ISO 14001, the standard for environmental management. With the 2008 release, the ISO committee purposely intended not to introduce substantive changes that will affect the QMS processes and documentation of currently certified organizations. Thus, the new ISO 9001:2008 standard has less impact on companies already certified.

Many of the edits to the new standard were to improve the clarity and consistency of the requirements but have no impact on the meaning of the text. There are, however, a few modifications that may require changes to your quality management system. Here is a list of some of the more substantive changes in the ISO 9001:2008 standard:

4.1 General Requirements	Ensure that the type and extent of control of your outsourced processes are clearly defined.
4.2.4 Control of Documents	Review the external documents you currently control to include those that pertain directly to the quality management system.
5.5.2 Management Representative	Confirm that your management representative is a member of your company's management, rather than someone who does not have management level responsibility or is not employed by your company.
6.2.1 Human Resources	Include in your training process all employees whose work directly or indirectly impacts conformity to product requirements or has responsibility for tasks within the quality management system.
6.2.2 Training	Confirm the necessary employee competence has been achieved following training.
6.3 Infrastructure	Include information systems in your infrastructure requirements.
6.4 Work Environment	Ensure that all applicable conditions listed in the new standard are being managed effectively.
7.2.1 Customer-related Processes	Include all applicable post-delivery activities described in the new standard in your planning processes.
7.3.3 Design and Development	Consider preservation of product (e.g. packaging/labeling requirements) during the design process.
7.5.5 Preservation of Product	Review controls in place to address applicable product preservation requirements as shown in the new standard.
7.6 Control of Monitoring and Measuring Equipment	Note the change from control of "devices" to "equipment"; also confirm computer software used for monitoring and measuring is verified and maintained rather than "calibrated."
8.2.1 Customer Satisfaction	Consider expanding your customer satisfaction to include more than a traditional customer survey.
8.2.2 Internal Audit	Distinguish between "corrections" and "corrective actions" in your audit process and records.
8.2.3 Monitoring and Measurement of Processes	Expand your use of correction and corrective action beyond problems affecting conformity of the product to include any process results that do not meet requirements.
8.2.4 Monitoring and Measurement of Product	Ensure that final authorization records include release of your product for delivery to the customer, not just internal release.

For most certified companies, upgrading your documentation to meet the ISO 9001:2008 requirements should be straightforward. As you get acquainted with the new standard, you should consider its impact on the following:

• Quality manual
• Procedures
• Quality records
• Internal audit

Changes to your quality manual should be based on ensuring that the documented quality manual policies are consistent with the revised requirements in the new standard. Review your current quality manual wording to reflect the intent of the new requirements.

You should also review your documented procedures that may be impacted by the modified sections of ISO 9001:2008. Pay special attention to the six mandatory procedures specified by the ISO standard that include:

1. Control of Documents (4.2.3)
2. Control of Records (4.2.4)
3. Internal Audit (8.2.2)
4. Control of Nonconforming Product (8.3)
5. Corrective Action (8.5.2)
6. Preventive Action (8.5.3)

Review your quality records to ensure that they adequately address the new requirements. Pay special attention to records of training (6.2.2), internal audit (8.2.2), and product release (8.2.4).

Finally, your internal audit process should be updated to ensure that your auditors are auditing to the current standard. To ensure this, you should update or replace any audit checklists being used by the team to ensure all ISO 9001:2008 requirements are being audited. You may also want to provide some training to your auditors to help them understand the changes.

The release of ISO 9001:2008 should be a fairly simple transition for most organizations. If you are currently preparing for your initial ISO 9001 certification, there is no reason to delay or to change your approach. You should simply purchase a copy of the new standard and review your documentation to ensure compliance.

If your company is currently certified, you also will need to get a copy of the ISO 9001:2008 standard to update your quality management system. To simplify your transition, you might consider using a set of updated documentation templates to reduce the time you'll need to hunt down which of your documents you need to update and to help your auditors quickly come up to speed.

9000World is providing a special ISO 9001:2008 Transition Kit to aid companies with upgrading to the new standard. This Kit provides specific guidance for updating your quality manual and other documentation along with an easy way to help your internal auditors implement the new requirements.