ISO 9001:2000 to ISO 9001:2008 Transition - What needs to be done?

For those who are already certified to ISO 9001:2000, you can follow the following simple list to ease your transition to ISO 9001:2008 version.

Since most of the changes in ISO 9001:2008 version are only clarifications, some of the below mentioned points may already be included in your QMS .

Action Plan for ISO 9001:2000 to ISO 9001:2008 transistion:

1. Ensure that the Management Representative (MR) of your organisation is employed by your organisation and is appointed by the Top Management. No external member of the organisation shall be appointed as the Management Representative from now on.

2. Identify areas/sections in your QMS documentation that can be simplified. Use this transistion opportunity to rewrite the manual and delete any procedures, paragraphs or formats which are redundant. Combine two or more procedures into one wherever feasible. ( Eg: Combine Control of Documents & Records into one procedure)

3. Change the "ISO 9001:2000" term to "ISO 9001:2008" at all places in the Quality Manual/ Procedures and formats. ( Or better still change it to ISO 9001 , so that in future when u need to make changes to the next version you do not need to keep changing everywhere)

4. Ensure that all the processes determined by the organisation are mentioned in the QMS documentation. It can be done in the Quality Manual , procedures or any other document of the QMS.

5. Indicate Outsourced processes and evaluate the sub contractor as per clause 7.4 ( Supplier evaluation)

6. Clearly indicate in the Quality Manual if there are any exclusions to the ISO 9001:2008 standard. Mentions the reasons for exclusions.

7. Prepare competence for personnel effecting conformity ( directly or indirectly ) and identify the person / function.

8. Replace the word " Device" with "Equipment" in all QMS documentation and ensure that a list of equipments which require calibration is identified and documented.

9. Ensure that data analysis covers :

Customer Satisfaction, Product Conformity, Suppliers and Process Effectiveness

Include formats which will be used for data analysis and the function responsible

10. Include Corrections and Effectiveness of Corrective Actions in Non Conformance Report. (Sample will be uploaded here soon !!)

11. Ensure Root Cause Analysis is conducted for finalizing Corrective Actions. ( Method of conducting root cause analysis and a sample shall be uploaded here soon !!)

12. Ensure that the internal audit procedure includes all aspects of audit plan, audit team, audit report, audit checklist, correction and corrective action.A list of approved internal auditors is to maintained. Competence for internal auditors shall be indicated. ( A General Internal Audit checklist for QMS shall be uploaded here soon !!)

Ensure that your internal auditors have undergone a training for the ISO 9001:2008 changes.

Once you have completed the required changes, you can conduct an internal audit and management review. Then inform your certification body for a surveillance or recertification audit so that you get certified to the ISO 9001:2008 version.

For further clarifications, please feel free to write to us : grahak.thecustomer@gmail.com