HIGHLIGHTS OF ISO 9001:2008 CHANGES

1. ISO 9001:2008 Version released in Nov 2008.

2. The Standard can be used for assessment of meeting organization’s capability to meet
customer, Statutory, regulatory requirements related to the product apart from
organizational requirements.

3. Purchase, Quality (Clause 4.1) : Control of outsourced processes (including Job work)
need to be elaborately detailed in the Quality Management system (QMS) including type
and extent of control:
a) Criteria for Selection, Evaluation of Supplier / service provider of outsourced
processes with related records such as supplier approval form, supplier evaluation
report.
b) Job-work Quality Plan
c) Inspection records of receipt of material after job work processing
d) Annual Maintenance Contract /Job work order
e) Service visit report of service provider
f) Visit report to job-worker

4. Documentation requirements-MR (Clause 4.2.1)- Multiple procedures /documents

can be combined into one and vice versa.

5. Document Control (Clause 4.2.3): External documents related to planning and

operation of QMS need to be determined.

6. Mgt Representative -MR (Clause 5.5.2)- Mgt Representative should be member of

organization’s own management.

7. Human resources –HR- (Clause 6.2.2)-Competency of personnel performing work

directly or indirectly affecting conformity to product requirements need to be identified.
Training should be provided to achieve the necessary competence.

8. Infrastructure –Admin (Clause 6.3)- Information systems-Computer controls

/Electronic data controls included.

9. Work environment-Admin (Clause 6.4)-Requirements made more elaborate such as

Temperature, noise, lighting, humidity controls.

10. Customer related processes-Marketing (Clause 7.2)- The post-delivery (Warranty,

etc) activities should be covered under contract review process.

11. Design-(Clause 7.3) - Design Review, Verification and Validation can be combined or
conducted separately as appropriate.
Packing requirements need to be considered during design output.

12. Identification and traceability-Production-(Clause 7.5.3)-Product identification

should be maintained throughout Production cycle.

13. Control of monitoring and measuring equipment-Calibration-(Clause 7.6)-

Computer software, if used for monitoring and measurement will be confirmed for ability
to satisfy intended application.

14. Customer Satisfaction-Marketing-(Clause 8.2.1)-Sources of customer feedback to

include Lost business analysis, customer appreciation, warranty claims, dealer reports,
customer data on product Quality.

15. Monitoring and measurement of product-Quality (Clause 8.2.4)-Records should

indicate person authorizing release of product for delivery to customer.

16. Corrective and preventive action-Clause 8.5.2, 8.5.3-Effectiveness of corrective

action and preventive action should be reviewed.