Update on FDIS Changes to ISO 9001:2000

The FDIS version of ISO 9001:2000 has changed some clause numbering, as well as, added or revised numerous requirements. 

Clause Numbering
Quality plan (5.5.5), document control (5.5.6), and record control (5.5.7) of the Management Responsibility section of the DIS version are now under Documentation Requirements in 4.2.2, 4.2.3, and 4.2.4, respectively. The 5.5 Administration section has become Responsibility, Authority, and Communication. 

Another numbering change is the movement of process validation from 7.5.5 in the DIS to 7.5.2 in the FDIS, along with a revised title of Validation of Processes for Production and Service Provision.

Outsourced Processes

An addition in 4.1 General Requirements is a statement that any outsourced processes affecting product conformity must be identified and controlled. 


Management Reviews
The Review Input under 5.6.2 now includes “recommendations for improvement” as an agenda item for management reviews. 


Process Development
A new note under 7.1, Planning for Product Realization, says an organization may also apply the design and development requirements of 7.3 to the development of product realization processes. 


Internet Sales
A new note under 7.2.2, Review of Requirements Related to the Product, states
that in some situations, such as Internet sales, a formal review is impractical for
each order. In these cases, the review can cover relevant product information in catalogs and advertising material. 


Purchasing Information
The Design and Development Outputs addressed by 7.3.3 now require information for Purchasing to be provided in addition to the information for production and service. 


Configuration Management
A new note under 7.5.3, Identification and Traceability, states that for some industry sectors, configuration management is used to maintain identification and traceability.


Equipment Identification
A new clause, 7.6.c, under Control of Monitoring and Measurement, requires measuring equipment to be identified to enable calibration status to be determined. 


Auditor Independence
Auditors no longer have to be independent of the audited activity. According to 8.2.2, Internal Audit, auditors must now be selected to ensure objectivity and impartiality. However, they still must not audit their own work. 


Preventive Action
A new requirement under 8.5.3, Preventive Action, requires an organization to reevaluate the “need” for action to prevent occurrence of nonconformities. 


You can order the full set of FDIS standards (9000, 9001, and 9004) from ASQ for a member price of $79.50.  You can order the standards online at: http://qualitypress.asq.org