Significant changes in the ISO 9001:1994 revision
The significant changes in the ISO 9001:1994 revision are given below :
Significant changes in ISO 9001:1994
The relevance of the quality policy to customer expectations and needs as well as to the suppliers internal organizational goals has been enhanced. The clause emphasizes the need to address process and quality system problems, rather than only the nonconformity of products. This clause now requires the identification and provision of resources not only for verification but also for management and performance of work.
This clause now calls for the preparation of a quality manual that defines the documentation structure of the quality system. The reference to the quality manual, which was originally covered by the note to this clause. It has been brought into the main text. The clause also states that the quality plan ” shall include or make reference” to the procedures which form part of the suppliers quality system.
This requirement now includes tender review in addition to review before acceptance of a contract of order.
It has been expanded to include design validation and separate requirements for design review and design verification.
Document and data control
This clause now covers data in addition to documents. It also recognizes that data can be in any form of media such as hard copy or electronic media. This requirement calls for the identification of obsolete documents which are retained for legal and knowledge preservation purposes.
The term “assessment of subcontractors” has been replaced by “evaluation”, which connotes a more comprehensive examination of the subcontractors capability. The verification of purchased products now covers verification at the subcontractors premises by the supplier as well as the customer.
This clause now includes additional requirements for the maintenance of process equipment to ensure continuing process capability.
Corrective and preventive action
The scope of this clause has been expanded to cover preventive action in addition to corrective action. Corrective action is desired towards eliminating the causes of actual nonconformities, while preventive action is directed towards eliminating the causes of potential nonconformoties.
Handling, storage, packaging, preservation and delivery
A separate subclause on preservation has been added to emphasize its importance in the quality system.
Internal quality audits
It is made clear that an audit must be carried out by personnel independent of those owning a direct control for the act is being audited. Follow up audits are now required to verify and record the implementation and effectiveness of any corrective action taken. The results of internal quality audits have to be compulsory put up for review by management.
This clause now requires suppliers to identify needs for statistical techniques and to establish procedures to implement and control the application of identified statistical techniques.
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