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Cypress Technologies Successfully Upgraded to ISO 9001:2008

Permalink 06/17/09 | by admin Email | Uncategorized, Manufacturing,

Cypress Technologies Successfully Upgraded to ISO 9001:2008

June 6, 2009

After the re-assessment of the existing ISO certification to ensure that all elements of the scope of registration and all requirements of the management standard have been met, Cypress Technologies successfully upgraded to ISO 9001:2008. There were no nonconformities identified.

Cypress Technologies is one of the first companies to achieve this accomplishment.

ISO 9001:2008 was introduced with no new requirements but with content to refine and clarify some of the requirements of ISO 9001:2000. The need to revise ISO 9001:2000 is based on ISO's continual review process, incorporation of user defined inputs and keeping the standard aligned to recent developments in management system practices. Users of the former standard should evaluate their existing management system against the changes as identified in ISO 9001:2008, Annex B, and make any required adjustments prior to requesting their registrar to verify conformance to the new standard at their next surveillance or recertification audit.

The following are examples of changes for General Requirements of ISO 9001:2008:

4.1 General Requirements

a) Determine the processes needed for the quality management system and their application throughout the organization (see 1.2),

Although similar, the words 'Identify' and 'Determine' have slightly different meanings. To identify is to recognize or establish something as being a particular thing. To determine is to apply reason and reach a conclusive decision. Therefore, to determine the processes implies more analysis and judgment than merely identifying them.

e) monitor, measure (where applicable) and analyze these processes, and ...

Processes are monitored, but may not need to be measured. Therefore, the requirement change indicates processes are only measured where applicable.

Later in clause 4.1 regarding outsourcing:

The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system.

This addition clarifies that specific controls are to be defined and applied, not just identified. See the new Note 3 below for an explanation of the type and extent of controls for an outsourced process.

Next, the current Note under clause 4.1 has been expanded and two new Notes have been added:

NOTE 1: Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization, and measurement, analysis, and improvement.

This change expands from "measurement" to "measurement, analysis, and improvement" to match the title for clause 8. And, by deleting "should", the Note clearly states that these processes are included.

The new Notes are:

NOTE 2: An outsourced process is identified as one being needed for the organization's quality management system but chosen to be performed by a party external to the organization.

This new Note provides an explanation of what is considered an outsourced process. The next Note identifies the factors influencing the control of an outsourced process.

NOTE 3: The type and nature of control to be applied to the outsourced process may be influenced by factors such as:

a) the potential impact of the outsourced process on the organization's capability to provide product that conforms to requirements;

b) the extent to which the control for the process is shared;

c) the capability of achieving the necessary control through the application of clause 7.4.

Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory, and regulatory requirements.

Outsourcing a process to another organization typically involves the purchase of those services. As a result, the requirements of clause 7.4, including the controls mentioned in 7.4.1, apply to the supplier selected to perform the outsourced process.

1 BSI Customer News Letter – February 2009
2 Whittington Newsletter – January 2008
3 Whittington Newsletter – January 2008

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