ISO 9001 requirements   by Sonal Gupta

in Business    (submitted 2011-10-08)

During an ISO audit, the auditor will be asking for records or evidence the quality system being audited has effectively maintained the records required. For example, when an auditor is reviewing the corrective and preventive action system, he or she will be looking for a CAPA Report to provide evidence that the CAPA system has met the requirements for section 8.52 Corrective Action and 8.5.3 Preventive Action.Yhe ISO 9000 Quality Management System Standard has many references to 4.2.4 Control of Records. Everywhere ISO 9001 references 4.2.4, there must be a record. Although the ISO 9001:2008 only requires six procedures the standard has twenty one (21) references to Control of Records (4.2.4). Note: Section 7.6 of the standard contains two references.ISO 9001 mandatory procedures

* Document control procedure 4.2.3
* Control of Records procedure 4.2.4
* Internal audit procedure 8.2.2
* Control of non-conformance procedure 8.3
* Corrective action procedure 8.5.2
* Preventive action procedure 8.5.3

ISO 9001 requirements:

* Quality policy
* Quality objectives
* A quality manual
* Other documents required for effective planning, operation and control
* The records specified by ISO 9001

Summary

* The purpose of the audit is to ensure that the quality management system is as required by the ISO 9001 Standard and appropriately maintained.
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Implementing a new Quality System takes time and resources. Your new ISO 9001 Quality Manual and Quality System will become your road map to success. There are many resources that can help keep an implementation on the right track. The International Organization for Standards has a wealth of information at your disposal. ISO has some of the most valuable resources available in the form of guidance documents. Some of these resources are listed below:

* Guidance on ISO 9001:2008
* Guidance on the documentation requirements of ISO 9001:2008
* Guide to the Terminology used in ISO 9001 and ISO 9004
* Guidance on the concept and use of the process approach for management systems
* Guidance on "Outsourced processes"
* Implementation guidance for ISO 9001:2008

You are required to maintain a documented procedure specifying the process of the internal audit.
* The auditor bears a lot of responsibility. Therefore he must be perspective to the environment that he is auditing, must own the skills for evaluating and examining, with a wide view of things.
* The auditor must be polite with high manners, be patient and persistent. The audit is not an easy task to perform. The organization must maintain an audit program. The purpose of the program is to ensure that the audits are conducted as planned.
* At the end of the audit the auditor must deliver a specified report about the audit. This report is designated to the function that is responsible for the auditee.

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About the Author

ISO is Short form of International Organization for Standard. ISO 9001:2008 require an organization to develop a quality management system that fits the product & Process requirement as well as regulatory requirement AS an ISO 9001:2008 certified company.
The main consultant we depute understand the type of your industry and associated activities hence will design the Quality Management System most suitable for your needs. We will also provide training to all your employees regarding QMS and will suitably modify the system as a result of such interactions.
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