1) Control of Documents Procedure:-
This is one of the “Mandatory Procedure” requires by the ISO 9001. Any documents required by the ISO 9001 system must be controlled. Documents include:
- Internal documents (like Quality Policy, Quality Objective, Quality Manual, Quality Procedure, Work Instruction, BOM, Inspection Standard and etc)
- External documents (like Law Book related to organization, Customer Drawing, Customer Specification Requirement and etc).
- Records, in ISO 9001 system, Quality Records and Forms (like Inspection record, Production Record and etc) are a special type of document, and the control must follow the Clause 4.2.4 “Control of Records”
Records are generated to provide evidence of implementation, monitoring and control of Quality Management System processes. The control method must include:
- To ensure identification of record, in common practice, we will assign a form number to identify it.
- To ensure the storage methods able to prevent damage, lost and able to retrieved by other
- To ensure the retention of records are identify clearly.
- To ensure the disposition of records are identify clearly.
- To ensure records are remain legible to other.
3) Internal Audit Procedure
Internal audits carried out at planned intervals to ensure the maintenance, improvement and integrity of QMS and its processes.
4) Control of Non-conforming Product Procedure
If any Nonconformity found during the internal audit, the management of the organization is responsible to ensure any necessary corrections and corrective actions are taken without undue delay to eliminate the nonconformities and their causes. This ensures that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery.
5) Corrective Action Procedure
ISO 9001 requires organization to take action to eliminate the causes of nonconformities in order to prevent recurrence. The corrective actions taken must able to address the nonconforming root cause.
- The organization must establish a procedure to define:
- Reviewing the nonconformities including customer complaints
- To determine the causes of the nonconformities
- Determining and implementing necessary action needed to correct the nonconformities.
- To review the action taken and effectiveness of the actions to ensure that nonconformities do not recur.
- Record result of correction action
6 )Preventive action Procedure
ISO 9001 requires organization to take action to eliminate the causes of potential nonconformities in order to prevent their occurrence. The preventive actions taken must able to address the potential problems.
- The organization must establish a procedure to define:
- Reviewing the potential nonconformities and their causes
- Determining and implementing necessary action needed to prevent occirrence of nonconformities.
- To review the action taken and effectiveness of the actions.
- Record result of preventive action
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ISO 9001
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iso 9000
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