Interpretation of various clauses in ISO : 9001 Model

ByDhaval ShahKaushal PatelVarun Patel

Krunal HiraniKhumansinh Chavda

• Management Responsibility• Contract Review• Documents Control• Purchaser Supplied Product• Product Identification and Traceability• Inspection Measuring and Test Equipment• Control of Non-Conforming Products• Handling, Storage, Packaging and Delivery• Internal Quality Audit• Inspection and Test Status

List of Clauses:

• Quality System• Design Control• Purchasing• Process Control• Inspection and Testing• Servicing• Corrective Action• Quality Records• Training• Statistical Techniques

• Document Control• Quality Records• Internal Quality Audit

We are here to explain 3 clauses as mentioned below:

Document ControlDocument Control refers to the establishment and

maintenance of a documented procedure for maintaining, approving, issuing, reviewing all the documents.

Following documents should be documented:• Quality Manual• Standard Operation Procedure• Process Specification (Procedure to be Followed)• Flow Charts (Process Steps)• Operation Process Sheet (Routing Sheet)• Gantt Charts (Project Schedule)• Control Charts (Process Variation Control)

Quality RecordsQuality Records are the documents related to the Quality of

past products/processes and they need to be maintained for a certain amount of time.

This clause takes care of the following:• Establish, Document and maintain procedures for Identification,

Collection, Indexing, Filling, Storage, Maintenance and Disposition of Quality Records.

• Quality Records should be Legible and Identifiable.• Retention Period should be established and recorded.• Proper procedure must be maintained for removal/disposal of records

after they are out of date.

Internal Quality AuditInternal Quality Audit refers to the auditing of the system in place and

checking for its effectiveness and also suggesting corrective measures for the same.

It includes:• Carrying out planned and documented internal quality audit.• Audit should be scheduled on the basis of the status and importance of the

activity.• Audits must be used to verify the effectiveness of the quality system.• Findings, conclusions, and recommendations should be submitted in

documentary form containing examples of non-conformance, reasons for it and appropriate corrective actions for the same.

• Implementations and Effectiveness of corrective actions should be assessed in the future audits.

Thank You.

Questions?