Mandatory Records for ISO 9001 QMS

ISO 9001 standard is a generic universal standard applicable to all kind of busienss organizations. Number of records that a company has to maintain to comply with ISO 9001 standard depends a lot of parameters like nature, size, process complexity, customer requirement etc. There are some mandatory records identified by the standard during various clauses wherein reference to clasuse 4.2.4 is made.

Given below are the mandatory records for ISO 9001 :2008 Quality Management System.

 

4.2.3 – Control of Documents

•

5.6.1 – Management Review, General

•

6.2.2 – Competence, Training and Awareness

•

7.1 – Planning of Product Realization

•

7.2.2 – Review of Requirements related to the product

•

7.3.2 – Design and Development Inputs

•

7.3.4 – Design and Development Review

•

7.3.5 – Design and Development Verification

•

7.3.6 – Design and Development Validation

•

7.3.7 – Control of Design and Development Changes

•

7.4.1 – Purchasing Process

•

7.5.2 – Validation of processes for production and service provision

•

7.5.3 – Identification and Traceability

•

7.5.4 – Customer Property

•

7.6 – Control of Monitoring and Measuring (2 References)

•

8.2.2 – Internal Audit

•

8.2.4 – Monitoring and Measurement of Product

•

8.3 – Control of Non-Conforming Product

•

8.5.2 – Corrective Action

•

8.5.3 – Preventive Action

Please note that this is the minimum records list. an organization has to maintain process/business specific additional records to ensure overall busienss effectiveness and control.