QMS

Quality Manual Reference

Are processes for QMS identified and their sequence & interaction defined?

Is scope of QMS Included in Manual?

Does manual include Details of exclusions with justifications?

Are all elements of QMS addressed?

Any Statutory and/or regulatory requirements applicable to the product identified and complied with?

Is there a documented statement of Quality Policy?

Have Quality objectives & targets been identified and are monitored?

Are the six mandatory documented procedures available? (any other procedure need to be referred

Are Internal audits conducted as planned? Date of Last Internal Audit?

Are Management reviews conducted as planned? Date of Last MRM?

Are customers complaints recorded? Is there evidence of resolving the same?

Are there any open customer complaints?

Is there any outsourced process effecting in the conformity of the product?

Is there any Special Process? If yes specify the same

Observations (Areas Of Concerns Which May Be Identified As Non Conformities During Stage 2 Audit)