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General Information
Who is responsible for Quality on site?
Are you responsible for the manufacture of your products or do you act as a distributor?
What products do you produce?
Do you inform your customers of any changes?
How do you inform customers of any changes?
Independent formal certification or accreditation
Do you have any independent formal certification or accreditation?
When was your last surveillance visit by your Certification / Accreditation body?
Quality Management System
Is there a QMS in place?
Is there a Quality Manual in place and can a copy be provided?
Do you have a self inspection program in place?
Do you have a document control system in place?
Do you regularly review all your controlled documents?
Is there a documented procedure for dealing with non-conforming product?
Is there a corrective and preventative action system in place (CAPA)?
Do you have a complaints system in place?
Who would be your primary contact for making a complaint?
How do you keep the complainant up to date with regard to the progress of their complaint?
Are all complaints logged and given a unique tracking number?
Do you have a recall system in place?
How do you notify customers about a recall?
Do you have a change management system in place?
Do you have a risk management system in place?
Do you issue Certificates of Analysis (CofA) for your products?
What certification do you provide for products of animal origin or containing animal derived components?
Do you have a training programme and training records in place?
Do you have any procedures for calibration, maintenance and verification of equipment?
Would you be willing to be audited by us?
Do you subcontract any part of the manufacturing process or distribution?
Do you have a supplier audit programme or vendor rating scheme in place?
Are supplies / products obtained from formerly approved suppliers?
Is a batch numbering system used for the Products?
How are products stored before dispatch?