Jules 2011

Refs

INTERNAL AUDIT CHECKLIST ISO 9000 2008 STANDARD

Issued by: Juliet Namayanja Requirements Date: 30-08-2011 What to look for and how Auditee: Head Medical Department Complian ce Auditor notes and evidence

4.2.2 Quality manual- ISO 9000 2008 : Standard 4.2.2 Does your organization have a quality Manual? Does it include the following: The scope of your QMS(as in up) and justifications and details of any exclusions The documented procedures for the QMS or reference them? A description of interactions Is the quality manual addressing all relevant requirements of ISO 13485 and CFR 21 Part 820? Are exclusions from Section 7, Product Realization, documented in the quality manual (if any)? Are operational procedures included or referenced in the quality manual? How the interaction between the processes of the quality system is documented (process map, flowcharts, etc.)? How is the structure of the quality system documentation outlined in the manual? Look at the manual

Between the processes of the

QMS The scope of the quality management system and exclusions, operational procedures or references to them, description of the interaction between the processes of the quality

INTERNAL AUDIT CHECKLIST

Refs Requirements What to look for and how

Internal Auditee 2011 Complian ce

Auditee: Head of Medical Business

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Auditor notes and evidence

system, and Outline of the structure of the quality system documentation? The organizational structure reflecting all company positions? Are staffs aware of the quality manual and make reference to it often when necessary?

Customer service Charter Do you have a customer complaints register? In how many days do you respond to such complains? Do you avail customers with your contact details? Do you have a customer service desk? Does it register and handle customer inquiries? How do you secure clients information? How have you safeguarded the environment?

Copy of the complaints register Evidence of response Evidence to that effect Actual desk to be shown Copy of register for complaints and evidence of handling Security evidence Details of any environmental campaigns the company is involved in A look around the office

INTERNAL AUDIT CHECKLIST

Refs Requirements What to look for and how

Internal Auditee 2011 Complian ce

Auditee: Head of Medical Business

Pg. 3 of 3

Auditor notes and evidence

Is the office surroundings,secure, warm and safe