ISO9001:2008 Auditor Checklist - Eagle Certification Group

1 Eagle Certification Group 123 Webster Street, Suite 300 | Dayton, OH 45423 | | fax | 1 iso9001 : 2008 Auditor Checklist Auditor Directions: Record the document(s) and/or record(s) reviewed in the Client Question column to verify that the requirement has been implemented. If company has justified an exclusion, write exclusion as the response. Clause Description Client Question General Does the organization have a copy of iso 9001 : 2008 and is it included as part of their external documents? General Requirements of Quality Management System 1. Has the company determined processes? 2. Any processes being outsourced (organization responsible for meeting the requirements, even if the customer designates the source)? Quality Manual 1. Have company documents been revised to meet the intent of iso 9001 : 2008 ? 2. Have these documents been reviewed and approved? Control of Records 1.

2 Are records controlled? 2. Are the controls defined in the required procedure? Management Representative 1. Is the Management Representative an employee of the company? 2. Is the Management Representative given authority to make decisions regarding the QMS? 3. If the Management Representative is a contracted employee or consultant, are they actively involved in the management of the QMS and given authority to make decisions? Management Review Did Top Management review changes to the QMS as it relates to iso 9001 : 2008 ? Human Resources (General) What records of training/competence are available for all employees whose work affects conformity to the product (quality, service, delivery, maintenance, etc.)? Infrastructure Are Information Systems defined as a support system in the QMS as applicable to electronic documents, records and data? Eagle Certification Group 123 Webster Street, Suite 300 | Dayton, OH 45423 | | fax | 2 iso9001 : 2008 Auditor Checklist Clause Description Client Question Work Environment Has the organization considered the effect of environment to product conformity (physical, environmental and/or noise, temperature, humidity, lighting, weather, ) Determination of Requirements Related to the Product Have post-delivery requirements been addressed, as applicable, defined by warranty provisions, maintenance services, or others such as recycling or final disposal?

3 Design & Development Outputs If Design is covered under the QMS, has preservation of product been considered for the production and service provision (shelf life, exposure, storage, obsolescence, recycling, disposal)? Identification & Traceability Are materials properly identified throughout possession (no suspect or unidentified material)? Customer Property Has both intellectual and personal data been addressed with regard to effective control and confidentiality? Customer Property Has effective control and confidentiality been considered with regard to both intellectual and personal data (customer property)? Preservation of Product Is product protected while in possession and delivered according to customer requirements? Control and Monitoring of Measuring Equipment Is measurement software validated before use? Is software current and controlled? Customer Satisfaction Have customer perception methods been addressed/ defined?

4 Internal Audits Has an audit been performed to verify implementation and effectiveness? Monitoring & Measuring of Processes 1. Have all identified processes been measured for effectiveness? 2. Is each identified process achieving organizational objectives? Monitoring & Measuring of Product Has evidence of conformity been maintained with acceptance criteria? Criteria: Corrective Action/ Preventive Action Have actions been taken to eliminate nonconformities and are these actions effective?