ISO 9001: 2000 INTERNAL AUDIT SCHEDULE ISO …

1 iso 9001 : 2000 INTERNAL AUDIT SCHEDULE iso 9001 : 2000 Section Ref. quality management system Evidence Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec General Requirements Process Flowcharts Documentation Requirements All QA Documents General All QA Documents quality Manual quality Policy Manual Control of Documents Procedure QS 02 Control of Records Procedure QS 04

2 iso 9001 : 2000 Section Ref. management RESPONSIBILITY Evidence Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec management Commitment From Senior Managers Customer Focus SMT Mtgs & Contracts quality Policy Policy Statement

3 Planning quality Objectives Cancer Core Standards quality management Syst. Planning All QA Documents Respons, Authority & Communictn Responsibility and Authority Job Descriptions management Representative quality Managers jobs INTERNAL Communication Minuted meetings management Review General Review Mtg minutes Review Input Review Mtg minutes Review Output

4 Review Mtg minutes Profile Consulting iso 9001 : 2000 INTERNAL AUDIT SCHEDULE iso 9001 : 2000 Section Ref. RESOURCE management Evidence Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Provision of Resources SMT Mtgs Human Resources Procedure QS 06 andTraining Records General Procedure QS 06 Competence, Awareness & Training Training Records Infrastructure management Review Work Environment management Review iso 9001 : 2000 Section Ref.

5 PRODUCT REALIZATION Evidence Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Planning of Realization Cancer Core Standards Customer-Related Processes Requirements related to Product Service Contracts Review of Requirements & Product Service Contracts Customer Communications Patient Information Design and Development CL 01- 03, RA 01- 02,RP 02- 03 Purchasing Purchasing Process Standing Orders Purchasing Information Standing Orders Verification of Purchased Product Standing Orders Production and Service Provision Production & Service Provision RA 01- 08, RP 01- 09, NS 01- 07.

6 OP 01- 03 Validation of Processes for management Review Identification and Traceability Patient Notes Customer Property Trust Policy Preservation of Product Procedure QS 04 Monitoring & Measuring Devices RP 04- 06, RP 08 & RA 03 Profile Consulting iso 9001 : 2000 INTERNAL AUDIT SCHEDULE iso 9001 : 2000 Section Ref. MEASUREMENT, ANALYSIS AND IMPROVEMENT Evidence Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec General Monitoring and Measurement Customer Satisfaction Patient Satisfaction Surveys & analysis INTERNAL AUDIT Procedure QS 05 Monitoring & Measure of Processes Procedures QS 05, & QS 01 Monitoring & Measure of Product Procedure QS 05 Control of Nonconforming Product Procedures QS 03, & RP 07.

7 OP 03 Analysis of Data management Review Improvement Continual Improvement Procedure QS 01 Corrective Action Procedure QS 03 Preventive Action Procedure QS 03 Profile Consulting