1. The International Organization for Standardization (ISO) is responsible for creating quality standards, with over 800 new standards issued annually. ISO 9000 is the quality management system standard series. 2. ISO 9001:2008 provides requirements for a quality management system, including demonstrating the ability to consistently provide products that meet customer and regulatory requirements through effective processes and continual improvement. 3. A quality management system involves all organizational functions to direct and control an organization with respect to quality through activities like quality planning, assurance, and improvement. It defines the organization's quality environment.

1. Business Excellence Through QMS Conformance to Performance By Arefin Khan Director, QUICK ISO.com (B.Sc. IT, MBA Marketing, Lead Auditor ISO 9001 series, ISO 14001, ISO 18001, ISO 27001,HACCP) E-mail: [email_address] , Web: www.quickiso.com Contact : +91 9768374277

9. P- D- C- A CYCLE ACT CHECK PLAN DO TAKE APPROPRIATE ACTION Check effects Determine goal Determine Method of Reaching goal Education & training Implementation

11. Process Definition Process Outputs Input A system of activities which uses resources to transform inputs into outputs. Effectiveness of process:Ability to achieve desired result Efficiency of process: Results achieved Vs resources used Includes resources Product- result of process

31. List of Mandatory Records Required Design & Development - review 7.3.4 6 Design & Development - input 7.3.2 5 Customer Related Processes 7.2.2 4 Service Realization 7.1 3 Human Resources 6.2.2 2 Management Review 5.6.1 1 Type of Record Clause No. Sl.No.

32. Continued......... Customer Property 7.5.4 7.5.4 14 Validation of Processes for Production and Service Provision 7.5.2 7.5.3 13 Process Validation 7.5.2 12 Planning 7.5.1 11 Purchasing/Supplier Evaluation 7.4.1 10 Design & Development –review of changes 7.3.7 9 Design & Development - validation 7.3.6 8 Design & Development - verification 7.3.5 7

33. Continued......... Preventive Action 8.5.3 20 Corrective Action 8.5.2 19 Control of Nonconforming Services 8.3 18 Monitoring & Measurement of Services 8.2.4 17 Internal Audit 8.2.2 16 Control of Monitoring & Measuring Devices 7.6 15