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
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
“ All activities of overall management function that determines the quality policy, quality objectives and responsibilities and implement them by means of such as quality planning, quality assurance and quality improvements within the quality system” or in short “ this is a management system to direct and control an organization with regard to quality”
The quality management system defines the quality environments within a business. Every business is different and so each QMS will be unique and different.
Improvements required where requirements (customer, legal, policy, and objectives) are not being met
Improvement should be integral to and achieved through the quality system
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.
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
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
New ISO 9001:2008 Certification valid for 3 years , Surveillance Audit will be held after 1 year,9 months or 6 months of certification Audit to ensure continued implementation & Continual improvements in the Organization.