Freelance ISO Consultant
SBSR Management Systems
Total des années d'expérience :29 years, 8 Mois
• Helping the clients in identifying/documenting/implementing/maintaining the ISO systems compliance to the standard requirements including ISO trainings, internal audits, MRM, make the client to face external audits, documentation issue/control, Risk Assessments, Risk Analysis, Risk Treatment Plan, Statement of Applicability, SOPs, Policy, Objectives, RCA, CAPA, etc.
• Analyzing of Customer Complaints, Feedbacks, Root Cause, CAPA, Supplier Performance, Objectives.
• Ensuring all the relevant Systems are identified, established, implemented, maintained and monitored effectively.
• Identify the areas for improvement based on analysis of internal & external audit reports, feedback from customers/interested parties.
• Quality Assurance activities like product release/clearance, deviation control, rejection control, out of specification, handling of out of calibration equipments, product recall, handling of recalled product, process capabilities/improvements, QC chemist qualification, analytical method verification/validation, process validation, RCA of non conforming products, processes, CAPA, SOPs etc..
• ISO systems compliance, internal audits, MRM, ISO trainings, face external audits, documentation issue/control, SOPs, MR, RCA, CAPA, etc.
• Handling of customer complaints, root cause analysis, CAPA.
• Ensuring all the relevant Systems are established, implemented, maintained and monitored effectively.
• Identify the areas for improvement based on analysis of internal & external audit reports, feedback from customer.
• Conduct Third party audit (Certification/Surveillance/Recertification) at clients end.
• Review of audit reports.
• Ensuring Certification System is established, implemented, maintained and monitored effectively.
• Suspension/withdrawal of clients which are not fulfilling the certification agreement rules.
• Identify the areas for improvement based on analysis of internal & external audit reports, feedback from customer.
• Coordinate with channel partners.
• Conduct Third party audit (Certification/Surveillance/Recertification) at clients end.
• Management Representative of the organization.
• Ensuring Certification System is established, implemented, maintained and monitored effectively.
• Suspension/withdrawal of clients which are not fulfilling the certification agreement rules.
• Conduct internal audits & management review meeting, report on performance of the certification system to management.
• Provide training to employees of the clients in relation to ISO 9001, root cause analysis, corrective and preventive action for nonconformities and Internal Audit.
• Provide consultancy to clients regarding documentation, implementation and maintenance of QMS requirements.
• Coordination of ISO related activities at clients end with certification bodies and other concerned agencies.
• Conduct second party audit at clients end.
• Interaction with top management of the clients for major issues in relation to ISO 9001.
• Prepare internal audit checklist, audit plan and audit schedule at clients end.
• Identify training needs at clients end.