continuous Improvement Program (CIP) in response to the feedback that clients have provided to us, about their engagement processes and areas for their performance improvement. Continuous Improvement is an ongoing effort to improve products, services or processes.
Operon Strategist provides below support to the organisations after the certification and licensing activities.
- CAPA Monitoring
- SOPs Up-gradation as per requirement
- Implementation at a site to meet the latest requirements ( Eg. 21 CFR )
- Customer Complaint Handling
- Internal Audit Handling, MRM ( Management Review Meetings)
- Need-based Trainings like ISO 9001:2015, ISO 13485:2016 & 21 CFR Part 820
CAPA Monitoring in Continuous Improvement Program
Corrective Action (CA) is a step that is taken to remove the causes of an existing nonconformity or undesirable situation. Corrective action will target the root cause so that the non-conformity or undesirable situation does not re-occur. Preventive Action (PA) is a step that is taken to remove the causes of potential nonconformities or potential situations that are undesirable. Preventive action is like risk management, where the non-conformity or undesirable situation has not actually occurred. Defining and performing CAPA is a critical part of the Quality Management System, as it will provide good benefits for your organization for the long run.
SOPs Up-gradation as per requirement
Systems are subject to improvement which results in changes in operating procedures. Hence standard operating procedures (SOPs) need to be upgraded as per the requirements. We are continuously updated on the latest requirement of System Implementation. And therefore assist you to upgrade the SOPs
Implementation at a site to meet the latest requirements
We being the medical device consultant for various manufacturers in the healthcare industry, make sure that we provide our every client gets knowledge about the quality system compliances to meet the regulatory requirement.
Customer Complaint Handling
When a customer complains, it is an important part of every organization to take care of their customer as it is usually for a good reason or genuine concern. This complaint occurs as the customers have made a purchase and that they did not meet their expectation—a product, service, or maybe a combination of the two. We never avoid complaints; we take care of our customers by listening to their complaints, and resolving it, to ensure a happy customer.
Internal Audit Handling, MRM
Internal Audits is something that inspects or checks systematically. This internal audit handling is an independent inspection of the system to determine whether the arrangement that was planned is implemented effectively and whether are appropriate to achieve the objectives.
Need-based Training like ISO 9001:2015, ISO 13485:2016 & 21 CFR Part 820
We provide different training courses to help you to understand, implement, and audit to the new version of ISO 9001:2015, ISO 13485:2016, 21 CFR part 820 plus some more in-depth.
Read More - continuous Improvement Program (CIP)
Contact details –
Phone no - 93702 83428
Mail id – enquiry@operonstrategist.com
Phone no - 93702 83428
Mail id – enquiry@operonstrategist.com
If You Want Medical Devices Services Consultation For Following.- Medical Device Consulting
- cdsco registration
- FDA 510k Clearance
- ce mark medical device
- CDSCO Manufacturing License
- CDSCO import license
- TURNKEY PROJECT CONSULTANT
- medical device manufacturing
- iso 15378 certification
- 21 cfr part 210 and 211
- ISO 13485 Medical Device Consultant
- Primary Packaging Turnkey Project Consultant
- Clean Room Design Consultant
- manufacturing site conceptualization
- Market Analysis and feasibility for Medical Devices
- manufacturing plant layout design
- medical device design and development
- DMF file submission guideline
- 21 cfr part 820
- qms certification services
- capa management
- design control requirements
- medical device process validation
- combination product
- continuous improvement program
- Medical Device Compliance & Regulatory Services
- Cdsco India authorized agent for medical device
If You Want Medical Devices Services Consultation For Following.
- Medical Device Consulting
- cdsco registration
- FDA 510k Clearance
- ce mark medical device
- CDSCO Manufacturing License
- CDSCO import license
- TURNKEY PROJECT CONSULTANT
- medical device manufacturing
- iso 15378 certification
- 21 cfr part 210 and 211
- ISO 13485 Medical Device Consultant
- Primary Packaging Turnkey Project Consultant
- Clean Room Design Consultant
- manufacturing site conceptualization
- Market Analysis and feasibility for Medical Devices
- manufacturing plant layout design
- medical device design and development
- DMF file submission guideline
- 21 cfr part 820
- qms certification services
- capa management
- design control requirements
- medical device process validation
- combination product
- continuous improvement program
- Medical Device Compliance & Regulatory Services
- Cdsco India authorized agent for medical device
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