Operon Strategist is implementing an enhanced 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 with pleasure announces the service to provide support after the certification.
- 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
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 for 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.
Training Introductory courses:
- Implementation of ISO 9001:2015
This course is all about how to undergo into the new ISO 9001:2015 which is referred to Quality Management Systems. This will help you with the implementation of the changes within your business with specific root cause and corrective action analysis within the organisation.
- The requirement of ISO 13485:2016, Medical Device
ISO 13485:2016 is the requirement for every medical device manufacturers where they include their management systems in order to gain compliance in the medical device industry. This training will assist you in how to design and develop a medical device as per the international quality standard. And also maintain a quality management system as per internal regulatory standard.
- Implementation of 21 CFR Part 820
Every manufacturer gets a knowledge on how to establish and maintain a quality system that is appropriate for their specific medical devices. 21 CFR Part 820 is applicable to any finished medical device for human use, that is manufactured, imported in any State or Territory of the United States. In these courses,cGMP System Regulation is involved that summarizes the essential elements of cGMP regulations governing the methods and facilities used for the servicing, installation, storage, labelling, packaging etc. Finally, the aim of this course is to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act).