Kahlity We are a team of dynamic consultants with a proven track record for managing projects and providing consulting services to companies within the medical devices and pharmaceutical industries

Quality assurance​​

Full Quality Management System (QMS) design and implementation

To obtain an ISO certification, our consultants design, implement, maintain and improve your QMS.

We work with notified bodies to support the certification process.

We are pragmatic and will always look for the best solutions aligned with your business strategy.

 

Who would be interested by this service?

Small to medium sized companies willing to implement a QMS and/or get ISO certified

 

Process design and implementation 

We design, implement, maintain and improve your specific QMS processes, such as Complaints Handling, Non-Conforming Products, Corrective and Preventive Actions (CAPA), Risk Management, Change Controls, Internal Audits, Supplier Handling.

We provide you support to close findings (e.g. from external and/or internal audits) to maintain your process effectiveness.

We go to the essential, simplify your system, and ensure process repeatability.

 

Who would be interested by this service?

All companies willing to implement or improve a process

 

Transition from local to global processes 

We transform some of your local processes into one global process applicable for all sites. 

We guide you to choose which local processes can be transitioned to global processes, and which local processes should be kept as site-specific processes.

We harmonize and standardize your working methods to increase effectiveness and efficiency.

Who would be interested by this service?

Large companies willing to improve and simplify their QMS

Large companies willing to integrate the QMS of newly acquired companies during post-acquisition activities

 

QMS readiness for audits and inspections

We help you to be ready anytime for an audit or an inspection. 

For example, ISO 13485 audits are not always scheduled and can be unannounced. In this case, we help you to define a strategy to host such audits. 

Our purpose is not only focused on your QMS compliance with applicable requirements, but also your ability to handle unplanned situations, work under pressure, think fast and talk smart.

 

Who would be interested by this service?

All companies willing to remove or handle the anxiety of an audit or an inspection