Quality Expressed – ISO 9001:2015 & ISO 13485:2016

Kemp Proteins, LLC operates under an overarching Quality Management System (QMS) that has been certified against the ISO 9001:2015 (View Certification) Standard by NQA, a Global Certification Body. Underpinning this broad certification of the QMS is our ISO 13485:2016 Certification (View Certification). Our QMS was designed to meet both Standards and established and maintains the organization and processes through which we provide a menu of protein-based services and products to the pharmaceutical, diagnostic, and research industries.

While the ISO 9001 standard focuses on designing, implementing, and maintaining a QMS that is focused on customer needs as a measure of quality and sets forth operating standards which support quality product realization, ISO 13485 provides more in-depth specifics aimed at ensuring the Quality of Medical Devices. These specifics include the use of risk-management to document methods for “uncertainty management”, monitoring and measurement of product status, product cleanliness and detailed documentation requirements, all designed to improve medical device safety and customer satisfaction. We believe that by organizing our QMS to meet the requirements of these two standards, our scientists can provide consistent services and products that meet or exceed the Quality standards required by our clients. In many cases we are seen as an extension of clients own faculties where they operate under similar Quality standards.

A question often asked is “what is the difference between cGMP and ISO13485?” or “if you are 13485 does that mean you are GMP?”. The main difference between the two is that cGMP is regulated and controlled under Federal Laws and follow USFDA guidelines for finished medical devices (21 CFR Part 820). ISO 13485:2016 is not a Federal Law but rather, is an internationally recognized standard that closely aligns with USFDA, EMA and PMDA regulations and is a more comprehensive standard for medical devices.

In line with the ISO (International Organization for Standardization) ethos, Kemp’s executive management continuously strives to improve the processes and capabilities by investing in personnel, state-of-the-art equipment, and continuous-improvement quality programs while also evaluating and mitigating the risks associated with the processes of developing and manufacturing novel protein-based products for our diverse client base. Kemp recruits, trains, and maintains a highly skilled, dedicated, professional, and knowledgeable workforce to achieve these goals.

As part of our overall Quality structure, the Kemp management team is focused on providing leadership and innovation to establish and maintain a world-class business supported by best practices and quality processes, to deliver to our clients a consistent and high-quality service experience.

ISO 9001 & 13485 Process Related Documentation

Every project performed within our facility progresses through a collaborative process involving our project team (Internal Interested Party) and the client (External Interested Party) before we commit to project initiation. Using the information gained during this collaboration, we seek to gain an understanding of the client’s design criteria together with the key acceptance criteria specifications of the project. Using this document, we develop a statement of work (a Job Summary) that will be used to guide and monitor the project as it progresses to conclusion. The plans are defined in various types of documents, such as processes, production work orders, operator instructions, and process reports. Product realization planning includes, as applicable:

Define quality objectives and requirements for the product (Project Inputs)
Establish the processes, product documentation, and define resources specific to the product (the Resources)
Establish required verification, monitoring, inspection, and test activities specific to the product and criteria for product acceptance
Define records necessary to demonstrate process and product conformity (in Process Controls)

At several points, we check back against the client design inputs to ensure that we are meeting the client’s specifications, and we communicate the results with the client at these points. Using this quality-based focus, we expect to deliver product (Project Output) that meets specifications and, in so doing, meet the customer expectations.

Certificate of Analysis and Final Report

As part of our final deliverable, each project is completed by the supply of the final paperwork that may include:

A data report as agreed with client
A final report generated with the development process and results
A Certificate of Analysis with the client-agreed specifications