Since the start of Progress in 1999, we have offered strong expertise in the field of cGMP regulations. Our regulatory expertise has since expanded to other quality regulations, such as Biological Safety (BSL), specific requirements for radiopharmaceuticals and ISO compliance. We are therefore fully equipped to provide ISO Support. Depending on the scope and effort, certification is usually achievable within one calendar year.

Progress can effectively support organizations that want to develop a business case for implementing or updating a Quality Management System (QMS), for example according to ICH Pharmaceutical Quality System Q10, whether GMP or ISO based. Every organization wants to improve internal business processes and strives to provide the best service to its clients. A well-implemented QMS will help you achieve that goal.

Laboratories that perform release testing of (bio-)pharmaceutical products require GMP certification. For most other purposes, laboratories will benefit most if their organization is ISO certified. In some cases, the clients may require ISO certification or find it beneficial from a preferred supplier. For testing laboratories, ISO17025 specifically applies and to obtain an ISO17025 certificate, multiple chapters of ISO9001 must be included. Therefore, both ISO17025 (ISO/IEC 17025 – General requirements for the competence of testing and calibration laboratories) and ISO9001 (ISO 9001 What does it mean in the supply chain?) are taken into account here.

The current ISO9001 ‘General Quality Management Systems’ and ISO17025 ‘General Requirements for the Competence of Testing and Calibration Laboratories’ will help improve overall performance and provide a sound basis for sustainable development initiatives. Obtaining and maintaining certification should not be a bureaucratic exercise; instead, it is a set of documentation that supports the standardization of processes in a Lean manner and drives continuous improvement.

In summary, the following topics are covered in a QMS:

1. Leadership
2. Planning and support
3. Operation (both development and commercial manufacturing/service)
4. Performance evaluation
5. Validation of methods and tests

This certainly does not only apply to ‘mature’ companies; in our experience it has also proven to be especially useful for start-ups and scale-ups.

We can advise and support you from the beginning to the completion of the certification process. Our ISO services include:

1. Performing gap analyzes (business cases)
2. Delivering documentation
3. Auditing
4. Project management
5. Staff training
6. Performing ad-interim quality management roles
7. Implementing Lean Six Sigma and Agile tools and practices

Establishing and/or improving a QMS for optimal effectiveness and business success requires a combination of requirements and cultural behaviors (hard and soft skills). The current tight labor market in the Netherlands also requires standardized, efficient, and Lean processes.

Our team of more than fifty consultants with deep and extensive experience guarantees the availability of a wide range of expertise. Each project is supported by the full knowledge base and wealth of experience available within Progress. Progress offers various services: Consultancy, Project Management, Interim Management and Temporary Staffing.