WHY USE
STRATEGNOS FOR YOUR
COMPLIANCE
NEEDS?

Using a highly structured approach the Strategnos team will interpret and implement the requirements of any specified regulation, standard or guideline to meet audit requirements and achieve compliance for the appropriate certification.

IMPLEMENTATION

The Strategnos team will interpret the requirements and develop a project plan to assist clients in meeting these requirements. We will structure and implement a Quality Management System (QMS) as the foundation for implementation of any regulation, standard or guideline. Using proprietary templates the appropriate procedures, forms and records will be documented based on inputs from the client. Change management and training underpin the project plan in order to ensure the entire organisation is aligned with the requirements.

MAINTENANCE

Managing and maintaining a Quality Management System (QMS) in line with any of the above standards or guidelines is a challenging task. Ensure proper document control and standardization is key. Strategnos can assist clients in ensuring that the QMS is maintained and up to date all times in an audit ready state.

OUR COMPLIANCE SCOPE:

  • ISO 9001 – Quality Management System Requirements
  • ISO 22716 – Good Manufacturing Practices (GMP)
  • ISO 13485 – Medical Devices Quality Management Systems
  • ISO 17025 – General Requirements for the Competence of Testing and Calibration Laboratories
  • Good Manufacturing Practice (GMP)
  • Good Distribution Practice (GDP)
  • Good Warehouse Practice (GWP)

Managing and maintaining a Quality Management System (QMS) in line with any of the above standards or guidelines is a challenging task. Ensure proper document control and standardization is key. Strategnos can assist clients in ensuring that the QMS is maintained and up to date all times in an audit ready state.