Accreditation and commercialization services are essential for companies aiming to achieve Good Manufacturing Practice (GMP) licenses and ISO certifications. Becoming licenses or certified in these regulations are mandatory for pharmaceutic or medical device manufacturers and to ensure product quality, safety, and regulatory compliance.

Do you want to find out more how we can help your business achieve GMP licensing or ISO accreditation?

This article outlines the key aspects of these services and the standards we support.

Key Accreditation Standards Supported

Our services routinely support companies in achieving the following key standards:

1. Good Manufacturing Practice (GMP):

   • Applicable to pharmaceutical and veterinary facilities.

   • Ensures products are consistently produced and controlled according to quality standards.

   • Reduces risks involved in pharmaceutical production, such as contamination, mix-ups, and errors.

2. ISO 13485:

   • Pertains to medical device manufacturing, including in vitro diagnostics (IVDs) and related software.

   • Specifies requirements for a quality management system that demonstrates the organization's ability to provide medical devices and related services that consistently meet customer and regulatory requirements.

3. ISO 17025:

   • Relevant for testing and calibration laboratories, especially those supporting clinical trials or biotechnology.

   • Covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.

4. ISO 9001:

   • Focuses on quality management systems across various industries, including medical technology and biotechnology.

   • Emphasizes customer satisfaction through the effective application of the system, including processes for improvement and assurance of conformity to customer and applicable statutory and regulatory requirements.

Our Approach to Accreditation Support

We provide flexible support tailored to your needs, whether you require comprehensive project management or additional assistance to supplement your team's efforts. Our approach ensures that your team gains a thorough understanding of the accreditation standards and becomes capable of maintaining compliance independently.

1. Day-to-Day Direction:

   • Offering hands-on guidance to ensure daily operations align with accreditation requirements.

   • Providing expert advice on best practices and regulatory updates.

2. Team Involvement:

   • Empowering your team to take ownership of the accreditation process.

   • Facilitating knowledge transfer to build in-house expertise and capabilities.

QSN Framework and Six Pillars of Implementation

Our methodology is based on the QSN Framework and the Six Pillars of Implementation, which guide companies through the development and change processes required for accreditation. These pillars include:

1. Leadership and Commitment:

   • Ensuring top management is committed to achieving and maintaining accreditation.

   • Establishing a clear vision and strategic quality objectives.

2. Risk Management:

   • Identifying and assessing risks related to compliance and accreditation.

   • Implementing controls to mitigate identified risks.

3. Process Approach:

   • Adopting a systematic approach to implement, manage and control processes.

   • Ensuring processes are effective, efficient, and aligned with accreditation standards.

4. Improvement:

   • Promoting a culture of continuous improvement.

   • Implementing mechanisms to identify opportunities for improvement and address non-conformities.

5. Evidence-Based Decision Making:

   • Using data and metrics to inform decisions.

   • Ensuring decisions are based on objective evidence rather than assumptions or intuition.

6. Engagement of People:

   • Involving employees at all levels in the accreditation process.

   • Providing training and development opportunities to enhance skills and knowledge.

Conclusion

Accreditation and commercialization services play a critical role in ensuring that companies meet regulatory requirements and maintain high standards of quality and safety. By supporting companies through the accreditation process for GMP, ISO 13485, ISO 17025, and ISO 9001, we help them navigate compliance responsibilities, manage compliance risks, and achieve their strategic objectives.

Our approach, grounded in the QSN Framework and the Six Pillars of Implementation, ensures a thorough and systematic process that empowers your team to maintain compliance independently.