DQS audits combine ISO 9001 management-system expertise with GMP-aligned knowledge of primary packaging — glass, plastic, rubber, foil, and closure systems. The result: certification that translates directly into supplier qualification value with pharmaceutical customers.
Deep knowledge of pharma packaging realities.
One audit reflects both layers of expectation.
A recognized reference in pharmaceutical supplier qualification.
Certification under applicable accreditation frameworks, depending on country and certification scope.
Pharmaceutical manufacturers operate under intense regulatory scrutiny — and they extend that scrutiny to every primary packaging supplier. ISO 15378 certification gives your customers a structured, recognized signal that your processes meet GMP-aligned expectations, supporting smoother supplier qualification, faster customer audits, and longer-term partnerships.
The value of certification extends beyond external proof of conformity. Many organizations use recurring audits and assessment processes as a framework for continuous improvement, operational transparency, and stronger cross-functional alignment. In practice, companies often report effects such as:
Save time and internal effort with a clearly structured certification process. Request your personal quote for your ISO 15378 certification now.
ISO 15378 certification is designed for organizations supplying primary packaging materials to the pharmaceutical industry:
A clear process means fewer questions and faster results. These are the stages of your ISO 15378 certification with DQS — transparent from start to finish.
Once your ISO 15378 management system has been implemented across the organization, it is ready for certification. Your initial interaction will involve discussing your organization, your quality management system, and the objectives you aim to achieve with your ISO 15378 certification. Based on this, you will promptly receive a detailed quote tailored to your individual needs. For complex certification processes, project planning can help coordinate timelines and audit execution across sites or departments.
The certification audit begins with a system analysis (stage 1 audit) as well as an evaluation of your documentation, the results of your management review, and your internal audits. The goal is to determine whether your management system is adequately developed and ready for certification. In the next stage, the system audit (stage 2), your auditor evaluates the effectiveness of all management system processes on-site or through suitable remote techniques, including GMP-aligned controls specific to primary packaging. After the audit is completed, you will receive a detailed presentation of the results in a closing meeting, along with information on potential areas of improvement for your company. If necessary, action plans will be agreed upon.
After the certification audit, the results are evaluated by the independent certification body of DQS. You will receive an audit report documenting the audit results. If all standard requirements are met, following a positive certification decision, you will receive the accredited ISO 15378 certificate of DQS.
To ensure continuous improvement and the ongoing effectiveness of your quality management system, key system components are audited at least once a year, during which potential areas for improvement are once again identified.
An ISO 15378 certificate is valid for three years. Well before expiration, a recertification is performed to confirm ongoing conformity with the ISO 15378 standard requirements. If all requirements of the standard are met, a new internationally recognized certificate will be issued.
Once your organization meets these requirements, you are ready to contact DQS to begin your ISO 15378 certification.
ISO 15378 certification can be efficiently combined with ISO 9001, ISO 14001, ISO 45001, and ISO 13485 audits. A bundled approach reduces audit days, simplifies planning, and provides a single certification partner across your management systems.
From inquiry to certificate, most organizations complete initial certification in 4 to 8 months, depending on the maturity of your existing QMS and GMP-aligned controls. Learn more in our ISO 15378 Knowledge Center.
ISO 15378 certificates are valid for three years, with annual surveillance audits. Recertification confirms continued conformity at the end of the cycle. Learn more in our ISO 15378 Knowledge Center.
Cost depends on the number of employees, company size, number of sites, complexity of your packaging technologies, exisiting certificates and accreditation requirements. Request a quote to receive a tailored offer covering audit days and surveillance planning.
Most effort goes into aligning GMP requirements with your ISO 9001 quality system, with particular attention to cleanroom controls, contamination prevention, and change control. Learn more in our ISO 15378 Knowledge Center.
No. ISO 15378 supports GMP-aligned quality management for primary packaging materials, but it does not replace applicable regional GMP regulations, customer requirements or supplier qualification obligations.
