ISO 15378 Certification
Quality management standard for primary packaging materials for medicinal products, combining ISO 9001 with GMP requirements.
Improve your organisation's performance, win more contracts and gain international recognition with ISO 15378 certification from UniCert — a UK-based accredited certification body trusted by organisations worldwide.
Quick Facts
ISO 15378
Medical & Life Science
2–6 months
3 years
Worldwide
What is ISO 15378 Certification?
ISO 15378 specifies requirements for a quality management system for primary packaging materials for medicinal products. It combines the requirements of ISO 9001 with the application of Good Manufacturing Practice (GMP) principles. The standard ensures that packaging materials in direct contact with pharmaceutical products meet stringent quality and safety requirements.
ISO 15378 certification is awarded by accredited third-party certification bodies like UniCert after a rigorous audit process. The certification demonstrates to customers, partners, regulators, and stakeholders that your organisation meets internationally recognised standards of excellence. It provides a structured framework for continual improvement and helps organisations of all sizes — from SMEs to multinational corporations — enhance their operational performance.
Achieving ISO 15378 certification is not just about compliance — it's about building a culture of quality, efficiency, and accountability. Organisations that implement ISO 15378 typically see measurable improvements in customer satisfaction, operational efficiency, risk management, and employee engagement within the first year of certification.
Scope & Applicability
Manufacturers of primary packaging materials for pharmaceutical and medicinal products including glass, plastic, rubber, and aluminium components.
UniCert ISO 15378 certification audit in progress
Benefits of ISO 15378 Certification
Organisations that achieve ISO 15378 certification gain a significant competitive advantage. Here are the key benefits your company can expect:
Beyond these direct benefits, ISO 15378 certification also helps organisations reduce operational costs through improved process efficiency, minimise risks, and create a foundation for integrating other management systems such as ISO 14001 and ISO 45001.
Who Needs ISO 15378 Certification?
ISO 15378 is applicable across a wide range of industries and organisation sizes. Whether you're a small business looking to improve your operations or a large enterprise meeting supply chain requirements, certification can deliver real value.
Many organisations pursue ISO 15378 certification because it is required by clients, regulators, or industry bodies. Others choose it voluntarily to gain a competitive edge, improve internal processes, or demonstrate their commitment to excellence.
Industries We Certify
ISO 15378 Certification Process
Our ISO 15378 certification process follows a clear, structured approach designed to get your organisation certified efficiently and thoroughly. Every step is guided by experienced auditors who understand your industry.
The entire process typically takes 2–6 months depending on your organisation's size, complexity, and current level of management system maturity. UniCert also offers fast-track certification options for organisations that need to meet tight deadlines.
Gap Analysis
Our experienced auditors assess your current management systems against the standard's requirements, identifying gaps and creating a detailed action plan tailored to your organisation. This initial assessment typically takes 1–2 days depending on your company's size and complexity.
Documentation Review
We guide you through the development and alignment of your management system documentation — policies, procedures, work instructions, and records — ensuring they fully meet the standard's requirements while remaining practical for your team.
Internal Audit
A thorough internal audit is conducted to verify your organisation's readiness for certification. Our auditors identify any remaining non-conformities and provide clear corrective action recommendations before the formal assessment.
Stage 1 Audit
The formal Stage 1 audit reviews your documentation, management system design, and readiness for the certification audit. This is conducted by our qualified lead auditors either on-site or remotely, depending on your preference.
Stage 2 Certification Audit
The on-site Stage 2 audit verifies that your management system is effectively implemented, operating as documented, and achieving its intended outcomes. Our auditors evaluate real-world evidence of compliance across your operations.
Certification Issued
Upon successful completion, your internationally recognised certificate is issued — valid for 3 years. Annual surveillance audits maintain your certification, and we provide ongoing support throughout the entire certification cycle.
ISO 15378 Certification Cost
The cost of ISO 15378 certification varies based on several factors including your organisation's size, number of employees, number of sites, industry sector, and the complexity of your operations and processes.
At UniCert, we provide transparent fixed-price quotations with no hidden fees. Our pricing includes the complete certification process — from initial gap analysis through to the final certification audit and certificate issuance. There are no surprise costs or additional charges.
To get an accurate quote tailored to your organisation, simply fill out our free consultation form and our team will provide a detailed proposal within 24 hours.
What Affects Certification Cost?
Number of employees and management complexity
Single-site vs multi-site organisations
Some sectors require additional audit time
Existing management systems reduce preparation time
Determined by staff numbers and complexity
Why Choose UniCert for ISO 15378 Certification
UniCert is a UK-based accredited certification body with a global network of experienced auditors. We combine international standards expertise with a practical, client-focused approach that makes the certification journey straightforward and valuable.
UK Based Certification Body
Headquartered in London with a network of experienced auditors across the UK, Europe, Middle East, and Asia — providing local expertise with global reach for multinational organisations.
Experienced Industry Auditors
Our auditors bring deep sector-specific knowledge and a practical, value-adding approach. They don't just assess compliance — they help you understand how to genuinely improve your management systems.
Fast Certification Timeline
Our streamlined certification process ensures you achieve certification as quickly as possible — typically within 2–4 months. We offer expedited and fast-track options for organisations with tight deadlines.
Competitive Fixed Pricing
Transparent, fixed-price quotations with absolutely no hidden fees, surprise charges, or unexpected costs. You know exactly what you'll pay before you commit — guaranteed.
International Recognition
Our accredited certifications are recognised worldwide across all industries and markets, helping you access new customers, markets, and supply chain opportunities internationally.
Ongoing Dedicated Support
Every client receives a dedicated account manager who provides guidance, answers questions, and ensures a smooth experience throughout the entire certification lifecycle — from initial enquiry to recertification.
Start Your ISO 15378 Certification Today
Get a free, no-obligation consultation with our certification experts. We'll assess your needs and provide a tailored proposal within 24 hours. Join hundreds of organisations that have chosen UniCert for their ISO 15378 certification journey.
Request ISO 15378 Certification Quote
Frequently Asked Questions
Everything you need to know about ISO 15378 certification. Can't find your answer? Contact our team for personalised guidance.
Explore Our Other Certification Services
Many organisations combine ISO 15378 with other management system standards to create an integrated management system (IMS) for maximum efficiency and value.
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