Maintaining compliance, safeguarding patient data, and ensuring consistent product quality across global supply chains is complex — but essential. ISO certification provides a recognised, structured approach for meeting these obligations and demonstrating control at every stage of the pharmaceutical lifecycle.
Whether operating in research, manufacturing, distribution, or digital therapeutics, ISO frameworks help strengthen trust, reduce risk, and accelerate market readiness.
Pharmaceutical organisations face constant demands for quality, traceability, data integrity, and ethical compliance — from early-stage development to global distribution. Regulatory pressure from agencies such as the MHRA, EMA, and FDA continues to rise, while market access increasingly depends on demonstrable environmental and data security commitments.
Digital transformation brings new risks — with sensitive clinical data, connected devices, and AI-driven platforms all requiring strong governance.
With public health at stake, there is little room for error. ISO certification allows pharmaceutical organisations to demonstrate compliance, manage risk, and improve operational resilience in a clear and auditable way.
AvISO brings experience across clinical, manufacturing, and digital health environments. We help organisations design ISO systems that align with regulatory frameworks, simplify internal compliance, and support growth.
We support GMP-aligned QMS development, risk management, supplier controls, and business continuity planning. Whether you’re seeking standalone certification or integrated systems, we help build a framework that reflects how your business operates.
ISOvA Toolbox ensures secure, auditable recordkeeping for procedures, corrective actions, clinical documentation, and regulatory readiness — all in one platform.
We offer internal audit training, CAPA management, and ISO awareness for QA teams, production leads, and executive stakeholders. Delivery is adapted to your operation type and compliance timelines.
A pharmaceutical packaging provider implemented ISO 9001, ISO 14001, and ISO 27001 to meet GMP requirements and client data security expectations. With AvISO’s support and ISOvA Toolbox, they created an integrated system that streamlined audits, reduced admin, and helped win new international clients.
A foundational system supporting good manufacturing practice (GMP), product conformity, and quality assurance. Required or expected by most global supply chains.
ISO 13485 – Medical Devices Quality Management
Mandatory for companies developing or distributing medical devices or companion diagnostics. Covers design control, traceability, and post-market surveillance.
ISO 27001 – Information Security Management
Protects sensitive R&D data, clinical records, IP, and digital platforms. Supports GDPR compliance and aligns with FDA and EMA cybersecurity expectations.
ISO 22301 – Business Continuity Management
Ensures operations can recover during crises such as cyberattacks, supplier failure, or pandemics. Essential for protecting production continuity and patient safety.
ISO 14001 – Environmental Management
Addresses regulatory and ethical requirements for waste disposal, emissions, packaging sustainability, and ESG reporting.
ISO 27701 – Privacy Information Management
An extension of ISO 27001 for managing personal health data in accordance with GDPR, HIPAA, and global privacy frameworks — especially relevant for clinical trial or app-based products.
ISO 42001 – Artificial Intelligence Management
As AI becomes embedded in discovery, diagnostics, and patient engagement, ISO 42001 provides a governance framework to ensure ethical and transparent deployment — aligning with regulatory guidance and public expectations.
Pharmaceutical regulation is already complex. Your ISO system doesn’t have to be.
At AvISO, we simplify documentation, policies, and audit processes so teams can focus on product quality and patient outcomes — not bureaucracy. Every process we design is clear, relevant, and manageable for your team and your auditors.
🔗 How we simplify compliance →
Whether managing a GxP environment or launching a digital health platform, AvISO and ISOvA provide a scalable solution for compliance and growth.
We help you move faster, stay compliant, and build trust across the product lifecycle.
We also support:
Whether you’re scaling production, entering new markets, or digitising patient engagement, we help ensure your compliance systems are ready.
If you would like to know more about ISO Standards, Certification and the value of a good management system you can add to your business we would love to hear from you: Kent: 01892 800476 | London: 02037 458 476 | info@avisoconsultancy.co.uk
