For manufacturers of medical devices, ensuring both product quality and a sterile environment is non-negotiable. Regulatory bodies and global markets demand not just compliance, but proof of it, through rigorous standards like ISO 13485 and ISO 14644.
When a combined audit is scheduled, covering both your Quality Management System (QMS) and cleanroom standards, the stakes are high, but so is the opportunity to elevate your operational excellence. In this article, we’ll break down what each standard covers, where they overlap, the key challenges in a joint audit, and, most importantly, how to prepare for success.
What is ISO 13485 for Medical Devices?
ISO 13485 is an internationally recognised standard that outlines the requirements for a quality management system specific to the medical device industry. It ensures organisations can consistently meet customer and regulatory requirements throughout the product lifecycle, from design and development to production, storage, distribution and servicing.
This standard emphasises risk management, design control, process validation, traceability and corrective/preventive actions (CAPA), all critical for ensuring the safety and performance of medical devices. Certification is often a prerequisite for market entry, especially in regulated regions like the EU, US and Canada.
What is ISO 14644 for Cleanrooms?
ISO 14644 is a series of standards that govern the classification, operation and monitoring of cleanrooms and controlled environments. The most referenced part, ISO 14644-1, classifies cleanrooms based on the number and size of airborne particles per cubic metre of air.
It’s a vital standard for environments where contamination control is critical, such as in pharmaceutical, biotech and medical device manufacturing. ISO 14644 covers not only the classification of air cleanliness but also guidelines for cleanroom design, testing, monitoring and behaviour protocols for personnel.
Understanding ISO 13485 and ISO 14644 – Key Differences and Overlaps
While ISO 13485 focusses on the quality system and ISO 14644 focusses on the cleanroom environment, the two standards often converge in real-world applications, especially for manufacturers of sterile or implantable medical devices.
Here are a few key overlaps and differences:
- Overlap: Both require stringent documentation, ongoing validation and staff training. Cleanroom practices must align with the QMS framework established under ISO 13485.
- Difference: ISO 13485 is broader, encompassing design controls, supplier management and post-market surveillance. ISO 14644 is more technical and focussed on environmental controls and contamination risks.
- Integration: Cleanroom SOPs, monitoring records and maintenance logs must feed into your QMS documentation and CAPA system.
Understanding where these two standards intersect can help streamline compliance and prevent duplication of efforts.
Top Challenges in a Combined Audit
Preparing for a combined ISO 13485 and ISO 14644 audit can be overwhelming. Organisations often face challenges such as:
- Siloed documentation: Cleanroom procedures are sometimes maintained separately from QMS records, leading to inconsistencies.
- Incomplete training records: Personnel may be trained in cleanroom protocols but not in how those practices fit into the wider QMS.
- Gaps in validation: Equipment and processes may pass cleanroom requirements but lack the validation documentation expected under ISO 13485.
- Overlooked classifications: Cleanroom classifications may be outdated or not aligned with current ISO 14644-1 revisions.
Without a unified preparation strategy, these gaps can result in non-conformities or delays in certification.
Preparation Tips for ISO 13485 and ISO 14644 Compliance
To succeed in a dual audit, manufacturers must ensure both systems are synchronised and audit-ready. Here are key areas to focus on:
Conduct a Gap Analysis against Both Standards
Start by reviewing your current systems, procedures and documentation against the requirements of both ISO 13485 and ISO 14644. Identify what’s missing, outdated, or non-compliant. This should include evaluating:
- QMS structure and processes
- Cleanroom classification and environmental monitoring
- Validation and calibration documentation
- Training logs and behavioural protocols
A comprehensive gap analysis helps prioritise corrective actions and ensures you’re not caught off guard during the audit.
Align QMS and Cleanroom Documentation
Documentation is at the heart of both standards. Ensure that cleanroom-specific documents, like environmental monitoring records, gowning procedures and maintenance logs, are integrated into your QMS. All procedures should have a consistent format, clear version control, and approval signatures.
Suggested Read – What are QMS Audits?
For instance, cleanroom SOPs should not stand in isolation but should link to risk management files, supplier qualification documents, or CAPA reports, where applicable. This alignment shows auditors a coherent and unified approach to quality and compliance.
Calibrate and Validate All Equipment Used in Cleanroom Environments
Both ISO 13485 and ISO 14644 emphasise the importance of validated processes and calibrated equipment. Whether it’s HVAC systems, particle counters, autoclaves, or packaging machines, ensure that:
- Calibration is performed according to a defined schedule
- Records are traceable and include calibration certificates
- Equipment validation is documented and includes operational qualification (OQ) and performance qualification (PQ)
Don’t forget software validation if electronic systems are used for environmental monitoring or quality documentation.
Train Staff on Dual Compliance Areas
Training is often a weak spot in audits. For combined compliance, staff must understand not just cleanroom behaviour (e.g., gowning, hand hygiene, restricted movement) but also how their actions affect QMS documentation and product traceability. Training should be documented, reviewed periodically, and tailored to each job role.
Ensure all personnel who operate in cleanroom environments receive training on:
- ISO 13485 basics and their role in the QMS
- ISO 14644 cleanroom classifications and practices
- Documentation protocols (e.g., real-time recording, error correction)
- Risk awareness and contamination prevention
Review Risk Management and CAPA Documentation
ISO 13485 requires a risk-based approach to all processes, including cleanroom operation. Make sure your risk management files include risks related to environmental controls, cross-contamination, and equipment failures.
Additionally, your Corrective and Preventive Action (CAPA) system should track and close any issues related to cleanroom deviations, such as failed particle counts, excursions in temperature/humidity, or operator breaches of protocol. Auditors will expect to see a closed-loop system where cleanroom data leads to timely investigations, root cause analysis and process improvement.
Ensure Cleanroom Classifications Are Up to Date with ISO 14644-1
ISO 14644-1 (updated in 2015) redefined how cleanrooms are classified and tested. Ensure your classifications are based on the latest methodology, using the correct sample volumes, particle size ranges, and location criteria.
Also verify that:
- classification reports are available and updated regularly (typically every 6–12 months).
- environmental monitoring plans align with classification levels.
- alerts and action limits are defined and documented.
- any classification excursions have documented responses and follow-ups.
Failing to maintain updated classifications is a red flag in any ISO 14644 audit.
A combined ISO 13485 and ISO 14644 audit requires more than just ticking boxes. It demands a fully integrated approach to quality and contamination control. By understanding the purpose and scope of each standard, bridging the gaps between them and preparing both your systems and your team, you can navigate the audit process with confidence. Combined compliance not only ensures you meet global regulatory expectations but also builds trust with customers, reduces product risk and strengthens your overall manufacturing integrity.
Need help preparing for your next combined ISO audit? Our inspection and compliance experts at GIM can guide you through documentation reviews, gap analyses and audit readiness strategies tailored to your operations. Contact us today to ensure your facility is fully prepared, inside and out.