ISO 9001 Certification
At Q2ESB Ingénierie, quality is not simply a department; it is part of our working culture. Our ISO 9001:2015 certification, issued by the International Certification Authority (ICA) under certificate number ICATO 210291, is official proof of our commitment.
But beyond this document, there are teams who understand what designing a cleanroom represents for a Tunisian industrial company: a strategic decision, a major investment, and a compliance requirement where there is no room for error.
Our ISO 9001 Certification: Quality Commitment for Your Cleanrooms
Q2ESB Ingénierie is recognized for the performance of its quality management system in Tunisia. Issued by the International Certification Authority (ICA), our quality management system has been assessed and found to comply with the requirements of the ISO 9001:2015 standard for the following scope:
This scope is far from incidental. It covers the entire lifecycle of a cleanroom project, from feasibility studies to IQ/OQ/PQ qualification protocols, with a level of documentation and process rigor that only truly well-structured companies can maintain.
Applicable Standards
- ISO 14644 and NF ISO 17141 cleanroom standards (control of biocontamination).
- NF S 90-351 hospital standard.
- Requirements of Tunisian GMP standards (Good Manufacturing Practices / GMP).
What This Certification Means for You in Practice
Beyond obtaining ISO 9001:2015 certification, our commitment is demonstrated through the consistent application of our quality standards, tested through annual audits. For your controlled-environment projects, working with Q2ESB provides you with:
Complete Document Traceability
Specifications, execution drawings, particle tests, test reports, and more... Every stage is subject to rigorous documentation and archiving. You maintain full visibility over project progress, as do your own auditors.
Risk-Reduction Processes
ISO 9001 requires a proactive approach. Before construction even begins, we identify the critical points specific to your business, whether it involves a pharmaceutical cleanroom, a microbiology laboratory, or an electronic production area.
A Single Accountable Point of Contact
Our procedures clearly define responsibilities at every stage of the project. You do not have to manage complex interfaces between different trades: we coordinate all technical workflows on your behalf.
Full Compliance with Your Regulatory Requirements
Whether you are preparing a marketing authorization application, an FDA inspection, a client audit, or GMP compliance documentation, our quality system makes the process easier. Our deliverables are structured to integrate directly into your validation documentation.
Ensure Your Processes Comply with the Expertise of a Qualified Professional
Given the complexity of ISO 14644 requirements and GMP standards, effective management of technical risks is essential. Our qualified engineers analyze your specifications to secure the design and validation of your controlled environments.
FAQ: Everything You Need to Know About ISO 9001 Certification
What is the difference between ISO 9001 and ISO 14644?
These are two complementary but completely different standards:
- ISO 9001 applies to the company's Quality Management System (QMS). It demonstrates that Q2ESB's internal organization is structured to meet customer requirements and continuously improve its processes.
- ISO 14644 is a purely technical standard. It defines airborne particulate cleanliness classes and specific performance requirements within cleanrooms.
In short: ISO 9001 ensures the quality of your project's organization and management, while ISO 14644 governs the technical performance of the final installation.
Do cleanrooms need to be certified?
From a technical standpoint, a cleanroom is not technically “certified” but qualified. Unlike a service provider or company that may be certified for its management processes (such as ISO 9001), a controlled-environment facility undergoes regulatory qualification in accordance with ISO 14644. This rigorous protocol uses physical tests (particle counting, pressure differentials, airflow measurements) to demonstrate the installation's compliance through the IQ/OQ/PQ stages.
Furthermore, to maintain its authorization to operate and meet the specific requirements of GMP guidelines or the NF S 90-351 hospital standard, this qualification is not permanent: it must be renewed periodically through requalification audits, generally scheduled every 6 to 12 months.
What does IQ, OQ, and PQ qualification involve for a cleanroom?
Qualification is the technical and regulatory process used to verify the compliance of your controlled environment. It consists of three structured phases carried out by our engineers:
- IQ (Installation Qualification): Verification that all equipment (air handling units, HEPA filters, partitions) has been installed in accordance with the approved plans and specifications.
- OQ (Operational Qualification): Dynamic testing to demonstrate that the system operates correctly within its specified operating limits, including pressure, airflow, and temperature control.
- PQ (Performance Qualification): Verification that the cleanroom consistently maintains the required environmental conditions during actual production activities.