Quality management
Defined systems and controls support consistent execution across industrial operations.
Quality built into every operation.
Culture, systems, and evidence for market-specific pharmaceutical collaboration.
Quality overview
At PiSA® Pharmaceutical, we strive every day to keep Good Manufacturing Practices current throughout the Product Life Cycle.
Our quality systems are designed to ensure that every product undergoes rigorous testing and validation processes before reaching healthcare professionals and patients.
Compliance with international pharmaceutical standards.
Product safety and efficacy.
Continuous process improvement.
Compliance with regulatory requirements.
Patient-centered manufacturing practices.
Quality management systems
Evidence should be specific.
Structured quality systems support consistent operations across the company’s industrial infrastructure.
Quality Policy
Excellence and Continuous Improvement
We foster a quality culture based on compliance, sustainability, and the ongoing improvement of our processes to build trust, efficiency, and long-term value.
Compliance with our customers' requirements to achieve their satisfaction.
Compliance with applicable legal, regulatory, and statutory requirements.
Care for the environment.
Continuous improvement of our management system through the establishment and review of objectives.
Optimized use of resources.
Standards and recognition
Certifications and standards that support our operations
Our operations are supported by management systems, regulatory standards, and internationally recognized certifications that underpin the quality, safety, reliability, and continuous improvement of our processes.
ISO 9001:2015
Certification reference
ISO 13485:2003 + AC:2007
Certification reference
NOM-059-SSA1-2015
Regulatory standard
AENOR
Certification reference
IQNet SR10
Certification reference
Shingo Silver
Operational-excellence recognition