ISO Audit Services

ISO Audit Services Offered

Our audits typically require 1-3 days onsite, during which our certified auditors perform a detailed assessment of the systems, processes, and documentation to identify areas of noncompliance. Following the audit, Pro QC develops a corrective action plan to help address any nonconformities, guiding the organization toward full compliance with ISO standards. This approach ensures that businesses not only meet certification requirements but also fosters continuous improvement and operational excellence.

Our comprehensive suite of ISO audits includes:

ISO 9001 Audits

ISO 9001 focuses on Quality Management Systems (QMS). Our ISO 9001 audit services help implement and maintain effective QMS practices that align with international standards. We conduct thorough assessments of company processes, identify areas for improvement, and provide actionable insights to enhance product quality and customer satisfaction. Our audits ensure an organization’s commitment to quality, leading to improved performance and operational excellence.

ISO 13485 Audits

Designed specifically for the medical device industry, ISO 13485 ensures quality management systems are in place to meet regulatory requirements. Our ISO 13485 audit services offer meticulous evaluations of a QMS, focusing on risk management, regulatory compliance, and product safety. We help navigate the complex regulatory landscape, ensuring products meet stringent quality and safety standards and provide support for achieving and maintaining certification.

ISO 14001 Audits

ISO 14001 is centered on Environmental Management Systems (EMS). Our audits help develop and maintain effective EMS practices that minimize environmental impact. We assess an organization’s environmental policies, procedures, and compliance with regulations, providing recommendations for improvement.

ISO 45001 Audits

Occupational health and safety are critical components of any organization. ISO 45001 focuses on Occupational Health and Safety Management Systems (OHSMS). Our ISO 45001 audit services evaluate workplace safety practices, identify potential hazards, and ensure compliance with health and safety regulations. We provide a comprehensive review of the OHSMS.

ISO 22716 Audits

ISO 22716 pertains to Good Manufacturing Practices (GMP) for the cosmetics industry. Our ISO 22716 audit services ensure manufacturing processes meet GMP requirements, focusing on product safety and quality control. We conduct detailed audits of production facilities, evaluate quality management practices, and provide guidance on compliance with ISO 22716 standards.

ISO 14644 Audits

ISO 14644 specifies the classification of air cleanliness in cleanrooms and controlled environments. Our ISO 14644 audit services ensure cleanroom facilities meet the required standards for air cleanliness. We evaluate cleanroom practices and assess compliance with ISO 14644 standards.

ISO 11135 Audits

ISO 11135 focuses on healthcare product sterilization using ethylene oxide. Our ISO 11135 audit services ensure that sterilization processes meet the necessary standards for safety and effectiveness. We assess sterilization procedures, review documentation, and ensure compliance with ISO 11135.

ISO 22000 Audits

ISO 22000 addresses food safety management systems. Our ISO 22000 audit services ensure organizations meet international food safety standards, from farm to fork. We assess food safety practices, identify potential hazards, and provide actionable recommendations to enhance food safety and regulatory compliance.

Request a quote

Our ISO Audit Coverage

Global Coverage with Local Expertise

Pro QC operates in over 100 countries across North America, Europe, Asia, South America, and Africa. Our widespread presence allows us to understand and navigate regional regulations and cultural nuances, providing seamless audit services that are both globally standardized and locally relevant.

Discover our Global Coverage.

With a vast network of certified auditors and technical experts, we are equipped to respond promptly and efficiently to your audit needs, no matter where your operations are based. Our extensive coverage means we can deploy resources quickly and provide consistent service quality across all locations. Our auditors possess in-depth local knowledge, enabling them to provide region-specific insights while adhering to international standards. This blend of global standards and local expertise ensures comprehensive audits tailored to your unique environment.

Industry Expertise

We serve a wide range of industries, including:

• Softlines: textile, footwear, bags, soft toys
• Hardlines: battery, bicycles, electronics, electrical equipment, furniture, jewelry, packaging, kitchenware
• Industrials: industrial machinery, energy, metals and fabricated metals,
• Medical & Health care: medical devices, cosmetics
• Transportations: automotive, e-cars, aerospace

Our auditors are experienced in various sectors, ensuring that our ISO assessments are customized to meet specific regulatory and operational requirements, regardless of location.

Request a quote