Documented Procedures
Comprehensive documentation ensuring consistent processes
Keystone Adjustable Cap Company, Inc. (Keystone Safety and Cleanroom Products, "Keystone") specializes in the development, manufacture, and marketing of disposable protective apparel and specialty products for cleanroom and industrial applications. At Keystone, quality is the foundation of our operations, our culture, and our customer relationships.
Our Quality Management System (QMS) is aligned with ISO 9001:2015 / Amendment 1:2024 and is implemented across all business functions from sourcing to shipment.
"At Keystone Safety and Cleanroom Products, quality is a system-wide responsibility. It is reflected in our processes, our materials, and our commitment to consistent and compliant outcomes."
Our QMS governs the acquisition, manufacture, and distribution of all disposable protective apparel and specialty products. It ensures full traceability, control, and continuous improvement across all operations.
Our Keystone Cleanroom Products Division manufactures and packages products in ISO Class 6 and ISO Class 8 certified cleanroom environments. These facilities meet the stringent contamination control standards required by pharmaceutical, biotech, medical device, and electronics industries.
All Keystone products are manufactured using animal-free materials. No animal-derived components are used, supporting compliance with religious, ethical, and allergen-sensitive requirements.
Keystone's leadership is responsible for the effectiveness of the Quality Management System. Quality objectives are aligned with business strategy and supported by the necessary resources to ensure compliance and continual improvement.
Roles and responsibilities are clearly defined across the organization. Employees are trained, informed, and encouraged to contribute to quality through ownership and accountability.
Management regularly reviews QMS performance, audit results, and customer feedback to ensure alignment with requirements and opportunities for improvement.
In alignment with ISO 9001:2015 / Amendment 1:2024, Keystone considers climate change as a relevant factor in its business planning. We evaluate environmental risks and stakeholder expectations as part of our risk and opportunity management framework.
Keystone supports customers who operate in regulated and contamination-sensitive environments. Our disciplined systems, skilled workforce, and verified controls demonstrate our commitment to delivering reliable quality outcomes.
We don't claim certification.
We demonstrate conformance every day.
