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Product Quality and Safety Compliance
The trust and confidence of our customers relies on the standards we set to make safe and effective products of the highest quality. As our companies evolve to operate under a single quality framework with a common set of quality and compliance elements, these actions help to ensure the highest quality products on which our customers have relied for more than a century.
Each Johnson & Johnson operating company is expected to ensure that:
Many of our businesses and facilities have been certified to meet International Organization for Standardization (ISO) requirements for quality management. ISO certification means that a quality management system has been thoroughly reviewed by an outside audit committee and found to satisfy rigorous standards.
All of our facilities that make medicines or medical devices meet current Good Manufacturing Practices (cGMP), as outlined by the FDA or one or more other national regulatory agencies.
Training programs at our companies give employees the necessary tools to create and manage quality systems that ensure our products perform as intended and meet all regulatory requirements.
External Manufacturing Compliance
Our commitment to compliance extends to our external manufacturers who we rely on to produce ingredients as well as finished goods. The Johnson & Johnson Responsibility Standards for Suppliers help us identify and select partners who operate in a manner consistent with our values, and they help our manufacturing partners understand our expectations.
External manufacturers must meet agreed upon quality requirements in order to provide goods and services that consistently meet required specifications and customers’ needs, perform as intended and are safe for their intended use.
Each Johnson & Johnson operating company is expected to ensure that:
• Products meet safety and quality requirements and perform as required throughout their shelf life;
• All products and ingredients we purchase from suppliers meet our requirements;
• Changes to materials, product labeling, packaging, processes, systems, facilities, methods and equipment are reviewed and approved before they are made, and;
• Procedures are in place to prevent diversion of our products from their intended distribution channels and to protect them from counterfeiting.
Many of our businesses and facilities have been certified to meet International Organization for Standardization (ISO) requirements for quality management. ISO certification means that a quality management system has been thoroughly reviewed by an outside audit committee and found to satisfy rigorous standards.
All of our facilities that make medicines or medical devices meet current Good Manufacturing Practices (cGMP), as outlined by the FDA or one or more other national regulatory agencies.
Training programs at our companies give employees the necessary tools to create and manage quality systems that ensure our products perform as intended and meet all regulatory requirements.
External Manufacturing Compliance
Our commitment to compliance extends to our external manufacturers who we rely on to produce ingredients as well as finished goods. The Johnson & Johnson Responsibility Standards for Suppliers help us identify and select partners who operate in a manner consistent with our values, and they help our manufacturing partners understand our expectations.
External manufacturers must meet agreed upon quality requirements in order to provide goods and services that consistently meet required specifications and customers’ needs, perform as intended and are safe for their intended use.