Chemical & Pharmaceutical
What can a Management System (i.e. ISO 9001,ISO 45001, ISO 14001) bring to your organization? First, a quality management system has the potential to make your organization more cost effective and efficient, providing your customers consistent quality products. Second, it will arm you with a powerful competitive tool to help your business grow and prosper. Quite simply, compliance with management system standards sends a very strong message to your customers: Your company takes quality seriously.
Services for the Chemical & Pharmaceutical Industries
In today’s marketplace of changing technology and stringent regulatory requirements, time to market and product quality are essential in developing a competitive advantage.
At Nucleus Consultants, our fluency in the Chemical & Pharmaceutical industry helps you gain the competitive edge you need. Our industry experts, supported by qualified personnel, reducing your time to market.
Our quality systems consultancy services guide your team through the ISO 9000, ISO 14001 and ISO 45001 certification process, providing your company a competitive advantage through improved processes, continuous improvement, and market recognition.
Nucleus Consultants Chemical & Pharmaceutical services include:
- – ISO 9001 and ISO 14001 Consulting, Implementation and Training
- – ISO 45001 Consulting, Implementation and Training
- – Other ISO Management System Consulting, Implementation and Training
- – GMP Documentation, Implementation and training
- – Drug Approvals and Regulatory and clinical evaluation documentation
For more information regarding our full suite of services for the Chemical and Pharmaceuticals. contact us.
About ISO 9001
Originally published in 1987 by the International Organization for Standardization, ISO 9001 is a generic quality systems standard that specifies, in very broad terms, the necessary components of a quality management system. Rather than being specific to any one industry, ISO 9000 details the basic requirements of the quality function for all industries. ISO 9001 gives you the tools to grow a better business through continuous improvement and refined processes. The latest version of ISO 9001 is ISO 9001:2015. Today more than 500,000 businesses have achieved ISO 9001 certification throughout the world, making it by far the most recognized symbol for quality in the global marketplace. (See more about ISO 9001.)
About ISO 45001
The (ISO 45001) specification gives clearer direction to an occupational health and safety management system. ISO 45001is an audit/certification specification, not a legislative requirement or a guide to implementation. It should be noted that ISO 45001does not state specific performance criteria, or give detailed specifications for the design of a management system. Instead, the system is geared towards reducing and preventing accidents and accident-related loss of lives, resources, and time.
ISO 45001 has been developed to be compatible with the ISO 9001 (Quality) and ISO 14001 (Environmental) management systems standards. It is its hope that any organization that implements ISO 45001 can easily integrate it with other quality, environmental or occupational health and safety management systems. The ISO 45001 Specification follows the Plan-Do-Check-Act cycle, with a concurrent emphasis on continual improvement. This model aligns well with the structure of other management system documents such as ISO 14001, thus aiding the progress of integrated management systems.
The elements of ISO 45001 includes Policy and commitment, Hazard identification, risk assessment & risk controls, Legal requirements, Objectives and Programs, Organization and personnel, Training, Communication and Consultation, Documentation and records, Operational Controls, Emergency Readiness, Measurement and monitoring, Accident and incident investigation, corrective and preventive action, Audit and Review, and Application and Relevance in the Industry.(See more about ISO 45001 .)
About ISO 14001
Protection of the environment is one of society’s key goals. A significant increase in environmental awareness and stricter environmental regulations has led many organizations to integrate environmental protection into their corporate management systems structure.
Leading corporations have been utilizing environmental management systems (EMS) for years to help them reach defined environmental objectives. Now, a streamlined environmental management tool is available to all corporations in the form of ISO 14001, an internationally recognized environmental management system conformance standard. Very similar in structure to the ISO 9001 quality management system standard, ISO 14001 outlines key requirements to which companies should comply in order to operate in an environmentally responsible manner.
The ISO 14001 elements provide diverse organizations a framework for managing and continually improving their environmental programs. Many companies already monitor air and water permits, or toxic use reduction programs. Utilizing ISO 14001, companies can now merge environmental programs into one coherent system to efficiently manage all environmental activities.
In short, ISO 14001 can provide your company a competitive advantage, by demonstrating to your customers that your environmental processes and impact is effectively managed, continually improving, and part of the corporate management system.(See more about ISO14001…)