What can a Management System (i.e. ISO 13485, NABH, 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.
Nucleus Consultants is a leading management systems consultants, providing services on ISO 22000, ISO 9001, ISO 45001 and 14001 environmental management systems Implementation, Training and Auditing.
Services for the Life Science Industry
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 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 13485, NABL, 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 Life Sciences services include:
- ISO 13485 Consulting, Implementation and Training
- NABL Consulting, Implementation and Training
- ISO 9001 and ISO 14001 Consulting, Implementation and Training
- ISO 45001 Consulting, Implementation and Training
- Other ISO Management System Consulting, Implementation and Training
- Clinical Evaluation Documentation, Implementation and training
- Medical Devices Regulatory Approvals Documentation, Implementation and training
For more information regarding our full suite of services for the Healthcare Industry. contact us.
About ISO 13485
ISO 13485 is the most accepted standard world-wide for manufacturers of medical devices (e.g. in the US, Japan, Canada, EU). This standard includes requirements specific to this business sector and defines terms such as medical device, active medical device, active implanted medical device, sterile medical device, and many more. ISO 13485 supports the reduction of unexpected risks for companies who construct, manufacture or use medical products and services, both during fabrication as well as for later use. It aims to increase reputation in the eyes of customers and authorities. It will be an independent standard which can be used without consideration of ISO 9001, provided a company works only within the medical industry. (See more about ISO 13485.)
The National Accreditation Board for Testing and Calibration Laboratories (NABL) undertakes the assessment and accreditation of Testing and Calibration Laboratories, in accordance with the international standard ISO / IEC 17025 and ISO/IEC 15189. (See more about NABL.)
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 45001 does 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…)