ISO Management Systems, Total Quality Management Consultancy Services

Nucleus Consultants - Consulting, Implementing, Auditing and Training of TQM and ISO Systems
 
Life Sciences


Services for the Life Sciences 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 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 OHSAS 18001 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 9000 and ISO 14000 Consulting, Implementation and Training


- OHSAS 18001 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.
 

 

 

 

Services for the Life Science Industry


What can a Management System (i.e. ISO 13485, NABH, ISO 9001, OHSAS 18001, 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.

Nucleus Consultants is a leading management systems consultants, providing services on ISO 22000, ISO 9001, OHSAS 18001 and 14001 environmental management systems Implementation, Training and Auditing. With qualified auditing staff, we service various customers in multiple industries, including Life Science Industries.  
 



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 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..)

 

About NABH


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 OHSAS 18001


The (OHSAS) specification gives clearer direction to an occupational health and safety management system. OHSAS 18001 is an audit/certification specification, not a legislative requirement or a guide to implementation. It should be noted that OHSAS 18001 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.

OHSAS 18001 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 OHSAS 18001 can easily integrate it with other quality, environmental or occupational health and safety management systems. The OHSAS 18001 Specification follows the Plan-Do-Check-Review 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 OHSAS 18001 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 OHSAS 18001..)

 


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 14000 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...)

 

 

Contact Us

Have questions about a specific Nucleus Consultants service? Whatever your inquiry, just mail us to info@nucleus-india.com or call us +91 9600001996.