ISO 9001  
  ISO 9001 specifies requirements for a quality management system where an organization  
Needs to demonstrate its ability to consistently provide product or         service that meets customer and applicable statutory and regulatory requirements,
» Aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system.

Benefits of ISO 9001 include   

Needs to demonstrate its ability to consistently provide product or        
» Aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system.
    Driving down costs, reducing rejections
    Managing risk more effectively
     Improving customer satisfaction
» A quality management system gives you the framework you need to monitor and improve performance in any area you choose

Some of the requirements in ISO 9001 include

A set of procedures that cover all key processes in the business    
» Monitoring  & measuring processes to ensure they are effective
» keeping adequate records for different processes
» checking output for deficiencies, with appropriate corrective & preventive action where necessary
» regularly reviewing individual processes and the quality management system itself for effectiveness
» facilitating continual improvement
ISO 9001 is by far the world’s most established quality framework, currently being used by more than 896,000 organizations in 170 countries worldwide.
» All requirements of ISO 9001 are generic and are intended to be applicable to all organizations, regardless of type, size and product/service provided.
  ISO 14001  
The ISO 14001 is a standard for environmental management systems that is applicable to any business, regardless of size, location or income. The aim of the standard is to reduce the environmental footprint of a business and to decrease the pollution and waste a business produces. The ISO 14000 environmental management standards help organizations minimize the negative effect on the environment. In structure it is similar to ISO 9000 Quality management..

Benefits of Certification


ISO 14001:2004 is a tool that can be used to meet  Internal & External Objectives 

» Provide assurance to management that it is in control of the organizational processes and activities having an impact on the environment
» assure employees that they are working for an environmentally responsible organization.
» provide assurance on environmental issues to external stakeholders – such as customers, the community and regulatory agencies
» Comply with environmental regulations
» support the organization's claims and communication about its own environmental policies, plans and actions
» provides a framework for demonstrating conformity via suppliers' declarations of conformity, assessment of conformity by an external stakeholder - such as a business client - and for certification of conformity by an independent certification body

ISO 13485


Medical devices -- Quality management systems -- Requirements for regulatory purposes

  ISO 13485 is an ISOstandard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture ofmedical divices.  

Other specific differences include:

the promotion and awareness of regulatory requirements as a management responsibility, will providing resources and during reviews
» controls in the work environment to ensure product safety
» focus on risk management activities and design transfer activities during product development
» specific requirements for documentation and validation of processes for sterile medical devices
» specific requirements for verification of the effectiveness ofcorrective and preventive action.

Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Device is assessed before sale is permitted.

  ISO 17020  

General criteria for the operation of various types of bodies performing inspection


This standard defines the criteria to be followed by the bodies performing inspection of infrastructure projects and the guidance for application of the criteria. It also describes the procedure that will be followed by the Inspection Bodies (IBs) seeking approval by the Quality Council of India (QCI) as an inspection body performing  inspection of infrastructure projects

  Infrastructure including :  
Railway tracks, signaling system, stations
» Roads, bridges, runways, ports  and other airport facilities
» Telecommunication  services
» Pipelines for water, crude oil, slurry, waterways, port facilities
» Canal networks for irrigation, sanitation or sewerage.
» Vehicles, aircrafts
» Power generating plants
» Production of crude oil, purification of water
» Ships and other vessels.
» A highway projects  including other activities being an integral part of the highway project
» water supply projects, irrigation projects, water treatment system sanitation and sewerage system or solid waste management system
» an industrial park or special economic zone
» Electricity (including generation, transmission and distribution) 
» construction relating to projects involving agro-processing and supply of inputs to agriculture
» construction of educational institutions and hospitals
» any other infrastructure facility of similar nature
  *Source: “Quality council of India “  
  OHSAS 18001  

OHSAS 18001 is a non ISO standard which specifies assessment criteria for a Occupational Health and Safety Management Systems. It was developed to help organizations meet their health and safety obligations in an efficient and effective manner.

  The benefits of  OHSAS  

Reduce the exposure of employees and other parties to occupational health and safety risks associated with the organizations activities

» Potential reduction in resultant costs
» Greater assurance of conformance with occupational health and safety policy
» Demonstration of conformance to third parties, and of due diligence generally
» Consistent and proven management approach to H&S risks, present and future
» Deployment of method for continual improvement of the occupational health and safety management system
  ISO 22000  


  ISO 27001  

ISO 27001  is an Information Security management System (ISMS) standard published  by theInternational standers for Organisation(ISO)


ISO 27001 formally specifies a management system that is intended to bring information security under explicit management control. Being a formal specification means that it mandates specific requirements.

  The security controls in operation typically address certain aspects of IT or data security, specifically, leaving non-IT information assets (such as paperwork and proprietary knowledge) less well protected on the whole. Business continuity planning and physical security, for examples, may be managed quite independently of IT or information security ISO/IEC 27001 requires that management  

Systematically examines the organization's information security risks, taking account of the threats, vulnerabilities and impacts

» Designs and implements a coherent and comprehensive suite of information security controls and/or other forms of risk treatment (such as risk avoidance or risk transfer) to address those risks that it deems unacceptable
» Adopts an overarching management process to ensure that the information security controls continue to meet the organization's information security needs on an ongoing basis
  AS 9100  

AS9100 is a widely adopted and standardized quality management system for the aerospace industry

» AS9100 replaces the earlier AS9000 and fully incorporates the entirety of the current version of ISO 9000, while adding additional requirements relating to quality and safety. Major aerospace manufacturers and suppliers worldwide require compliance and/or registration to AS9100 as a condition of doing business with them
» Prior to the adoption of an aerospace specific quality standard, various corporations typically used ISO 9000 and their own complementary quality documentation /requirements, such as Boeing's D1-9000 or the automotive Q standard. This created a patchwork of competing requirements that were difficult to enforce and/or comply with. The major American aerospace manufacturers combined their efforts to create a single, unified quality standard, resulting in AS9000.

During the rewrite of ISO 9000 for the year 2000 release, the AS group worked closely with the ISO organization. As the year 2000 revision of ISO 9000 incorporated major organizational and philosophical changes, AS9000 underwent a rewrite as well. It was released as AS9100 to the international aerospace industry at the same time as the new version of ISO 9000.


AS9100 Revision C was released in January, 2009

  ISO / TS 16949  

TS 16949 is a Technical Standard expressing “particular requirements for the application of  ISO 9001 for automotive production and relevant service part organizations”


Prepared by International Automotive Task Force (IATF) + Japan    Automobile Manufacturers Association  (JAMA)


The aim of ISO/TS16949 is the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain. Applicable to sites of the organization where customer-specified parts, for production and/or service, are manufactured. ISO/TS 16949 can be applied throughout the automotive supply chain.

  SA 8000  

SA8000 is a global social accountability standard for decent working conditions, developed and overseen by

  SA8000 is based on the UN Universal declaration of human right, Convention on the rights of the child and various International Labour Organization(ILO) conventions. SA8000 covers the following areas of accountability  

Child Labour

» Forced Labour
» Workplace safety and health
» Freedom of Association
» Discrimination
» Discipline
» Working Hours
» Remuneration
» Management System



National Accreditation Board for Hospitals & Healthcare Providers (NABH) is a constituent board of Quality Council of India, set up to establish and operate accreditation program for healthcare organizations.


NABH is an institutional member of the International Society for Quality in Health Care (ISQUA). ISQUA is an international body which grants approval to Accreditation Bodies in the area of healthcare as mark of equivalence of accreditation program of member countries.


  In India, Heath System currently operates within an environment of rapid social, economical and technical changes. Such changes raise the concern for the quality of health care. Hospital is an integral part of health care system.

  Accreditation would be the single most important approach for improving the quality of hospitals. Accreditation is an incentive to improve capacity of national hospitals to provide quality of care. National accreditation system for hospitals ensure that hospitals, whether public or private, national or expatriate, play there expected roles in national heath system.  

Benefits for Patients


Patients get the benefit of high quality  health care and patient safety. The patients are serviced by credential medical staff. Rights of patients are respected and protected.


Benefits for Hospitals


Accreditation stimulates continuous improvement. It enables hospital in demonstrating commitment to quality care. It increases community confidence in the services provided by the hospital. The hospitals accredited by NABH will have international recognition. This will boost  medical tourism.


Benefits for Hospital Staff


It provides for continuous learning, good working environment, leadership and above all ownership of clinical processes. It improves overall professional development of Staff.


Benefits to paying and regulatory bodies


Provides an objective system of empanelment by insurance and other third parties. Accreditation provides access to reliable and certified information on facilities, infrastructure and level of care.


NABH Standards has ten chapters incorporating 100 standards and 514 objective elements.


Outline of NABH Standards
Patient Centered Standards


Access, Assessment and Continuity of Care (AAC)

» Care of Patient (COP)
» Management of Medication (MOM)
» Patient Right and Education (PRE)

Hospital Infection Control (HIC)


Organisation Centered Standards


Continuous Quality Improvement (CQI)

» Responsibility of Management (ROM)

Facility Management and Safety (FMS)

» Human Resource Management (HRM)

Information Management System(IMS)

*Source: “Quality council of India “

ISO 17025 is the main standerd used by testing and calibration laboratories. And it applies directly to those organizations that produce testing and calibration results.


There are two main sections in ISO/IEC 17025 - Management Requirements and Technical Requirements. Management requirements are primarily related to the operation and effectiveness of the quality management system within the laboratory. Technical requirements address the competence of staff, methodology and test/calibration equipment.


Laboratories use ISO 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. It is also the basis for accreditation from an Accreditation Body. Since the standard is about competence, accreditation is simply formal recognition of a demonstration of that competence.


ISO 15189:2003 Medical laboratories - Particular requirements for quality and competence specifies the quality management system requirements particular to medical laboratories. This working group included provision of advice to users of the laboratory service, the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency and the lab's role in the education and training of health care staff.


Scope of Accreditation

NABL Accreditation is currently given in the following fields:
» Biological
» Chemical
» Electrical
» Electronics
» Fluid-Flow
» Mechanical
» Non-Destructive
» Photometry
» Radiological
» Thermal
» Electro-Technical
» Mechanical
» Fluid Flow
» Thermal & Optical
» Radiological
» Clinical Biochemistry
» Clinical Pathology
» Haematology and Immunohaem-atology
» Microbiology and Serology
» Histopathology
» Cytopathology
» Genetics
» Nuclear Medicine (in-vitro tests only

*Source : Quality Council of India


At the second QCI National Quality Conclave in February 2007, Dr. A. P. J. Abdul Kalam, then President of India, stressed the need for development of a standard for the schools to ensure quality of education across the nation. In line with this recommendation QCI has developed the Accreditation Standard for Quality School Governance. This standard provides framework for the effective management and delivery of the holistic education program aimed at overall development of the students. synonyms being breeding, civilization, coaching, cultivation, culture development, discipline, edification, enlightenment, improvement, knowledge, nurturing, teaching, training, tutoring etc


The standard has been developed in consultation with academicians, parents, administrators and quality professionals of education is characterized by creation of the capacity for life long learning. There are three basic elements for quality in education; management quality, teacher quality and student quality.

  This standard has been developed with a view to define and implement systems to provide educational services that aim to enhance satisfaction level of all interested parties, provide a basis for assessing and where required, rating the effectiveness of an educational management system, develop quality consciousness among interested parties involved in school activities.

  The standard focuses on establishing systems to enable learning, self development and improved performance. It encourages schools to pursue continual excellence. The standard is non- prescriptive; but its compliance is in conjunction with the applicable statutory and regulatory requirements. The standard can be adapted  
  The standard can be adapted  

as a self improvement tool

» for third party accreditation/certification

by statutory and regulatory authorities. 

*Source: “Quality council of India “

An abbreviation of Conformité Européene, CE Marking is a legally mandated conformity marking for products regulated by the New Approach Directives, a series of European health, safety, environmental and consumer protection laws.  These products must carry CE Marking in order to be placed on the market or put into service in the European Economic Area (EEA), which consists of the European Union (EU) and three countries of the European Free Trade Association (EFTA).


CE Marking is required for toys, machinery, electrical equipment, electronic equipment, personal protective equipment, pressure equipment, medical devices, active implantable medical devices, in vitro diagnostic medical devices, telecommunications terminal equipment, simple pressure vessels, gas appliances, lifts, recreational craft, equipment and protective systems for use in explosive atmospheres, non-automatic weighing instruments, cableways, construction products, explosives for civil use and new hot water boilers.

 It is not required for chemicals, pharmaceuticals, cosmetics and foodstuffs.

  Contact No
  Email Id
  Service Required
Home  |   About Us   |   Services   |   Enquiry   |   Blog   |   Contact Us   |   Sitemap
  © 2009 Orbit Quality & Management Solutions All rights Reserved