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  ISO CERTIFICATION


  ISO 9001
  ISO 14001
  TS 16949
  OHSAS 18001
  ISO 27001
  SA 8000
  ISO 13485:2003
  ISO 10002:2004
  ISO 22000

ISO 9001 Quality Management Systems

The ISO 9001 standards give organizations an opportunity to increase their value activities and to improve their performance continually, by focusing on their major processes. The standards provide great emphasis on making quality management systems closer to the processes of organizations. As a result, they direct organization to the achievement of business results, including the satisfaction of customers and other interested parties. The management of an organization should look upon this certification as the adoption of the quality management system standards as a profitable business investment, not just as a required certification issue.

Customer Benefits:
The ISO 9000 series of standards have been developed to enable organizations to have quality based management systems. This enables them to understand their customers' requirements and improve customer satisfaction, through the review and improvement of their internal activities.

Benefits of Using ISO 9001:

The benefits of using the standards are as follows:
  • Improved consistency of service and product performance
  • Higher customer satisfaction levels.
  • Improved customer perception
  • Improved productivity and efficiency
  • Cost reductions
  • Improved communications, morale and job satisfaction
  • Competitive advantage and increased marketing and sales opportunities

ISO 14001 Environmental Management System (EMS)

What is ISO 14000/ISO 14001?
ISO 14000 is an Environmental Management System (EMS), which requires that an organization consider the environmental aspects of its products and services.
Iso14000 standard is the world’s first series of internationally accepted Standards for Environmental Management Systems (EMS).

Benefits of Implementing ISO 14001

  • Reduce cost of waste management
  • Savings in consumption of energy and materials
  • Improved compliance
  • Overall Costs Reduced
  • Fewer accidents
  • Competitive advantage
  • Improved use of resources
  • Framework for continuous improvement of your environmental performance
  • Improved corporate image among regulators, customers and the public

TS 16949

What is TS 16949 ?

The result of the IATF's effort is the TS 16949 specification. TS 16949 form the requirements or the application of ISO 9001 for automotive production and relevant service part organizations.

Who are the IATF?
The IATF is an ad hoc group of OEM's and automotive trade associations whose common goal is to improve the quality of products to automotive customers worldwide. IATF members include the Big 3, along with Fiat, Citroen, VW, Renault and national automotive trade associations from the US, Germany, UK, Italy and France. Additionally, the Japanese vehicle association, JAMA, has been involved with the IATF's efforts to develop TS 16949.


Steps for TS 16949 Certification

  • TS 16949 Audit /Assessment (Gap Analysis).
  • Development of an Implementation Plan.
  • Provide Awareness Training to all employees.
  • Allocate Resources that will be necessary to develop and implement the system
  • Prepare Quality System Documentation - Tier 1, 2, 3 documents (Quality Manual, Quality System Procedures, Work Instructions and Quality Records/Forms).
  • Determine Training Needs of Employees - Job and Employee Skill Matrix (ie. overview of new system, internal auditing, problem solving, teamwork, etc...).
  • Implement the New System.
  • Conduct Internal Audits.
  • Take Corrective Actions, if necessary.
  • Re-Audit/Follow-up, if necessary.
  • Registrar Audit Preparation/Training
  • Registration Application.
  • Registration Audit.
  • Registration Certificate Issued.
  • Maintain, Improve and Innovate the System.

OHSAS 18001

Companies can expect considerable benefits from developing a health and safety management system certified to OHSAS 18001. The presence of formal management systems, incorporating a structured approach to hazard identification and risk management, can contribute to the avoidance of a high proportion of accidents and occupational health problems. The development of such a system, can make the management of health and safety more transparent and effective by translating OHSAS 18001 Certification.

What is OHSAS 18001?

OHSAS stands for Occupational Health and Safety Assessment Series. OHSAS 18001 is a consensus standard developed in 1999 by an independent group of national standards bodies and certification bodies (registrars).

OHSAS 18001 is structured the same way as ISO 14001, the environmental management system standard, and has essentially the same elements. It was specifically developed to be compatible with ISO 9001, the quality management system standard, and ISO 14001 to allow companies to develop and register integrated quality, environmental and occupational safety and health management systems.

 Benefits of OHSAS Certification

Organizations that have implemented a system to improve the management of health and safety practices have reported reduced improved employee safety awareness, fewer accidents and reduced costs. In addition, OHSAS 18001 provides a structure, companies can use to integrate quality, environmental and safety and health program management for increased management efficiencies.

Steps to OHSAS 18000 Certification
 
The process for establishing an OHSAS 18001 management system is essentially the same as the process used of implementing an ISO 14001 system:

  • Preliminary review of existing programs and systems
  • Identification of hazards and applicable laws and regulations
  • Developing new procedures
  • Training personnel
  • Implementing new programs such as internal audit and management review
  • Seeking certification of the OHS program

 

ISO 27001 Information Security Management System

The ISO 27001 standard was published in October 2005, essentially replacing the old BS7799-2 standard. It is the specification for ISMS, an Information Security Management System. BS7799 itself was a long standing standard, first published in the nineties as a code of practice

ISO 27001 enhanced the content of BS7799-2 and harmonized it with other standards. A scheme has been introduced by various certification bodies for conversion from BS7799 certification to ISO27001 certification.

The objective of the standard itself is to "provide a model for establishing, implementing, operating, monitoring, reviewing, maintaining, and improving an Information Security Management System".

The standard defines its 'process approach' as "The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management". It employs the PDCA, Plan-Do-Check-Act model to structure the processes

 

SA 8000 - Social Accountability

SA 8000 is a standard for social accountability in the workplace. In essence, social accountability means managing business activities in a manner that respects and promotes the basic human rights of all workers.

Social accountability expectations can vary from one company to another. Fair compensation, reasonable working hours, a safe and healthy environment and prohibition of child labour and forced labour are common to all codes. Some codes add requirements for non-discrimination, freedom of association, disciplinary practices, or management system controls. A few mix in non-social issues such as drug interdiction, customs issues, or basic environmental controls. Expectations of the level of conformance to each of the above issues also vary dependent upon the code or standard selected. The absolute minimum expectation would be compliance with applicable laws, however this is often inadequate from the viewpoint of civil society and more stringent criteria are usually adopted.

Social accountability requirements:

  • No child labour
  • No forced labour
  • Health and safety at the workplace
  • Freedom of association and right to collective bargaining
  • No discrimination on race, creed, caste and sex
  • Disciplinary practices
  • Working Hours
  • Remuneration
  • Management Systems

ISO 13485:2003


ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.


ISO 13485:2003 - Requirements

  • Establishment of a quality management system for medical devices. A manufacturer must have quality procedures that are documented, controlled, and effectively implemented and maintained.
  • Ensuring that personnel have the right experience, education, training, and skills. Acceptable levels of competence must be defined. Training needs must be established and assessed. A record of competence must be maintained.
  • A detailed plan on how remedial processes will be used to assure conformity.
  • Planning and performance of regular internal audits.
  • Creating a procedure to gather feedback from customers and a feedback system to monitor emerging problems.

 

ISO 10002:2004 (Customer Satisfaction guidelines for complaints handling)


ISO 10002:2004 is a process of complaints handling related to products within an organization, including planning, design, operation, maintenance and improvement. The complaints-handling process described is suitable for use as one of the processes of an overall quality management system.
ISO 10002:2004 is not applicable to disputes referred for resolution outside the organization or for employment-related disputes. It is also intended for use by organizations of all sizes and in all sectors. ISO 10002:2004 addresses the following aspects of complaints handling:

  • Enhancing customer satisfaction by creating a customer-focused environment that is open to feedback (including complaints), resolving any complaints received, and enhancing the organization's ability to improve its product and customer service;
  • Top management involvement and commitment through adequate acquisition and deployment of resources, including personnel training;
  • Recognizing and addressing the needs and expectations of complainants;
  • Providing complainants with an open, effective and easy-to-use complaints process;
  • Analysing and evaluating complaints in order to improve the product and customer service quality;
  • Auditing of the complaints-handling process;
  • Reviewing the effectiveness and efficiency of the complaints-handling process.

ISO 22000

What is HACCP?

HACCP stands for "Hazard Analysis Critical Control Points".

  • It finds out hazardous factors that can cause at whole stages such as production of raw material, manufacturing, processing, distribution, and last customer's ingestion stage.
  • It is a scientific sanitation control system through independent, systematic and effective control for securing safety of food, distribution,and last customer's ingestion stage.
  • It is scientific sanitation control system through independent, systematic and effective control for securing safety of food.

Certification Process

  • Certification Application and Contract
  • Audit preparation
  • Document review
  • Onsite Audit
  • Clearance of non-clearances
  • Audit report
  • Verification
  • Certification Registration and Issuing a Certificate
  • Surveillance audit: once or twice per year
  • Renewal audit: once every 3 years
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