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ISO 9001:2008

ISO 9001:2008 specifies requirements for a quality management system where an organization:

Needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and Aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

Where any requirement(s) of ISO 9001:2008 cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to ISO 9001:2008 are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements. www.iso.org.

ISO 14001:2004

ISO 14001:2004 specifies requirements for an environmental management system to enable an organization to develop and implement a policy and objectives which take into account legal requirements and other requirements to which the organization subscribes, and information about significant environmental aspects. It applies to those environmental aspects that the organization identifies as those which it can control and those which it can influence. It does not itself state specific environmental performance criteria.

ISO 14001:2004 is applicable to any organization that wishes to establish, implement, maintain and improve an environmental management system, to assure itself of conformity with its stated environmental policy, and to demonstrate conformity with ISO 14001:2004 by

  • making a self-determination and self-declaration, or
  • seeking confirmation of its conformance by parties having an interest in the organization, such as customers, or
  • seeking confirmation of its self-declaration by a party external to the organization, or
  • seeking certification/registration of its environmental management system by an external organization.

All the requirements in ISO 14001:2004 are intended to be incorporated into any environmental management system. The extent of the application will depend on factors such as the environmental policy of the organization, the nature of its activities, products and services and the location where and the conditions in which it functions.

ISO 14001:2004 also provides, in Annex A, informative guidance on its use. www.iso.org.

HACCP System

HACCP is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. For successful implementation of a HACCP plan, management must be strongly committed to the HACCP concept. A firm commitment to HACCP by top management provides company employees with a sense of the importance of producing safe food.

HACCP is designed for use in all segments of the food industry from growing, harvesting, processing, manufacturing, distributing, and merchandising to preparing food for consumption. Prerequisite programs such as current Good Manufacturing Practices (cGMPs) are an essential foundation for the development and implementation of successful HACCP plans. Food safety systems based on the HACCP principles have been successfully applied in food processing plants, retail food stores, and food service operations. The seven principles of HACCP have been universally accepted by government agencies, trade associations and the food industry around the world.

The following guidelines will facilitate the development and implementation of effective HACCP plans. While the specific application of HACCP to manufacturing facilities is emphasized here, these guidelines should be applied as appropriate to each segment of the food industry under consideration. www.fda.gov.

ISO 22000:2005

ISO 22000:2005 specifies requirements for a food safety management system where an organization in the food chain needs to demonstrate its ability to control food safety hazards in order to ensure that food is safe at the time of human consumption.

It is applicable to all organizations, regardless of size, which are involved in any aspect of the food chain and want to implement systems that consistently provide safe products. The means of meeting any requirements of ISO 22000:2005 can be accomplished through the use of internal and/or external resources.

ISO 22000:2005 specifies requirements to enable an organization:

  • to plan, implement, operate, maintain and update a food safety management system aimed at providing products that, according to their intended use, are safe for the consumer,
  • to demonstrate compliance with applicable statutory and regulatory food safety requirements,
  • to evaluate and assess customer requirements and demonstrate conformity with those mutually agreed customer requirements that relate to food safety, in order to enhance customer satisfaction,
  • to effectively communicate food safety issues to their suppliers, customers and relevant interested parties in the food chain,
  • to ensure that the organization conforms to its stated food safety policy,
  • to demonstrate such conformity to relevant interested parties, and
  • to seek certification or registration of its food safety management system by an external organization, or make a self-assessment or self-declaration of conformity to ISO 22000:2005.

www.iso.org.

OHSAS 18001:2007

OHSAS 18001 is an specification 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.

BENEFITS:

The benefits of taking the OHSAS route are often seen as follows:

  • 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

There is no doubt that OHSAS enables a structured, recognized framework for the effective management of health and safety risks. As such, it is going from strength to strength. www.18001.org.

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.

All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.

If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls.

If any requirement(s) in Clause 7 of ISO 13485:2003 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system.

The processes required by ISO 13485:2003, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system. www.iso.org.

ISO 27001:2005

ISO/IEC 27001:2005 covers all types of organizations (e.g. commercial enterprises, government agencies, not-for profit organizations). ISO/IEC 27001:2005 specifies the requirements for establishing, implementing, operating, monitoring, reviewing, maintaining and improving a documented Information Security Management System within the context of the organization's overall business risks. It specifies requirements for the implementation of security controls customized to the needs of individual organizations or parts thereof.

ISO/IEC 27001:2005 is designed to ensure the selection of adequate and proportionate security controls that protect information assets and give confidence to interested parties.

ISO/IEC 27001:2005 is intended to be suitable for several different types of use, including the following:

  • use within organizations to formulate security requirements and objectives;
  • use within organizations as a way to ensure that security risks are cost effectively managed;
  • use within organizations to ensure compliance with laws and regulations;
  • use within an organization as a process framework for the implementation and management of controls to ensure that the specific security objectives of an organization are met;
  • definition of new information security management processes;
  • identification and clarification of existing information security management processes;
  • use by the management of organizations to determine the status of information security management activities;
  • use by the internal and external auditors of organizations to determine the degree of compliance with the policies,
  • directives and standards adopted by an organization;
  • use by organizations to provide relevant information about information security policies, directives, standards and procedures to trading partners and other organizations with whom they interact for operational or commercial reasons;
  • implementation of business-enabling information security;
  • use by organizations to provide relevant information about information security to customers.

www.iso.org.

AS 9100 Rev C

AS9100 Quality Management System standard for Aerospace is a management system based on ISO 9001:2000. It includes an additional requirements for the aerospace industry.

AS9100 applies throughout the aerospace supply chain, so whether you are accessory supplier or involved in airline operation, AS9100 applies to you.
The AS9100 standard contains the requirements of ISO 9001:2000 and its associated guidelines. AS9100 adds aerospace specific quality and reliability requirements including:

  • Configuration Management
  • Planning product realization
  • Design and development with in-process control points
  • Design and development validation
  • Identifying and maintaining suppliers
  • Supplier Control
  • Supplier Management
  • Communication requirements
  • AS9110 applies to maintenance organizations
  • AS9120 applies to distributors dealing with aerospace “stockist”
  • AS9100 has been endorsed by the International Aerospace Quality Group (IAQG),Federal Aviation Administration (FAA), US Department of Defense (DoD), NASA as well as several OEM's.

Benefits

  • Meet customer requirements (GE Aircraft Engines, Boeing, Pratt & Whitney, Rolls-Royce etc.)
    Increased customer satisfaction
  • Systems meet agreed standards
  • Better planning, less post process verification.
  • Improved documentation.
  • Better communication with suppliers, customers, regulators and other interested parties.

www.sae.org.

TL 9000

The purpose of TL 9000 is to define the unique communications quality system requirements for design, development, production, delivery, and service. In addition, it specifies measurements for companies to help evaluate the effectiveness of quality implementation and improvement programs.
In 1998, QuEST Forum developed the TL 9000 Quality Management System to meet the supply chain quality requirements of the worldwide telecommunications industry. Through TL 9000, it set out to achieve the following goals:

  • Establish and maintain a common set of telecom QMS requirements, which reduces the number of standards for the industry
  • Foster a system that protects the integrity and use of telecom products hardware, software and services
  • Define effective cost and performance-based measurements to guide progress and evaluate the results of QMS implementation
  • Drive continual improvement and enhance customer relationships
  • Leverage the industry conformity assessment process

TL 9000: A Two-part Quality Management System

The TL 9000 standard is the telecom industry's unique extension to ISO 9001 and includes supplemental requirements in the following areas:

  • Performance measurements based on reliability of product
  • Software development and life-cycle management
  • Requirements for specialized service functions such as installation and engineering
  • Requirements to address communications between telecom network operators and suppliers
  • Reporting of quality measurement data to a central repository

As a result, the TL 9000 is a two-part quality system with significant management and measurement components. In particular, TL 9000 registered organizations are required to comply with:

  • All requirements clauses of the International Standards ISO 9001
  • Telecom-specific requirements that apply to all registrations
  • Telecom-specific requirements that apply to hardware, software and/or service registrations
  • Telecom industry measurements that apply in all product categories
  • Telecom industry measurements that apply in certain product categories specific to hardware, software and/or services

The TL 9000 Requirements Handbook and Measurements Handbook provide exhaustive information on both aspects of this quality management system. www.tl9000.org.

ISO 20000 – Information technology - Service management

IT is essential to delivering today’s business. However, concerns are increasingly being raised about IT services, internal and outsourced, not aligning with the needs of businesses and customers.

A recognized solution to this problem is to use an IT Service Management System (ITSMS) based on ISO/IEC 20000, the international standard for IT service management. Certification to this standard enables you to independently demonstrate to your customers that you meet best practice.

ISO/IEC 20000 is based on and replaces BS 15000, the internationally recognized British Standard.

Benefits

Primarily, ISO/IEC 20000 certification demonstrates that an organization has adequate controls and procedures in place to consistently deliver a cost effective, quality IT service. Some of the key benefits are listed below:

  • IT service providers become more responsive to services which are business led rather than technology driven
  • External service providers can use certification as a differentiator and win new business as this increasingly becomes a contractual requirement
  • Gives you the ability to select and manage external service providers more effectively
  • More opportunities to improve the efficiency, reliability and consistency of IT services impacting costs and service
  • Certification audits enable the regular evaluation of the service management processes, which helps to maintain and improve effectiveness
  • The certification process can reduce the amount of supplier audits, thereby reducing costs
  • ISO/IEC 20000 is fully compatible with the ITIL (IT Infrastructure Library) framework of best practice guidance for ITSM processes

SA 8000

SA 8000 is an international certification standard that encourages organizations to develop, maintain and apply socially acceptable practices in the workplace.

The areas SA 8000 addresses include forced and child labor, occupational health and safety, freedom of association and collective bargaining, discrimination, disciplinary practices, working hours, compensation and management systems.

As well as setting workplace standards worldwide, SA 8000 also embraces existing international agreements, including conventions from the International Labor Organization, the Universal Declaration on Human Rights and the United Nations Convention on the Rights of the Child.

Benefits of SA 8000 Certification Standard

  • Proves your commitment to social accountability and to treating your employees ethically and in compliance with global standards.
  • Improves the management and performance of your supply chain.
  • Allows you to ensure compliance with global standards and reduce the risk of negligence, public exposure and possible litigation.
  • Supports your corporate vision and build and reinforce the loyalty of your employees, customers and stakeholders.
  • Enables you to demonstrate proper social accountability when bidding for international contracts or expanding locally to accommodate new business.

ISO 22301:2012 - Societal security -- Business continuity management systems

ISO 22301, the international standard for business continuity management is your formal business continuity framework. It will help you to develop a business continuity plan that will keep your business running during and following a disruption. Follow it and you will minimize the impact so you can resume normal service quickly, ensuring key services and products are still delivered.

Benefits of ISO 22301:2012 Certification Standard

Maximize quality and efficiency
ISO 22301 provides a framework based on international best practice based around the 'Plan, Do' Check, 'Act' concept.

Resilience
Whether its an international disaster or localised disruption, your organization will be robust enough to be able to get up and running again quickly, or minimize disruption until normal service is resumed.

Reputation
Keep your reputation secure.

Competitive advantage
Opens new markets and helps you win new business. Gain client confidence through the universal acceptance of ISO standards that open up global opportunities.
Win more contracts more cost effectively
Provides you with a marketing edge and, coupled with certification, can help reduce the cost of tendering.

Business improvement
Certification requires a clear understanding of your entire organization which can identify opportunities for improvement.

Continuous improvement
The certification process involves regular audits that ensure your management system is up to date

Compliance
Demonstrate that you meet the requirements of applicable laws and regulations.

Cost savings
You'll have the opportunity to reduce the burden of internal and external BCM audits, improve financial performance and reduce business disruption insurance premiums.

Delivery
Your BCMS framework supports rehearsed management processes that allow you to supply an agreed level of critical services and products within a specified timeframe after disruption.

Management
A BCMS provides proven management capability during times of disruption.

CE Marking

CE Marking is the symbol as shown on the top of this page. The letters "CE" are the abbreviation of French phrase "Conformity European" which literally means "European Conformity". The term initially used was "EC Mark" and it was officially replaced by "CE Marking" in the Directive 93/68/EEC in 1993. "CE Marking" is now used in all EU official documents.

"CE Mark" is also in use, but it is NOT the official term. For instance, in the Directive 2007/47/ec, of 5 September 2007, amending the directives 90/385/eec, 93/42/eec & 98/8/ec, the term CE Marking appears 9 times whereas CE Mark appears nowhere in the entire 35-page document.

1. CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, in practice by many of the so-called Product Directives.*
*Product Directives contains the "essential requirements" and/or "performance levels" and "Harmonized Standards" to which the products must conform. Harmonized Standards are the technical specifications (European Standards or Harmonization Documents) which are established by several European standards agencies (CEN, CENELEC, etc).
CEN stands for European Committee for Standardization.
CENELEC stands for European Committee for Electrotechnical Standardization.

2. CE Marking on a product indicates to governmental officials that the product may be legally placed on the market in their country.

3. CE Marking on a product ensures the free movement of the product within the EFTA & European Union (EU) single market (total 28 countries), and

4. CE Marking on a product permits the withdrawal of the non-conforming products by customs and enforcement/vigilance authorities.

Along with more directives' becoming effective, more and more products are required to bear the CE Marking for gaining access to the EFTA & European Union market. However, many non-EU exporters are still unaware of or unsure about this fact and its impact on their business.