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iso 9001 requirements guide

iso 13485 requirements guide

iso 14001 requirements guide
iso 18001 requirements guide
iso 22716 requirements guide

iso 31000 requirements guide

We Build Advanced Management Systems to Meet the Requirements of ISO Certification Standards

Since the advent of the World Trade Organization (WTO) and its Agreement on Technical Barriers to Trade, conformity assessment in general has assumed greater importance and the International Organization for Standardization's work in particular is recognized by the WTO for its role in enhancing world trade.

Conformity assessment has become an important component of world trade. At its simplest, "conformity assessment" means checking that products, materials, services, systems or people measure up to the specifications of a relevant standard.

The mission of ISO is to develop International Standards, not to verify that ISO standards are being implemented by users in conformity with the requirements of its standards. The voluntary criteria contained in these guides represent an international consensus on what constitutes best practice. Their use contributes to the consistency and coherence of conformity assessment worldwide and so facilitates trade across borders.

AS 9100 - Aerospace

AS9100 is the internationally recognized Aerospace quality management system. Quality management systems have been used in the aerospace industry for many years.  Efforts by members of the aerospace industry to establish a single common Quality Management System resulted in AS 9100, 9110, 9120. They are used and supported by the world's leading aerospace companies and also throughout their supply chain partnerships.

HIPAA & HITECH Compliance - Health Care

HIPAA requirements state that a covered entity may not use or disclose protected health information except as provided in the HIPAA privacy rule. Those provisions include uses and disclosures to the individual (patient or health plan member) himself or herself; for treatment, payment or health care operations; as authorized by the individual; for research, public health or health care operations in the form of limited data sets; for listings in facility directories or disclosures to those involved in the individual’s care provided that the individual does not object; to business associates; as required by law for health oversight activities, compliance investigations or other public purposes.

ISO 9001- Quality Management

ISO 9001 is by far the world’s most established quality framework, currently being used by around 897,000 organizations in 170 countries worldwide, and sets the standard not only for quality management systems, but management systems in general. It helps all kinds of organizations to succeed through improved customer satisfaction, staff motivation and continual improvement.

ISO 14001- Environmental Management

ISO 14001 is an internationally accepted standard that sets out how you can go about putting in place an effective Environmental Management System (EMS). The standard is designed to address the delicate balance between maintaining profitability and reducing environmental impact; with the commitment of your entire organization, it can enable you to achieve both objectives.

[BS OHSAS] ISO 18001 & ISO 45001 - Occupational Health & Safety Management

BS OHSAS 18001 is the internationally recognized assessment specification for occupational health and safety management systems. It was developed by a selection of leading trade bodies, international standards and certification bodies to address a gap where no third-party certifiable international standard exists. BS OHSAS 18001 has been designed to be compatible with ISO 9001and ISO 14001, to help your organization meet their health and safety obligations in an efficient manner.

ISO 13485- Medical devices

ISO 13485 is the international standard recognized for medical device regulations around the world.  As a medical device manufacturer you have a responsibility to consistently deliver products that are safe and effective. The Standard is structure by "class" of medical products. You may elect to be "in compliance" or to be ISO 13845 Certified, which includes ISO 9001 Registration.

IATF 16949 - Quality Management Systems for the Automotive industries

IATF 16949 has been developed by the industry, the International Automotive Task Force (IATF), to encourage improvement in both the supply chain and the certification process. In fact, for the majority of leading vehicle manufacturers around the world, certification to the ISO/TS 16949 is a mandatory requirement for doing business. On some occasions ISO 9001 certification and operating in compliance to the specification may be acceptable to your customer.

ISO 17025 - Laboratory Competence

ISO/IEC 17025 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods. Often ISO 9001 is viewed as a requirement for laboratory competence, as well as other standards that are compelled by parallel industry and governmental organizations.

ISO 20000 - Information Technology

ISO 20000 is the internationally recognized ISO Standard for Information Technology services.  IT is essential to delivering today’s business. Increasingly, however, concerns are being about the integrity of IT services, both internal and outsourced services, questioning their alignment with the real needs of their own business or that of their 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.  ISO Certification to this standard enables you to independently demonstrate to your customers that you meet best practice.

ISO 22000- Food Quality and Safety Management

ISO 22000 is an international standard that defines the requirements of a food safety management system covering all organizations in the food chain from “farm to fork”. This is an essentially ISO Standard if you intend to offer your food products into the international marketplace or various US government agencies, including the US Department of Defense.

ISO 22716 - Cosmetic Safety Management

The introduction of ISO 22716 marked a major step in the realization of a globally recognized standard for cosmetic products safety. This standard was prepared by ISO Technical Committee (TC) 217 Working Group (WG) 6 between 2002 and 2006. The final document was published in November 2007.

ISO 22301 - Business Continuity

ISO 22301, derived from BS 25999:2006, is the world’s first International standard for business continuity management (BCM). In the event of a disruption, whether due to a major disaster or a minor incident, the ability to continue operating at a productive level is a fundamental requirement for any organization.  ISO 22301 standard for business continuity has been developed to help you minimize the risk of such disruptions.

ISO/IEC 27001- Information & Data Security

ISO 27001 is the only auditable international standard which defines the requirements for an Information Security Management System (ISMS). The standard is designed to ensure the selection of adequate and proportionate security controls. This helps you to protect your information assets and give confidence to any interested parties, especially your customers. The standard adopts a process approach for establishing, implementing, operating, monitoring, reviewing, maintaining, and improving your ISMS.