CERTIFICATION BRANCH

Quality management systems.

This international standard defines the quality management system requirements for an organization when:

  • It has to demonstrate that it is able to continuously supply or provide a product that meets the customer’s requirements as well as applicable regulatory and other regulatory requirements,
  • Aims to increase customer satisfaction with the effective use of the system, including processes that ensure system development and compliance with customer and applicable regulatory requirements.
  • All requirements of the standard are of general application and are intended to be applicable to all organizations, regardless of their type, size, delivery and the service provided.

 

Environmental management systems.

This international standard defines requirements for an environmental management system that an organization can use to improve its environmental performance. This international standard is intended to be used by an organization which seeks to manage its environmental responsibilities systematically, contributing to the environmental pillars of sustainability. This international standard helps the organization achieve its planned environmental management system, which is a value for the environment, organization and stakeholders. In line with the organization’s environmental policy, the planned results of the environmental management system include:

  • Improving environmental performance;
  • Fulfillment of compliance obligations;
  • The achievement of environmental goals.

This international standard applies to any organization irrespective of size, type and nature, as well as the environmental aspects of its activities, products and services that the organization determines to be able to maintain or influence under the lifecycle approach.

It does not set specific criteria for environmental performance and can be applied partly or fully to the systematic development of environmental management. However, claims to comply with this international standard may not be accepted unless all of its requirements are incorporated into the organization’s environmental management system and are performed without exception.

The quality management system set up by the German Automotive Industry (VDA) is based on the ISO 9001 and ISO 9004 standards but sets specific requirements for automotive product manufacturing organizations.

Information technology. Security techniques. Information security management systems.

This international standard provides requirements for the design, implementation, maintenance and continuous development of an information security management system in the environment of the organization concerned. This international standard also contains requirements for the assessment and management of information security risks tailored to the needs of the organization. The requirements set out in this international standard are of general application and are intended to apply to all organizations, regardless of their type, size or nature. None of the requirements set out in 4-10. Chapters can be excluded when an organization claims compliance with this international standard.

 

Health care services. Quality management systems. Requirements based on EN ISO 9001:2008

This European standard specifies requirements for a quality management system where an organization:

  • needs to demonstrate its ability to consistently provide health care services that meet requirements from customers as well as applicable statutory and regulatory requirements, and professional standards

  • aims to enhance customer satisfaction through the effective application of the system, including continual improvement of the management system, the clinical processes and the assurance of conformity to requirements related to the quality characteristics ; appropriate, correct care; availability; continuity of care; effectiveness; efficiency; equity; evidence/knowledge based care; patient centred care including physical, psychological and social integrity; patient involvement; patient safety and timelines/accessibility. Material products such as tissue, blood products, pharmaceuticals, cell culture products and medical devices have not been focused in the scope of the standard as they are regulated elsewhere. This European Standard is focused on requirements for clinical processes. Organizations that also include research or education processes, or both in their quality management system could use the requirements in this European Standard where applicable. This European Standard aims to adjust and specify the requirements, as well as the “product” concept and customer perspectives in EN ISO 9001:2008 to the specific conditions for health care where products are mainly services and customers are mainly patients. The focus of this European Standard is the clinical processes and their risk management in order to promote good quality health care.

This European Standard

  • gives requirements for systematic approaches for the organization’s ability to produce good quality health care.

  • can be used by management at all levels in the health care organization to implement and maintain a quality management system or by internal and external parties, including certification bodies, to assess the organization’s ability to meet patients’ needs and expectations as well those from other customers

  • is applicable to health care organizations, regardless of structure, organization, owner, size or type of health care services provided.

  • is applicable to e.g. primary health care, pre-hospital and hospital care, tertiary care, nursing homes, hospices, preventive health care, mental health services, dental services, physiotherapy, occupational health services and pharmacies.

  • is focused on requirements for clinical processes. Organizations that also include research or education processes, in the scope of their quality management system could use the requirements in this standard where applicable. Where any requirement(s) of this European Standard cannot be applied due to the nature of a health care organization and its product (including services), this can be considered for exclusion. Where exclusions are made, claims of conformity to this European Standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the health care organization’s ability, or responsibility, to provide products (including services) that meets customer and applicable statutory and regulatory requirements.

Energy management systems.

This International Standard specifies requirements for establishing, implementing, maintaining and improving an energy management system, whose purpose is to enable an organization to follow a systematic approach in achieving continual improvement of energy performance, including energy efficiency, energy use and consumption. This International Standard specifies requirements applicable to energy use and consumption, including measurement, documentation and reporting, design and procurement practices for equipment, systems, processes and personnel that contribute to energy performance. This International Standard applies to all variables affecting energy performance that can be monitored and influenced by the organization. This International Standard does not prescribe specific performance criteria with respect to energy. This International Standard has been designed to be used independently, but it can be aligned or integrated with other management systems. This International Standard is applicable to any organization wishing to ensure that it conforms to its stated energy policy and wishing to demonstrate this to others, such conformity being confirmed either by means of self-evaluation and self-declaration of conformity, or by certification of the energy management system by an external organization. This International Standard also provides, in Annex A, informative guidance on its use.

Using the Occupational Health and Safety Management System (OHSAS), it is possible to identify and analyze possible hazards and evaluate the relevant risks that can be used as a basis for planning and designing goals and programs that aim to improve employee safety. By defining responsibilities and educating the workforce, take precautions and prepare for any possible emergency situations.
The system can be applied and certified for all types of businesses.

Food safety management systems. Requirements for any organization in the food chain.

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.

Hazard Analysis and Critical Control Points (Hazard Analysis and Critical Control Points) identify hazardous emerging hazards and risk avoidance in food production. By using it, consumers will be guaranteed hygiene in the handling of foodstuffs. By introducing HACCP standards, priority management of hygiene and food safety can be demonstrated.

Through the entire food chain industry, we audit companies from raw material producers, from feed manufacturers, from gastronomy and food manufacturers to trade.

Certification of HACCP systems in accordance with the requirements of Codex Alimentarius Hungaricus 1-2-18 / 1993.

Learning services for non-formal education and training.
Basic requirements for service providers.

Certification of cleaning services. Well-integrated system of requirements as described in ISO 9001, ISO 14001 and MSZ 28000 standards.

Quality Management – Customer Satisfaction – Managing Customer Complaints for Organizations.
This is used as an international standard guideline for effective customer complaint handling processes for commercial or non-commercial activities, including e-commerce, for designing and deploying. It is intended to benefit the companies employing them and their clients and any other interested parties in complaint cases.
The information obtained during a complaint handling process can be used to develop products and processes, and if complaints are properly handled, it can also improve the company’s judgment regardless of size, location, and sector in which it works.
It is perfectly integrated with the ISO 9001 standard requirements, which can be the basis for certification.

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PRODUCT BRANCH 

For products to be brought to the market, regulatory and other legal requirements necessary for commercialization fall into this category.

The purpose of our activity is to actively assist the product by exploring the surplus expectations of the EU market space for our clients.

Safety of machinery. General principles for design. Risk assessment and risk reduction.

Safety of machinery. Safety-related parts of control systems. Part 1: General principles for design.

ISO 13849-1:2006 provides safety requirements and guidance on the principles for the design and integration of safety-related parts of control systems (SRP/CS), including the design of software. For these parts of SRP/CS, it specifies characteristics that include the performance level required for carrying out safety functions. It applies to SRP/CS, regardless of the type of technology and energy used (electrical, hydraulic, pneumatic, mechanical, etc.), for all kinds of machinery. It does not specify the safety functions or performance levels that are to be used in a particular case. ISO 13849-1:2006 provides specific requirements for SRP/CS using programmable electronic system(s). It does not give specific requirements for the design of products which are parts of SRP/CS. Nevertheless, the principles given, such as categories or performance levels, can be used.

Safety of machinery. Safety-related parts of control systems. Part 2: Validation.

This part of ISO 13849 specifies the procedures and conditions to be followed for the validation by analysis and testing of — the specified safety functions, — the category achieved, and — the performance level achieved by the safety-related parts of a control system (SRP/CS) designed in accordance with ISO 13849-1. NOTE Additional requirements for programmable electronic systems, including embedded software, are given in ISO 13849-1:2006, 4.6, and IEC 61508 .

This is a conventional sign, the meaning of which comes from the following term: Conformité Européenne = European conformity.
As a result of the free trade of goods in the European Union, it has become essential that only safe products can be placed on the market. To achieve this goal, a number of regulations and directives have been adopted, the enforcement of which is primarily the responsibility of Member State authorities. It is therefore important that only the products on the European Union’s internal market comply with the requirements of the law.
The CE marking is actually a signal to authorities.

The logo certifies that the product complies with the requirements and specifications that apply to it.
Certification may be certified either by the manufacturer or the first distributor of the product within the European Union, by signing the certificate of conformity, personally to assume that the product complies with the relevant requirements. On the other hand, at the request of the Authority, it can present the technical documentation of the product and, if necessary, the EC type-examination certificate.

The rules to be used in the technical harmonization directives fix and use the CE conformity marking and the conformity assessment procedures for their use. Council Decision 93/465 / EEC of 22 July 1993. Its scope extends to producers who wish to market industrial products within the European Union within the scope of the technical harmonization directives provided for in Decision 90/683 / EEC.

At the request of our clients, we can assist with CE conformity modules in performance tests and related quality management certificates.

Council Decision 93/465 / EEC of 22 July 1993 laying down the modules for the various phases of conformity assessment procedures and the rules to be used for the indication and use of the CE conformity marking in the technical harmonization directives are directly applicable in the territory of the Republic of Hungary. It covers producers of all products intended to be marketed within the European Union within the meaning of Council Decision 90/683 / EEC, which are subject to the technical harmonization directives.
In the case of our clients, we can assist you with the CE compliance modules, in related quality management certifications.

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EDUCATION, TRAINING 

We organize organizational internal auditor and system manager training in conformity with the operation of the standard management systems.
Training of interactive systems according to ISO 9001: 2015 & ISO 14001: 2015 & ISO 50001: 2011 May 30-31 and June 01, 2017 will begin.
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