IMS

Integrated Management System 

 

  Integrated Management System (IMS) is a set of several management systems of the organization, such as quality management systems, environmental management systems, personnel health management systems.

  ISM can have the following structures:

  • ISO / IEC 14001 + OHSAS 18001,
  • ISO / IEC 9001 + ISO / IEC 14001,
  • ISO / IEC 9001 + OHSAS 18001,
  • ISO / IEC 9001 + ISO / IEC 14001 + OHSAS 18001, and etc.

 

  Benefits of IMS:

  • Increase efficiency of development, implementation and operation of management systems;
  • Development of a single harmonized system / management structure;
  • Reducing the costs of development, operation and certification;
  • Ability to combine a number of processes within the IMS (planning, management review, documentation management, training of personnel, training, internal audits, etc.)
  • Increased mobility and adaptability to changing conditions,
  • Greater attractiveness for consumers, stakeholders and investors.

 

Integrated Management System Certification

Smarttrans LLC certifies IMS in accordance with the requirements of the following documents:

  • IAF MD 11:2013 Iaf Mandatory Document for the Application of Iso/Iec 17021 For Audits of Integrated Management Systems,
  • IAF MD 3:2008 IAF Mandatory Document for Advanced Surveillance and Recertification Procedures,
  • IAF MD1:2007 IAF Mandatory Document for the Certification of Multiple Sites Based on Sampling.

ISO 9001

Quality Management System - Requirements

 

  ISO 9001 is a standard that establishes the requirements for a quality management system.
 It helps businesses and organizations to be more efficient and improve customer satisfaction.

  Implementing a quality management system will help organizations:

  Assess the overall context of 
organization to define who is affected by the work and what they expect. This will enable to clearly state the objectives of organization and identify new business opportunities.

  • Put the customers first, making sure the organization consistently meet their
 needs and exceed their expectations. This can lead to repeat custom, new clients and increased business for the organization.
  • Work in a more efficient way as
 all the processes will be aligned and understood by everyone in
 the business or organization. This increases productivity and efficiency, bringing internal costs down.
  • Meet the necessary statutory and regulatory requirements.
  • Expand into new markets, as some sectors and clients require ISO 9001 before doing business.
  • Identify and address the risks associated with the organization.
  •  

  ISO 9001 builds on seven quality management principles. With these principles firmly in place, implementing a quality management system will be much easier.

The seven quality management principles are:

  1. Customer focus,
  2. Leadership,
  3. Engagement of people,
  4. Process approach,
  5. Improvement,
  6. Evidence-based decision making,
  7. Relationship management.

Quality Management System Certification

Smartartrans LLC certifies QMS in accordance with the requirements of the following documents:

 

  • ISO 9001:2015 - Quality management systems -- Requirements
  • ISO/IEC 17021-3:2017 Conformity assessment -- Requirements for bodies providing audit and certification of management systems -- part 3: Competence requirements for auditing and certification of quality management systems
  • IAF MD 5:2015 Determination of audit time of quality and environmental management systems
  • IAF MD3:2008 IAF Mandatory document for advanced surveillance and recertification procedures
  • IAF MD1:2007 IAF Mandatory document for the certification of multiple sites based on sampling

OHSAS 18001

Occupational health and safety management system- Requirements

 

Organizations of all kinds are increasingly concerned with achieving and demonstrating occupational health and safety performance by controlling their OHSAS risks, consistent with their OHSAS policy and objectives. They do so in the context of increasingly stringent legislation, the development of economic policies and other measures that foster good OHSAS practices, and increased concern expressed by interested parties about OHSAS issues.

  The OHSAS Standards covering OHSAS management are intended to provide organizations with the elements of an effective OHSAS management system that can be integrated with other management requirements and help organizations achieve OHSAS and economic objectives. These standards, like other International Standards, are not intended to be used to create non-tariff trade barriers or to increase or change an organization’s legal obligations.

 OHSAS Standard specifies requirements for an OHSAS management system to enable an organization to develop and implement a policy and objectives which take into account legal requirements and information about OHSAS risks. It is intended to apply to all types and sizes of organizations and to accommodate diverse geographical, cultural and social conditions. The success of the system depends on commitment from all levels and functions of the organization, and especially from top management. A system of this kind enables an organization to develop an OHSAS policy, establish objectives and processes to achieve the policy commitments, take action as needed to improve its performance and demonstrate the conformity of the system to the requirements of this OHSAS Standard. The overall aim of this OHSAS Standard is to support and promote good OHSAS practices, in balance with socio-economic needs. It should be noted that many of the requirements can be addressed concurrently or revisited at any time.

 

Occupational Health and Safety Management System Certification

            Smartartrans LLC certifies OHSAS in accordance with the requirements of the following documents:

  • OHSAS 18001:2007 Occupational health and safety management systems. Requirements,  
  • EA 3/13 M:2016 EA Document on the Application of ISO/IEC 17021-1 for the Certification of Occupational Health and Safety Management Systems,
  • IAF MD3:2008 Mandatory document for advanced surveillance and recertification procedures,
  • IAF MD1:2007 Mandatory document for the certification of multiple sites based on sampling.

ISO/IEC 27001

Information security management systems

 

 The ISO/IEC 27001 helps organizations keep information assets secure.

Using this family of standards will help an organization manage the security of assets such as:

  • financial information,
  • intellectual property,
  • employee details or
  • information entrusted to you by third parties.

  ISO/IEC 27001 is the best-known standard in the family providing requirements for an information security management system (ISMS).

  The ISO contains descriptions of the world's best practices in information security management. ISO/IEC 27001 specifies requirements for an information security management system to demonstrate the organization's ability to protect its information resources. This standard has been prepared as a model for the development, implementation, operation, monitoring, analysis, support and improvement of information security management system (ISMS).

 

Information Security Management Systems Certification

            Smarttrans   LLC certifies Information Security Management Systems in accordance with the requirements of the following documents:

  • ISO/IEC 27001:2015 Information technology - Security techniques - Information security management systems – Requirements,
  • ISO/IEC 27006:2012 Information technology -- Security techniques -- Requirements for bodies providing audit and certification of information security management systems
  • IAF MD 3:2008 Mandatory document for advanced surveillance and recertification procedures,
  • IAF MD1:2007 Mandatory document for the certification of multiple sites based on sampling

  


ISO 14001

Environmental management systems -- Requirements with guidance for use

 

  ISO 14001 specifies the requirements for an environmental management system that an organization can use to enhance its environmental performance. ISO 14001:2015 is intended for use by an organization seeking to manage its environmental responsibilities in a systematic manner that contributes to the environmental pillar of sustainability.

 Organizations of all kinds have implemented environmental management systems to ensure compliance and to achieve and demonstrate sound environmental performance by controlling the impacts of their activities, products and services on the environment. They do so in the context of increasingly stringent legislation, growing pressures on the environment from pollution, over-consumption of resources, degradation of eco-systems and biodiversity, and an increasing world population, compounded by greater expectations from society for sustainable development, transparency and accountability.

  International Standards covering environmental management are intended to provide organizations with knowledge, tools and techniques to build success over the long term and create new opportunities for development and growth by: 

(i) leveraging the organization’s ability to reduce its direct operational footprints;

(ii) influence the way its products and services are designed, manufactured, distributed, consumed and disposed by using a life- cycle perspective to ensure that environmental burdens aren’t inadvertently shifted elsewhere in the cycle; and

(iii) communicating environmental information to relevant interested parties. These tools can be aligned with an organization’s priorities, strategy and decision-making by integrating them with other business requirements and embedding environmental governance into its overall management system, thereby achieving both environmental and economic goals.

 

Environmental management systems Certification

            Smarttrans LLC certifies Environmental Management System in accordance with the requirements of the following documents:

  • ISO 14001:2016 Environmental management systems. Requirements with guidance for use
  • ISO/IEC TS 17021-2:2013 Conformity assessment -Requirements for bodies providing audit and certification of management systems  Part 2: Competence requirements for auditing and certification of environmental management systems
  • ISO 14031:2016 Environmental management-Environmental performance evaluation- Guidelines,
  • IAF MD 5:2015 Determination of audit time of quality and environmental management systems,
  •  EA-7/04 M:2017 Legal Compliance as a part of accredited ISO 14001:2015 Certification
  • IAF MD 3:2008 IAF Mandatory document for advanced surveillance and recertification procedures,
  • IAF MD1:2007 IAF Mandatory document for the certification of multiple sites based on sampling.

ISO/IEC 15189

Medical laboratories - Requirements for quality and competence

 

  ISO 15189 is an international and recommendatory standard that includes the main provisions of ISO/IEC 17025 and ISO 9001, and contains the requirements for competence and quality for medical laboratories.

  The government can accept it as a standard operating in the country. In the absence of a strict prescription, the implementation of the ISO 15189 standard is carried out on the basis of professional ethics by laboratory management, which strives to guarantee maximum efficiency, competence and quality to patients and users of the laboratory.
  It is known that there is a direct relationship between patient satisfaction and increase in the organization's profit.

              In medical laboratories, biological samples are tested to produce results that are used for screening, diagnosis, further examination and treatment, and for the prevention of diseases of patients. The task of the laboratory is not only to obtain reliable results and ensure the safety of the patient, but also to ensure adequate deadlines for performing the work, as well as to ensure that all laboratory procedures are monitored in accordance with ethical principles.

              In terms of the significance of laboratory results and the potential negative consequences of inaccurate laboratory results, most leading experts in the field of laboratory diagnostics around the world agree on the need to implement internationally recognized standards. This need is further confirmed by the need to improve the quality of laboratories, as well as the fact that today all laboratories raise quality in priority.

              Another important factor is the need to conform laboratory indicators between laboratories, i.e. ensure traceability and uniformity of results of laboratory. In connection with the increase in mobility of the global population, the need for ensuring reproducibility of the results obtained in different laboratories has arisen, especially for patients who need long-term treatment.

 


ISO/IEC 17025

General requirements for the competence of testing and calibration laboratories

 

   ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main ISO standard used by testing and calibration laboratories. In most major countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. In many cases, suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by the International Organization for Standardization in 1999. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 is more specific in requirements for competence, and applies directly to those organizations that produce testing and calibration results. 

  The standard was first published in 1999 and on 12 May 2005 the alignment work of the ISO/CASCO committee responsible for it was completed with the issuance of the reviewed standard. The most significant changes introduced greater emphasis on the responsibilities of senior management, and explicit requirements for continual improvement of the management system itself, and particularly, communication with the customer.

   The ISO/IEC 17025 standard itself comprises five elements that are Scope, Normative References, Terms and Definitions, Management Requirements and Technical Requirements. The two main sections in ISO/IEC  17025 are 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 includes factors which determines the correctness and reliability of the tests and calibrations performed in laboratory.

  Laboratories use ISO/IEC 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. A prerequisite for a laboratory to become accredited is to have a documented quality management system. The usual contents of the quality manual follow the outline of the ISO/IEC 17025 standard. 


ISO 22000

Food Safety Management Sysytem

   The consequences of unsafe food can be serious and ISO’s food safety management system helps organizations identify and control food safety hazards. As many of today's food products repeatedly cross national boundaries, food safety management system is needed to ensure the safety of the global food supply chain.

  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 can be accomplished through the use of internal and/or external resources.

  ISO 22000 specifies requirements to enable an organization

a) 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,

b)to demonstrate compliance with applicable statutory and regulatory food safety requirements,

c) 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,

d)to effectively communicate food safety issues to their suppliers, customers and relevant interested parties in the food chain,

e) to ensure that the organization conforms to its stated food safety policy,

f) to demonstrate such conformity to relevant interested parties, and

g) 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

 

  All requirements of ISO 22000 are generic and are intended to be applicable to all organizations in the food chain regardless of size and complexity. This includes organizations directly or indirectly involved in one or more steps of the food chain. Organizations that are directly involved include, but are not limited to, feed producers, harvesters, farmers, producers of ingredients, food manufacturers, retailers, food services, catering services, organizations providing cleaning and sanitation services, transportation, storage and distribution services. Other organizations that are indirectly involved include, but are not limited to, suppliers of equipment, cleaning and sanitizing agents, packaging material, and other food contact materials.The International Standard allows an organization, such as a small and/or less developed organization to implement an externally developed combination of control measures.

Food Safety Management Systems Certification

              Smarttrans LLC certifies Food safety Management Systems in accordance with the requirements of the following documents:

  • ISO 22000:2005 Food safety management systems - Requirements for any organization in the food chain,
  • ISO/TS 22003:2013 Food safety management systems - Requirements for bodies providing audit and certification of food safety management systems
  • IAF MD 3:2008 IAF Mandatory document for advanced surveillance and recertification procedures,
  • IAF MD 1:2007 IAF Mandatory document for the certification of multiple sites based on sampling.  

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