Health And Social Care Level 3 Unit 14 P4

As well as ensuring that the equipment meets the required safety standards, it should be age and ability appropriate to the people using it, and regularly checked to make sure that it is still in good repair, and fit for purpose.

| State how emergencies should be responded to in accordance with organisational authorisation and personal skills when involved with fires, spillages, injuries and other task-related hazards.

When an emergency situation arises, it's essential that you are able to recognise it, as well as respond. Emergency situations such as fires are suddenly notice and quick recognition can be crucial. When aware of a fire, alert the nearest fire alarm and evacuate the building through the nearest fire exit. If you at any point in the school day hear the fire alarm. Everyone must immediately leave the building via their nearest fire exit (this is rehearsed often throughtout the year to make sure everyone is fully aware of what to do). If a child has an illness, then you must first speak to the child in question and become

The process for storing data must lead to the technician and if the sample shows odd results, the technician and must be contacted immediately. Therefore, basic information, such as the name and barcode of the product must be included with its hazard symbols. Also, background information of the products must be registered with the technician.

In 1987, the British government called upon the international organisation for standardisation (ISO) to implement BS 5750 as an international standard. Upon doing so the international standard was named ISO 9000.

Basic emergency procedures, including who to call and what support resources and services are available.

Managers shall develop and implement an emergency action plan for the department(s) in which they are responsible for. Managers must consider the unique differences in their departments and how this will affect the development of each of their emergency action plans. Managers shall conduct periodic reviews of their department 's emergency action plans with the assistance of the Health and Safety Manager and the Company’s Health and Safety Committee. Managers must ensure that their department’s workforce are adequately trained for any emergency situation that may occur on the worksite.

Therefore the plan should provide information on how to handle crisis events and provide procedures for the following:

Regulatory: Regulatory will make sure at Sweeney’s Medical Device Inc. that we meet all laws and compliance that to meet or exceed the manufacture of medical instrument to the health care industry. They must use their skill set and experience insure the products, which are developed, manufactured or distributed by the Sweeney’s Medical Device Inc. will meet the required laws and specifications in the medical industry. Regulatory will report directly to the president.

The evolution of quality would continue throughout World War 1 and 2 along with major reformations in quality control through the computer age in the 1980’s (Mitra, 2006, p. 5). A greater scale of cooperation was needed to develop and align common economic goals and strategic objectives. After the European Free Trade Association was founded in 1960 (Grønningsæter, 2014) and countless countries join throughout the decades; an agreement was signed in 1992 where the standardisation of quality control would be common amongst European markets. European Countries wishing to do business with one and other could now standardise their quality control and assurance through standardised means of practise; though this would be done through a standardisation agency.

The next phase, organisation, involves training the company’s calibration staff – normally maintenance technicians, service engineers, process and quality engineers and managers – in using the chosen tools and how to follow the approved standard operating procedures. Staff carrying out these activities must follow the appropriate instructions before calibrating the device, including any associated safety procedures. The calibration is then executed according to the plan, although further instructions may need to be followed after calibration. The documentation and storage of

As part of Class I sterile, the proposed medical design requires the certification and approval by a Notified Body (NB) for manufacturing and sterility standards [14]. At the same time the Council Directive 93/42/EEC recommends to conform to the EN ISO 13485 and EN ISO 14971 European standards, although it is not require [14][26][27]. Furthermore, for basic class I devices, only the declaration of conformity is required before receiving the CE marking, making market entrance more accessible for small companies [13].

They should advice about the same with the QA, Production team and Management before the implementation. The challenge here is to monitor any changes related to the device regulations. This is an issue, when the RA department is outsourced to an external company. The problems faced here are the need for technical expertise to discuss about the regulations and the consideration of the cost factors to implement the new standards and the time that takes for the transition. These issues need to be addressed and discussed with the management authorities to identify the need for the new regulations in the facility and thereby providing adequate training and orientation to the QA, production team and other concerned team about the proposed regulations during the implementation phase.

The conformity assessment of the goods baring the CE marking can only be effective in a transnational level between the member states of the EU and EEA. Under the scope of the relevant EU Regulations and Directives each member-state, or any other state that has concluded a Mutual Recognition Agreement (MRAs) and Protocols to the Europe Agreement on Conformity Assessment and Acceptance of Industrial Products (PECAs), can delegate competent Authorities (notifying authorities ) with the duty to designate notified bodies, and further on be notified by the European Commission . For example in the UK the Medicines and Healthcare products Regulation Agency (MHRA) is the designating authority for NBs

Created in 1947, the International Organization for Standardization (ISO) hoped to bring standardization to a chaotic system of manufacturing. ISO intends to help standardize the quality and safety of products bought and sold between two companies, either domestic or abroad. In fact, Heizer & Render (2014) stated “the move towards global supply chains has placed so much emphasis on quality that the world has united around a single quality standard, ISO 9000” (p. 210). Its guiding principles are to ensure quality and safety starting at the top of management within any given organization all the way through supplier relationships. ISO’s mission to ensure accurate record keeping and detailed documentation started with the collaboration