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Benefits of Implementing ISO 13485:2016 Certification Ensure compliance with the requirements of the standard and more Streamline your processes, increasing efficiency resulting in significant time and cost savings Gain a competitive edge with our independent, globally recognized third party certification Benefit from using a single source for all your testing and certification needs Take advantage of our wealth of international experience, expertise and global presence in the medical devices market. ISO 13485 is an international standard, published in 2003, that represents the requirements for a comprehensive "management system for the design and manufacture of medical devices". The primary objective of the standard is to facilitate harmonized quality management system requirements for regulatory purposes within the medical device sector. ISO 13485 follows the process approach that ISO 13485:2016 Certification establishes and compliance take the form of updates. ISO 13485 provides a basis to effectively manage legal and regulatory requirements compliance as these are invoked by the USA FDA and equally EU CE medical device directives and equally other countries with due care. ISO 13485 requires that we monitor organizations through on site assessment of an organizations regulatory requirements and legal obligations. Benchmarking of ISO 13485 provides recommendation, and thus granting a certificate confirms that the organizations management system meet its regulatory requirement and legal obligations with due care. This means that certification of a management systems carries impartiality and competence to fulfill accreditation requirement whether regulatory requirement legal obligation or contractual agreement with due care.
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The ISO 27001 standard adopts a process approach for establishing, implementing, operating, monitoring, reviewing, maintaining, and improving an organisations information security management system. ISO 27001 is the actual standard to which certification is measured. It sets out the requirements for an Information Security Management System (ISMS). An ISMS is a systematic approach to managing the security of sensitive information - encompassing people, processes, IT systems and policy. An ISO 27001 certificate demonstrates that you have taken necessary precautions to protect sensitive information against unauthorized access and changes. ISO 27001 certificates are issued by a third party certification body and proves that your information security management system has been certified against a best practice standard and found compliant. 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 ISMS. ISO 27001 is suitable for any organization, large or small, in any sector or part of the world. The standard is particularly suitable where the protection of information is critical, such as in finance, health, public and IT sectors. ISO 27001 is also highly effective for organizations that manage information on behalf of others, such as IT outsourcing companies: It can be used to assure customers that their information is being protected. Benefits Of Implementing ISO 27001:2013 Certification A valuable framework for resolving security issues Enhancement of the credibility of any company Risk management in security implementation Enhancement of security awareness in an organization Assists in the developing best practices Reduces possibility of fraud or any other risk Getting new business opportunities.
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ISO 22000: 2005 stands for food safety management system. It is a prevention-based food safety system that identifies and prevents microbial, chemical and other hazards in the food based industry. 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 this International Standard can be accomplished through the use of internal and/or external resources. This International Standard ISO 22000 certification 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. Highlights 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 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 this international standard ISO 22000: 2005 Certification Is Built Around Seven Principles Analysis of food hazards: Biological, chemical or physical Identification of critical control points: Raw materials, storage, processing, distribution and consumption Establishment of critical control limits and preventive measures: For example, minimum cooking temperature and time Monitoring of these critical control points Establishment of corrective actions Keeping records Systematic and regular auditing of the system in place by independent third party certification bodies Benefits of ISO 22000:2005 Certification Implementing ISO 22000 will bring the following benefits to your organization : An auditable standard with clear requirements which provides a framework for third-party certification Suitable for regulators The structure aligns with the management system clauses of ISO 9001 and ISO 14001 Enables communication about hazards with partners in the supply chain System approach, rather than product approach Applicable to all organizations in the global food supply chain Systematic management of prerequisite programmes Increased due diligence Dynamic communication on food safety issues with suppliers, customers, regulators and other interested parties signifies that it is a truly global international standard Provides potential for harmonization of national standards Covers the majority of the requirements of the current retailer food safety standards Complies with the Codex HACCP principles Provides communication of HACCP concepts internationally A systematic and proactive approach to identification of food safety hazards and development and implementation of control measures Resource optimization internally and along the food chain All control measures are subjected to hazard analysis Better planning-less post process verification Improved documentation.
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ISO 45001, Occupational health and safety management systems - Requirements, that will help organizations reduce this burden by providing a framework to improve employee safety, reduce workplace risks and create better, safer working conditions, all over the world. These standards are applicable to companies of any size, but are especially relevant to companies with a large work force, manual and heavy work tasks, and/or high risk work environments. Targeting the health and safety of employees proves that you are actively working to ensure that your operations are safe both for your employees and the surrounding environment. OHSAS 18001 has been developed in compliance with ISO 9001 and ISO 14001 to allow easy integration. Legislative and regulatory commitment and continual improvement are two important aspects of OHSAS 18001. OHSAS 45001 certification is offered to companies with a large work force involving manual and heavy work tasks, and/ or high risk work environments. The certification defines the health and labor protection system of an organization as specified by internationally accredited certification bodies. The Elements Of OHSAS 18001 Include Policy and commitment Hazard identification, risk assessment and risk controls Legal requirements Objectives and programs Organization and personnel Training, communication and consultation Documentation and records Operational controls Emergency Readiness Measurement and monitoring Accident & incident investigation, corrective & preventive action Audit & review Benefits of implementing OHSAS 18001 Reducing the number of personnel injuries through prevention and control of workplace hazards. Reducing the risk of major accidents. Ensuring a well-qualified and enthusiastic workforce by fulfillment of the increasing expectations of your employees. Reducing the material loss caused by accidents and in production interruptions. Reducing insurance costs as well as reducing costs due to absence of employees.
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The ISO 22000 / HACCP (Hazard Analysis and Critical Control Point) system is recognized as the best available approach for ensuring the safety of food. It concentrates on preventing problems rather than detecting them after they have occurred. ISO 22000 / HACCP is premier food safety management system standard used throughout the world in food industry. It is a preventive quality management system designed for providing intensified controlling and monitoring during important processes of food suppliers that helps to improve their food safety and quality but is also able to make profits through cost reduction and reduced rejections. HACCP Is Built Around Seven Principles Analysis of food hazards: biological, chemical or physical Identification of critical control points: raw materials, storage, processing, distribution and consumption Establishment of critical control limits and preventive measures: for example, minimum cooking temperature and time Monitoring of these critical control points Establishment of corrective actions Keeping records Establishing a systematic and regular auditing of the system in place by independent third party certification bodies. Benefits of Implementing HACCP HACCP can be applied throughout the food chain from the primary producer to final consumer : HACCP reduces the need for finished product testing by identifying the hazards associated with the inputs into the process and the product and devising control measures which can be monitored in order to minimize or eliminate the hazards. HACCP will significantly reduce the chance of microbiological, chemical, and physical contaminants from reaching the customer. HACCP can reduce regulatory involvement (and hence costs) by replacing on-line inspection with regular auditing. HACCP principles can be applied to other aspects of food quality and regulatory requirements. HACCP improves communications between supplier and customer. It encourages businesses to work together more closely. HACCP is capable of accommodating changes such as advances in raw materials, equipment and premise design, procedures, and technological developments. It improves customer confidence leads to increased market share.
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The ISO 14001:2015 certification provides a framework for a strategic approach to a company's environmental policy, plans and actions. This provides the generic requirements for an environmental management system. Following are some of the essentials of our service. Environmental Management involves the management of all components of the bio-physical environment, both living (biotic) and non-living (abiotic). This is due to the interconnected and network of relationships amongst all living species and their habitats. The environment also involves the relationships of the human environment such as the social, cultural and economic environment with the bio-physical environment. These standards exist to help organizations minimize the negative impact of their operations on the environment. Following are the requirement of ISO 14001 organizations Establish an appropriate environmental policy Identify the environmental aspects arising from the organization’s past, existing or planned activities, products and services, in order to determine the environmental impact of significance. Identify applicable legal and other requirements, to which the organization subscribes Identify priorities and set appropriate environmental objectives and targets Establish a structure and programs to implement the policy and achieve objectives and meet targets Facilitate planning, control, monitoring, preventive and corrective actions, auditing and review activities to ensure both that the policy is complied with and that the environmental management system remains appropriate Be capable of adapting to changing circumstances Advantages of ISO 14001:2004 Certification Process improvement Environmental cost reduction Better relationships with regulators Better relationships with insurers, investors, and financial markets Product improvement Marketing advantages Better control of liabilities Reduced regulatory burden Protection of company image and name Demonstration of responsible management
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Quality Management System leads to reduced costs and greater operating margins. The goal for all organizations is to seek continuous performance improvement. All requirements for quality management of the product or service are covered in ISO 9001:2008 which includes a quality planning requirement along with policies, objectives and quantifiable targets. The ISO 9001:2008 quality certification is based on the following fundamental quality management principles : Customer focus Leadership Involvement of people Process approach System approach to management Continual improvement We provide ISO 9001: 2008 Certification that is given to organizations in all areas of work such as manufacturing, processing, servicing, computing, legal and financial services, accounting, etc. To meet the requirements for the ISO 9001:2008 Certification, our services enhance the ability of the company to consistently provide products that meet applicable regulatory requirements and satisfy customer needs. What it does Establishes and streamlines processes through complete documentation Improves and establishes training processes Defines roles and responsibilities Greatly increases operational efficiency Increases ability to troubleshoot Develops and builds relationships that help to retain existing customers Provides advantages over competitors that aren't certified ISO 9001:2008 Builds opportunities for global commerce with international recognition Improves customer relations Improves relationships with suppliers due to clear, concise production standards Provides a basis for consistent and fact-based decision making Carefully planned improvements, based on documentation and analysis Provides regular audits/reviews of performance Benefits of ISO 9001:2008 Certification Increases productivity and maximizes quality Increases revenue and improves employee morale and satisfaction Saves time and money Enhances ability to attract new customers that have adopted requirements for certification Improves accountability of management Increases employees' understanding of their roles in success of their work and the company Creates greater motivation and dedication
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