Royalcert India Janakpuri, Delhi

We provide ohsas 18001 certification services. ohsas 18001, developed in 1999 and revised in 2007, is a comprehensive occupational health and safety (oh&s) management system specification, deigned to enable an organization to control oh&s risks and improve its performance. Ohsas 18001 certification demonstrates that a safety oriented approach has been integrated into the company's processes, a company's commitment to a safe working environment and to protecting employees against injury at work. ohsas 18001 has been developed to be compatible with iso 9001 and iso 14001 management systems standards, in order to facilitate the integration of quality, environmental and oh&s management systems by organizations. Legislative & regulatory commitment and continual improvement are two important aspects of ohsas 18001. the standard is in two sections; ohsas 18001 is the specification against which certification is awarded. Ohsas 18002 provides guidance on implementing an occupational health and safety management system and corresponds directly to the specification.

We provide iso 9001 certification services. iso 9001: 2008 is the fourth edition of iso 9001 quality management system. It does not contain any new requirements and simply elaborates the existing system by fine tuning the clauses of iso 9001: 2000 iso 9001:2008 specifies requirements for a quality management system where an organization l needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and l aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. all requirements of iso 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. an organization in order to operate efficiently must focus and manage many activities connected to each- other. an activity that employs resources and that is managed to allow the transformation of incoming elements into out coming elements can be considered a process. sometimes an out coming element is the incoming element on the next process. the model pdca (plan, do, check, act,) can be applied to all the processes.

We provide iso 27001 certification services. iso 27001 or more precisely iso/iec 27001:2005 information technology, security techniques, specification for an information security management system is an internationally recognized standard that governs the design, implementation, monitoring, maintenance, improvements, and certification in the area of information security management systems (isms). Iso 27001 is the formal standard against which organizations may seek independent certification of their isms. the it department is the main focus of iso 27001 implementation, but the standard involves areas in the entire company as well. The main driver, sponsor, and promoter of the change must be the company's management, while its it is mainly responsible for its execution. In addition to management and it, the departments that must be involved include hr, training and education, building security, building maintenance, legal department as well as suppliers, outsourcing and, last but not least, employees. iso/iec 27001 is also highly effective for organizations that manage information on behalf of others, such as it outsourcing companies. This standard requires and organization to assure customers that their information is being protected. iso 27001:2005 information security management systems (isms) involves three core principles – confidentiality, integrity and availability, which, in turn, cover eleven areas: security policy organization of information security asset management human resources security physical and environmental security communications and operations management access control information systems acquisition, development and maintenance information security incident management business continuity management; and compliance basic requirements iso 27001 requires the organization to: · analyze risks related to information security · define specific and optimal security goals (the standard requires a company to specify its own security goals which an auditor verifies) · define defined and documented methods which all activities should follow · document all risks, goals, and methods · implement measures to mitigate and manage risks · assign accountability for risk management · measure information security · embed continuous improvement approach

We provide iso 22000 certification services. since iso 22000 is a generic food safety management standard it can be used by any organization directly or indirectly involved in the food chain including farms, fisheries, dairies, meat processors, manufacturers of soups, snacks, bread, cereal, beverages, canned and frozen food, etc as well as food service providers such as restaurants, fast food chains, hospitals and hotels. supporting services are also important, including providers of food transportation, storage and distribution, catering services, product suppliers for equipment, additives, raw materials, cleaning and sanitizing products and packaging. If your products touch the food industry or the food we eat, part or all of the iso 22000 requirements will apply. it is the one standard that encompasses both consumer and market needs. It speeds and simplifies processes without compromising other quality or safety management systems. By integrating multiple principals, methodologies and applications, iso 22000 is easier to understand, apply and recognize. That makes it more efficient and effective as an entry-to-market tool than previous combinations of national standards. the standard has become necessary because of the significant increase of illnesses caused by infected food in both developed and developing countries. In addition to the health hazards, food-borne illnesses can give rise to considerable economic costs covering medical treatment, absence from work, insurance payments and legal compensation.

We provide iso 14001 certification services. elements of the standard 14001:2004 contains the core elements for an effective environmental management system. It can be applied to both service and manufacturing businesses. The standard requires a company to define environmental objectives and targets, and the management system necessary to attain these targets. The standard requires that the company adheres to that system's processes, procedures, and activities. the main elements of the standard are: â· environmental policy â· planning â· implementation and operation â· checking and corrective action â· management review elements of an effective environmental system can be integrated with other management requirements to assist organizations to achieve their environmental and business-specific goals. Iso 14001 requires companies to commit to prevention of pollution and continuous improvement as part of the normal management cycle.

We provide iso 13485 certification services. the certification of a quality management system, specifically for medical devices to iso 13485 proves advantageous, and in many cases essential, for medical companies which export their products to global markets. Some of the additional requirements relate to design controls, process controls (including environmental controls), special processes, traceability, record retention, and regulatory actions, which are more critical for the medical device industry. an iso 13485 compliant management system adopt a risk management appoach which includes assessment to identify & estimate risk, uses risk controls and techniques with a view to eliminate hazardous situations throughout product realization. iso 13485: 2003 represents the requirements that medical device manufacturers must incorporate into their management systems. iso 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. the primary objective of iso 13485 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of iso 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this international standard cannot claim conformity to iso 9001 unless their quality management systems conform to all the requirements of iso 9001. all requirements of iso 13485 are specific to organizations providing medical devices, regardless of the type or size of the organization. 13485 dictates that risk management must be thoroughly documented and conducted throughout a product's entire lifecycle, from initial concept to delivery and post-delivery. whatever devices you produce, as a medical device manufacturer you have a responsibility to consistently deliver devices that are safe and effective. Iso 13485:2003 is the international standard recognized for medical device regulations around the world. iso 13485: 2003 has been harmonized against the three directives (medical devices, in-vitro diagnostic devices and active implantable devices) so certification to this standard by an international certification body such as smc automatically demonstrates compliance with specific clauses in the regulations.

We provide haccp certification services. haccp is a preventative approach to food safety and pharmaceutical safety which addresses physical, chemical, and biological hazards as a means of prevention rather than finished product inspection. Haccp is compatible with management systems, such as iso 9001and certification is recognized worldwide by government food authorities and food businesses. background haccp was developed as a microbiological food safety system for astronauts at the beginning of the manned us space program. The pillsbury company, nasa and the us army laboratories at natick pioneered the original system. At that time food safety systems were based on end-product testing. Ensuring full safety required testing 100 percent of the product. The preventive food safety system was born to ensure high level of food safety without using the entire product. haccp principles, developed by the codex alimentarius of the world health organization, demand that organizations establish effective food safety systems through the application of a systematic approach to hazard and risk analysis. This standard is used in the food industry to identify potential food safety hazards, so that key actions, known as critical control points (ccp's) can be taken to reduce or eliminate the risk of the hazards. food safety and public health agencies recognize haccp as the preferred tool for food safety assurance and improving regulatory food standards. The food safety and inspection service of the us department of agriculture (fsis-usda) mandated haccp in meat and poultry processing in 1996. The food and drug administration (fda) later mandated haccp for seafood and juices. The world health organization (who) advises the incorporation of haccp into international and national food legislation to improve food inspection efficiency. benefits provides employees with an understanding of the importance of producing safe food reduces spoilage costs helps reduce and possibly eliminate food safety liabilities improves consistency in product quality and safety improves business that relies on compliance with haccp gives customers increased confidence in your food safety improves competitiveness and makes your company a supplier of choice

We provide gmp certification services. these requirements concern methods, equipment or testing, which are used for the production, processing, packaging and / or storage of drugs. This ensures that medicine products fulfil the necessary quality criteria. At the same time the gmp regulations have an increasing influence on suppliers of the pharmaceutical industry such as suppliers of api’s and excipients, packaging materials, manufacturing facilities and testing equipment. The compliance of gmp-regulations is constantly examined by inspectors of health care system authorities. gmp is referred to as "cgmp" mostly in the united states of america. The "c" stands for "current," reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation.

We provide rohs certification services. weee (waste from electrical and electronic equipment) is a directive that controls how electric and electronic equipment is handled and recycled. Most businesses that must ensure rohs compliance must also ensure weee compliance as well. the rohs directive aims to restrict certain dangerous substances commonly used in electronic and electronic equipment. any rohs compliant component is tested for the presence of lead (pb), cadmium (cd), mercury (hg), hexavalent chromium (hex-cr), polybrominated biphenyls (pbb), and polybrominated diphenyl ethers (pbde). rohs regulations went into effect in the europe and the uk in 2006. They are currently in place, which means that all electric and electronic equipment being made today must meet rohs directive rules. if you are involved in the sale, manufacture or export or import of electric or electronic equipment or parts, you are likely affected by rohs regulations and you should familiarize yourself with rohs.

We provide ce marking services. ce marking is the manufacturer's declaration showing compliance with all applicable directives. For most products sold in the eu, the use of ce marking and a declaration of conformity are mandatory. with the exception of some high-risk products, most products can be self- assessed by the manufacturer to meet the essential requirements. While ce marking permits a product's access to the eu, it is not an approval certification or quality mark; nor is it intended to be a marketing tool. Ce is a "marking" that is only a declaration of the supplier's own responsibility. While enabling products to be placed on the european market, it only allows for the free movement of goods and permits the withdrawal of non-conforming products. the ce marking should not be confused with other approval marks or certifications issued by an eu-accredited certification body. As stated in the european commission's guide to the implementation of community harmonization directives: "manufacturers are responsible for ensuring that the products they place on the market meet all relevant regulations. Where these regulations do not require mandatory certification, manufacturers often seek voluntary certification to assure themselves that their products do meet the requirements set by law."