ISO Certification Services in Vikas Puri, Delhi

Use ISO 13485 : To establish a Quality Management System (QMS) that is oriented towards the design, development, production, and installation of medical devices and related services. To demonstrate your ability to supply medical devices and related services that meet customer expectations and comply with regulatory requirements. To evaluate how well your organization is able to meet customer expectations and comply with regulatory requirements. To become certified or registered. ISO 13485 is not a product standard. It’s a process standard. Therefore, it’s not enough to establish a Quality Management System (QMS) that complies with the ISO 13485 standard, you also need to comply with all relevant product and service oriented technical standards and regulations. ISO 13485 Vs ISO 9001 : ISO 13485 is based on the ISO 9001 Quality Management standard. Both standards are organized in the same way and use basically the same numbering system. In addition, most of the ISO 13485 requirements are taken directly from ISO 9001 without modification. However, some ISO 9001 requirements were modified and others were excluded. Of course, ISO 13485 also includes a special set of requirements specifically related to the supply of medical devices and related services. In general, ISO 13485 is made up of two kinds of requirements: old ISO 9001 requirements and new requirements that are specifically related to medical devices and associated services. ISO 13485 excludes ISO 9001 requirements related to continual improvement and customer satisfaction. Continual improvement is excluded because most medical device regulations require organizations to maintain their Quality Management Systems, not to improve them. And customer satisfaction is excluded because committee members thought it was too subjective. When ISO 9001 wants you to document a procedure, it also wants you to implement and maintain it. Section 4.2.1 of ISO 13485 expands on this idea by including requirements, activities, and special arrangements. More precisely : When ISO 13485 wants you to document a procedure, the standard also wants you to implement and maintain it. When ISO 13485 wants you to document a requirement, the standard also wants you to implement and maintain it. When ISO 13485 wants you to document an activity, the standard also wants you to implement and maintain it. When ISO 13485 wants you to document an arrangement, the standard also wants you to implement and maintain it. Whenever a procedure, requirement, activity, or special arrangement must be documented, it does so by explicitly asking you not only to document it but also to implement and maintain it. ISO 13485 also places a greater emphasis on the use of procedures to regulate and control how activities and processes should be performed. In this sense, ISO 13485 is somewhat more prescriptive than ISO 9001. ISO 9001 often leaves it up to you to decide how work should be controlled, whereas ISO 13485 seems to have removed some of this flexibility by insisting on the use of formal procedures. Since ISO 13485 is all about medical devices and related services, it of course adds many new requirements to address the specific needs of this industry such as ISO 14971 Risk Management.Possible exclusions : ISO 9001 says that you may exclude or ignore some requirements if you can justify doing so. You can exclude section 7 product realization requirements if you cannot apply them because of the nature of your organization and its products. Similarly, ISO 13485 2003 says that you can exclude section 7 requirements if they are not applicable in your situation and does not violate the organization's medical devices statutory regulations. You may also exclude section 7.3 design and development if official regulations allow you to do so and if you have made alternative arrangements that comply with these regulations. Occasionally ISO 13485 uses the phrase “if appropriate? or “where appropriate? When a requirement uses this phrase, you may ignore or exclude it if you can justify doing so. Whenever you decide to exclude or ignore an ISO 13485 requirement make sure that you’ve got a good reason. Make sure you can justify and explain why, and make sure this explanation is documented in your quality manual. How to develop a QMS :In order to become certified, you need to develop a Quality Management System (QMS) that complies with the ISO 13485 standard. But how do you do that? One common approach is to carry out a Gap Analysis. Such an analysis will identify the gaps that exist between the new standard and your organization's processes. Once you know exactly what and where your gaps are, you can take steps to fill them. And once all of your gaps are filled, your Quality Management System will be ISO 13485 compliant. By using this approach, you will not only meet the new ISO 13485 standard, but you will also improve the overall effectiveness of your Quality Management System. If you're currently ISO 13485:1996 or ISO 9001:2000 certified, you can call us to conduct Gap Analysis Tool on your Quality Management System to the new ISO 13485:2003 standard.Once we've completed the Gap Analysis and filled all of the gaps, you're ready to ask a Registrar to audit the effectiveness of your Quality Management System. If your QMS meets ISO 13485:2003 requirements then the Registrar will then issue an official certificate to you and record your achievement in their registration. Identify your organization’s environmental aspects. Study normal and abnormal operating conditions, as well as accidents, disasters, and emergency situations. Identify the environmental aspects associated with all operating conditions and situations. Clarify the legal and other requirements that apply to your organization’s environmental aspects. Legal requirements include National and International as well as local and regional laws and regulations. Other requirements include agreements that have been established with governments, customers, community groups and others as well as commitments, guidelines, principles, or codes of practice that influence how your environmental aspects ought to be handled. Examine your organization’s current environmental management policies, procedures, and practices. Pay special attention to your organization’s purchasing and contracting policies, procedures, and practices. Define the scope of your EMS. When ISO 14001 asks you to define the scope of your EMS, it is asking you to define its boundary. You can choose to apply ISO 14001 to the entire organization or only to a specific operating unit or facility. Once you’ve made this decision, you’ve defined the scope or boundary of your EMS. Henceforth, all activities, products, and services that falls within this boundary must comply with the ISO 14001 standard. Once you’ve considered the above factors, you can begin the development of your organization’s unique Environmental Management System. But if you’ve already established an EMS and you simply need to update it to meet the new standard, you need to do a Gap Analysis. A Gap Analysis will compare your current EMS with ISO’s new ISO 14001 standard. This comparison will pinpoint the areas that fall short of the standard (the gaps). Once you know where to focus your attention, you can begin to make the changes that are needed to comply with the new ISO 14001 standard.

We are offering iso certification services. The implementation of a qms should be a strategic decision of the organization implementing qms. Various factors influence the design and implementation of qms. These include – diverse needs and risks of organizations; particular goals and objectives; complexity of products and services provided;

We are the service provider of iso 9001 ,iso 14001 ,iso 18001,iso 13485,iso 27001 ,iso 22000, ce certification,who-gmp,isots16949,haccp, rohs,sa 8000 & others certificate.

Boost your business with ISO certification in India sitting at your home within a week with expert help and guide. This is a very important certificate for enhancing your business. 

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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.

Iso 14001 is often seen as the corner stone standard of the iso 14000 series. However, it is not only the most well known, but is the only iso 14000 standard against which it is currently possible to be certified by an external certification authority. Having stated this, it does not itself state specific environmental performance criteria. 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.

Ohsas 18001 is part of ohsas 18000, the generic name given to a family of international standards developed to provide a framework around which an occupational health and safety management system can effectively be implemented. It comprises two parts:  ohsas 18001 – occupational health and safety management systems specification  ohsas 18002 – guidelines for the implementation of ohsas 18001 ohsas 18001 is the auditable standard in the ohsas 18000 family. Isoqar audit to ohsas 18001 and are accredited by ukas. Why seek certification to ohsas 18001? registration to ohsas 18001 by an independent, third party, certification body demonstrates a commitment to implement, maintain and improve the way in which you manage your health and safety system. Organisations registered to ohsas 18001 can be more confident about meeting the requirements of health and safety legislation. The setting of targets through the health and safety policy, together with the ongoing measurement against it ensures a process of continual improvement. ohsas 18001 will also bring your business other benefits:  acquiring this leading international standard will broaden your business opportunities  demonstrate due diligence, good governance, low risk and a competent management that is committed to health and safety in the workplace  oshas 18001 will raise both the performance and morale of your employees  look after your most valuable asset – your employees  gives potential clients assurance of your effective risk management procedures and full regulatory compliance  promote safer working environments by heightening adherence to your health and safety policy and procedure  improve efficiencies in health and safety budgeting for costs such as training, ensuring that money is well spent and related to real needs of the organisation  provide reassurance to stakeholders that you are taking all reasonable steps to protect the business against damage to your reputation and breach of legislation

We are offering iso certification service. Iso 9001:2008 is an international standard related to quality management, relevant for any organization from all types of business sectors to be well established around the world as an invaluable quality management system. Provide a structure for taking an organized approach for managing your business processes to meet the quality requirements and also help your organization to improve your management processes to complete globally. Its goal is to provide quality management system that will be beneficial for your organization to help manage your business effectively and put in place best practice methodology. Iso 9001:2008 is based on following eight management principles: customer focus leadership involvement of people process approach system approach to management continual improvement

ISO refers to the International Organization for Standardization and enhances the value of your product or service internationally. ISO stands for International Organization for Standardization, and it is an independent international organization that sets different standards for goods/services. While the overarching body sets these standards, implementation and certification depend on local certifying bodies, which conduct audits in order to ensure compliance. Furthermore, while ISO certification remains voluntary for many sectors, some others may see it as a legal requirement, while some stakeholders may include a valid certification as a contractual prerequisite. ISO enhances global standardization for the quality specification for your products, services, materials, information and quality management. It brings more credibility to your products or services that your products or services meet the quality expectations of your customers. Register for our ISO certification package today, and our team of experts will spearhead efforts to get your product/service ISO certified and ensure that you get the least amount of headache from the entire procedure. Sign up now so that you can proudly showcase that your product meets the international standards! eStartIndia is the best legal and business services platform for services relating to ISO certification in India, offering a variety of registration services like Trade License registration, ISO certification, MSME registration, etc.

We are one of the eminent ISO Certification Providers in the country. Our company has a team of highly experienced and trained personnel hired by us after following stringing recruiting policies. Our team is well-versed in procedures of obtaining varied ISO Certifications. Our members are great at auditing and providing solutions to make your company achieved the desired certifications. We can carry out documentation, planning and other follow ups on your behalf. Contact us anytime of the year.

Many organizations are implementing an Occupational Health and Safety Management System (OHSAS) as part of their risk management strategy to address changing legislation and protect their workforce. An OHSAS promotes a safe and healthy working environment by providing a framework that allows organization to consistently identify and control its health and safety risks, reduce the potential for accidents, aid legislative compliance and improve overall performance. Your organization can become more efficient and productive by systematically minimizing the risk of accidents and work-related illnesses. Benefits of OHSAS 18001 Certification • Risk minimising of accidents and occupational diseases • Higher productivity and working quality • Minimising of fees and penalties in occupational health and safety performance • Improvement of working conditions for workers • Increasing of satisfaction and loyalty of workers • Increasing of organisation ethics • Increase control and reduction of hazards through the setting of objectives, targets and evolved responsibility • Increase reputation for safety and occupational health • Reduction in insurance premiums

Iso 22000 (fsms) has been aligned with iso 9001 to enhance the compatibility of the two standards. This international standard integrates the principles of the haccp system and application steps developed by the codex alimentarius commission. The system focuses on continual improvement. This is done by having management review meeting, internal audit, corrective and preventive action, monitoring of quality objective and analysis of data. Who can go in for iso 22000 (fsms) certification? the international organization for standardization developed a food safety management system. The standard is applicable to any company in the food industry, from farmers, manufacturers and transporters to packagers and retailers. Benefits of iso 22000 (fsms) certification • this makes iso 22000 more than a set of standards. It’s a business- building tool for organizations wishing to extend their reach. • provide a more logical and structured approach to food safety management • gain easier access to global markets • iso 22000 tackles key issues in the food supply chain, each contributing to an organization’s ongoing business performance in relation to food safety management: • clear communication across the entire supply chain • traceability – identification of an organization’s impact on food safety within the supply chain • control/reduction of food safety hazards • management of food safety risks • legal compliance • cost reduction due to a more efficient system • smooth conversion from existing food safety certifications • continuous improved business performance in line with the iso 22000 food safety policy and objectives.

OHSAS ISO 18001 is the code for International occupational health and safety management system standard. These standards are applicable on every size of company (small or large scaled). This is basically connected with the companies having large work force. This standard is made to ensure the better health and safety of the employees. So here we add one more service in our profile that is OHSAS ISO 18001 Certification. Having an in-depth knowledge of the dynamic global marketplace, we provide our consultation services &solutions as per the requirements of our clients. We are admired for our services which are offered at honest prices. Last but not the least; we are the renowned service OHSAS 18001 Certification Consultant of India.

The current European medical device quality system standard is EN ISO 13485:2003, which replaced current harmonized standards EN ISO 13485:2000 and EN ISO 13488:2000. The three-year transition period ended in July 2006. When manufacturers are active in the world market, the focus on global or international standards (e.g., ISO) is not only advantageous - it may be stipulated by certain countries. For example, Canada requires that medical device manufacturers marketing their products in Canada must have a quality system certified to ISO 13485:2003. Benefits of ISO 13485:2003 Certification â�¢ Adopting this standard is beneficial to the organization in many ways:- â�¢ Promotes harmonization of regulatory requirements for the manufacturers of medical devices on an international scale. Â�¢ ISO 13485 is a quality system standard for organizations that design, develop, produce or service medical devices. All requirements of ISO 13485 are specific to organizations manufacturing medical devices, regardless of the type or size of the organization. Â�¢ Companies that achieve ISO 13485 certification enjoy the benefits of an increased amount of customers who have more reason to trust and purchase products of consistent high quality. Â�¢ ISO 13485 will benefit customers, suppliers, management, and especially workers â�¢ Rapid and effective communication, feedback, and recognition on efforts made, results achieved, and work to be done â�¢ Continuous assessment, improvement, and re-registration of systems.

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