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ISO 13485 Certification
UQSR is an ISO 17021 accredited certification body. We are accredited to issue ISO 13485:2016 certificate. We provide ISO 13485 certification services all across India. ISO 13485 is also known as 'Medical Device Quality Management System (MDQMS). Contact UQSR for QMS certification in India. Get accredited MDQMS certificate.
ISO 13485 Certification in India
Product Price: Rs 25,000 / CertificateGet Best Price
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Product Details:
| Certifications Provided | ISO 13485 |
| Target Location | Pan India |
| Document verification Mode | Online |
| Services offered | Audit |
| Type of Certification | New Certification |
| Type of Industry | Medical Device |
| Mode of Report | Soft Copy |
| Service Duration | 10 Days |
As the international standard for Quality Management Systems in the medical device industry, ISO 13485 has already been tested and proven. Companies that have achieved certification can show proof to potential clients that they comply with best practices, and with regulatory requirements. And, along the way, your company will naturally enjoy better control over its processes, and continual improvement. The benefits of ISO 13485 cannot be overstated. Companies of all sizes have realized significant savings in cost and time, plus other improvements that an efficient Quality Management System naturally bring about. The following is a list of six top reasons to implement ISO 13485 in your company:Improve your company’s credibility and image. ISO 13485 is the internally recognized gold standard for quality in the medical device industry. Certification to this standard shows clients and customers that your company takes quality very seriously, and that you have a system in place to ensure it. Your QMS can be a powerful marketing tool, and it has become a requirement in many countries for suppliers to show compliance. This translates to more opportunity. Improve customer satisfaction. The ISO 13485 standard is built on a set of quality management principles, one of which is ensuring customer satisfaction. This can be achieved by assessing customer needs and expectations, and striving to meet them. Customers know what they want, and what they need, and many of them will not even entertain a supplier that isn’t certified. Beyond that, ensuring the satisfaction of your existing customers keeps them coming back, and helps you sell your services to new customers. This translates directly to increased revenue.Improve your processes. Using the process approach outlined in ISO 13485, it’s much easier to discover opportunities for improvements. You’ll be able to identify and eliminate waste within and between processes, reduce errors, and avoid rework—facilitating greater efficiency and cost savings.Improve decision-making. Another quality management principle of ISO 13485 regards the use of evidence-based decision making. When you use facts and data to drive your decisions, those decisions tend to be better aligned with the strategic goals of your company. While “gut feelings” may be appropriate in some social situations, they can spell trouble in business. An added bonus is the increased insight into the health of your processes, and any improvements that are made, once you keep track of the data.Create a culture of continual improvement. A third quality management principle making up the foundation of ISO 13485 is the concept of continual improvement. When adopted as the culture in your organization, management and staff will always be on the lookout for ways to improve on how things are done. By establishing systematic processes for reducing problems and mitigating their effects, everyone will spend less time cleaning up mistakes, and more time delivering quality products and services.Better employee engagement. When employees are asked to help look for ways to improve their own processes, not only will they often provide the best insight – they will also be much happier and more invested in the success of the company. The more your employees understand their roles in delivering quality products and services, the more engaged they are, which leads to increased efficiency and productivity.
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ISO 13485 2016 Certification Service
Product Price: Rs 15,000 / CertificateGet Best Price
Minimum Order Quantity: 1 Certificate
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Product Details:
| Mode of Report | Soft Copy |
| Type of Industry | Medical Device |
| Type of Certification | New Certification |
| Services offered | Audit |
| Document verification Mode | Online |
| Target Location | Pan India |
| Certifications Provided | ISO 13485 |
| Certification Provided with in | 7 days |
ISO 13485 is the medical industry's optimal medical device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs. ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals and other medical settings.ISO 13485:2016 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonised medical device regulatory requirements. The standard contains specific requirements for manufacture, installation and servicing of medical devices and calls for:Implementation of a Quality Management System with several enhancements, Risk Management approach to product development and product realisation, Validation of processes, Compliance with statutory and regulatory requirements, Effective product traceability and recall systems. Implementing a Quality Management System for Medical Device Manufacturing to your business can cite numerous benefits. ISO 13485 provides a framework for good management practice which demonstrates the businesses commitment to manufacturing high-quality medical devices.
ISO 13485 was created to ensure that medical devices, no matter where they are from, demonstrate the same reliability and quality. Having this standard can help expand potential market and lead advantages for regulatory approval in major markets like the European Union and Canada. Having ISO 13485 can also have a positive impact, indicating an organization’s commitment to high quality.Larger medical device businesses prefer to work with vendors who have implemented a quality management system for medical devices and are ISO 13485 certified. Revisions in the 2016 update to this standard meant that companies are responsible for ensuring that any subcontractors also conform to ISO 13485 standards. Subcontractors that are already ISO 13485 certified are likely to be prioritized.The standards documentation is designed to help personnel have access to the information they need, when they need it. Having access to the right information can reduce the time and expense associated with product development. Documenting the processes associated with their medical devices could also help organizations develop a consolidated knowledge base; this can help to identify problems, improve the product, and streamline the manufacturing process. A process is the transformation of inputs to outputs, which takes place as a series of steps or activities which result in the planned objective(s). Often the output of one process becomes an input to another subsequent process. Very few processes operate in isolation from any other.Even an audit has a process approach. It begins with identifying the scope and criteria, establishes a clear course of action to achieve the outcome and has a defined output (the audit report). Using the process approach to auditing also ensures the correct time and skills are allocated to the audit. This makes it an effective evaluation of the performance of the QMS.
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ISO 13485 Certification in Delhi
Product Price: Rs 25,000 / CertificateGet Best Price
Minimum Order Quantity: 1 Certificate
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Product Details:
| Certifications Provided | ISO 13485 |
| Target Location | Pan India |
| Document verification Mode | Online |
| Services offered | Audit |
| Type of Certification | New Certification |
| Type of Industry | Medical Device |
| Mode of Report | Soft Copy |
| Certification Provided with in | 7 days |
ISO 13485:2016 ensures that medical devices used in healthcare settings are designed, produced, installed, and serviced to the highest standards. As any business owner knows, these standards must not only meet client obligations, but also regulatory and legal specifications. Adopting ISO 13485:2016 into the heart of your practices means you will build a clear, practical foundation to address these specifications, as well as demonstrate a commitment to safety, quality, and competence. Benefits of ISO 13485:2016:1) Taking control of your supply chain-A good tell of whether the organisations in your supply chain are quality focused is to see if they are ISO 13485 certified. You are an original equipment manufacturer (OEM) of medical devices, so it is your responsibility to ensure that every producer within your supply chain is regulation compliant. Without ISO 13485:2016’s mark of quality, verification can be a tedious and unrewarding task.2) Ensuring control processes are robust in every step of your product’s life-From development, to manufacture, to distribution, every stage of your product’s journey needs to be carefully controlled so that it meets regulation and avoids inadequacy at any step. ISO 13485:2016 makes the process less overwhelming by providing you with a solid, easy-to-manage framework to help you manage your control processes.3)Reducing costs through a more efficient QMS-ISO 13485:2016’s carefully curated framework not only prioritises best practices in the product journey, but also the efficiency of these practices. With a methodical approach to medical device manufacturing, you will have a logical plan for your workforce, saving time and reducing waste.4) Becoming up-to-speed with the needs of regulatory authorities in your area-In a time when public health is at the forefront of everyone’s mind, authorities are more stringent than ever when it comes to regulating the medical device manufacturing industry. ISO 13485:2016 provides you with a useful framework that has already taken into account that there will be legal requirements associated with the medical device, so it makes these easy to control and manage.5)Qualified with an internationally-recognised certification-ISO 13485:2016 is the leading qualification of its kind, meaning it is recognised across the world as a mark of quality and competence. Certification gives you confidence to emerge onto the global market and open yourself up to new business opportunities. The process of getting ISO 13285:2016 certified with UQSR is a trouble-free step-by-step approach.1)Initial consultation-We help you outline your goals, focusing on what your business wants to achieve and how it defies success, particularly in relation to your clients’ requirements.2)Producing your organisation’s ISO 13485:2016 documentation-Next, the UQSR consultant will assess your existing procedures and help you document the new systems that will help deliver success – both existing and how you will improve these. This documentation sets out how your business should operate going forward so that it can deliver ISO 13485:2016.3) Submission to a third-party external auditor-Before you can be awarded the ISO 13485:2016 certification, your organisation applies to the third-party certifying body that you have selected to conduct your audit. This audit is an objective view on whether your business is conforming to ISO 13485:2016. As we will have provided excellent support and guidance to your business every step of the way, you can be assured that the outcome will be successful.4)ISO 13485:2016 awarded-Once confirmed that you are ISO 13485:2016 compliant, your organisation will be presented with your certificate. This international certification will be recognised by current, potential, and future clients as a mark of excellence in medical device manufacturing.
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ISO 13485 Medical Devices Certification
Product Price: Rs 25,000 / CertificateGet Best Price
Minimum Order Quantity: 1 Certificate
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Product Details:
| Certifications Provided | ISO 13485 |
| Target Location | Pan India |
| Document verification Mode | Online |
| Services offered | Audit |
| Type of Certification | New Certification |
| Type of Industry | Medical Device |
| Mode of Report | Soft Copy |
| Certification Provided with in | 7 days |
ISO 13484 is derived from the ISO 9000 quality management standard series and it is a stand-alone one. ISO 13485 follows the ISO 9000 process-based model for a regulated medical apparatus manufacturing environment. This is more regulatory nature and requiring a thorough documented QMS.ISO 13485 supports medical apparatus manufacturers in designing a quality management system that ascertains and maintain their processes of effectiveness. The constant design, development, production, installation and delivery of medical equipment are ensured and confirm the safety of their proposed purpose.The benefit of ISO 13485 in your organization;Promote your organization’s image and credibility: ISO 13485 is the gold standard for quality in the medical apparatus industry. This certification shows your clients that you are looking at the quality meticulously and you have a proper system to ensure it. Your QMS is a powerful marketing tool and it is being mandatory in many countries for suppliers to show your compliance which leads to a huge opportunity.Improve your processes:With this process approach, it is easier to discover opportunities for improvements. You will be able to spot and eliminate waste within and between the processes, mitigate errors, avoid rework that facilitates greater efficiency and cost savings.Better employee engagement:When employees are asked to improve their own processes, they not only provide their best insight, but also they will feel happier and more invested in the company’s success. The employees’ understandability in delivering quality products, services, and their full commitment helps in increasing efficiency and productivity.Increase customer satisfaction:The ISO 13485:2016 standard is designed on the basis of ensuring customer satisfaction. It can be achieved by analyzing customer needs, expectations. Customers know about their wants and needs and many of them certainly not entertain a supplier without proper certification. Above all, ensuring the satisfaction of your existing customers make them come back, supports to sell your services to new customers which leads to the increased revenue ultimately.ISO 13485:2016 compliant management systems comply with a risk management approach that includes an assessment to identify and estimate the risk, uses risk controls and techniques with a vision of eliminating hazardous situations throughout the product realization.Strongly emphasizes the sterility and cleanliness in the production area which in turn increases efficiency and improves safety at the work spot.It is being a condition of doing business; so many companies adapt ISO 13485. It aligns with many global regulations which include CE marking of medical equipment under U.S. Food and Drug Administration (FDA) and European directive requirements that medical apparatus manufacturers’ set up and comply with the quality systems.The most apparent candidates for ISO 13485:2016 certification are Medical apparatus manufacturers and suppliers of medical devices, medical device distributors and importers, service providers for medical devices such as installation, technical support or QMS services.
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ISO 13485 Certification in Mumbai
Product Price: Rs 25,000 / CertificateGet Best Price
Minimum Order Quantity: 1 Certificate
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Product Details:
| Certifications Provided | ISO 13485 |
| Target Location | Pan India |
| Document verification Mode | Online |
| Services offered | Audit |
| Type of Certification | New Certification |
| Type of Industry | Medical Device |
| Mode of Report | Soft Copy |
| Certification Provided with in | 7 days |
ISO 13485 is a Quality Management System for medical device/component manufacturers. This includes any organization that designs, produces, installs, or services medical devices and components. Due to the vital nature of such products, conformity is paramount. As a globally-recognized standard, ISO 13485:2016 makes product conformity possible amidst expanding international supply chains. ISO 13485 certification helps medical device manufacturers meet industry requirements and regulations. As a global standard of medical device quality, ISO 13485 opens your business to more markets, ensuring compliance with internationally recognized best practices and safety protocols. When you pursue ISO 13485 certification with us, you get more than a piece of paper. You get a quality management system that can transform your business. As a medical device manufacturer, you can leverage this certification to demonstrate quality control measures and compliance with industry regulations. ISO 13485 certification offers many benefits for small manufacturers and provides opportunities to engage a larger market. Effective Risk Management-ISO 13485 gives you the tools for effective risk management, creating consistency across your organization to ensure safe and reliable products. QMS Practices for Safe and Effective Medical Devices-ISO 13485’s Quality Management System (QMS) practices establish protocols for quality control, ensuring safe and effective products. With compliant oversight, monitoring, and accountability, you can consistently meet critical requirements for medical device production. Foundation for Compliance With FDA, MDD or CE-ISO 13485 certification is a common first step for manufacturers seeking compliance with the Medical Device Directive (MDD) and the CE marking process in the European Union. Many countries now base their regulatory requirements on ISO 9001 and 13485. For example, the U.S. revised Quality System Regulation (FDA 21 CFR 820) incorporates both standards. ISO13485 references the ISO 9001:2008 standard, not the latest 2015 version. However, ISO 13485 goes beyond ISO 9001 with many controls specific to medical devices. Improved Processes-ISO13485 requirements help you streamline their regular processes. With the monitoring and evaluation required by ISO 13485, you can establish efficient systems and optimize productivity across your organization. New Business Opportunities-Because ISO 13485 requirements are recognized world-wide, certification exposes you to a broader market. When you demonstrate compliance with a proven, globally-recognized standard, you can engage with new customers. In the medical device industry, quality and safety are crucial. The International Organization for Standardization (ISO) developed ISO 13485 to standardize the quality and safety requirements for medical devices worldwide. With ISO-compliant quality management, you can reduce risk in the supply chain and increase customer satisfaction. By meeting ISO 13485 requirements, you empower your business to move forward and engage new markets. The medical device manufacturing requirements of ISO 13485 set your business apart. They prove your commitment to quality and safety, building trust with consumers as you continually deliver safe, effective products and components. ISO 13485 certification also streamlines your day-to-day manufacturing processes. With an ISO 13485 management system, you get more value from your operations, increasing productivity and cost-efficiency across your organization. You must complete several steps to achieve and maintain certification. Certificates are issued by a third-party registrar following a certification audit, and everyone in your organization will need to be involved in the process. To learn more about the basics of certification, download our free guide or contact us to speak with a consultant.
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ISO 13485 Certification in Bangalore
Product Price: Rs 25,000 / CertificateGet Best Price
Minimum Order Quantity: 1 Certificate
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Product Details:
| Certifications Provided | ISO 13485 |
| Target Location | Pan India |
| Document verification Mode | Online |
| Services offered | Audit |
| Type of Certification | New Certification |
| Type of Industry | Medical Device |
| Mode of Report | Soft Copy |
| Certification Provided with in | 7 days |
An ISO 13485 certification is a way to exhibit an organization’s compliance with the ISO 13485 standard created by the International Organization for Standardization (ISO) for the medical device manufacturing industry. Its current version is the ISO 13485:2016 standard, which is typically valid for 3 years as with other ISO certifications. Closely related to its importance, being certified for the ISO 13485 standard merits organizations the following major benefits:Reduced need for repeating processes, Streamlined quality management, Recognition of being up to par with international industry standards, Increased profitability, Continuous customer satisfaction. Depending on the business or organization, some of the initial requirements and steps on how to get an ISO 13485 certification may vary. Nonetheless, the following steps should be able to get you started:1. Planning-This is where your organization plans how to establish your QMS and align it to the standard’s quality planning requirements. Part of such is to create a quality manual and provide an optimized method of documenting quality plans when implementing relevant changes to your QMS2. First internal audit-The first internal audit helps your organization to verify the effectiveness of your QMS even before the third-party certification body conducts the initial audit. This way, you can pinpoint nonconformities and their root causes from the get-go and design necessary actions to mitigate and address them.3. Corrective actions-Based on the internal audit report, you can now determine if there are issues needing to be eliminated or areas needing improvement. This is where you initiate a Corrective and Preventive Action (CAPA) process. Such a quality management procedure will help you devise the necessary actions and process improvements to be done by everyone involved in those areas.4. First management review-Just before applying for the third-party audit, it’s essential that you let your top management review your organization’s quality objectives. After the review, the management finalizes a list of action items found in internal audits and improvements to be implemented. The list can then be used as a guiding document for the next management review before applying for the certification.5. Initial ISO 13485 certification audit-In this step, start by researching and choosing which third-party organization will conduct the certification among recognized ISO 13485 certification bodies. Then, the overall application for the certification begins—from filling out the form, reviewing it, and submitting it to the certification body. In most cases, this is where contract signing is also accomplished.Furthermore, this step is comprised of two stages:Stage 1 (Documentation Survey) – The third-party auditor focuses on checking how well an organization documents its systems. Hence, the CAPA process, management review schedule, and overall QMS should be in place. Some of the documents you need to prepare for the first stage include the following:Quality manual, Organizational chart, Internal auditing process and schedule, CAPA protocols and log, Management review process and findings.Stage 2 (Primary Audit) – This is where you ensure that the rest of the ISO 13485 certification requirements are complete in your organization. The certification auditor now checks if all regulatory requirements have been met, especially those that are recognized in international markets. In addition, the auditor evaluates the effectiveness of your overall quality system by sampling records from each and every process your organization implements. Lastly, the second stage of the initial certification will also help you identify the schedule of surveillance audits (typically done yearly) and reassessment.
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ISO 13485 Certification in Chennai
Product Price: Rs 25,000 / CertificateGet Best Price
Minimum Order Quantity: 1 Certificate
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Product Details:
| Certifications Provided | ISO 13485 |
| Target Location | Pan India |
| Document verification Mode | Online |
| Services offered | Audit |
| Type of Certification | New Certification |
| Type of Industry | Medical Device |
| Mode of Report | Soft Copy |
| Certification Provided with in | 7 days |
The ISO 13485 standard provides manufacturers, designers, and suppliers to the medical device industry with a framework necessary to demonstrate compliance to regulatory requirements and mitigate risks to stakeholders. It places more emphasis on risk-based thinking and decision-making while it also offers stronger intra-operability between the clauses and requirements.Perhaps most importantly, it focuses on ensuring consistent quality, product safety and the sustainable success of your products or services, using competent and efficient quality management systems to support them. Persistent pressures from global competition demand that organisations continually improve your products, services, and business processes to remain competitive.To satisfy these conformity and QMS needs, many manufacturers are discovering the benefits of working with a third-party testing company. The benefits of management systems certification:Your management system’s conformity with ISO 9001, ISO 13485, ISO 14971, or ISO14001 can help your company open doors to untapped domestic and international business opportunities, and reap the benefits of:Expanded market access – National regulatory authorities require or strongly prefer that manufacturers marketing medical products in their countries have a third-party audited and certified management system in place.Reduced cost of sales –Improved performance – Based on a uniform and widely-accepted system of process control, your company’s certified management system helps you improve your products and processes. The path to certification consists of seven steps - and UQSR professionals will be there to guide you throughout the entire process.Step 1 – Commitment-Once you’ve selected UQSR as your certification body and your audit date is set, you’ll be assigned a lead auditor to guide you through the entire process. Our network of Total Quality Assured Experts will be your trusted partners through your certification process and beyond.Step 2 - Pre-assessment-This step is optional, but it can be extremely helpful in identifying potential problem areas and improving the likelihood of achieving certification on your first attempt. It’s a small investment that can pay dividends later, by saving the time and money required to perform a second audit. Performed during the review of your documentation and management system’s implementation, this step also helps to familiarize employees with the process for your formal assessment.Step 3 - Stage I audit-At this stage, your lead auditor will confirm that your management system has been designed to conform to the requirements of the standard and achieve the organization’s policy objectivesStep 4 - Stage II audit-Your assessment team, supervised by your lead auditor, will review your management system in the least disruptive manner possible. The objectives of the audit are to confirm that the management system conforms to all the requirements of the standard, and that your organization has effectively implemented the system so it can achieve the organization’s policy objectives. You will be given a predetermined amount of time to correct any nonconformity found.Step 5 - Certification decision process-Upon completion of each certification activity, UQSR personnel will conduct an independent and impartial review of the audit to evaluate the outcomes of the audit processes including related recommendations of the auditing team prior to issuing certification.Step 6 – Certification-At this point, your company has achieved its certification and will be registered as such. When you receive your certificate, you’ll gain the assurance your certification affords.
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ISO 13485 Certification in Kolkata
Product Price: Rs 25,000 / CertificateGet Best Price
Minimum Order Quantity: 1 Certificate
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Product Details:
| Certifications Provided | ISO 13485 |
| Target Location | Pan India |
| Document verification Mode | Online |
| Services offered | Audit |
| Type of Certification | New Certification |
| Type of Industry | Medical Device |
| Mode of Report | Soft Copy |
| Certification Provided with in | 5 days |
ISO 13485 is an international standard that specifies the quality management system requirements for organizations involved with medical devices at any stage of the product lifecycle. This would include the design, development, production, storage, distribution, installation, service and technical support of the device. The ISO 13485:2016 revision is the third edition of the standard and supersedes the previous ISO 13485:2013. This latest revision of the standard contains considerable updates regarding risk-based quality processes, supplier management, and strict adherence to regulatory requirements. This standard may be applied to parties that provide material, product or services to the organization and is applicable to organizations of all sizes large and small. In addition, any processes required to obtain or maintain compliance to the ISO 13485:2016 standard that are not performed within the organization, remain the responsibility of the organization and must be included within the quality management system. The organization must monitor, control and ensure proper maintenance of the external processes.The ISO 13485:2016 standard focuses on a process approach to quality management within an organization. The process approach is a review of the sequence, the inputs and outputs and interaction of processes. Any activity that receives inputs and produces outputs is considered a process. In most cases, the output of one process is the input for the next and so on. The process approach perceives the management system not as a collection of documents but as an active system of processes. Quality system processes should identify and mitigate risk. In particular, the risk to product and process quality, to the business in general, and to meeting customer or regulatory requirements. Organizations that utilize a process approach to quality management tend to: Better understand and consistently meet or exceed product requirements, Evaluate each process from a value-added perspective, Achieve a higher level of process performance, Continually improve processes based upon performance data and not on speculation or opinion, Medical technology is expanding at an astounding rate. New medical techniques, medications, equipment and devices are currently being developed that could not have been imagined just a few decades ago. Recent advancement in medicine, new medical technology, including diagnostic and therapeutic devices, have revolutionized modern healthcare. With this swift advancement of medical technology and devices, there is inherent risk. Companies that are producing medical devices and equipment must develop the most effective quality practices. Today’s consumers are constantly being bombarded by advertisements regarding litigation against medical device manufacturers. Just one major issue can have a profound impact not only on the manufacturer, medical practitioner and most importantly the patient’s well-being. Quality issues in many other types of products may cause inconvenience or put consumers at nominal risk of illness or injury. With medical devices, quality issues could not only cause serious health issues but can also lead to death. Medical device manufacturers must develop and implement a very robust quality management system that must encompass the entire product life cycle. To ensure the quality system is sufficient, most organizations pursue certification of their quality management system to the latest revision of the ISO 13485 standard for Medical Devices Quality Management Systems.
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ISO 13485 Certification in Pune
Product Price: Rs 25,000 / CertificateGet Best Price
Minimum Order Quantity: 1 Certificate
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Product Details:
| Certifications Provided | ISO 13485 |
| Target Location | Pan India |
| Document verification Mode | Online |
| Services offered | Audit |
| Type of Certification | New Certification |
| Type of Industry | Medical Device |
| Mode of Report | Soft Copy |
| Certification Provided with in | 5 days |
The International Organization for Standardization, ISO 13485 applies to companies in one or more stages of medical device production. This includes the sourcing of materials, distribution, design, and sterilization, among other functions in the manufacturing life cycle. Quality management system general requirements, management’s responsibility, documentation standards, and product realization are among the subjects covered in ISO 13485. If an organization can prove conformance to the elements of the quality management system, it can become ISO certified.Faster Cycle Times-Quality and process excellence initiatives utilize statistical process control, waste reduction and systems thinking to increase customer satisfaction. A common result of quality management system deployment is faster cycle times in the supply chain and on the production facility floor. This is because products, processes, and systems are under constant review and re-design when quality management is part of organizational culture. Whether it’s in administration, accounting or purchasing, quality can lead to faster cycle times and better service.Less Waste-Waste reduction in all parts of the production process is a direct result of building an organization to conform to ISO standards. Identification and removal of overproduction, waiting, excess inventory, defects, and scrap are among the benefits of quality management system deployment. There are also fewer internal machinery failures and fewer customer returns. All of this leads to lower production costs and higher profit margins. Reduction of labor hours allows for cost-savings and the reallocation of resources to value-added activities.Systematic Process Improvement-Although it’s the responsibility of employees at all levels of an organization to enhance the efficiency and effectiveness of operations, it’s hard to do so without having a common language to describe inefficiencies and process improvements. A quality management system not only creates effective communication channels to articulate deficiencies, but it also provides systematic methods for improving processes through six sigma and lean techniques. Whether it’s through quality auditing or corrective action requests, systematic improvement is a benefit of ISO 13485 certification.Higher Customer Satisfaction-Quality management systems reduce the cost of non-conforming products, enhancing customer satisfaction. This is true for suppliers of raw materials and other entities in the supply chain, and it can lead to better customer experiences. Given that medical devices have such an impact on people’s lives, there is little room for error or customer returns. For example, statistical process control can help remove special cause variation from the machining process, to create a product that rarely deviates from design thresholds. This can enhance the quality of people’s lives over the long run because medical devices can withstand environmental strains and deliver on their intended purpose.Higher Prestige-Meeting ISO requirements enable companies in the medical device industry to better market their products and services. When they become certified, they have met an objective standard of excellence that enhances their competitive advantage in the marketplace. While creating an organization that meets quality management system standards is not a simple process, it is well worth the effort and investment of time and energy. This is because quality is the driving force behind business success and failure.
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ISO 13485 Certification in Ahmedabad
Product Price: Rs 25,000 / CertificateGet Best Price
Minimum Order Quantity: 1 Certificate
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Product Details:
| Certifications Provided | ISO 13485 |
| Target Location | Pan India |
| Document verification Mode | Online |
| Services offered | Audit |
| Type of Certification | New Certification |
| Type of Industry | Medical Device |
| Mode of Report | Soft Copy |
| Certification Provided with in | 7 days |
ISO 13485 Certification provides a complete framework for medical device manufacturers, suppliers, or any other external party related to medical devices to ensure product quality and regulatory compliance with the standard.ISO 13485:2016 Certification is vital for medical device organizations to demonstrate compliance with regulatory requirements so-called law of the land. In the life and health sciences industry, quality management is a multidimensional and non-negotiable issue, covering more than just verification that a finished product meets certain expectations and is safe for use. As a component of the regulatory ISO 13485 standard, a quality management system requires a systematic process for controlling, monitoring, and verifying, analyzing, and improving any activity or process that could affect product conformance. From the manufacturing floor to the end-user the medical devices should be aligned as per the guidelines of the standard. This helps in providing quality products and devices for the consumers.The International Organization for Standardization (ISO) developed ISO 13485 standard with a revised version in the year 2016 from ISO 13485:2012. Although ISO 13485:2016 standard is based on ISO 9001, (though ISO 13485:2016 is not based on the Annex SL High Level Structure) incorporating the majority of the same requirements, it requires additional controls which include regards to documentation, validation, verification, and identification of regulatory requirements, Increased focus on risk management, Coordination with global regulatory requirements.ISO 13485 Medical Device Quality Management System MDQMS certification focuses on the capability and reliability of your quality, and degree of effectiveness in the areas of design, development, production, and customer care of medical devices and equipment. There is no compromise when it comes to defective devices. The motto of this standard ISO 13485 is to facilitate harmonized quality management system requirements for the medical devices sector.Benefits of ISO 13485 Certification; Improve the credibility of your organization by providing health safety by achieving ISO 13485 Certification. Other benefits are:Improve the process of production, Ensures safety in medical devices, Reduces operational cost, Continuous Improvement in medical devices, The innate trust of stakeholders and customers, Validate customer satisfaction and wellbeing, Encouragement of staff and employee training in medical service providers.,Helps in CE Marking of Medical equipment.Extensive market access approval.The ISO certification processs involves;1) Conduct gap analysis,2) Guidance regarding documentation and implementation,3) Guidance regarding risk/opportunity assessment, 4)Internal audit by consultant, 5)External audit by certifying body, 5) closure of conformities as per Iso 13485 standard, 6) Issuing certificate. Requirements of ISO 13485 apply to medical devices, the requirements apply equally to associated services as supplied by the organization. ISO 13485:2016 set down requirements for a Quality Management System to medical device equipment and related services such as;Identify and adopt a risk management approach to product development and product realization, Creation of QMS Manual, Processes, Procedures, Formats/Records, Creation of Medical Device Master File, Analysis of the validation of processes and procedure, Compliance with Regulatory requirements and guidelines of the standard, Proper maintenance, control, and repair of medical devices, Effective and quick product traceability and recall systems in case of any errors, Enhancement and continual improvement in technology, An Internal Audit of the organization.
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ISO 13485 Certification in Noida
Product Price: Rs 25,000 / CertificateGet Best Price
Minimum Order Quantity: 1 Certificate
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Product Details:
| Certifications Provided | ISO 13485 |
| Target Location | Pan India |
| Document verification Mode | Online |
| Services offered | Audit |
| Type of Certification | New Certification |
| Type of Industry | Medical Device |
| Mode of Report | Soft Copy |
| Certification Provided with in | 7 days |
ISO 13485 is recognized by the Global Harmonization Task Force (GHTF) and has become the model QMS standard for the medical industry, and in major markets around the world. A well-run operation with processes under control leads to financial rewards for your hard work and investment in the Quality Management System. It has been observed that QMS certified companies have shown improvements in financial performance as compared to uncertified ones. An ISO 13485 QMS can help an organization:Meet legal, regulatory, contractual and marketing requirements, Improved product safety, Although not fully harmonized, an ISO 13485 Quality Management System (QMS) is very close to the Food and Drug Administration’s .Implementing ISO 13485 will have many benefits for your organization. Although changes in your QMS will take immediate additional energy, the results of having an ISO 13485 quality management system will provide you with many benefits in operations, sales, and customer satisfaction. Increased Customer Satisfaction-Many organizations decide to implement ISO 13485 and obtain registration because it assures customers that the company has a good Quality Management System (QMS). An organization with an effective QMS will typically meet customer expectations better than an organization that does not have one. This is because the Goals and Objectives of the QMS take the customer needs into account. As goals focus on the customer, the organization spends less time focusing on individual goals of departments and more time working together to meet customer needs.
Internal Effectiveness through Process Improvement-ISO 13485 emphasizes audit processes, management review and improved processes based on collected data. Using facts and a system of documentation and analysis, improvements are carefully planned and implemented. This ensures that the best decisions are made for your company, which leads to better operations, improved performance, and improved profitability. Improved Decision Making & Involvement of Top Management-With the QMS in place and working for you, the organization is focused towards the Quality Goals. Management is provided with data on a continual basis and able to see progress or lack of progress towards goals and take appropriate action. The organized, scheduled process of conducting Management Reviews (Clause 5.6) ensures that this evaluation takes place. It provides the mechanism of reviewing performance against goals on a scheduled basis, and for taking action based on the evaluation.
Because of the requirements addressed in the Standard, organizations often see an increased involvement of top management with regards to the Quality Management System. This starts with the setting of the Quality Policy (Clause 5.3) and Quality Goals and Objectives. It continues with Management Review looking at data from the QMS, and taking actions to make sure that Quality Goals are met, new Goals are set, and continual improvement is achieved. The quality policy also ensures that corrective action is taken whenever defects occur. Increased Employee Involvement-ISO 13485 requires that employees understand their role in the QMS. With improved training and qualification of employees, productivity and involvement increase. Better documentation or control of processes leads to consistency in performance, and less scrap and rework. Managers experience fewer late-night troubleshooting calls; employees have more information for troubleshooting problems on their own, and new employees are able to find information they need to follow processes. ISO 13485 creates a work atmosphere that is open to feedback and idea sharing, allowing employees the chance to provide their thoughts on current processes.
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ISO 13485 Certification in Gurgaon
Product Price: Rs 25,000 / CertificateGet Best Price
Minimum Order Quantity: 1 Certificate
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Product Details:
| Certifications Provided | ISO 13485 |
| Target Location | Pan India |
| Document verification Mode | Online |
| Services offered | Audit |
| Type of Certification | New Certification |
| Type of Industry | Medical Device |
| Mode of Report | Soft Copy |
| Certification Provided with in | 7 days |
ISO 13485 is a stand-alone Quality Management System standard for medical devices, obtained from the globally acknowledged and accepted ISO 9000 QMS series.The ISO 13485 certification supports medical device manufacturers in plotting a QMS that creates and maintains the efficacy of their processes. It ensures the consistent design, development, production, installation, and delivery through to the disposal of medical devices that are safe for their intended purpose.The ISO 13485 standard also provides a planned structure and realistic foundation to stick to medical device directives, regulations, protocols, and responsibilities.The standard essentially enables you to full fill the medical device manufacturers’ commitment to the safety and quality of medical devices.The ISO 13485 certificate can be obtained by any company manufacturing medical devices irrespective of their size or location. The ISO 13485 implementation is carried out by companies in almost 21 countries.Below are key benefits of ISO 13485 implementation in any business related to medical devices manufacturing:1. Improve your company’s credibility and identity-The ISO 13485 certificate is the globally recognized standard for quality in the medical device industry.This certification is proof to the customers that the organization follows high-quality standards and informs them that they have a standard in place to ensure it.Furthermore, the ISO 13485 implementation in any organization can serve as a powerful marketing tool and is an essential thing for medical device manufacturers to show compliance.2. Evidence-based decision making-With the ISO 13485 certification in place, the company can stay focused and work towards quality goals. The management is provided with data on a continual basis. These facts and data can be used to make decisions that can align better with the strategic goals and objectives of the company.If the management sees any lack of progress towards the set goals, appropriate action will be taken.3. Continual improvement-Continuous improvement is one of the core principles of the ISO quality management systems. When a QMS is adopted in any organization, it leads to cultural change, where management and staff will be looking out for improvements.Moreover, setting up systematic processes can eliminate problems and reduce the work burden, leading to high performance, strategic leadership, and employee engagement. This in turn can deliver high-quality products and services.4. Increased employee involvement-With proper documentation and control of processes, employees are able to understand their role in ISO 13485 implementation. When they are asked to look for a way to enhance the processes, they feel so happy and give the best insight that can help the company succeed. The more the employees understand their roles, the more they become engaged. This results in higher operational efficiency and productivity.5. Enhanced customer satisfaction-One of the core principles of the ISO 13485 implementation is to ensure customer satisfaction. Companies that are ISO 13485 certified are considered more reliable by the customers than the company that doesn’t have one. This is because the customers strongly believe that the company has a good QMS in place. The goals of the company with ISO 13485 implementation are focused on the customer needs rather than focusing on the individual goals of the department. This will help get new customers for business and boost the revenue.
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ISO 13485 Certification in Ambala
Product Price: Rs 25,000 / CertificateGet Best Price
Minimum Order Quantity: 1 Certificate
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Product Details:
| Certifications Provided | ISO 13485 |
| Target Location | Pan India |
| Document verification Mode | Online |
| Services offered | Audit |
| Type of Certification | New Certification |
| Type of Industry | Medical Device |
| Mode of Report | Soft Copy |
| Certification Provided with in | 7 days |
ISO 13485:2016 is a quality system management standard. It’s similar to ISO 9001, but has a few more stipulations to help companies meet the more specialized demands that come with making medical components and healthcare related products. Although not in itself a specific license to make a medical product, it is a clear demonstration of a supplier’s accountability and conformance to industry best practices when making components that are essential for safeguarding human health.Here we take a more detailed look at the provisions of ISO 13485:2016. When a manufacturer applies these management tools correctly, they can also be beneficial in improving the quality and reliability of every product they make;1. Risk Management-The management team begins by conducting a comprehensive analysis of all relevant production and processing steps involved in making the finished product, especially those that might compromise quality. Sometimes this analysis is aided by relevant outside consultants.2. Clarification of Management Responsibilities-One of the primary causes of preventable errors in a manufacturing environment is a breakdown in communication between individuals, supervisors and work teams. Therefore, the roles and responsibilities of every team member must be clear and unambiguous to reduce mistakes and achieve optimal performance.In order to clarify these channels of communication, and to delegate authority and responsibility effectively, a rigorous audit of management structure is performed. This audit often reveals previously unknown weaknesses or inefficiencies whose mediation serves to enhance the quality and reliability of the supplier’s output.4. Facility Improvements-Having a well-organized factory is a core component for many quality management systems, including lean / Kaizen and ISO 9001. But a focus on upgrading the facilities goes far beyond the cosmetic benefits.Cleanliness and orderliness help to quickly identify problems or non-conformances because it’s easier to spot when something is out of place. Tools don’t go missing, there is a place to put all needed items, and all machinery and equipment can be laid out in the most sensible and efficient way. This also protects worker safety and comfort.Beyond this, there may be some needed facility upgrades that leverage new technologies like robotics, digital product tracking or advanced metrology equipment. All of this improves the ability of the supplier to conform to the needed quality specifications of the customer, which is essential for medical device approvals.5. Design and Development-One of the recent modifications to the ISO 13485 standard is a renewed emphasis on the importance of design and development guidelines for some product categories.This is important because medical products in particular are becoming more specialized, small and complex. All of this places an extra burden on the manufacturer to ensure that what can be designed on paper can actually be made in the real world, with reliable and repeatable results. 6. Control of the Supply Chain-Supply chains in the modern manufacturing world can be highly diffuse and, depending on the materials involved, difficult to both track and control. And yet it’s essential that all materials used to make life-saving medical components must comply with both engineering specifications as well as ethically responsible business practices.This can be done only when the manufacturer institutes a robust system of inspection and verification for all incoming materials using scientific analytic equipment. This is then backed up with a labeling and tracking system which guarantees that no non-conforming materials can get into the supply stream or contaminate products during processing.
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ISO 13485 Certification in Hyderabad
Product Price: Rs 25,000 / CertificateGet Best Price
Minimum Order Quantity: 1 Certificate
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Product Details:
| Certifications Provided | ISO 13485 |
| Target Location | Pan India |
| Services offered | Audit |
| Type of Certification | New Certification |
| Type of Industry | Medical Device |
| Mode of Report | Soft Copy |
| Certification Provided with in | 7 days |
ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
Certification to ISO 13485
Like other ISO management system standards, certification to ISO 13485 is not a requirement of the standard, and organizations can reap many benefits from implementing the standard without undergoing the certification process. However, third-party certification can demonstrate to regulators that you have met the requirements of the standard. ISO does not perform certification.
ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the previous version of ISO 9001, ISO 9000:2008 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance; therefore it is more prescriptive in nature and requires a more thoroughly documented QMS.ISO 13485 was written to support medical device manufacturers in designing a QMS that establishes and maintains the effectiveness of their processes. It ensures the consistent design, development, production, installation and delivery through to disposal of medical devices that are safe for their intended purpose. High performing organizations expect ISO 13485 auditing to be thorough, competent, relevant and challenging of the manufacturers' QMS. Effective auditing provides significant benefits for the manufacturer.The beneficial outputs of an effective audit include:Meaningful feedback on the effectiveness of the quality
management system,Confidence in compliance with regulations,Identification of areas requiring attention,Detection of areas of non-compliance and risk,Reporting and certification that is valuable and recognized,ISO 13485 is important to designers, manufacturers, and distributors of medical devices. In addition, suppliers and service providers can enhance an organization's marketability as more and more manufacturers require certifi cation in order to do business with a vendor,When it comes to medical device manufacturing, patient safety greatly depends on the quality and consistency of medical products, and ensuring effectiveness, control and maintenance of your QMS is critical to customers, stakeholders, patients and users, and regulatory agencies,The value of ISO 13485 is not just in the implementation, but also in providing a tool for a thorough audit to test the effectiveness of the system. It provides the manufacturer with a higher level of confi dence in the ability to consistently achieve and maintain compliance with regulatory requirements. It can also help to minimize surprises and failures which might adversely affect patient safety and damage a manufacturer's reputation.The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.
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ISO 13485 Certification in Nalagarh
Product Price: Rs 25,000 / CertificateGet Best Price
Minimum Order Quantity: 1 Certificate
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Product Details:
| Certifications Provided | ISO 13485 |
| Target Location | Pan India |
| Document verification Mode | Online |
| Services offered | Audit |
| Type of Certification | New Certification |
| Type of Industry | Medical Device |
| Mode of Report | Soft Copy |
| Certification Provided with in | 7 days |
ISO 13485 is a stand-alone Quality Management System standard for medical devices, obtained from the globally acknowledged and accepted ISO 9000 QMS series.The ISO 13485 certification supports medical device manufacturers in plotting a QMS that creates and maintains the efficacy of their processes. It ensures the consistent design, development, production, installation, and delivery through to disposal of medical devices that are safe for their intended purpose.The ISO 13485 standard also provides a planned structure and realistic foundation to stick to medical device directives, regulations, protocols, and responsibilities. The standard essentially enables you to fulfill the medical device manufacturers’ commitment to the safety and quality of medical devices.The ISO 13485 certificate can be obtained by any company manufacturing medical devices irrespective of their size or location. The ISO 13485 implementation is carried out by companies in almost 21 countries. The Process of ISO 13485 Implementation; Like any other ISO standards, the ISO 13485 implementation also follows the Plan, Do, Check, Act (PDCA) framework. After considering the customer requirements, the medical device manufacturers can find out the quality objectives and prepare the quality manual and policy documents. The ISO 13485 implementation ensures that the company is able to achieve and maintain the quality requirements and comply with the internationally recognized quality standards.Benefits of ISO 13485:2016 Medical Devices Quality Management System.Below are key benefits of ISO 13485 implementation in any business related to medical devices manufacturing: Improve your company’s credibility and identity-The ISO 13485 certificate is the globally recognized standard for quality in the medical device industry. This certification is proof to the customers that the organization follows high-quality standards and informs them that they have a standard in place to ensure it. Evidence-based decision making-With the ISO 13485 certification in place, the company can stay focused and work towards quality goals. The management is provided with data on a continual basis. These facts and data can be used to take decisions that can align better with the strategic goals and objectives of the company.If the management sees any lack of progress towards the set goals, appropriate action will be taken. Continual improvement-Continuous improvement is one of the core principles of the ISO quality management systems. When a QMS is adopted in any organization, it leads to cultural change, where management and staff will be looking out for improvements.Moreover, setting up systematic processes can eliminate problems and reduce the work burden, leading to high performance, strategic leadership, and employee engagement. This in turn can deliver high-quality products and services. Increased employee involvement-With proper documentation and control of processes, employees are able to understand their role in ISO 13485 implementation. When they are asked to look for a way to enhance the processes, they feel so happy and give the best insight that can help the company succeed.The more the employees understand their roles, the more they become engaged. This results in higher operational efficiency and productivity. Enhanced customer satisfaction-One of the core principles of the ISO 13485 implementation is to ensure customer satisfaction. Companies that are ISO 13485 certified are considered more reliable by the customers than the company that doesn’t have one. This is because the customers strongly believe that the company has a good QMS in place.The goals of the company with ISO 13485 implementation are focuse.
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