|POLICY AND MANUAL|
|SCOPE OF ISO 13485|
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ISO 13485 can be described as a unique, standalone Quality Management System standard that has been obtained from ISO 9000 QMS series that is accepted and familiar universally at all parts of the globe. ISO 13485 works as a standard that governs the manufacturing of different types of medical devices. The primary function of ISO 13485 is to carry out regulatory compliance. ISO 13485 is predominantly prescriptive in nature which means that it requires a quality management system that is thoroughly documented and regulated. ISO 13485 was originally created for supporting the medical device manufacturers when it comes to developing quality management systems which can establish and regulate the effectiveness of all associated processes. For all practical purposes, ISO 13485 helps to make sure that consistent design is maintained while manufacturing these products. It also helps to regulate the development, installation, production as well as the delivery of different types of medical devices so that they are deemed safe for all intended purposes.
ISO 13485:2016 is the latest version of this certification and it clearly states the regulations associated with the quality management system that a company must adhere to while designing and manufacturing medical devices that meet the expectations of the customers. By following the concepts stated under ISO 13485:2016, it is possible for a company to stick to the applicable regulatory requirements. Organizations that opt for the ISO 13485:2016 can be involved in the various stages of the product lifecycle, such as designing and development, manufacturing and production, distribution and storage, installation and/or servicing of some type of medical device. The company may also be involved in the technical support required for such medical devices. The ISO 13485:2016 may also apply to suppliers and/or other external parties which can provide with such products and services, including services related to the quality management system to organizations involved in this industry.
The necessities linked with ISO 13485:2016 can be beneficial to business establishments regardless of their type or size where it is specified clearly. While dealing with health devices, all requirements are applied equally for different kinds of allied services that are offered by the business.
Because we keep the entire process simpler, ISO 13485 Certification can take just 7 – 30 days to complete the process based on your company’s size. In fact, our ‘Hassle-free certification’ approach provides the following benefits
There are numerous distinct benefits of implementing the ISO 13485:2016 and it is due to this reason that companies of varying capacities and sizes invest their time, resources and energy to obtain this certification.
ISO 13485 is regarded as the gold standard when it comes to quality within the industry of medical device manufacturing and supplying. Therefore, having this certification lets your customers and clients know that you take your company’s eminence and productivity very seriously. It also informs them that your company has got a dedicated system to implement it. Therefore it can be said that your QMS works as a highly productive marketing tool which can become necessary for you in many cases to show compliance to definite laws.
When you use the process approach as it is mentioned in ISO 13485, you can have greater access to prospects for improvements. You can also detect and reduce waste in processes, bring down the chances of errors as well as avoid rework, thus facilitating enhanced cost savings and efficiency.
ISO 13485 standard states numerous quality management principles and one of them is certainly guaranteeing improved customer satisfaction. You can learn about what your customers want and then strive to meet them. The enhanced quality of all medical devices is also going to make sure that your customers always stay happy with what your company has to offer.
|RISK AND OPPORTUNITIES 1|
|PROCEDURE FOR RISK MANAGEMENT (ISO 14971)|
|RISK MANAGEMENT PLAN|
|PROCEDURE FOR PRELIMINARY HAZARD ANALYSIS (PHA)|
|PROCEDURE FOR FEMA RISK ASSESSMENT|
|RISK AND OPPORTUNITIES 2|
|PROCEDURE FOR HAZARD AND OPERABILITY STUDY|
|PROCEDURE FOR HACCPT|
|PROCEDURE FOR EQUIPMENT MAINTENANCE|
|PROCEDURE FOR MEASUREMENT EQUIPMENT|
|PLAN FOR PREVENTIVE MAINTENANCE OF EQUIPMENT|
|MAINTENANCE AND CALIBRATION RECORD|
|PROCEDURE FOR ETO STERILIZATION|
|PROCEDURE FOR STEAM STERILIZATION|
|PROCEDURE FOR DRY HEAT STERILIZATION|
|PROCEDURE FOR IONIZING RADITATION STERILIZATION|
|RECORD OF WAREHOUSING TEMPRATURE CONTROL|
|PROCEDURE FOR ADVERSE EVENT INVESTIGATION|
|INTERNAL AUDIT SCHEDULE|
|PRODUCTION AND SERVICE PROVISION|
|PROCEDURE FOR PRODUCTION AND SERVICE PROVISION|
|RECORD OF PRODUCTION PROCESS VALIDATON|
|RECORD OF MEDICAL DEVICE INSTALLATION|
|RECORD OF SERVICING ACTIVITIES|
|PROCEDURE FOR INTERNAL AUDIT|
|INTERNAL AUDIT PLAN|
|INTERNAL AUDIT CHECKLIST|
|INTERNAL AUDIT REPORT|
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