ISO 13485 Medical Devices Quality Management System –Nigeria

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ISO 13485 Medical Devices Quality Management System –Nigeria
Published in ExpertCertifier | 2 months ago

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ISO 13485 - QMS for Medical Devices

ISO 13485 certification Nigeria is that the International standard for QMS for Medical Devices. It ensures your company with a set of principles that enables you to understand standard sense approach to the management of your business activities to consistently achieve customer satisfaction while standardizing your processes and continually improving effectiveness of the business processes.

By getting ISO 13485 Certified there's the potential for increased business in both current and new markets. additionally , there's an overall improvement within the service/product quality being offered to the client. Having a certification in situ will provide a definite advantage over other competitors and helps your ability in client acquisitions.

We are a corporation known for offering professional consulting services altogether global locations. In Nigeria we provide our services altogether major locations like Lagos, Kano, Kaduna, Ibadan etc.

ISO 13485:2016 standard indicates necessities for a high quality administration framework where an association must exhibit its capacity to offer medicinal gadgets and related administrations that reliably meet client and pertinent administrative prerequisites in Nigeria, Nigeria. Such associations are often engaged with a minimum of one phases of the life-cycle, including plan and advancement, generation, stockpiling and circulation, establishment, or adjusting of a therapeutic gadget and description and improvement or arrangement of related exercises (e.g. specialized help) in Nigeria, Nigeria. ISO 13485:2016 can likewise be utilized by providers or outer gatherings that give item, including quality administration framework related administrations to such associations in Nigeria, Nigeria.

Necessities of ISO 13485:2016 are appropriate to associations paying little mind to their size and paying little reference to their sort with the exception of where unequivocally expressed. Wherever prerequisites are indicated as applying to restorative gadgets, the necessities apply similarly to related administrations as provided by the association in Nigeria, Nigeria.

ISO 13485 Certification in Nigeria:

ISO 13485 Nigeria may be a specific certification standard for medical device industry. ISO 13485 certification fulfills your needs associated with production control, quality management, regulatory compliance's & specific needs associated with production of a specific medical device. ISO 13485 is essentially a QMS for medical device industry that's why it's also referred to as ‘MD QMS’. ISO 13485 certificate satisfies each and every potential customers with the very fact that a tool has been manufactured following internationally recognized ISO 13485 standard. ISO 13485 audit by Expert Certifier ensures that an organization meets all guideline of ISO 13485:2016 & this is often the rationale why Expert Certifier is an industry trusted ISO 13485 certification company. Our ISO 13485:2016 certification process is result oriented &

100% customer satisfaction. We are a foremost ISO 13485 certification body of India. All requirements of ISO 13485 are specific to organizations providing medical devices, no matter the sort or size of the organization

Benefits of ISO 13485 Certification in Lagos

* ISO 13485 In Lagos ensures performance or products & processes of a medical device company. * ISO 13485 certificate in Lagos is universally recognized & it covers regulatory & statutory norms of most of nations , your product gets an expended market access. * ISO 13485 works as a brand ambassador of your medical device hence your sales & cost will reduce. * ISO 13485 in Lagos certification gives faith to your customers that device is safe to be used & it meets requirements of most of recognized technical standards associated with medical device

ISO 13485 Certification Process in Ibadan

* Apply for ISO 13485:2016 certificate by submitting filled in ISO 13485 form (Soft copy or hard copy). * form are going to be reviewed by our ISO 13485 auditor / expert & if accepted a quotation for ISO 13485 certification are going to be issued. * Upon submission of ISO 13485 certification fee, we'll send you ISO 13485 audit plan (stage-1) & subsequently audit are going to be conducted. * After successful Completion of stage-1 audit closure of Non Confirmatives (if any), Expert Certifier will send you stage -2 ISO 13485 audit plan. After successful audit, Lead auditor will recommend your organization for ISO 13485 certification. * supported auditor’s recommendation & audit findings Expert Certifier certification authority will take decision for grant of ISO 13485 certificate

Changes Between ISO 13485:2003 & ISO 13485:2016

Now ISO 13485:2016 certification standard has accompany many changes. Few important changes are as follows-

Flexible – New standard ISO 13485:2016 is more flexible because it allows you to form exclusions in section 6, 7 & 8 if it are often justified while in previous standard ISO 13485:2003 only in section 7 exclusion was permissible . during this way new standard ISO 13485:2016 is more flexible.

Regulations – In Previous version of standard ISO 13485:2003 a QMS had to established supported requirements of the quality & product, while in remake ISO 13485:2003 emphasis has been given on meeting regulatory requirements. Now QMS has got to be established encompassing applicable regulatory requirements.

Risk Based Approach – In ISO 13485:2003 version risk analysis approach was applicable to only ‘product realization’, while in new version ISO 13485:2016 risk based approach is applicable to all or any processes of QMS

Enhanced Record Keeping – New standard ISO 13485:2016 insist you to keeps record of supplier monitoring, evaluation & re-evaluation. Now privacy has got to be maintained in maintaining confidential health information.

Product Realization – In ISO 13485:2016 Standard informs to determine procedures such as storage, traceability, measurement & re-validation additionally to requirements where as in old standard ISO 13485:2003 which required procedure for verification, validation, monitoring, inspection & testing

Training of Users – The new standard ISO 13485:2016 says to teach / train the user about product safety & regulatory norms.

Now ISO 13485 certification standard has accompany many changes. Few important changes are as follows-

Flexible – New standard ISO 13485:2016 is more flexible because it allows you to form exclusions in section 6, 7 & 8 if it are often justified while in previous standard ISO 13485:2003 only in section 7 exclusion was permissible . during this way new standard ISO 13485:2016 is more flexible.

Regulations – In Previous version of standard ISO 13485:2003 a QMS had to established supported requirements of the quality & product, while in remake ISO 13485:2016 emphasis has been given on meeting regulatory requirements. Now QMS has got to be established encompassing applicable regulatory requirements.

Risk Based Approach – In ISO 13485:2003 version risk analysis approach was applicable to only ‘product realization’, while in new version ISO 13485:2016 risk based approach is applicable to all or any processes of QMS

Enhanced Record Keeping – New standard ISO 13485:2016 insist you to keeps record of supplier monitoring, evaluation & re-evaluation. Now privacy has got to be maintained in maintaining confidential health information.

Product Realization – In ISO 13485:2016 Standard informs to determine procedures such as storage, traceability, measurement & revalidation additionally to requirements where as in old standard ISO 13485:2003 which required procedure for verification, validation, monitoring, inspection & testing

Training of Users – The new standard ISO 13485:2016 says to teach / train the user about product safety & regulatory norms.

How to get ISO 13485 certification in Nigeria– Consultants in Nigeria

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