ISO 13485 for medical devices Quality management system - New Jersey

ISO 13485 for medical devices Quality management system - New Jersey

ExpertCertifier is one of leading brand in the ISO consulting and certification sector , offering international quality management consulting and certification

What is ISO 13485?

The ISO 13485 standard is a Medical Device quality management system that demonstrates the power to supply medical devices and its related services to satisfy the buyer needs. The regulatory requirement of ISO 13485 clauses is applicable only on medical devices and its related services.In ISO 13485 Certification New Jersey requirements for material paying little reference to the span of the organizations and paying little reference to their sort with the exception of where unmistakably expressed. Wherever requirements applying to medical devices are indicated, the wants apply similarly to related services as provided by the organization. The ISO 13485 required procedures that are relevant to the organization, yet aren't executed by the organization, are the part of the organization and are representing within the organization’s quality management system by maintaining, controlling and observing of the procedures.

How to get ISO 13485 certification?

A successful ISO 13485 implementation in New Jersey is feasible when the project is planned professionally and implemented with expert certification consultants in South Africa. We use our internationally proven ISO 13485 certification implementation methodology that's fine-tuned to the local South Africa working culture.

ISO 13485:2016 implementation plan and project charter finalization

Awareness training on ISO 13485 certification New Jersey to the teams and employees across the organization.

Business Process Review and Gap Assessment of your existing Medical Devices - Quality Management system to seek out the degree of compliance and gaps as per ISO 13485:2016 standards.

Process design and certification documentation including QMS policy, procedures, manuals, checklist, forms, risk assessment, work instructions, templates, SOPs and process maps.

Training your employees about the newly developed ISO 13485:2016 Medical Devices - Quality Management System for effective implementation.

Internal auditor training and conduct of internal audit.

Assistance in closure of the internal audit findings and ISO 13485:2016 Medical Devices - Quality Management system improvement.

Pre-assessment audit if required to see readiness of the organization for the ultimate certification audit as per ISO 13485:2016 standard and carrying our required corrections / corrective actions to make sure your organization is 100% ready for the certification audit.

Coordinating with the certification body on your behalf if required and scheduling the ultimate ISO 13485:2016 certification audit for your organization.

Support during the certification audit to make sure your organization gets ISO 13485 certification with no hassles.

Changes between ISO 13485:2003 & ISO 13485:2016

ISO 13485:2016 certification standards have 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

In old standard ISO 13485:2013 a QMS had to established supported requirements of the quality & product, while in remake ISO 13485:2006 emphasis has been given on meeting regulatory requirements. Now QMS has got to be established encompassing applicable regulatory requirements.

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

Product Realization – New standard ISO 13485:2016 says to determine procedures for storage, handling of products, traceability, measurement & revalidation additionally to requirements of old standard ISO 13485 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.

Why Expert Certifier?

Expert Certifier issues accredited Certificates, hence universally valid.

The Knowledge, skills gained through experience and therefore the International presence of Expert Certifier has created a history of executing successful large-scale, complex international projects. Our people understand the culture and nature of the local market and perform internationally in an efficient and consistent manner.

Expert Certifier conducts the audits in additional sensible and value added manner to profit the clients of small, medium and enormous organization. Our flexible procedure is straightforward to know and therefore the services are timely and price effective.

Our presence is in India, Singapore, Malaysia, Indonesia, Oman, Saudi Arabia, UAE, Qatar, Kuwait, Philippines countries.

We have successfully addressed mostly the sectors broadly diversified in industry , Consumer electronics, industry , production , Industrial equipment, FMCG industry, Aerospace manufacturing, Healthcare Industry, Food industry, Textile industry, Oil and Gas, Energy, Telecommunication, IT Industry, Hospitality industry.

We understand the culture and nature of the local market and execute the Audit in an efficient and reliable manner.

The assessment process for achieving certification consists of a two stage Initial Certification Audit as follows:-

Stage 1 - The aim of this visit is to verify the readiness of the organization for full assessment. The assessor will:-

Confirm that the standard manual conforms to the wants of ISO 13485

Confirm its implementation status

Confirm the scope of certification

Check legislative compliance

Produce a report that identifies any non-compliance or potential for non-compliance and agree a corrective action plan if required.

Produce an assessment plan and ensure a date for the Stage 2 assessment visit.

Stage 2 - The aim of this visit is to verify that the standard management system fully conforms to the wants of ISO 13485 in practice. The assessor will:-

Undertake sample audits of the processes and activities defined within the scope of assessment

Document how the system complies with the quality

Report any non-compliances or potential for non-compliance

How to get ISO 13485:2016 certification in New Jersey – Consultants in New Jersey?

Our masters have more than 15 plus years of global experience, with hands-on experience in the field of ISO certification, assessment and training.

With Expert Certifier your Business and process excellence is guaranteed.

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