(EN) ISO 13485:2016
Medical Device component manufacturers, finished good manufacturers, Medical Software developers, Medical Device designers and Developers, and pharmaceutical suppliers interested in enjoying a worldwide presence must prove their devices are manufactured under certain auditable standards, which means it’s safe and effective. ISO 13485:2016 Certification is a solution for this issue!!!
Regulatory authorities in most major markets like European Union, United States, Canada, Japan, and Taiwan require, or strongly prefer, that manufacturers marketing medical devices in their countries have a third-party audited and certified Medical Device Quality Management System in place. An ISO 13485:2016 compliant system expedites access into those countries that require it.
ISO 13485:2016 Certificate will be issued by an accredited third party after assessing your compliance with Medical Device Quality Management System. We are there to help you in the training, documentation, implementation, and internal audit. You will be getting much useful information while you continue reading our website.
Benefits of ISO 13485:2016 Certification
Adopting this standard is beneficial to the organization in many ways:-
- Promotes harmonization of regulatory requirements for the manufacturers of medical devices on an international scale.
- 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.
- Companies that achieve ISO 13485 certification enjoy the benefits of an increased number of customers who have more reason to trust and purchase consistently high-quality products.
- ISO 13485 will benefit customers, suppliers, management, and especially workers
- Rapid and effective communication, feedback, and recognition of efforts made results achieved, and work to be done.
- Continuous assessment, improvement, and re-registration of systems.
- ISO 13485 certification is advantageous to medical device companies that 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 critical for the medical device industry.
- ISO 13485 compliant management systems adopt a risk management approach that includes an assessment to identify & estimate risk, uses risk controls and techniques to eliminate hazardous situations throughout product realization.
- Assures the customers that the product complies with all relevant product & service-oriented technical standards & regulations.
- Emphasizes the cleanliness & sterility in the production area, which in turn increases efficiency & enhances safety at the workplace.
ISO 13485 Implementation Procedure
We have developed a nine-stage ISO 13485: 2016 implementation program. Sincere effort and dedicated team guarantee successful completion and certification through our consultancy.
||Appoint consultants – Well experienced in Medical device certification. Knowledge in FDA, MDD, and GMP have added advantages for the consultants.
||Perform a 13485 GAP Analysis – If the organization already implemented ISO 9001 quality management system. This is not required for those implementing the first time.
||Project Schedule – Consultants will work with the acting MR to prepare a project schedule. The schedule will list the actions needed. The Process Owners will be informed about their duties and responsibilities along with the timeline.
||Develop Process Mapping – Consultants will guide you to develop Process Mapping. There will be 2 levels of Process Maps:
- Define process interactions.
- Process Mapping is based on its own.
||Develop Documentation Consultants will identify the required documents. This will include:
- Quality Manual.
- QMS procedures.
- Protocols, Forms, Formats, Records, Reports, etc.
||Employee Training Consultants will help you identify the training needs of your employees. Consultants will provide training for all levels of people in the organization like awareness, GMP, and internal auditor training.
||Implementation Do what you documented, document what you do/td>
||Establish quality goals and understand how they can best be incorporated into your business operations.
||Internal Audit – Consultants will provide internal audits along with certified internal auditors.
||Certification Audit – Consultants will be present during the day of the certification audit to help the in-house team…
ISO 13485:2016 Requirements
The following are the major requirements
|Clause 1: Scope
||A Quality Management System for an organization that provides medical devices and services that meets customer requirements.
|Clause 2: Normative Reference
||ISO 9000:2005 should be used along with ISO 13485 standards. It outlines the Quality Management Systems-Fundamentals and Vocabulary
|Clause 3: Terms and Definitions
||Gives definitions used in the standard, many of which are in addition to ISO 9001.
|Clause 4: General Requirements
- Quality Manual with Scope of ISO 13485:2016
- Required Procedures
- Required Forms & Records
- Control of Documents
- Control of Forms
|Clause 5: Management Responsibility
- Management Responsibility
- Quality Policy & Objectives
- Customer Focus & Customer Satisfaction
- Management Review
|Clause 6: Resource Management
- Personnel & Training
- Resource Management
|Clause 7: Product Realization
- Production of the product or service
- Customer-related processes and Customer Feedback
- Process control
- Identification and Traceability
- Customer Property
|Clause 8: Measurement, Analysis, and Improvement
- Requirements for monitoring processes to improve
- Customer Satisfaction
- Internal Audits
- Control of Non-Conforming Product
- Corrective and Preventive Action
ISO 13485 Consultants
Medical Device Quality Management Systems, also known as ISO 13485:2016 or EN ISO 13485:2016, must be enforced for regulatory purposes by those involved in the manufacturing, design, distribution, servicing, testing, or sterilization of medical devices.
Since the ISO 13485 implementation is primarily for regulatory purposes, the role of ISO 13485 consultants is critical. By way of the latest Harmonized Standards, the European Medical Device Directive or New Medical Device Regulation for CE Marking mandates EN ISO 13485:2016. At this time, EN ISO 13485:2016 Consultants is critical. I want to draw your attention to the fact that an ISO consultant and a medical device regulatory consultant are not the same things. An experienced ISO 13485 Consultant will always be able to provide accurate technical and scientific knowledge.
You can hire a QMS ISO consultant if you’re just a distributor and don’t intend to apply CE Marking, but if you want to CE Mark your device, EN ISO 13485:2016 implementation is required and should be planned by MDR /IVDR guidelines. As a result, manufacturers seeking CE Marking or FDA clearance must hire regulatory consultants with experience implementing EN ISO 13485:2016.
To be enforced and accredited, the general EN ISO 13485:2016 enforcement criteria include several required procedures and record forms, all of which must be checked, authorized, retained, and revised to remain in compliance. To ensure complete compliance with the EN ISO 13485:2016 standard, we specialize in document drafting, training, support, analysis, and internal auditing for all manufacturing and related services. We can also design paper systems, electronic systems, or even web-based document management systems that can be accessed from anywhere in the world and customized to your organization’s structure and needs.
EN ISO 13485:2016 plays a critical role, as the standard was updated and released on March 1, 2016. IAF Resolution 2015-13 specifies a three-year transition period from the date of publication.
As ISO 13485 consultants, we primarily work with medical device and IVD businesses, so we are familiar with the industry’s specific requirements and manufacturing scenarios. EN ISO 13485:2016 lead auditors and certified internal auditors are among our ISO 13485 consultants. Our ISO 13485 consultants tailor your ISO 13485 quality framework to your organization’s unique requirements and ensure that you are ready for an ISO 13485 certification audit by a Certification Body.
In our ISO 13485 consulting, a few benefits are listed below:
- Qualified and experienced medical device ISO 13485 consultants
- EN ISO 13485:2016 Consultants are certified, Lead Auditors
- Largest fool of full-time ISO 13485 consultants
- Largest reference standard and document collection
- Offsite (online) ISO 13485 consultancy with a very standard fee
- Payments based on deliverables.
- Good reputation with all Certifying bodies.
ISO 13485 Implementation and Certification timeline
A mid-sized company of 30 workers takes about four weeks to draught the paperwork after hiring I3CGlobal, and another 4 to 6 weeks to implement. Larger companies with more than 50 staff and several locations can take longer. The availability of the Certification Body and its certified auditors to inspect and certify your business also affects the certification timeline.
EN ISO 13485:2016 Consultation Fees
(Consulting, Implementation, Internal Audit, GAP Analysis, Training fees )
Medical Device Manufacturers ( OEM & OBL), Traders & Exporters can avail themselves of our services across the globe.
Type of Service and Fees
[A] OFFSITE Custom made the drafting of documents
- ISO 13485:2016 – Quality Manual & Mandatory Procedures with important templets in 20 working days – $199
- ISO 13485:2016 Quality Manual in 5 working days – $499
- ISO 13485:2016 Mandatory Procedures with Important Forms in 15 working days – $999
- Payment – 60% advance, 40% before document handover.
- Method of communication – Telephone / Skype / G talk.
- The language of communication is English.
- Documentation using an external Cloud server (DROPBOX).
[B] ONSITE IMPLEMENTATION SUPPORT SERVICE FEE
- ONSITE Man day fee – $350
- ONSITE Training & Quality Audit (IQA) fee – $450
- Consultants travel across the Globe from Bangalore, India OR Chicago, USA.
- Payment – 50% before the visit and 50% after the visit.
- Travelling & Lodging additional
- Documentation using an external Cloud server.
- Taxes are applicable as per Government rules.
- One Man-day is considered as 6 hours
Would you mind filling the Request For Quote (RFQ) here
EN ISO 13485:2016 Certification Fees
The cost of ISO 13485 Certification Cost depends on three factors:
- (A) Number of full-time employees
- (B) Number of devices manufactured in the facility
- (C) Number of activities carried out in the facility with design and without design
- (D) Shop floor area
Cost of Certification Body
This certification cost depends on the following factors
- Number of Employees
- The complexity of the medical device and variants
- Certification Body selected
- Traveling fees
- Auditor accommodation and daily expenses