ISO 13845 Consultants Roles & Responsibilities

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 consultants. Our ISO 13845 consultants tailor your ISO quality framework to your organization’s unique requirements and ensure that you are ready for an ISO 13485 certification audit by a certification body.

Medical device quality management systems, also known as ISO 13485 certification, must be enforced for regulatory purposes by those involved in the manufacturing, design, distribution, servicing, testing, or sterilization of medical devices.

Since the implementation is primarily for regulatory purposes, the ISO 13485 consultants roles are 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.

We want to draw your attention to the fact that an ISO consultant and a medical device regulatory consultant are not the same thing. An experienced consultant will always be able to provide accurate technical and scientific knowledge.

You can hire a QMS ISO 13485 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 according to MDR and IVDR guidelines.

As a result, manufacturers seeking CE marking or FDA clearance must hire regulatory consultants with experience implementing ISO 13485:2016.

To be enforced and accredited, the general 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.

ISO certification 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.

In our ISO 13485 Consultants services, a few benefits are listed below:

  • Qualified and experienced ISO 13485 consultants
  • Our ISO consultants are certified, as are our lead auditors.
  • The largest group of full-time consultants
  • Largest reference standard and document collection
  • Offsite (online) consulting with a very standard fee
  • Payments are based on deliverables.
  • Good reputation with all certifying bodies.
  • Implementation and Certification Timeline

ISO 13485 Certification

An ISO 13485 certification will be issued by accredited third-party consultants after assessing your compliance with the medical device quality management system. We are here to help you with ISO training, documentation, implementation, and an internal audit. You will be getting much useful information while you continue reading our website.

Medical device component manufacturers, finished goods 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 they’re safe and effective. ISO 13485 certification is a solution to this issue!

Regulatory authorities in most major markets like the European Union, the 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 to those countries that require it.

Benefits of ISO 13485 Certification

Adopting ISO 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 and estimate risk and uses risk controls and techniques to eliminate hazardous situations throughout product realization.
  • Assures the customers that the product complies with all relevant product and service-oriented technical standards and regulations.
  • Emphasizes cleanliness and sterility in the production area, which in turn increases efficiency and enhances safety at the workplace.

ISO 13485 Implementation Procedure

We have developed a nine-stage ISO 13485:2016 implementation program. Sincere effort and a dedicated team guarantee successful completion and certification through our consultancy.

Stage 01 Appoint ISO 13485 consultants: Well experienced in medical device certification. Knowledge of FDA, MDD, and GMP has added advantages for the consultants.
Stage 02 Perform a 13485 GAP Analysis – If the organization already implemented ISO 9001 quality management system. This is not required for those implementing it for the first time.
Stage 03 Project Schedule – ISO 13845 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.
Stage 04 Develop Process Mapping – ISO 13845 consultants will guide you in developing process mapping. There will be two levels of process maps:

  • Define process and interactions.
  • Process mapping is based on itself.
Stage 05  Develop Documentation ISO 13485 consultants will identify the required documents. This will include:

  • Quality Manual.
  • QMS procedures.
  • Protocols, Forms, Formats, Records, Reports, etc.
Stage 06 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.
Stage 07  ISO Implementation Do what you documented; document what you did.
Stage 08  Establish quality goals and understand how they can best be incorporated into your business operations.
Stage 09  Internal Audit – Consultants will provide internal audits along with certified internal auditors.
Stage 10  ISO 13845 Certification Audit – Consultants will be present during the day of the certification audit to help the in-house team.

ISO 13485 Requirements

Clause 1: Scope

A quality management system for an organization that provides medical devices and services that meet 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 the Scope of ISO 13485:2016
  • Required Procedures
  • Required Forms and Records
  • Control of Documents
  • Control of Forms
Clause 5: Management Responsibility
  • Management Responsibility
  • Quality Policy and Objectives
  • Customer focus and customer satisfaction
  • Management Review
Clause 6: Resource Management
  • Personnel & Training
  • Resource Management
Clause 7: Product Realization
  • Production of the product or service
  • Planning
  • Customer-related processes and customer feedback
  • Design
  • Purchasing
  • 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 Products
  • Corrective and preventive action

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 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

ISO 13485 Consultants Cost

(Consulting, Implementation, Internal Audit, GAP Analysis, Training Fees)

Medical device manufacturers (OEM and OBL), traders, and exporters can avail themselves of our services across the globe.

Type of ISO 13845 Service and Fees

[A] Offsite Custom made the drafting of documents

  1. ISO 13485:2016: Quality Manual and Mandatory Procedures with Important Tasks in 20 Working Days, $1899
  2. ISO 13485:2016 Quality Manual in 5 working days: $899
  3. ISO 13485:2016 Mandatory Procedures with Important Forms in 15 Working Days: $999

Important Information

  • Payment: 60% in advance, 40% before document handover.
  • Method of communication: telephone, Skype, or GTalk.
  • The language of communication is English.
  • Documentation using an external cloud server (DROPBOX).

[B] ONSITE IMPLEMENTATION SUPPORT SERVICE FEE

  1. Onsite Man Day fee: $850
  2. Onsite Training and Quality Audit (IQA) Fee: $950

Important Information

  • ISO Consultants travel across the globe from Bangalore, India, or Chicago, USA.
  • Payment: 50% before the visit and 50% after the visit.
  • Traveling and lodging are additional.
  • Documentation using an external cloud server.
  • Taxes are applicable as per government rules.
  • One man’s day is considered to be 6 hours.

Would you mind filling out the Request for Quote (RFQ) here?