IQ Sciences.org

Our staff members and associates have been certified ISO Senior Internal Auditors and Quality Assurance Managers for Medical Device Corporations and have been instrumental in attaining and maintaining ISO certifications.

We offer our services for those small and medium size businesses seeking ISO 13485 Medical Device Certification.

ISO 13485:2003 is based on the ISO 9001:2000 Quality Management Standard. Both standards are basically organized the same and most of the ISO 13485 requirements are taken directly from ISO 9001 without any modifications.  ISO 13485 includes additional requirements specifically related to companies that supply medical devices and also companies that provide related services.

IQ sciences is a small business and we understand first hand the concerns and sometimes anxiety on deciding whether becoming ISO certified is right for you. The costs of the International Organization for Standardization certification fees, possibly hiring new employees, retraining current employees and the overall rethinking of management and the company as a whole is a big money spending step.

Is ISO certification right for you?

We can help you make that decision.

We offer the following partial listing of individual or collective services:

Discussing whether ISO certification is right for your business.

Providing an overall outline of what is needed to be ISO certified.

Conduct a Gap Analysis or an Internal Audit at your site to see where you are compared to the ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes International Standard.

Establish and maintain a Quality Management System including Quality Assurance and Quality Control departments in accordance with the requirements of the International Standard.

Establish or upgrade your Document Control Department by setting up a numbering system by department for Standard Operation Procedures (SOPs), Records, Forms and Logs.

Assist or write the SOPs, Records, Forms, and Logs necessary for each department governed by ISO 13485:2003.

Identify and train personnel as Quality Assurance and Internal ISO Auditors.

Conduct internal audits, management review, corrective and preventive actions, and IQ Sciences Assessments.

Ensure that all processes and documentation reflect what is required by ISO 13485:2003

As a small business, IQ Sciences works with you to meet your goals at an affordable price that is mutually reasonable and within your budget.

Please contact us for more information.

Quality Management System

Management Responsibility

Management Committment

Customer Focus

Continual Improvement

Quality Policy

Planning

Management Review

Quality Control

Resource Management

Effectiveness

Provision of Resources

Internal Audit

Preventive Action

Corrective Action

Product Inspection

Product Realization

Traceability

Human Resources

Infrastructure

Quality Objectives

Work Environment

Product Realization

Internal Audit

Special Process

Process Approach

Design and Development

Purchasing

Quality Manual

Conformity

Quality Management

Audit Findings

Quality Planning

Outsource Process

Audit Criteria

Supply Chain

Analysis of Data

Inspection

Customer Satisfaction

Efficiency

Traceability

Work Environment

Objective Evidence

Communication

Monitoring and Measurement

Production

Authorized Vendors

Customer Survey

Inventory Control