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ACACD's comprehensive ISO 13485 training and consulting program and support program for FDA regulated industries enables your organization to implement an effective ISO 13485 quality management system, and meet FDA requirements for medical device and pharmaceuticals manufacturers.
Our ISO 13485 training courses include ISO 13485 Awareness Training for Management, ISO 13485 Awareness Training for Staff, ISO 13485 internal auditors Training, and ISO 13485 Design, Development and Implementation Workshop for FDA regulated industries.
The deadline for ISO 13485:2003 implementation is July 15, 2006 , possibly earlier in some markets. ACACD's ISO 13485 training and consulting program can help you protect your international medical device sales.
ISO (the International Organisation for Standardisation) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees.
International Standard ISO 9001:2000 was prepared by Technical Committee ISO/TC 176, Quality Management and quality assurance, subcommittee SC2, Quality Systems.
ISO 9001:2000 is the third edition of ISO 9001. This third edition of ISO 9001 cancels and replaces the second edition (ISO 9001:1994) together with ISO 9002:1994 and ISO 9003:1994. It constitutes a technical revision of these documents. Those organisations which have used ISO 9002:1994 and ISO 9003:1994 in the past may use this International Standard by excluding certain requirements in accordance with 1.2 of the ISO 9001:2000 requirements.
ISO 9001:2000 international standard specifies requirements for a quality management system when an organisation
- needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and
- aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.
ISO 13485 Quality Management System
AWARENESS TRAINING FOR MANAGEMENT
(1 Day of 7 hrs)
This course is designed for management who want to understand what is ISO 13485:2003 standard and what it takes to successfully implement the standard.
This course is also designed for management as part of the Consultancy Package to educate the management staff on the international standard and the consultancy approach and project phases that will lead the organisation to certification.
Objectives
- To raise levels of awareness and understanding of the ISO 13485:2003 quality management system requirements.
- To provide an understanding of the key factors associated with successful implementation of the ISO 13485:2003 quality management system.
- To provide an understanding of the methodology for implementing the ISO 13485:2003 system.
Course Outline
- What is ISO
- Direct comparison of ISO 13485:2003 standard to ISO 13485:1996, FDA’s GMPs / QSR and ISO 9001:2000 standard
- Implications of changes to ISO 13485, and how they will affect your company
- Regulators’ approach to the ISO 13485:2003 requirements
- Explanation of the risk management (ISO 14971) requirements
- Benefits of implementing ISO 13485:2003
- Guidelines for implementing ISO 13485:2003 system
- ISO 13485:2003 implementation methodology
- Role of Management
Who should attend
- This course is designed for management who want to have an understanding of the ISO 13485:2003 system and how to implement the system for certification purpose.
Course Fee
Course Award
- Certificate of successful completion: given to participants who attend the full duration of the course.
ISO 13485 Quality Management System
AWARENESS TRAINING FOR STAFF
(1 Day of 7 hrs)
This course is designed for staff who want to understand what is ISO 13485:2003 standard and what it takes to successfully implement the standard.
This course is also designed for management as part of the Consultancy Package to educate the management staff on the international standard and the consultancy approach and project phases that will lead the organisation to certification.
Objectives
- To raise levels of awareness and understanding of the ISO 13485:2003 quality management system requirements.
- To provide an understanding of the key factors associated with successful implementation of the ISO 13485:2003 quality management system.
- To provide an understanding of the methodology for implementing the ISO 13485:2003 system.
Course Outline
- What is ISO
- Direct comparison of ISO 13485:2003 standard to ISO 13485:1996, FDA’s GMPs / QSR and ISO 9001:2000 standard
- Implications of changes to ISO 13485, and how they will affect your company
- Regulators’ approach to the ISO 13485:2003 requirements
- Explanation of the risk management (ISO 14971) requirements
- Benefits of implementing ISO 13485:2003
- Guidelines for implementing ISO 13485:2003 system
- ISO 13485:2003 implementation methodology
- Role of staff
Who should attend
- This course is designed for management who want to have an understanding of the ISO 13485:2003 system and how to implement the system for certification purpose.
Course Fee
Course Award
- Certificate of successful completion: given to participants who attend the full duration of the course.
ISO 13485 Quality Management System
INTERNAL AUDITOR TRAINING
(3 Days of 7 hours each day)
This course is designed to satisfy the training requirement for individual performing internal audit to the ISO 13485:2003 standard.
Objectives
- The objective of this training course is to train participants to understand, develop and implement an in-house quality audit programme, which fulfils the requirements for Internal Audit.
Course Outline
- Introduction of Quality Principles, definitions, process approach and ISO 13485:2003 Quality Management System
- Direct comparison of ISO 13485:2003 standard to ISO 13485:1996, FDA’s GMPs / QSR and ISO 9001:2000 standard
- Implications of changes to ISO 13485, and how they will affect your company
- Regulators’ approach to the ISO 13485:2003 requirements
- Explanation of the risk management (ISO 14971) requirements
- Interpretation of ISO 13485:2003 requirements
- Types of audits
- Objectives of Internal Auditor Training Programme
- Responsibility and Authority of the Audit Team
- Planning, Preparing and Performing an Audit
- Auditing Skills and Documenting Non-conformities
- Corrective Actions and Follow-up
- Audit Reporting
- Case Studies and Exercise
- Exam
Who should attend
- This is designed for personnel who are responsible for conducting Internal Audit of their organisation’s quality management system. Managers who are appointed as Management Representative or Internal Audit Program Manager and other personnel who are responsible for establishing the Internal Quality Audit function will also benefit from this course.
Course Fee
Pre-requisite
- Participants should be familiar with the ISO 13485:2003 Standard as preparation for the course.
Further Training
- Participants who have successfully completed the Internal Auditor Training Course could enrol in the Auditor / Lead Auditor Training Course.
Course Award
- Certificate of Successful Completion: given to participants who attended the full duration of the course and pass the exam.
ISO 13485 Quality Management System
DESIGN, DEVELOPMENT & IMPLEMENTATION WORKSHOP
(3 Days of 7 hours each day)
Objective
- To give guidance and practical advice in interpreting, establishing and implementing a Quality Management System according to ISO 13845:2003 Standard.
Course Outline
- Concept of Quality Principles, definitions, process approach
- Direct comparison of ISO 13485:2003 standard to ISO 13485:1996, FDA’s GMPs / QSR and ISO 9001:2000 standard
- Implications of changes to ISO 13485, and how they will affect your company
- Regulators’ approach to the ISO 13485:2003 requirements
- Explanation of the risk management (ISO 14971) requirements
- Interpretation and Application of ISO 13845:2003 Quality Management Standards
- Development of Business Process approach to Quality Management System
- Preparation and documentation of Quality Management Manuals, Procedures and Work Instructions
- Overview of Audits and Assessment Techniques
- Implementing a Quality Management System
- Achieving Third Party Certification and Maintaining a Quality Management System
Who should attend
This course is designed for quality professionals or management staff who are likely or are currently involved in implementing and maintaining a quality management system to meet the ISO 13845:2003 Standard or its equivalent.
Course Fee
Further Training
Participants who have successfully completed the Design, Development and Implementation of ISO 13845:2003 Quality Management System course could enrol in the Internal Auditor or Lead Auditor Training Course.
Course Award
Certificate of Successful Completion: given to participants who attended at least 90% of the class.
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