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GDPMD (Good Distribution Practice for Medical Devices)

With the effective date (1 July 2013) of Act 737 and Medical Device Regulations 2012, manufacturers and distributors of medical devices are required to apply for their establishment licence to continue carrying out their manufacturing, distribution or importing activities.
Manufacturers require ISO13485 Medical Devices Quality Management System certification whereas Distributors, Importers and local Authorized Representative require Good Distribution Practice for Medical Devices (GDPMD) certification prior to applying for their Establishment Licence.
 

GDPMD requirements consists of 6 parts:

1. Preliminary
2. Organization and GDPMD Regulatory Compliance System
3. Establishment Responsibilities
4. Resource Management
5. Supply Chain and Device Specific
6. Surveillance and Vigilance
 

Benefits of GDPMD

Savings in cost from reduction of defects and rejects
Meet regulatory requirements and customer expectations
Consistency to proper storage, handling, distribution and traceability
Demonstrate ability to produce safer and more effective medical devices
Improve operation efficiency through continual improvement processes
 

How can ELITE assist you?

ELITE provides GDPMD training and consultancy services. We offer specialized expertise and extensive practical experience to assist client in developing management systems from the initial concept to establishment and successful implementation of the management systems.
We use the following consultation approach to assist you in achieving certification:
1. Identify areas requiring improvement or development within your current Management System
2. Prepare a strategic action plan, in conjunction with your company personnel, to address those improvement areas and assist with the communication of these requirements to key personnel at all levels
3. Provide system-related trainings for your company personnel to create awareness and provide them with the necessary knowledge and skills in the implementation of systems
4. Provide assistance and advice on the development and implementation of systems, including preparation of documentation
5. Advise and assist, if required, with the preparation and submission of applications to your certification body
6. Assist with the development of internal auditing procedures and training
7. Conduct internal audit to ensure the effective implementation of the management system prior to final audit by your certification body
8. Conduct Management Review Meeting to review performance of management system and identify areas for improvement prior to final audit by your certification body
 

ISO Training Courses

2-Day ISO9001/14001 Awareness & Application 
 
2-Day Internal Audit Course ISO 9001 
 
2-Day Internal Audit Course ISO 14001 

2-Day Internal Audit Course ISO 45001
 
2-Day Internal Audit Course ISO 22000
 
All Systems Assured courses are based at your office - you don’t pay for travel costs
 
Each delegate receives a certificate The course tutors are all IRQA working systems consultants with considerable experience in the implementation and auditing of each subject matter. 

ISO/TS 16949:2009 Automotive Quality Management System

ISO/TS 16949:2009, in conjunction with ISO 9001, defines the quality management system requirements for the design and development, production and, when relevant, installation and service of automotive-related products.
ISO/TS 16949 is applicable to sites of the organization where customer-specified parts, for production and/or service, are manufactured.
Supporting functions, whether on-site or remote (such as design centres, corporate headquarters and distribution centres), form part of the site audit as they support the site, but cannot obtain stand-alone certification to ISO/TS 16949.
ISO/TS 16949 can be applied throughout the automotive supply chain.

Requirements of ISO/TS 16949:2009

Scope
Normative Reference
Terms and Definitions
Quality Management System
Management Responsibility
Resource Management
Product realization
Measurement, analysis and improvement

Benefits of ISO/TS 16949:2009

Gain your licence to trade internationally and expand your business
Improve processes to reduce waste and prevent defects
Remove the need for multiples certificates for vehicle manufacturing
Integrate ISO/TS 16949 with other management systems
Demonstrate compliance to win new business and investment prospects

How can ELITE assist you?

ELITE provides management system training and consultancy services. We offer specialized expertise and extensive practical experience to assist client in developing management systems from the initial concept to establishment and successful implementation of the management systems.
We use the following consultation approach to assist you in achieving certification:
1. Identify areas requiring improvement or development within your current Management System
2. Prepare a strategic action plan, in conjunction with your company personnel, to address those improvement areas and assist with the communication of these requirements to key personnel at all levels
3. Provide system-related trainings for your company personnel to create awareness and provide them with the necessary knowledge and skills in the implementation of systems
4. Provide assistance and advice on the development and implementation of systems, including preparation of documentation
5. Advise and assist, if required, with the preparation and submission of applications to your certification body
6. Assist with the development of internal auditing procedures and training
7. Conduct internal audit to ensure the effective implementation of the management system prior to final audit by your certification body
8. Conduct Management Review Meeting to review performance of management system and identify areas for improvement prior to final audit by your certification body
 
 

ISO/IEC 17025:2017 General Requirements for the competence of testing and calibration laboratories

General requirements for the competence of testing and calibration laboratories is the main ISO standard used by testing and calibration laboratories. In most major countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. 
 

ISO 45001:2018 Occupational Health and Safety Management System

ISO 45001:2018 replaces OHSAS 18001:2007 as the globally recognized occupational health and safety management system certification standard. While it is similar to OHSAS 18001, the new ISO 45001 standard adopts the Annex SL top-level framework of all new and revised ISO management system standards
 

Transition from OHSAS 18001:2009 to ISO 45001:2018

ISO 45001 is anticipated to replace OHSAS 18001 over three years following its publication. It uses the management system standard structure guideline Annex SL to allow for simplified integration with other management system standards, such as ISO 9001 and ISO 14001.
How to make the transition?
Obtain a copy of ISO 45001:2018.
Identify the gaps in your existing OHSAS 18001 system which need to be addressed to meet any new requirements.
Develop an implementation plan.
Ensure that any new competence needs are met and create awareness for all parties that have an impact on the effectiveness of the OHSAS.
Update the existing OHSAS to meet the new requirements and provide verification of its effectiveness.
Where applicable, liaise with your certification body for migration arrangements.
 

Benefits of ISO 45001:2018

Improve employees morale and safety
Savings in cost for insurance premiums
Reduced occupational health & safety risks
Prevention of potential accidents and ill health
Enhance reputation among regulators, customers and public
 

How can ELITE assist you?

ELITE provides ISO 45001 management system training and consultancy services. We offer specialized expertise and extensive practical experience to assist client in developing management systems from the initial concept to establishment and successful implementation of the management systems.
We use the following consultation approach to assist you in achieving certification:
1. Identify areas requiring improvement or development within your current Management System
2. Prepare a strategic action plan, in conjunction with your company personnel, to address those improvement areas and assist with the communication of these requirements to key personnel at all levels
3. Provide system-related trainings for your company personnel to create awareness and provide them with the necessary knowledge and skills in the implementation of systems
4. Provide assistance and advice on the development and implementation of systems, including preparation of documentation
5. Advise and assist, if required, with the preparation and submission of applications to your certification body
6. Assist with the development of internal auditing procedures and training
7. Conduct internal audit to ensure the effective implementation of the management system prior to final audit by your certification body
8. Conduct Management Review Meeting to review performance of management system and identify areas for improvement prior to final audit by your certification body
 

ISO 22000:2018 Food Safety Management System

ISO 22000:2018 specifies requirements for a food safety management system where an organization in the food chain needs to demonstrate its ability to control food safety hazards in order to ensure that food is safe at the time of human consumption. It is applicable to all organizations, regardless of size, which are involved in any aspect of the food chain and want to implement systems that consistently provide safe products.
 

Requirements of ISO 22000:2018

Scope
Normative Reference
Terms and Definitions
Context of the Organization
Leadership
Planning for the Food Safety Management System
Support
Operation
Performance Evaluation
Improvement
 

How can ELITE assist you?

ELITE provides food safety management system training and consultancy services. We offer specialized expertise and extensive practical experience to assist client in developing management systems from the initial concept to establishment and successful implementation of the management systems.
We use the following consultation approach to assist you in achieving certification:
1. Identify areas requiring improvement or development within your current Management System
2. Prepare a strategic action plan, in conjunction with your company personnel, to address those improvement areas and assist with the communication of these requirements to key personnel at all levels
3. Provide system-related trainings for your company personnel to create awareness and provide them with the necessary knowledge and skills in the implementation of systems
4. Provide assistance and advice on the development and implementation of systems, including preparation of documentation
5. Advise and assist, if required, with the preparation and submission of applications to your certification body
6. Assist with the development of internal auditing procedures and training
7. Conduct internal audit to ensure the effective implementation of the management system prior to final audit by your certification body
8. Conduct Management Review Meeting to review performance of management system and identify areas for improvement prior to final audit by your certification body
 
 
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