The Medical Device industry falls under the ISO 13485 Standard.

ISO 13485:2003 gives specific requirements for a quality management system where a company needs to demonstrate its capabilities in providing medical devices and related services that always meet customer requirements and regulatory requirements that apply to medical devices and related services.

The main objective of ISO 13485:2003 is to assist synchronized medical device regulatory requirements for quality management systems. Therefore, it includes some specific requirements for medical devices and excludes some of the requirements of ISO 9001 that are not suitable as regulatory requirements. Because of these exclusions, companies whose quality management systems conform to this International Standard cannot declare conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.

All requirements of ISO 13485:2003 are specific to companies providing medical devices, despite the type or size of the organization.

ISO 13485 Certification will-

Facilitate your eligibility for doing business in the Medical Device Industry

Improve efficiency in operations

Provide International Recognition

Allow Use of the ISO 13485 logo to publicize compliance and increase marketability

ISO 13485 Certification is appropriate for product industries as well as service industries.

Key Feature A particularly key feature of the Simpletrak system for Medical Device Companies is the Document Control Module.  Simpletrak’s document control features allow you to track a document through the approval process.  When a document is uploaded, an ad hoc session can automatically be created to ensure that all stakeholders review and approve the document.  Next, the authority individual approves the document and their signature and date are permanently attached to the document.  When revision changes are made, the outdated document can be electronically archived to the archive document library and the new document approved in the same fashion as the original.  A document control notes tool, also allows affected parties to officially make comments on the document or revisions being made.  The notes taken, become part of the permanent record.  There is also an expiring document tool that allows the user to post a document an assign an expiration date causing the document to automatically archive if it hasn’t been approved in specified period of time.

Other key features of the system include the Calibration Module, Preventive Maintenance Module, the NCR/Corrective Action module, Auditing Module and Management Review Module.  There are also a wide variety of data mapping tools that assist you in analyzing the information gathered through each of the these modules.

• Pairing you with a Medical Device Industry Expert to oversee your implementation process and ensure it is executed seamlessly and in accordance with your specific industry requirements
• Creating and implementing a data driven system that specifically caters to your needs
• Training you on each module to ensure your understanding
• Creating a comprehensive documentation package that integrates your vital processes and your simpletrak system
• Coordinating with your Registrar to schedule your Certification Audit
• Performing gap analysis auditing to ensure that all requirements have been met
• Representing you on-site during  your Certification Audit (optional)
• Guiding you in the maintenance of your system throughout the year and leading up to each surveillance audit
• Staying ahead of Industry trends and keeping you informed, to ensure that you are always ahead of the curve
  
  

The Aerospace and Defense Industry falls under the AS9100 Standard

AS 9100 encompasses the ISO 9001:2000 quality system requirements along with added quality system requirements established by the aerospace industry.

The development of the additional requirements was the result of an international effort by top aerospace companies with a united goal of establishing a universal quality management system for use within the aerospace industry. The Aerospace standard is the result of this international effort.  The standard is supported by the International Aerospace Quality Group. 

AS9100 Certification will-

Facilitate your eligibility for doing business in the Aerospace Marketplace

Improve efficiency in operations

Provide International Recognition

Allow Use of the AS9100 logo to publicize compliance and increase marketability

AS9100 Certification is appropriate for product industries as well as service industries.

Key Feature

A particularly key feature of the Simpletrak system for Aerospace and Defense Companies is the Supplier Scorecard Feature.  The Supplier Scorecard tracks your Suppliers and configures a percentage and scoring for each supplier.  The information collected from each Supplier NCR populates the Scorecard percentage and charting.  The same green, yellow, red indicator system that is used throughout the program, allows you to instantly see the risk involved with using a supplier.  High risk Suppliers can be automatically moved to the re-evaluate category for further investigation or resurvey.  This shows the Aerospace and Defense Industry that you are taking a proactive approach and calculating the risk involved in using a Supplier, even in single source, or customer designated situations.

Other key features of the system include the Calibration Module, Preventive Maintenance Module, the Document Control Module, the NCR/Corrective Action module, Auditing Module and Management Review Module.  There are also a wide variety of data mapping tools that assist you in analyzing the information gathered through each of the these modules.

ION will facilitate your goals in acquiring certification by:

• Pairing you with an Aerospace and Defense Industry Expert to oversee your implementation process and ensure it is executed seamlessly and in accordance with your specific industry requirements
• Creating and implementing a data driven system that specifically caters to your needs
• Training you on each module to ensure your understanding
• Creating a comprehensive documentation package that integrates your vital processes and your simpletrak system
• Coordinating with your Registrar to schedule your Certification Audit
• Performing gap analysis auditing to ensure that all requirements have been met
• Representing you on-site during  your Certification Audit (optional)
• Guiding you in the maintenance of your system throughout the year and leading up to each surveillance audit
• Staying ahead of Industry trends, and keeping you informed to ensure that you are always ahead of the curve


Focus Groups

Quarterly focus groups at our facility pool together, Industry Experts, Certification Auditors, Consultants and ION staff to stay on top of current Industry focus, changing requirements and customer feedback.  The ION program is continually improving to ensure our clients are always on the cutting edge of market demands and innovation.

Metal Finishing/Heat Treating falls under the ISO 9001 standard and can assist you in later goals of acquiring NADCAP certification. 

The International Organization for Standardization (ISO) has established a series of accepted practices, technical requirements and terminology for products, services and systems that, when implemented by a company, assures clients, suppliers and end-product users of a universally acceptable level of quality.  The standard that ISO provides is designed to ensure the most effective, safe and efficient methods and products achievable.

ISO 9001 Certification will-

Increase your Opportunities in the Marketplace

Improve efficiency in operations

Provide International Recognition

Allow Use of the ISO logo to publicize compliance and increase marketability

Key Feature

A particularly key feature of the Simpletrak system for the Metal Finishing/Heat Treating Industry is the Maintenance Module.  The maintenance module keeps track of all of your preventive maintenance on your tanks.  The green, yellow, and red indicator system is used in the simpleview box to allow you to see at a glance when items are becoming due.  A weekly attention report that is sent via e-mail also informs you of any items that are becoming due.  Additionally, the Maintenance module enables you to schedule a service call or put an item in the down category.  While a tank is in the down category, the system begins to track the cost involved per hour until the tank is up and running again.  A simple report feature also calculates the total cost over specified periods of time.

Other key features of the system include the Calibration Module, the Document Control Module, the NCR/Corrective Action module, Auditing Module and Management Review Module.  There are also a wide variety of data mapping tools that assist you in analyzing the information gathered through each of the these modules.

ION will facilitate your goals in acquiring certification by:

• Pairing you with a Metal Finishing/Heat Treating Industry Expert to oversee your implementation process and ensure it is executed seamlessly and in accordance with your specific industry requirements
• Creating and implementing a data driven system that specifically caters to your needs
• Training you on each module to ensure your understanding
• Creating a comprehensive documentation package that integrates your vital processes and your simpletrak system
• Coordinating with your Registrar to schedule your Certification Audit
• Performing gap analysis auditing to ensure that all requirements have been met
• Representing you on-site during  your Certification Audit (optional)
• Guiding you in the maintenance of your system throughout the year and leading up to each surveillance audit
• Staying ahead of Industry trends, and keeping you informed to ensure that you are always ahead of the curve
  

Focus Groups

Quarterly focus groups at our facility pool together, Industry Experts, Certification Auditors, Consultants and ION staff to stay on top of current Industry focus, changing requirements and customer feedback.  The ION program is continually improving to ensure our clients are always on the cutting edge of market demands and innovation.

Distribution falls under the ISO 9001 Standard.  The International Organization for Standardization (ISO) has established a series of accepted practices, technical requirements and terminology for products, services and systems that, when implemented by a company, assures clients, suppliers and end-product users of a universally acceptable level of quality.  The standard that ISO provides is designed to ensure the most effective, safe and efficient methods and products achievable.

ISO 9001 Certification will-

Increase your Opportunities in the Marketplace

Improve efficiency in operations

Provide International Recognition

Allow Use of the ISO logo to publicize compliance and increase marketability

ISO Certification is appropriate for product industries as well as service industries.

Key Feature

A particularly key feature of the Simpletrak system for Distribution Companies is the Supplier Module.  ION works with you to create customized formulas for monitoring your supply chain.  These formulas calculate the risk involved in using a specific supplier, based upon their history of non-conformances.  Then, we can set up parameters (high risk, medium risk) that pull a supplier to the re-evaluate category when they are reached.  From there, investigations or resurvey can commence.

Other key features of the system include the Calibration Module, the Preventive Maintenance Module, the Document Control Module, the NCR/Corrective Action module, Auditing Module and Management Review Module.  There are also a wide variety of data mapping tools that assist you in analyzing the information gathered through each of the these modules.

ION will facilitate your goals in acquiring certification by:

• Pairing you with a Distribution Industry ISO Expert to oversee your implementation process and ensure it is executed seamlessly and in accordance with your specific industry requirements
• Creating and implementing a data driven system that specifically caters to your needs
• Training you on each module to ensure your understanding
• Creating a comprehensive documentation package that integrates your vital processes and your simpletrak system
• Coordinating with your Registrar to schedule your Certification Audit
• Performing gap analysis auditing to ensure that all requirements have been met
• Representing you on-site during  your Certification Audit (optional)
• Guiding you in the maintenance of your system throughout the year and leading up to each surveillance audit
• Staying ahead of Industry trends, and keeping you informed to ensure that you are always ahead of the curve
  

Focus Groups

Quarterly focus groups at our facility pool together, Industry Experts, Certification Auditors, Consultants and ION staff to stay on top of current Industry focus, changing requirements and customer feedback.  The ION program is continually improving to ensure our clients are always on the cutting edge of market demands and innovation.

Service falls under the ISO 9001 Standard.  The International Organization for Standardization (ISO) has established a series of accepted practices, technical requirements and terminology for products, services and systems that, when implemented by a company, assures clients, suppliers and end-product users of a universally acceptable level of quality.  The standard that ISO provides is designed to ensure the most effective, safe and efficient methods and products achievable.

ISO 9001 Certification will-

Increase your Opportunities in the Marketplace

Improve efficiency in operations

Provide International Recognition

Allow Use of the ISO logo to publicize compliance and increase marketability

ISO Certification is appropriate for product industries as well as service industries.

Key Feature

A particularly key feature of the Simpletrak system for Service Companies is the Customer Survey Module.  ION works with you to create customized surveys to obtain feedback from your customers in key areas.  These surveys are completed electronically and the Customer Survey Module automatically calculates a percentage based on the answers provided.  The NCR Module also enables the client to track and address customer complaints.  This allows you to monitor the effectiveness of your quality system from a customer service standpoint.

Other key features of the system include the Calibration Module, Preventive Maintenance Module, the Document Control Module, the NCR/Corrective Action module, Auditing Module and Management Review Module.  There are also a wide variety of data mapping tools that assist you in analyzing the information gathered through each of the these modules.

ION will facilitate your goals in acquiring certification by:

• Pairing you with a Service Industry ISO Expert to oversee your implementation process and ensure it is executed seamlessly and in accordance with your specific industry requirements
• Creating and implementing a data driven system that specifically caters to your needs
• Training you on each module to ensure your understanding
• Creating a comprehensive documentation package that integrates your vital processes and your simpletrak system
• Coordinating with your Registrar to schedule your Certification Audit
• Performing gap analysis auditing to ensure that all requirements have been met
• Representing you on-site during  your Certification Audit (optional)
• Guiding you in the maintenance of your system throughout the year and leading up to each surveillance audit
• Staying ahead of Industry trends, and keeping you informed to ensure that you are always ahead of the curve
  

Focus Groups

Quarterly focus groups at our facility pool together, Industry Experts, Certification Auditors, Consultants and ION staff to stay on top of current Industry focus, changing requirements and customer feedback.  The ION program is continually improving to ensure our clients are always on the cutting edge of market demands and innovation.

Commercial Manufacturing falls under the ISO 9001 Standard.  The International Organization for Standardization (ISO) has established a series of accepted practices, technical requirements and terminology for products, services and systems that, when implemented by a company, assures clients, suppliers and end-product users of a universally acceptable level of quality.  The standard that ISO provides is designed to ensure the most effective, safe and efficient methods and products achievable.

ISO 9001 Certification will-

Increase your Opportunities in the Marketplace

Improve efficiency in operations

Provide International Recognition

Allow Use of the ISO logo to publicize compliance and increase marketability

ISO Certification is appropriate for product industries as well as service industries.

Key Feature

A particularly key feature of the Simpletrak system for Manufacturing Companies is the Maintenance Module.  The maintenance module keeps track of all of your preventive maintenance on your equipment.  The green, yellow, and red indicator system is used in the simpleview box to allow you to see at a glance when items are becoming due.  A weekly attention report that is sent via e-mail also informs you of any items that are becoming due.  Additionally, the Maintenance module enables you to schedule a service call or put an item in the down category.  While a piece of equipment is in the down category, the system begins to track the cost involved per hour until the tank is up and running again.  A simple report feature also calculates the total cost over specified periods of time.

Other key features of the system include the Calibration Module, Document Control Module, the NCR/Corrective Action module, Auditing Module and Management Review Module.  There are also a wide variety of data mapping tools that assist you in analyzing the information gathered through each of the these modules.

ION will facilitate your goals in acquiring certification by:

• Pairing you with a Manufacturing Industry Expert to oversee your implementation process and ensure it is executed seamlessly and in accordance with your specific industry requirements
• Creating and implementing a data driven system that specifically caters to your needs
• Training you on each module to ensure your understanding
• Creating a comprehensive documentation package that integrates your vital processes and your simpletrak system
• Coordinating with your Registrar to schedule your Certification Audit
• Performing gap analysis auditing to ensure that all requirements have been met
• Representing you on-site during  your Certification Audit (optional)
• Guiding you in the maintenance of your system throughout the year and leading up to each surveillance audit
• Staying ahead of Industry trends, and keeping you informed to ensure that you are always ahead of the curve
  

Focus Groups

Quarterly focus groups at our facility pool together, Industry Experts, Certification Auditors, Consultants and ION staff to stay on top of current Industry focus, changing requirements and customer feedback.  The ION program is continually improving to ensure our clients are always on the cutting edge of market demands and innovation.