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Certification Services

American Certification Group-ACG is an ISO 17021-1 accredited registrar providing quality and environmental management system certification services

 

 

 

 

ISO 9001:2015

The ISO 9001 standard is a globally-recognized quality management system that is designed to assist companies in developing effective and controlled processes to improve product quality and overall efficiency across the entire organization with an emphasis on managing risk.

Key requirements included (but are not limited to):

  • Identifying and managing risk

  • Top management commitment

  • Adding value to the business and its customers

  • Operation controls

  • Record keeping

  • Corrective action plans

  • Continuous improvement

 

 

 

 

 

ISO 14001:2015

Waste in every facet of the operation should be eliminated. This includes environmental waste. As citizens we have a responsibility to balance economics with environmental responsibility. ISO 14001 is a globally-accepted Environmental Management System (EMS). It is applicable to any business who wants to be proactive in controlling their impact on the environment. The standard is designed to support environmental protection in balance with company economic needs.

 

At ACG we believe in this standard so much an the powerful impact it has on the environment we offer reduced audit rates to encourage companies who may  be on the fence.

 

Key requirements included (but are not limited to):

 

  • Identifying and managing risk

  • Identifying compliance requirements

  • Reduction of waste

  • Controlling environmental aspects

  • Record keeping

  • Corrective action plans

  • Continuous improvement

ISO 13485:2016

 

ISO 13485 focuses on medical device safety by ensuring a consistent manufacturing, assembly and distribution process. The standard identifies requirements for quality throughout the entire lifecycle of medical devices from design to shipment.

It outlines the requirements needed for organizations to establish a QMS that demonstrates their capability to consistently and safely deliver medical devices, and related services, to meet customer and regulatory requirements.

ISO 13485 is a stand-alone QMS standard, based on ISO 9001:2015. This standard as of January 31, 2024 is recognized by the FDA and will be used as a replacement to the 21 CFR 820 regulations by 2026.

https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked

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Initial Steps to Certification

1. Lean about the standard. To effectively meet the requirements you must have an understanding of the standard and how it can be applied to your organization.​

2. Perform a gap analysis.  You need to know where you are at before you know where you are going.  It is helpful to document an assessment of your current quality management system compared to the requirements in the standard.  This will help you prioritize tasks and ensure you have a documented plan of attack.​

3. Educate your employees.  The standard that requires all members of the product realization process to understand their responsibilities and how they fit into the bigger quality management system picture.  It is important to discuss the plan and get buy in at the early stages of the process.​

4. Document your system.  The standard does not always mandate documented procedures but it is a good idea to create procedures so you can analyze and define what you think are the best practices for each process. ​

 

5. Implement your system.  When departments have identified and defined best practices it is important to implement the changes.  You will need time to see if the updated processes are both manageable and effective.​

 

6. Audit your system.  It is important to continually audit your processes to ensure personnel are following the established rules.  Internal audits allow you to see deficiencies and make appropriate changes. You can’t improve an inconsistent process and auditing ensures everyone is on the same page. ​

 

7. Prepare and schedule your registration audit.  There is never a good time to schedule an audit.  Personnel will always feel they need more time.  Scheduling an audit puts a hard timeframe on the process.  This has a tendency to add some urgency to implementation of newly developed processes.​

 

8. Continual improvement. Achieving certification is only the first step. Certification does require continual improvement and evidence that your system is meeting your intended results.  There is no sin in falling short of an objective.  The sin is not reacting and improving the process when you do fall short.

 

9. At the American Certification Group, we know that getting certified requires considerable effort and can be confusing at times.  We are here to make sure you understand the steps and make sure you stay on track. 

Steps to Registration
 
Stage One Registration Assessment

As a first step in the certification process, ACG will perform a Stage 1 Registration Assessment. This review is conducted on site and focuses on determining the implementation status of your quality management system. This assessment helps identify any activities necessary for full compliance with requirements and helps establish an appropriate schedule for your final certification audit.

Stage Two Registration

 

The Stage 2 audit is a complete evaluation of your company’s Quality Management System including those areas reviewed during the Stage 1 assessment. The focus is on ensuring that policies and procedures are effectively implemented and your Quality Management System is suitable and effective in supporting your company’s quality policy and objectives.

During the audit, daily meetings will be held between the audit team and your management team to discuss audit progress and any concerns that may have arisen. The audit team will gather sufficient objective evidence to support a conclusion that your Quality Management System has been documented and effectively implemented in accordance with the ISO standard.

 

Upon review of the lead auditors recommendations and resolution of any required corrective actions ACG certification committee will authorize issuance of a certificate of registration.

 

Surveillance 

To ensure that your Quality Management System is effectively maintained, ACG will perform an annual surveillance audit.  At each surveillance audit areas including management review, internal audits and corrective action will be reviewed.  In addition, remaining standard requirements will be added.  All elements of the quality system will be reviewed at a minimum over the three year registration cycle.

Reassessment

Maintaining certification requires that your entire quality management system be reassessed at the end of each three-year certification cycle. The reassessment audit must be completed before the expiration date of your ISO registration certificate. After successful completion of all reassessment processes, including a review of the results of surveillance audits over the past certification period, ACG will issue a new Certificate of Registration..

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