Maintaining Your ISO 13485 Quality Management System

Sometimes, companies are certified but struggle to maintain and improve their quality management system or just need to update the knowledge and skills of the quality team.  SimpleQuE can help with consulting resources and continuous improvement initiatives.  In addition, outsourcing internal audits provides a fresh perspective that not only gives opportunities for improvement but also meets the standard’s requirements and prepares an organization for 3rd party surveillance audits. The experts at simpleQuE can keep you on track.

Let Us Perform Your Internal Audit

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Our ISO 9001 Audit and Gap Analysis can identify any areas where improvement is needed. Having simpleQuE perform these internal audits will result in increased operational efficiency and customer satisfaction. With simpleQuE’s consulting services at your disposal, you will have a quality management system in place that ensures you maintain your ISO 13485 certification.

More ways simpleQuE can help:

  • Implement the management review presentation materials and required records
  • Perform internal audits
  • Help with corrective action and finding closure. Both from internal audits and the certification body or from customer issues that have been identified
  • Facilitate and train for a more effective root cause analysis and problem-solving to get to systemic corrective actions and fixes for the business and the company
  • Preparation for outside 3rd party audits
  • Contingency planning
  • Document and record control
  • CAR (Corrective Action Request) tracking and timely closure
  • Continual improvement activities, such as helping to maintain the records and processes

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“simpleQuE developed an understanding of our objectives and expectations then helped us put both plan and actions into place ensuring we achieved our goals on time. I would definitely recommend simpleQuE for any business wishing to improve their Quality Management system.”

– Eddie Werner, Quality Manager – Western Reserve Wire Products (WRWP)

The simpleQuE Advantage

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Whether you have a management system in place or are just developing one, understanding the requirements and having an experienced consultant or auditor by your side is key. Our team members have third-party auditing experience, industry-related work experience, and firsthand knowledge of what is required to pass a certification assessment and maintain certification.

The experts at simpleQuE can keep you on track with their simple, customized approach – “Quality Excellence Made Simple”.

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