2653 S. Iris St.
Lakewood, CO
80227 USA

303-985-7942

ISO 13485 Consulting Develop new QMS Upgrade or optimize an existing QMS Conduct second party audits Assist with certification audits Implement documentation systems

ISO 13485 consulting services

Quality Works offers ISO consulting programs, on-line and on-site, to assist you in developing and implementing an effective Quality Management System (QMS) that meet the requirements of ISO 13485, Council Directive 93/42/EEC for CE marking of medical devices, and Canadian Medical Device Regulations (MDR). Our experienced consultants provide a full range of services such as:

• Development and implementation of new QMS

• Upgrade or optimization of your existing QMS to establish compliance with additional standards

• Conduct second party audits, including pre-certification audits

• Development and implementation of documentation systems

• Assistance in certification audits

On-line ISO Consulting Program:

Our on-line ISO 13485 consulting program may be suitable for those companies that need minimum disruption of their operation and would like to save consultant's travel expenses. Our online service is very similar to traditional on-site consulting, except most communication between our experienced consultants and clients is by phone and e-mail. So to use this service, you will need internet access and an e-mail address. With on-line ISO Consulting we will:

• Based on information you submit, provide you with a proposal and a firm quote similar to this example

• Develop an implementation plan similar to this example

• Include free of charge any of our publications needed to document your QMS

• Assist you in development of top level documentation: Quality Manual and second level procedures

• Review your procedures and records

• Based on the information you provide, issue monthly reports to ensure compliance with the plan and timely completion of your project

On-Site ISO 13485 Consulting Program

Our on-site ISO Consulting program may be added to your on-line consulting service at your discretion to enhance achieved results. In this phase we recommend:

• Training, such as standard overview for management

• Auditor training

• Pre-certification audit to ensure readiness of the quality management system and all employees

• Certification audit support. Our consultants either worked for or with different registrars and know what registrars are looking for

Affordable ISO Consulting Service

You now have a choice, on-line or on-site. Use our services to best suit your needs: augment your staff, assure ISO certification, resolve quality problems, qualify your suppliers, pass your next audit, or relieve critical resources. Understanding that time is money, our expert consultants will help you get back to business quickly. With Quality Works' on-site or on-line ISO 13485 consulting services, you can bring in expert help at a fraction of the price you would pay a full time consulting firm. For a free no obligation proposal and quote, please complete our Request for a Quote form.

Call us today to discuss your specific ISO management system needs!