ISO/QMS: CONSULTING PROGRAMS
FULL IMPLEMENTATION
At Qualmetrica, our dedicated, expert QMS consultants set us apart. We offer customized, simplified ISO consulting services for small to medium sized businesses seeking ISO certification and related standards. American owned and operated, we are committed to strengthening and improving your overall business needs. Our team will walk you through every step of the process improving your business on your way to certification.
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Our value proposition includes not only ISO 9001:2015 but with our extensive history and experience we can support other key industry sectors such as:
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ISO-14001 - Environmental QMS
AS91OOD - Aerospace / Aviation QMS
ISO-22000 - Food Safety Management System FSMS
ISO-13485 - Medical Device QMS
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ISO certification requires a compliant Quality Management System (QMS), with objective evidence e.g., proof that it’s working, and an external audit by a third-party registrar. That’s why we’re here to help.
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The average time to fully implement a robust QMS can take on average 9-12 months with full commitment and laser focus. Our seasoned subject matter experts can begin the process by conducting a 1-to-2-day gap assessment followed by a comprehensive report and proposal for the path forward. Once the gaps are identified, we offer a complete and easy to understand QMS IMPLEMENTATION ROADMAP customized for affordability and success.
In some cases, your organization may choose to simply engage in filling specific gaps in your QMS. In other cases, you may seek to obtain a full implementation that starts from the ground up and provides 100% of what is required to enjoy a healthy and sustainable QMS for many years to come.
Contact us today for a free 30-minute consultation with one of our expert consultants.
MEDICAL DEVICE
REMEDIATON PROGRAMS:
21 CFR 820 / ISO 13485: 2016 / MDSAP / EU-MDR
Our highly experienced team of professionals can provide expert subject matter experts who have worked directly with global medical device organizations that were subjected to Warning Letters, 483’s and even Consent Decrees.
We take great pride in providing robust, state of the art, full-service quality system remediation for your current or future issues with either notified bodies and/or FDA 21 CFR 820 concerns.
Every project begins with a comprehensive QMS gap assessment to your applicable ISO standards and regulations. Once the gaps are identified we offer a complete and easy to understand REMEDIATION ROADMAP customized for success.
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The REMEDIATION ROADMAP will include expert services such as complete (restoration-remediation) in the following areas:
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DOCUMENT CONTROL & CHANGE CONTROLS
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MEDICAL DEVICE – TECH FILES
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RISK MANAGEMENT ISO-14971
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QMS - e-QMS Application issues (implementation projects, harmonization issues)
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LEADERSHIP - MANAGEMENT REVIEW/COACHING & MENTORING
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EMPLOYEE TRAINING SYSTEMS
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ENVIRONMENTAL & CONTAMINATION ISSUES
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STERILIZATION CONTROLS
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DESIGN CONTROLS - PRODUCT DEVEL0PMENT - DHF/DMR verification and validation
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DESIGN TRANSFER
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SUPPLY CHAIN - PROCUREMENT/SUPPLIER QUALITY
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PRODUCTION AND PROCESS CONTROLS
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PROCESS, EQUIPMENT & SOFTWARE VALIDATIONS
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MATERIAL & WAREHOUSE CONTROLS
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METROLOGY (CALIBRATION CONTROLS)
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COMPLAINT HANDLING/INVESTIGATIONS
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RECALLS - MDR’s - Corrections and Removals
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ACCEPTANCE ACTIVITIES - Incoming, In-process and Final Inspection
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NCR & CAPA - ROOT CAUSE INVESTIGATIONS
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REGULATORY AFFAIRS
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INTERNAL & EXTERNAL AUDITING
OUR PROVEN PROCESS:
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Depending on your specific needs, we can deploy leadership (Workstream Experts) for any part of your medical device quality system. Our team of SME’s can provide the following services to bring you back into full compliance in this challenging regulated industry. Our team becomes embedded with key associates from your process owners to facilitate world class teamwork through collaboration to achieve full assurance of compliance restoration.
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Whether or not your quality system needs every item listed above or only specific areas, we are here to help. No job is too big or too small for Qualmetrica!
Contact us today for a free 30-minute consultation with one of our expert consultants.
QUALITY MANAGEMENT SERVICES:
At Qualmetrica, our experts can also provide multiple INTERIM STAFF ROLES to help your firm achieve its current and future needs.
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QUALITY DIRECTORS, QUALITY MANAGERS, QUALITY ENGINEERS, QUALITY TECHNICIANS, QUALITY AUDITORS and INSPECTORS.
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Contact us today for a free 30-minute consultation with one of our expert consultants.
Contact us today for a free
30-minute consultation with
one of our expert consultants.
QUALMETRICA L.L.C.
Highlands Ranch, CO. 80129
EMAIL: qms@qualmetrica.com
PHONE: 303-523-6444
