Quality Management System Audits

The quality management system (QMS) is a foundational framework that guides organizations to achieve operational and quality excellence through documenting company policies, processes, procedures, and responsibilities.

There are many industry-specific quality management systems, with ISO 9001:2015 being the most recognized and implemented around the world. Other QMS frameworks such as IATF 16949 for the automotive industry, or ISO 13485 for the Medical Device industry use ISO 9001 as a building block and then add specific industry compliance requirements to complete the framework.

Pro QC offers a range of technical audits that assess production capability and performance of your supplier against industry quality standards.

The QMS encourages organizations to adopt a continuous improvement mindset
from top management down to the production floor

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Pro QC’s QMS Audit Offering

We provide a comprehensive evaluation of the supplier’s policies, documents, procedures, and records to assess their ability to deliver consistent and sustainable quality performance to your organization. A few example standards are listed below and can be clicked for future information.

ISO 9001 Quality Management System

The most commonly known and globally recognized Quality Management System (QMS) standard within the manufacturing industry.

ISO 9001 Quality Management System

VDA 6.3:2016 Manufacturing
Process Audit

VDA 6.3 uses a process-based auditing standard for evaluating and improving controls related to new product introduction and manufacturing processes.

VDA 6.3:2016 Manufacturing Process Audit

IATF 16949 Quality Management System Audit

The IATF 16949:2016 uses ISO 9001:2015 as its basis and adds specific auto-industry standards. It has replaced the ISO/TS 16949:2009.

IATF 16949 Quality Management System Audit for Automotive

ISO 13485 Quality Management System Audit

ISO 13485:2016 specifies QMS requirements and production-consistency standards for vendors who produce medical devices and related medical services.

ISO 13485 Quality Management System Audit for Medical Devices

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Other Quality Management Systems Audits

Aside from the most commonly used QMS standards and audits listed above, Pro QC also has engineering professionals specialized in the following standards:

  • 21 QSR 820 GMP Audits for Medical Devices
  • ISO 22716 GMP Audit for Cosmetic Products
  • ISO 11137 Sterilization Process Audit
  • ISO 17025 Quality Management System for Laboratories
  • ISO 10012 Quality Management for Measurement Processes and Metrological Confirmation

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Supplier Quality Audits

We understand that not all factories will voluntarily pursue a certified ISO 9001 Quality Management System (QMS). Some factories can produce good quality products without specifically adhering to a QMS. Under these circumstances, a bespoke Supplier Quality Audit or Initial Supplier Evaluation can be requested.

Pro QC Supplier Quality Audit
Pro QC Initial Supplier Evaluation

A Supplier Quality Audit (SQA) or Initial Supplier Evaluation (ISE) is a cost-effective way for anyone from one-time buyers to large multinational companies to assess the legitimacy of a supplier and ensure the right purchasing decision is being made.

Initial Supplier Evaluation

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Pro QC’s Supplier Management Service

Most of our clients have a portfolio of five to 50+ factories that require quality assessments. Pro QC can work with an internal QA team to create a bespoke Supplier Qualification Program to assess, qualify, and develop the entire supplier portfolio. The usual approach to these programs is outlined below:

  1. Performing an initial social audit assessment
  2. Establishing a corrective action plan
  3. Verifying corrective action implementation through detailed follow-up activities
  4. Scheduling subsequent annual visits based on supplier risk level
  5. Providing a supplier portfolio dashboard and performance analysis

Our supplier management team can create a customized checklist that meets the most specific requirements. The supplier management service is particularly suitable for small QA teams with a large supplier base across the globe. Our project team will help reduce overhead and time spent dealing with suppliers and manage all necessary actions for each supplier. Get in touch with us and tell us how we can assist your team.

Other Factory Compliance Solutions

Factories have a range of local and global best practices and compliance standards to consider when aiming to be a reliable manufacturing partner. If a particular standard is not listed here, visit our Factory and Supplier Audits page to explore our wide range of supplier management services. Our team has the relevant experience to provide a bespoke approach or solution to meet any validation or certification requirement.

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Assess your supplier’s production capability and performance.
Help them achieve operational and quality excellence.

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