Quality Management System (QMS) Audit

Starting a business and managing are two completely different tasks. While starting a business may not be as difficult as it seems, maintaining it and keeping it running smoothly surely demands focus and right decisions from its directors and company owners. A business will only be able to run smoothly if it can keep its customers’ happiness bar up, speaking of which demands constant struggle and hardships regarding the quality of its product.

Managing a production of a better quality product and ensuring that its quality either remains the same or excels further demands a proper quality management system from business’s owners.

Worldwide Standards for QMS

Standard and regulatory bodies like ISO and FDA have proposed some QMS standards and QMS regulations for different organizations around the globe. These standards include ISO 9001, ISO 13485, and FDA’s QSR. The standards which are applicable to any type of organization are ISO 9001 – Quality Management System Standard. The FDA’s QSR, ISO 13485 are related to organization operating in the medical devices sector.

If your organization somehow fails complying with these standards and regulation, a company can face severe consequences regarding their product getting off from the market, loss of certification and loss of customer trust and reputation.

Although routine internal audits are conducted by organizations, but they fail to observe their processes and interactions between them due to which, organizations usually see a downfall in their progress. All of these non-conformities arise due to ineffective Quality Management Systems.

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Audit Criterions

Looking to Get Your QMS Audit Done by Area Experts?

TS Q & E offers QMS audit with professional auditors who took ISO 9001:2015 Lead Auditor course, or ISO 13485:2016 Lead Auditor course. With our team of auditors who can have trust in QMS audit process, we operate all across the Europe. We have been providing our valuable customers with the exclusive experience of first party and second party audits based on audit criterion of your choice. We also help companies to have audits on integrated audit criterion.

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First and Second Party Audits

Please let us know your requirements on the audit criterion, by our contact us form, and get a free quote for your requirements regarding auditing services.

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