Quality Assurance & Control

Full Lengthen Video | Quality Assurance & Control | Runtime 6:41 mins

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Auditing
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Gap Analysis
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QMS Documentation
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Post Market Support
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Precommer-
cialization
Documentation

QMS Design and Implementation

Using the Kapstone base QMS, we will design and implement a quality management system for your organization.

Strengthened by years of experience and numerous audits in the US and EU markets, your QMS will be comprehensive and customized

Your QMS can be based on an electronic platform (eQMS) or “paper-based”

Using the Kapstone base QMS, we will design and implement a quality management system for your organization.

Strengthened by years of experience and numerous audits in the US and EU markets, your QMS will be comprehensive and customized

Your QMS can be based on an electronic platform (eQMS) or “paper-based”

On-going Resource

Our expert resources will act as your quality representative whether precommercialization or post market

The Quality representative can integrate into a new product development process that Kapstone is doing or seamlessly plug in to your team.

Our expert resources will act as your quality representative whether precommercialization or post market

The Quality representative can integrate into a new product development process that Kapstone is doing or seamlessly plug in to your team.

Quality Consultant

Gap Analysis:

Focusing efforts and resources based on a gap analysis will save time and help ensure any deficiencies are addressed. Our gap analysis report presents a clear summary of where the major gaps exist, degree of compliance to chosen requirements, and corresponding actions that should be taken to close these gaps.

Audit:

More in depth than a gap analysis of your QMS, an internal audit assesses your procedures, how your organization is utilizing them, and your individuals’ knowledge of the system. Our audit summaries include nonconformities, observations, noteworthy efforts, and opportunities for improvement. Having an audit conducted by a consultant brings the up-to-date expertise and gives you more confidence in preparation for a regulatory body audit.

QMS Upgrade:

If you’re preparing to become ISO certified or want to upgrade your QMS to the latest standard, we can step in to assess what is needed and provide you with the appropriate action items.

Gap Analysis:

Focusing efforts and resources based on a gap analysis will save time and help ensure any deficiencies are addressed. Our gap analysis report presents a clear summary of where the major gaps exist, degree of compliance to chosen requirements, and corresponding actions that should be taken to close these gaps.

Audit:

More in depth than a gap analysis of your QMS, an internal audit assesses your procedures, how your organization is utilizing them, and your individuals’ knowledge of the system. Our audit summaries include nonconformities, observations, noteworthy efforts, and opportunities for improvement. Having an audit conducted by a consultant brings the up-to-date expertise and gives you more confidence in preparation for a regulatory body audit.

QMS Upgrade:

If you’re preparing to become ISO certified or want to upgrade your QMS to the latest standard, we can step in to assess what is needed and provide you with the appropriate action items.