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Compare QMS Packages

Choose your standards family, then compare the package scope that fits your organization.

Need a different combination of procedures? Select your own and review the total before checkout.

Every document is an editable Word or Excel file, for use on paper or in your eQMS. See how. 

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ISO 13485 QMS

ISO 13485:2016 and FDA QMSR documentation for medical device companies.

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BASE

Core document, design and quality-process foundation.

23 procedures

$1,195

DESIGN PLUS

Broader documentation for device development and supporting quality activities.

45 procedures

$1,995

MANUFACTURING PLUS

The broadest design and manufacturing set in this family.

73 procedures

$2,795

Dual-Standard QMS

ISO 9001:2026 + ISO 13485:2016 integrated documentation.

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BASE

A focused starting set for core document, design, supplier and quality processes.

27 procedures

$1,345

DESIGN PLUS

Broader design coverage, including software and supporting quality workflows.

49 procedures

$2,145

MANUFACTURING PLUS

The broadest integrated set, including design, production, clinical and software workflows.

75 procedures

$2,945

ISO 9001 QMS

ISO 9001:2026 quality-system documentation for manufacturers and their suppliers.

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BASE

Core document, purchasing, inspection and improvement processes.

20 procedures

$595

STANDARD

Adds design control, risk, production records and failure investigation.

38 procedures

$995

COMPLETE

The full set, adding validation, environmental controls, software and labeling.

54 procedures

$1,295

Food Safety Management System

ISO 22000:2018, FSSC 22000 and FDA 21 CFR 117 food safety documentation for food manufacturers and their suppliers.

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COMPLETE

The manual, HACCP workbook, 57 procedures and 104 forms.

57 procedures

$1,295

STARTER

The manual, HACCP workbook, 22 core procedures and 45 forms.

22 procedures

$595

HACCP WORKBOOK

Hazard analysis, CCP and OPRP plan and FSMA preventive controls.

10-sheet Excel workbook

$149

How to choose

Start with the standards you need. Then compare the included-document lists against your organization's activities. Larger packages contain more procedures, but the right scope matters more than the count.

 

Prices are in USD; the product page shows the current price. Already bought individual procedures? What you paid for them in the last 60 days is credited toward a package; contact us before you order. Consultants: every package has a Consultant license option, at three times the single-site price, that lets you pass the documents on to your clients.

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Using an eQMS? Read the eQMS guide.

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