Audit Standards Guide
Configurable audit standards and checklists.
Overview
Audit Standards in Buttress QMS provide pre-built checklists based on industry standards to ensure comprehensive and consistent audits.
Key Features
- Pre-configured Standards: Ready-to-use checklists for ISO 9001, IATF 16949, AS9100D, and more
- Clause-based Structure: Questions organized by standard clause for easy reference
- Customizable: Duplicate and modify standards to fit your specific needs
- Internal Audits: Department-specific audit checklists for internal quality audits
- Version Control: Track revisions and changes to audit standards
Available Standards
Buttress QMS includes pre-configured audit standards for major quality management systems:
ISO 9001:2015
Quality Management System standard applicable to all industries.
Key Clauses: Context, Leadership, Planning, Support, Operations, Performance Evaluation, Improvement
IATF 16949:2016
Automotive Quality Management System standard.
Key Areas: APQP, PPAP, FMEA, MSA, SPC, Control Plans
AS9100D / AS9110C / AS9120B
Aerospace Quality Management System standards.
Coverage: Design, Manufacturing, MRO, Distribution
ISO 13485:2016
Medical Devices Quality Management System.
Focus: Risk management, Regulatory compliance, Traceability
FDA 21 CFR 820
US FDA Quality System Regulation for medical devices.
Subparts: Design Controls, Production, CAPA, Records
Internal Audit Checklists
Department-specific internal audit templates.
Departments: Quality, Engineering, Purchasing, HR, Operations
Using Standards in Audits
Selecting a Standard for an Audit
Step 1: Create or Edit an Audit
Navigate to Audits and create a new audit or edit an existing one.
Step 2: Select Audit Standard
In the audit form, select the applicable standard from the Audit Standard dropdown. This populates the checklist.
Step 3: Review Checklist
The audit checklist is pre-populated with questions based on the selected standard, organized by clause.
Step 4: Conduct the Audit
For each checklist item, record:
- Finding: Conforming, Minor NC, Major NC, Observation, N/A
- Evidence: Objective evidence observed
- Notes: Additional comments
Step 5: Complete and Generate Report
After completing all checklist items, close the audit and generate the audit report.
Custom Standards
Create custom audit standards tailored to your organization's specific needs.
Creating a Custom Standard
- Duplicate an Existing Standard: Start from a pre-built standard to save time
- Modify Questions: Add, remove, or edit questions as needed
- Organize by Sections: Group questions into logical sections or clauses
- Set as Active: Enable the standard for use in audits
Best Practices for Custom Standards
- Keep questions specific and auditable
- Reference the applicable standard clause where relevant
- Include guidance notes for auditors
- Review and update standards annually
- Control access to prevent unauthorized changes
Admin Configuration
Administrators can manage audit standards through the Admin panel.
Accessing Audit Standards Admin
- Navigate to Admin > Audit Standards
- View all available standards
- Create, edit, duplicate, or deactivate standards
Standard Configuration Options
- Name: Display name of the standard
- Code: Short identifier (e.g., ISO9001, IATF)
- Version: Standard version/year
- Description: Brief description of scope
- Active: Toggle availability for audits
- Sections: Define clause/section structure
- Questions: Individual checklist items
Importing Standards
Standards can be imported from YAML definition files for rapid setup.