ISO Implementation Guide Skill

ISO Implementation Guide

Overview

The ISO Implementation Guide skill provides comprehensive capabilities for implementing ISO 9001:2015 Quality Management Systems. It supports gap assessment, documentation generation, process procedure creation, and certification readiness assessment.

Capabilities

Gap assessment against ISO 9001:2015
QMS documentation generation
Process procedure templates
Context of organization analysis
Risk-based thinking integration
Document control setup
Management review facilitation
Certification readiness assessment

Used By Processes

QMS-001: ISO 9001 Implementation
QMS-003: Quality Audit Management
CI-001: Operational Excellence Program Design

Tools and Libraries

QMS software
Document management systems
Audit management tools
Training platforms

Usage

skill: iso-implementation-guide
inputs:
  organization_context:
    industry: "Manufacturing"
    size: "Medium"
    scope: "Design and manufacture of electronic components"
  current_state:
    existing_qms: false
    documented_processes: ["production", "purchasing"]
    certifications: []
  implementation_timeline: 12  # months
  target_certification: "ISO 9001:2015"
outputs:
  - gap_analysis
  - implementation_roadmap
  - document_templates
  - process_maps
  - risk_register
  - readiness_assessment

ISO 9001:2015 Clause Structure

| Clause | Title | Requirements | |--------|-------|--------------| | 4 | Context of the Organization | Understanding context, interested parties, scope | | 5 | Leadership | Leadership commitment, policy, roles | | 6 | Planning | Risk/opportunities, objectives, planning changes | | 7 | Support | Resources, competence, awareness, communication | | 8 | Operation | Planning, design, production, delivery | | 9 | Performance Evaluation | Monitoring, internal audit, management review | | 10 | Improvement | Nonconformity, corrective action, continual improvement |

Required Documented Information

Mandatory Documents

Quality policy
Quality objectives
Scope of QMS
Process interactions

Mandatory Records

Competence records
Design/development records
Monitoring and measurement results
Internal audit results
Management review outputs
Nonconformity and corrective actions

Implementation Phases

Phase 1: Foundation (Months 1-3)

Leadership commitment
Context analysis
Scope definition
Gap assessment

Phase 2: Development (Months 4-6)

Process documentation
Risk assessment
Procedure creation
Training

Phase 3: Implementation (Months 7-9)

Process deployment
Record collection
Internal audits
Corrective actions

Phase 4: Certification (Months 10-12)

Management review
Pre-assessment audit
Certification audit
Continual improvement

Integration Points

Document management systems
Training management systems
Audit management platforms
ERP systems

Agent Skills: ISO Implementation Guide

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