standards-expert

ISO Standards and Quality Management Expert

Expert guidance for ISO standards, quality management systems, compliance, and certification processes.

Core Concepts

ISO Standards

• ISO 9001 (Quality Management)
• ISO 27001 (Information Security)
• ISO 14001 (Environmental Management)
• ISO 45001 (Occupational Health & Safety)
• ISO/IEC 17025 (Testing and Calibration)
• ISO 22000 (Food Safety)

Quality Management

• Plan-Do-Check-Act (PDCA) cycle
• Process approach
• Risk-based thinking
• Continuous improvement (Kaizen)
• Quality objectives and metrics
• Management review

Compliance & Certification

• Gap analysis
• Internal audits
• Corrective actions
• Document control
• Management system documentation
• Certification audits

ISO 9001 Quality Management System

from dataclasses import dataclass
from datetime import datetime
from typing import List, Optional
from enum import Enum

class ProcessCategory(Enum):
    MANAGEMENT = "management"
    OPERATIONAL = "operational"
    SUPPORT = "support"

@dataclass
class QualityProcess:
    process_id: str
    name: str
    category: ProcessCategory
    owner: str
    inputs: List[str]
    outputs: List[str]
    resources: List[str]
    kpis: List[str]
    risks: List[str]

class ISO9001QMS:
    """ISO 9001 Quality Management System"""

    def __init__(self, organization: str):
        self.organization = organization
        self.processes: Dict[str, QualityProcess] = {}
        self.quality_objectives = []
        self.risks = []
        self.opportunities = []

    def define_process(self, process: QualityProcess):
        """Define a quality process"""
        self.processes[process.process_id] = process

    def define_quality_objective(self, objective: Dict):
        """Define quality objective"""
        self.quality_objectives.append({
            'objective': objective['description'],
            'target': objective['target'],
            'measurement': objective['measurement'],
            'owner': objective['owner'],
            'deadline': objective['deadline'],
            'status': 'active'
        })

    def conduct_pdca_cycle(self, process_id: str) -> Dict:
        """Conduct PDCA cycle for process"""
        return {
            'plan': self._plan_phase(process_id),
            'do': self._do_phase(process_id),
            'check': self._check_phase(process_id),
            'act': self._act_phase(process_id)
        }

    def _plan_phase(self, process_id: str) -> Dict:
        """PDCA Plan phase"""
        process = self.processes.get(process_id)
        return {
            'objectives': 'Define objectives and processes',
            'resources': process.resources if process else [],
            'risks_identified': process.risks if process else []
        }

    def _do_phase(self, process_id: str) -> Dict:
        """PDCA Do phase"""
        return {
            'action': 'Implement the processes',
            'documentation': 'Document execution'
        }

    def _check_phase(self, process_id: str) -> Dict:
        """PDCA Check phase"""
        return {
            'monitoring': 'Monitor and measure processes',
            'analysis': 'Analyze results against objectives'
        }

    def _act_phase(self, process_id: str) -> Dict:
        """PDCA Act phase"""
        return {
            'improvements': 'Implement improvements',
            'corrective_actions': 'Take corrective actions'
        }