Skip to main content

​
Getting Started with ISO 9001

ISO 9001:2015 is the international standard for Quality Management Systems (QMS). It is the most widely adopted management system standard in the world, with over one million organizations certified across 170 countries. ISO 9001 applies to any organization regardless of size, sector, or industry. The standard focuses on consistently meeting customer requirements, enhancing customer satisfaction, and driving continual improvement. It follows the ISO Harmonized Structure, making it straightforward to integrate with ISO 27001, ISO 42001, and other management system standards. Matproof maps ISO 9001 requirements to controls, policies, and evidence workflows so you can build your QMS and prepare for certification.
Activate ISO 9001 under Settings - Frameworks - ISO 9001. Controls are pre-populated based on the standard’s clauses.

​
ISO 9001 Structure

ClauseTopicMatproof Module
4Context of the organization (interested parties, scope, QMS processes)Policies, Controls
5Leadership (commitment, policy, roles and responsibilities)Policies, People
6Planning (risks and opportunities, quality objectives, change planning)Risk Management
7Support (resources, competence, awareness, communication, documented information)People, Evidence
8Operation (planning, requirements, design, production, release, nonconforming outputs)Controls
9Performance evaluation (monitoring, analysis, internal audit, management review)Audit Programs, Controls
10Improvement (nonconformity, corrective action, continual improvement)Corrective Actions

​
The Seven Quality Management Principles

ISO 9001 is built on seven principles:

Customer Focus

Understand and meet customer requirements. Enhance customer satisfaction.

Leadership

Establish unity of purpose and direction. Create conditions for people to achieve quality objectives.

Engagement of People

Competent, empowered people at all levels are essential.

Process Approach

Manage activities as interrelated processes that function as a coherent system.

Improvement

Successful organizations focus on continual improvement.

Evidence-Based Decision Making

Decisions based on analysis and evaluation of data and information.

Relationship Management

Manage relationships with interested parties (suppliers, partners) to optimize performance.
1
Step 1 - Define QMS scope and context
2
  • Identify internal and external factors relevant to your organization’s purpose and strategic direction
  • Document interested parties and their requirements (customers, regulators, employees, suppliers)
  • Determine the scope of your QMS - which products, services, and locations are covered
  • Map your key processes and their interactions
    • 3
    Step 2 - Establish quality policy and objectives
    4
  • Go to Policies - Generate and create your Quality Policy
  • Ensure the policy includes a commitment to meeting requirements and continual improvement
  • Define measurable quality objectives at relevant functions, levels, and processes
  • Document how you plan to achieve each objective (actions, resources, responsibilities, timelines)
    • 5
    Step 3 - Risk-based thinking
    6
    ISO 9001:2015 integrates risk-based thinking throughout the standard:
    7
  • Go to Risk Management - New Risk Assessment
  • Identify risks and opportunities that could affect QMS outcomes
  • Plan actions to address risks and opportunities
  • Integrate these actions into your QMS processes
  • Evaluate the effectiveness of your risk treatments
    • 8
    ISO 9001 does not require a formal risk management methodology. A simple risk register with likelihood, impact, and treatment plans is sufficient for most organizations.
    9
    Step 4 - Process documentation and controls
    10
    Work through the controls in Controls - ISO 9001:
    11
  • Document key processes (inputs, outputs, responsibilities, resources, criteria)
  • Establish operational controls for product and service delivery
  • Define requirements for design and development (if applicable)
  • Set up controls for externally provided processes, products, and services
  • Document your release criteria and handling of nonconforming outputs
    • 12
    Step 5 - Competence and training
    13
  • Determine the competence needed for personnel affecting QMS performance
  • Go to People and document training records, education, and experience for relevant roles
  • Where gaps exist, provide training and verify its effectiveness
  • Retain documented information as evidence of competence
    • 14
    Step 6 - Monitoring, measurement, and analysis
    15
  • Determine what needs to be monitored and measured
  • Define methods for monitoring, measurement, analysis, and evaluation
  • Track customer satisfaction through surveys, feedback, and complaint analysis
  • Analyze data trends to identify improvement opportunities
    • 16
    Step 7 - Internal audit
    17
  • Go to Audit Programs - New Audit - ISO 9001
  • Plan audits covering all clauses and processes at planned intervals
  • Select auditors who are objective and impartial (auditors should not audit their own work)
  • Document findings as Corrective Actions
  • Verify corrective action effectiveness
    • 18
    Step 8 - Management review and certification
    19
  • Conduct a management review covering: audit results, customer feedback, process performance, risk assessment results, and improvement opportunities
  • Document decisions and actions from the review
  • When ready, engage an accredited certification body
  • Stage 1 audit reviews documentation; Stage 2 audit verifies implementation

    • ​
    Required Documented Information

    ISO 9001 requires you to maintain (policies/procedures) and retain (records/evidence) specific documented information:
    TypeExamples
    MaintainQuality Policy, quality objectives, QMS scope, process descriptions
    RetainMonitoring and measurement results, internal audit results, management review outputs, records of nonconformities and corrective actions, evidence of competence
    ISO 9001:2015 uses the term “documented information” rather than “documents” and “records.” You have flexibility in how you organize and store this information - Matproof handles both policies (maintained) and evidence (retained) in the appropriate modules.

    ​
    Next Steps