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ISO helps Businesses Improve Efficiency and Customer Satisfaction

ISO 9001 is a standard that sets out the requirements for a quality management system. It helps businesses and organizations to be more efficient and improve customer satisfaction (www.iso.org). The standard is divided in 10 sections:

  • Section 1—Scope
  • Section 2—Normative Reference
  • Section 3—Terms and Definitions
  • Section 4—Context of the organization
  • Section 5—Leadership
  • Section 6—Planning
  • Section 7—Support
  • Section 8—Operation
  • Section 9—Performance evaluation
  • Section 10—Improvement

Qualityze Solution Information Matrix for ISO 9001

Qualityze eQMS software is designed to help an organization to comply with ISO 9001 standards. The following matrix will provide essential information for you to understand how Qualityze Solution can help:

Requirements Section Description Qualityze Modules
Section 4: Context of the organization

 

  • Understanding the organization & its context
  • Understanding the needs & expectations of interested parties
  • Determining the scope of the QMS
  • The QMS and its processes
  • Process approach
  • Document Management
  • Change Management
  • Audit Management
  • NC Management
  • CAPA Management
Section 5: Leadership
  • Leadership & commitment
  • Quality policy
  • Organizational roles, responsibilities & authorities
  • Document Management
  • Change Management
  • Audit Management
  • NC Management
  • CAPA Management
  • Training Management
Section 6: Planning

 

  • Actions to address risks & opportunities
  • Quality objectives & planning to achieve them
  • Planning of changes
  • Document Management
  • Change Management
  • Audit Management
  • NC Management
  • CAPA Management
Section 7: Support
  • Resources: People, Infrastructure and Environment for Operations
  • Competence
  • Awareness
  • Communication
  • Documented information
  • Document Management
  • Change Management
  • Audit Management
  • NC Management
  • CAPA Management
  • Training Management
Section 8: Operation
  • Operational planning & control
  • Customer communication
  • Determination and review requirements for product & services
  • Operational planning process
  • Control of externally provisioned product & services
  • Development of goods & services
  • Identification, Traceability and Preservation
  • Production of goods & services, Control of changes and
    the release of goods & services
  • Control of Nonconforming goods & services
  • Document Management
  • Change Management
  • Audit Management
  • NC Management
  • CAPA Management
  • Training Management
  • Complaints Management
Section 9: Performance evaluation
  • Monitoring, measurement analysis & evaluation
  • Internal Audit
  • Management Review
  • Document Management
  • Change Management
  • Audit Management
  • NC Management
  • CAPA Management
  • Training Management
Section 10: Improvement

 

  • Nonconformity & corrective action
  • Improvement
  • Document Management
  • Change Management
  • Audit Management
  • NC Management
  • CAPA Management
  • Training Management
  • Complaints Management

Related Links

Compliance Management Software
ISO13485 Quality Management System
21 CFR 820 Quality System
FDA 21 CFR Part 11 Software
AS 9100 Quality Management Software
TS 16949 Automotive QMS Software