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A Quality Management System (QMS) is a collection of business process focused on achieving quality policy and quality objectives to meet customer requirements. It is expresses as the organizational structure, policies, procedures, processes and resources needed to implement quality management. Early systems emphasized predictable outcomes of an industrial product production line, using simple statistics and random sampling. Labour inputs were typically the most costly inputs in most industrialized societies, so focused shifted to team cooperation and dynamic, especially the early signaling of problems via a continuous improvement cycle

ISO 9001:2015 is a comprehensive management system standard and it is maintained by ISO, the International Organization for standardization and is administered by accreditation and certification bodies. Although the standard originated in the manufacturing sector, it’s in use across many industries. A “product”, in ISO vocabulary can mean a physical object, software or service.

A company or organization that has been independently audited and certified to be in conformance with ISO 9001:2015 may publicly state that is ISO 9001 certified or ISO 9001 registered
Certification to the ISO 9001:2015 standard certifies that formalizes business process with the intent of improving quality are being applied.

Elements of a Quality Management System

• • Context of the organization
  • Risk Management
  • Stakeholders
  • Organizational structure and responsibilities
  • Data Management
  • Processes – including purchasing
  • Product quality leading to customer satisfaction
  • Continual improvement
  • Quality Instruments
  • Control of documented information
  
  

Seven Quality Management Principles

• • Customer Focus
  • Leadership
  • Engagement of People
  • Process Approach
  • Improvement
  • Evidence – Based Decision Making
  • Relationship Management
  
  

Implementing a quality Management system will help you:
• Assess the overall context of your organization to define who is affected by your work and what they expect from you. This will enable you to clearly state your objectives and identify new business opportunities.
• Put your customers first, making sure you consistently meet their needs and exceed their expectations. This can lead to repeat custom new clients and increases business for your organization.
• Work in a more efficient way as all your process will be aligned and understood by everyone n the business or organization. This increases productivity and efficiency, bringing internal costs down.
• Meet the necessary statutory and regularly requirements
• Expand into new markets, as some sectors and clients require ISO 9001 before doing business.
• Identify and address the risks associated with your organization.

Structure of ISO 9001:2015
1. Scope
2. Normative references
3. Terms and Definitions
4. Context of the organization

• 4.1 Understanding the organization and its context
  4.2 Understanding the need and expectations of interested parties
  4.3 Determining the scope of the quality
  4.4 Quality management system and its process

5. Leadership

• 5.1 Leadership and commitment
  5.2 Policy
  5.3 Organizational roles, responsibilities and authorities

6. Planning

• 6.1 Actions to address risks and opportunities
  6.2 Quality objectives and planning to achieve them
  6.3 Planning of changes

7. Support

• 7.1 Resources
  7.2 Competences
  7.3 Awareness
  7.4 Communication
  7.5 Document information

8. Operation

• 8.1 Operational planning and control
  8.2 Requirements for products and services
  8.3 Design and development of products and services
  8.4 Control of externally provided processes, products and services
  8.5 Production and services provision
  8.6 Release of products and services
  8.7 Control of non-conforming outputs

9. Performances Evaluation

• 9.1 Monitoring, measurement, analysis and evaluation
  9.2 Internal Audit
  9.3 Management review

10. Improvements

• 10.1 General
  10.2 Nonconformity and corrective action
  10.3 Continual Improvement.