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ISO 9001 Quality

ISO 9001 Quality management can improve business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation. The standard brings the following benefits:

  • By assessing their context, organizations can define who is affected by their work and what they expect. This enables clearly stated business objectives and the identification of new business opportunities.
  • Organizations can identify and address the risks associated with their organization.
  • By putting customers first, organizations can make sure they consistently meet customer needs and enhance customer satisfaction. This can lead to more repeat customers, new clients and increased business for the organization.
  • Organizations work in a more efficient way as all their processes are aligned and understood by everyone. This increases productivity and efficiency, bringing internal costs down.
  • Organizations will meet necessary statutory and regulatory requirements.
  • Organizations can expand into new markets, as some sectors and clients require ISO 9001 before doing business.

The ISO 9000 family of quality management systems (QMS) is a set of standards that helps organizations ensure they meet customers and other stakeholder needs within statutory and regulatory requirements related to a product or service. ISO 9000 deals with the fundamentals of quality management systems, including the seven quality management principles that underlie the family of standards.  ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill.

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Third-party certification bodies provide independent confirmation that organisations meet the requirements of ISO 9001. Over one million organisations worldwide are independently certified, making ISO 9001 one of the most widely used management tools in the world today.

ISO 9001 Quality is known to be a requirement for businesses when tendering for large / governmental work.

The seven quality management principles are:

QMP 1 – Customer focus

QMP 2 – Leadership

QMP 3 – Engagement of people

QMP 4 – Process approach

QMP 5 – Improvement

QMP 6 – Evidence-based decision making

QMP 7 – Relationship management

Principle 1 – Customer focus

Organisations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.

Principle 2 – Leadership

Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.

Principle 3 – Engagement of people

People at all levels are the essence of an organisation and their full involvement enables their abilities to be used for the organization’s benefit.

Principle 4 – Process approach

A desired result is achieved more efficiently when activities and related resources are managed as a process.

Principle 5 – Improvement

Improvement of the organization’s overall performance should be a permanent objective of the organization.

Principle 6 – Evidence-based decision making

Effective decisions are based on the analysis of data and information.

Principle 7 – Relationship management

An organisation and its external providers (suppliers, contractors, service providers) are interdependent and a mutually beneficial relationship enhances the ability of both to create value.

In 2012, ISO TC 176 – responsible for ISO 9001 development – celebrated 25 years of implementing ISO 9001, and concluded that it was necessary to create a new QMS model for the next 25 years. They subsequently commenced the official work on creating a revision of ISO 9001, starting with the new QM principles. This moment was considered by important specialists in the field as “beginning of a new era in the development of quality management systems.” As a result of the intensive work from this technical committee, the revised standard ISO 9001:2015 was published by ISO on 23 September 2015. The scope of the standard has not changed; however, the structure and core terms were modified to allow the standard to integrate more easily with other international management systems standards.

The new ISO 9001:2015 management system standard helps ensure that consumers get reliable, desired quality goods and services. This further increases benefits for a business.

The 2015 version is also less prescriptive than its predecessors and focuses on performance. This was achieved by combining the process approach with risk-based thinking and employing the Plan-Do-Check-Act cycle at all levels in the organization.

Some of the key changes include:

  • High-Level Structure of 10 clauses is implemented. Now all new standards released by ISO will have this high-level structure
  • Greater emphasis on building a management system suited to each organization’s particular needs
  • A requirement that those at the top of an organization be involved and accountable, aligning quality with wider business strategy
  • Risk-based thinking throughout the standard makes the whole management system a preventive tool and encourages continuous improvement
  • Less prescriptive requirements for documentation: the organisation can now decide what documented information it needs and what format it should be in
  • Alignment with other key management system standards through the use of a common structure and core text
  • Inclusion of Knowledge Management principles
  • Quality Manual & Management representative (MR) are no longer mandatory