ISO 9001:2015
Quality Management System
What is ISO 9001?
ISO 9001 is an international standard for quality management and is one of the most well-known standards in the ISO series. The standard is applicable to all business types. It is based on seven quality management principles includes customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management.
Benefit of ISO 9001
In order to retain customers and satisfy them with your products or services, organization must first meet their needs and expectation. ISO 9001 provides a framework for organization to establish and implement quality management systems (QMS) that enhance the stability of product and service quality and continue to enhance the organization's quality performance, resulting in more business benefits.
Based on the universal acceptance of ISO 9001 all around the world, hundreds of thousand organizations prioritize to have a business relationship with the products or service providers who are already certified to ISO 9001.
ISO 9001 Requirements
This International Standard promotes the adoption of a Plan - Do - Check - Act (or PDCA) cycle and risk-based thinking approach, as reflected in the standard clauses 4 to 10 (Clauses 0 to 3 are introduction, scope, normative references, and terms and definitions, not subject to audit-able requirements). You can find out about the standard requirements in the following: (or by related links)
Clause 4 - Context of organization
This is the first step in establishing a QMS, which requires the organization to clearly determine:
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What are the internal and external issues related to the organization's business, policies, etc., which can affect the organization to achieve the intended results?
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Who are your interested parties? What are their needs and expectations?
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What is the scope of the QMS?
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What are the process of the QMS?
Clause 5 - Leadership
Top management is required to commit and proactively participate in the QMS. They need to be ultimately responsible for the performance of the QMS. The standards clearly state that these responsibilities include establishing and communicating quality policies, promoting quality objectives, providing resources, defining the role of organizational staff, authority and responsibility, understanding customer needs, improving customer satisfaction, and supporting other relevant management roles.
Clause 6 - Planning
Based on the internal and external issues and interested parties' needs and expectations determined from clause 4, the organization identifies the risks and opportunities associated with its operations, activities, services, products, and determine the actions to manage them. The standard also requires organizations to establish quality objectives to drive continual improvement. Any changes to the QMS must be performed in a planned and controlled manner.
Clause 7 - Support
The organization shall ensure that there is sufficient support to establish, implement, maintain and improve the QMS, including human resources, infrastructure, working environment, monitoring and measuring resources, organizational knowledge, personnel competence, awareness, communication, and documented information.
Clause 8 - Operations
The organization shall ensure that its operations are properly planned and controlled, including:
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Plan the processes
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Determine product/service requirements
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Control product/service design and development processes
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Control external providers (suppliers / contractors) and procurement process
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Control the delivery of production and service provision
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Control the release of products and services
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Control of nonconforming output
Clause 9 - Performance evaluation
The organization shall review the performance of the QMS, including understanding and monitoring customer satisfaction, analyzing product/service compliance, reviewing the effectiveness of actions addressing risks and opportunities, evaluating external providers' performance, and determining the need for improvement. The organization is also required to conduct internal audits and management reviews on a regular basis to check that QMS is effectively implemented and the performance is being reported to the organization's top management.
Clause 10 - Improvement
The organization shall drive continual improvement of the QMS based on the results of Section 9, the identification and control of risks and opportunities, and the investigation and corrective actions of any nonconformity.