What is ISO 9000?

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ISO 9000 Definition

ISO 9000 is a series of international standards on quality management and assurance developed to help organizations document the required elements to maintain an efficient quality management system (QMS). The ISO 9000 standard provides guidelines intended to increase business efficiency and customer satisfaction.

STANDARDS INCLUDED IN THE ISO 9000 SERIES

The ISO 9000 family of quality management standards can be applied to product manufacturing or service companies spanning any industry and is comprised of the following:

• ISO 9000:2015
  Quality Management Systems: Fundamentals and Vocabulary (definitions)
• ISO 9001:2015
  Quality Management Systems: Requirements
• ISO 9002:2016
  Quality Management Systems: Guidelines for the Application of ISO 9001:2015
• ISO 9004:2018
  Quality Management: Quality of an Organization – Guidance to Achieve Sustained Success (continuous improvement)

WHAT ARE THE QUALITY MANAGEMENT ELEMENTS ADDRESSED IN ISO 9000?

The ISO 900O series addresses the essentials of a quality management system (QMS) including processes and procedures that are needed to effectively design, produce, and maintain a product throughout the entire lifecycle. The key elements encompass organizational responsibilities, design and manufacturing processes, equipment maintenance, record keeping, employee training, inspection, and customer relations.

• Management Responsibility
  An organization’s management team should develop a quality policy and manual. The quality policy outlines the organization’s strategic goals and mission, whereas the quality manual documents the scope of the QMS.
• Design Controls
  Product teams should develop a comprehensive plan for designing and developing the product. User requirements (i.e., inputs) serve as the basis for how the product functions. In turn, documents such as drawings, design specifications, and assembly instructions (i.e., outputs) provide guidance on how the final product is produced. Design changes should be thoroughly documented and reviewed by key stakeholders throughout the new product development process. Additionally, verification and validation testing are necessary to ensure that the finished product meets user requirements and performs as intended.
• Process Control
  The development of procedures such as work instructions and assembly instructions is necessary to ensure that products are produced consistently, efficiently, and with fewer errors.
• Document Control
  A robust system must be in place to ensure that all product documentation is created, distributed, reviewed, revised, stored, and disposed of in a controlled manner.
• Product Handling
  Procedures for the proper storage and transport of products and supplies should by clearly documented and maintained.
• Product Identification and Tracking
  Proper labeling is necessary to ensure that products are easily identifiable and traceable throughout the lifecycle.
• Inspection and Testing
  All incoming parts and materials must be inspected prior to use. In-process and final inspections should also occur before the finished product is shipped. Records of all inspections should be maintained.
• Corrective and Preventive Actions (CAPAs)
  Teams must conduct investigations to identify the root cause of product nonconformities. In turn, countermeasures should be put in place to correct and prevent issues from reoccurring.

• Internal Audits
  Organizations should perform routine internal audits to ensure that their QMS meets the requirements of applicable regulations and standards. Results of the audit are subsequently communicated to the management team, and any deficiencies are addressed.
• Training Management
  Organizations must develop, maintain, and track training records to ensure that employees remain proficient on all current company policies, processes, and procedures.

• Equipment Maintenance
  Instruments and tools that are used for measuring, testing, and inspection should be calibrated and recorded regularly.
• Purchasing
  Procurement teams should document and implement procedures for evaluating vendors and suppliers and establish guidelines for sourcing parts and materials.
• Contract Review
  Product and service contracts should be reviewed to ensure that they align with customer needs and expectations.
• Statistical Methods
  Six Sigma and other statistical analysis techniques can be leveraged to determine how well a process is working and facilitate continuous improvement.
• Servicing
  Servicing of products should follow formal written procedures and meet customer expectations.

ISO 9000 QUALITY MANAGEMENT PRINCIPLES

The ISO 9000 series is made up of seven quality management principles which are aimed at helping organizations drive continuous improvement. They include:

1. Customer focus: Because organizations rely on their customers, they should strive to understand their needs and meet or exceed their expectations.
2. Leadership: Leaders of the organization establish unity of purpose and direction. They also create an environment in which individuals actively engage to achieve the organization’s quality objectives.
3. Engagement of people: To improve the organization’s ability to create and deliver value, all levels of the organization need competent, empowered, and engaged individuals.
4. Process approach: Consistent results are more easily achieved when activities are managed through processes.
5. Improvement: Successful organizations should always focus on continuous improvement.
6. Evidence-based decision-making: Desired results are more likely achieved when decisions are based on the analysis of data and information.
7. Relationship management: An organization should manage its relationships with interested parties (suppliers, contractors, service providers) to maintain long-lasting success.

* Source: https://www.iso.org/files/live/sites/isoorg/files/store/en/PUB100080.pdf

BENEFITS OF ISO 9000

ISO 9000 positively impacts businesses in several ways. Key benefits include:

• Instills a preventive mindset, enabling teams to identify ways to avoid product nonconformities and other issues
• Equips organizations with tools and resources to manage time efficiently
• Drives greater consistency across processes and helps minimize errors
• Provides employees clear understanding of their roles and responsibilities
• Increases customer satisfaction and brand loyalty