Скачать или смотреть Key Terms on Data, Information, & Documentation in ISO9000:2015-Quality Management System Essentials

In this video, we explore essential data, information, and documentation terms in ISO 9000:2015, which help organizations manage, validate, and verify critical information within their Quality Management System (QMS). Understanding these terms enables organizations to maintain clear, accessible, and accurate records that support effective quality management and compliance.

Let’s go over these key terms:

Data:
Data refers to raw facts and figures collected from various sources. In the QMS, data forms the basis for analyzing processes, performance, and trends.

Information:
Information is processed data that provides meaning and context. In quality management, information helps in making informed decisions and improving processes.

Objective Evidence:
Objective evidence consists of documented proof that a process or product meets specified requirements. This evidence is essential for audits and verifying compliance in the QMS.

Information System:
An information system is a structured arrangement of resources that gather, process, and store information. Within a QMS, it enables easy access to critical data and supports decision-making.

Document:
A document is a recorded piece of information, either written or digital. Documents in a QMS can include manuals, procedures, and instructions essential for maintaining standards.

Documented Information:
Documented information is a broader concept that includes both documents and records. It represents all the necessary information the QMS requires to operate effectively and meet regulatory standards.

Specification:
A specification defines the requirements for products, services, or processes. Specifications ensure that outputs meet customer and regulatory requirements.

Quality Manual:
The quality manual is a document that outlines the QMS structure, policies, and objectives. It serves as a reference for maintaining and implementing quality standards.

Quality Plan:
A quality plan outlines the steps and resources required to achieve quality objectives. It details the procedures and standards an organization must follow for specific projects or processes.

Record:
A record is a document that provides evidence of activities performed or results achieved. In the QMS, records serve as proof of compliance and performance over time.

Project Management Plan:
The project management plan documents the objectives, scope, and resources for a specific project. It guides teams in achieving quality objectives efficiently.

Verification:
Verification is the process of confirming that a product, service, or process meets specified requirements. It ensures that outcomes align with expectations before delivery.

Validation:
Validation is the confirmation that a product or service fulfills its intended use. In the QMS, validation ensures that processes and outputs meet customer needs.

Configuration Status Accounting:
Configuration status accounting tracks and records changes in product configurations. It ensures that all updates are documented and accessible for reference.

Specific Case:
A specific case refers to an individual instance or scenario that requires documentation. In the QMS, specific cases help track unique issues and provide insights for improvement.