What documents make up the quality management system?

How to structure your QMS documentation

• Quality Policy. A policy represents a declarative statement by an organization.
• Quality Manual. The manual should fit your organization.
• Quality procedures. Quality procedures can have different formats and structures.
• Work instructions.
• Records and forms.

What are the six types of documents used in a quality management system?

We currently classify documents as one of the following from highest to lowest level documentation: processes; workflows; desk level procedures; work instructions; letters; forms; logs; and templates. There is always confusion on the difference between a desk level procedure and a work instruction.

What are the main features of quality documents?

Eight Features of a Quality Controlled Document Management System

• Standards. Standards provide a tangible baseline of requirements against which the quality of a document management system can be measured.
• Integrity.
• Access.
• User Interface.
• Projects.
• Efficiency.
• Integration.
• Communication.

What is quality standard document?

Quality standards are defined as documents that provide requirements, specifications, guidelines, or characteristics that can be used consistently to ensure that materials, products, processes, and services are fit for their purpose.

What are controlled documents in quality assurance?

QA document control is an essential part of the quality assurance system for all aspects of GMP, GCP and GLP. It allows you to approve, review and update documents; make changes and identify revision status; control document distribution; and prevent use of obsolete documents, facilitating proper archiving.

What is ISO documentation?

ISO certification certifies that a management system, manufacturing process, service, or documentation procedure has all the requirements for standardization and quality assurance. ISO standards are in place to ensure consistency. Each certification has separate standards and criteria and is classified numerically.

What are the different types of documents?

Types of documents

• Structured text. Frequently asked questions and answers.
• Unstructured text. HTML files. Microsoft PowerPoint presentations. Microsoft Word documents. Plain text documents. PDFs.

What is quality control documentation?

Quality assurance document control is the process used in the management, coordination, control, delivery, or support of an item required for quality assurance purposes. QA document control is an essential part of the quality assurance system for all aspects of GMP, GCP and GLP.