What is master copy and controlled copy?

Master Copy: It is the final approved / authorized copy of any document which is maintained by QA & stamped as “MASTER COPY” on top centre of each page. B. Controlled Copy : QA shall keep record for all the issued controlled copies.

What is controlled copy in ISO?

Controlled Copy: A controlled copy is a formal copy of the latest, correct issue (approved version) of a document; an identified issue of a document to an individual or location of record. A controlled copy must be officially tracked, updated and stored for use. Data: Facts about an object. ( ISO 9000:2015).

What is a controlled document ISO 9001?

The entire process of organizing updated documentation according to ISO 9001 is commonly referred to as having a “control of documented information.” Like its name suggests, ISO 9001 requires that you have a “controlled,” or organized set of documents that reflect the details of your quality management system.

What is controlled and uncontrolled copy?

A controlled copy is the latest version of the document and when a change is made the document needs to be retreived and replaced. An uncontrolled copy, is a non controlled copy, meaning that is not replaced when a new version is issued.

What is the content of SOP?

In general, technical SOPs will consist of five elements: Title page, Table of Contents, Procedures, Quality Assurance/Quality Control, and References: 1. Title Page – See Section 3.1.

How do you control documents and records?

Identify the changes and current document revision status. Make relevant documents available at points of use. Ensure the documents remain legible and readily identifiable. Identify external documents and control their distribution.

What are controlled copies of documents?

Simplistically, a controlled document is a document that must undergo formal review, formal approval, controlled distribution, controlled modification and controlled storage and access. Or, in other words, a controlled document is a document that goes through Document Control processes.

What are examples of controlled documents?

Examples of controlled documents include engineering drawings, industrial diagrams, operating procedures, contracts, and plans. The process of document control manages the revisions of documents insuring that only the latest version is available to its users.

What is considered a controlled document?

What is the main difference between controlled and uncontrolled documents?

Controlled documents are regularly updated while uncontrolled documents are not.