ISO 9001 Clause: 7.5 Documented Information

In ISO 9001 Clause 7.5, documented information refers to all documents and records that are required to ensure the effective implementation and operation of the Quality Management System (QMS). It includes information that needs to be created, maintained, and controlled to prove compliance with the QMS requirements and to ensure consistency in processes, products, and services.

There are two main categories of documented information:

1. Documents (Controlled Information) – These are documents that provide instructions or guidance on how processes should be carried out. Examples include procedures, work instructions, quality policies, manuals, and guidelines.
2. Records – These are the evidence or proof that processes have been followed and requirements have been met. Examples include inspection reports, test results, audit reports, and meeting minutes.

ISO 9000 Quality management systems — Fundamentals and vocabulary

3.8.5 document

information (3.8.2) and the medium on which it is contained
EXAMPLE:Record (3.8.10), specification (3.8.7), procedure document, drawing, report, standard.
Note 1 to entry: The medium can be paper, magnetic, electronic or optical computer disc, photograph or master sample, or combination thereof.
Note 2 to entry: A set of documents, for example specifications and records, is frequently called “documentation”.
Note 3 to entry: Some requirements (3.6.4) (e.g. the requirement to be readable) relate to all types of documents. However there can be different requirements for specifications (e.g. the requirement to be revision controlled) and for records (e.g. the requirement to be retrievable).

3.8.6 documented information

information (3.8.2) required to be controlled and maintained by an organization (3.2.1) and the medium on which it is contained
Note 1 to entry: Documented information can be in any format and media and from any source.
Note 2 to entry: Documented information can refer to: — the management system (3.5.3), including related processes (3.4.1); — information created in order for the organization to operate (documentation); — evidence of results achieved (records (3.8.10)).
Note 3 to entry: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1.

3.8.7 specification

document (3.8.5) stating requirements (3.6.4)
EXAMPLE:Quality manual (3.8.8), quality plan (3.8.9), technical drawing, procedure document, work instruction.
Note 1 to entry: A specification can be related to activities (e.g. procedure document, process (3.4.1) specification and test (3.11.8) specification), or products (3.7.6) (e.g. product specification, performance (3.7.8) specification and drawing).
Note 2 to entry: It can be that, by stating requirements, a specification additionally is stating results achieved by design and development (3.4.8) and thus in some cases can be used as a record (3.8.10).

3.8.10 record

document (3.8.5) stating results achieved or providing evidence of activities performed
Note 1 to entry: Records can be used, for example, to formalize traceability (3.6.13) and to provide evidence of verification (3.8.12), preventive action (3.12.1) and corrective action (3.12.2).
Note 2 to entry: Generally records need not be under revision control.

Key Requirements of Clause 7.5

1. Creating and Updating – Organizations must ensure that documents are adequately identified, reviewed, and approved before use. They must be regularly updated as needed.
2. Control of Documented Information – Documented information must be properly controlled to ensure it is available and suitable for use when needed. This includes ensuring that it’s protected, readable, stored properly, and can be retrieved easily. Controlled documents should be version-controlled, meaning old or obsolete versions are removed or marked as such to avoid confusion.
3. Access and Protection – Proper access controls must be in place to ensure that only authorized personnel can create, modify, or delete documented information. It also must be safeguarded from loss or damage.

By maintaining, controlling, and protecting this documented information, an organization ensures that it operates efficiently, complies with ISO 9001, and maintains transparency and consistency in its processes.

Clause 7.5.1 in ISO 9001 takes the idea of documented procedures and records and simplifies them into one term: documented information. This basically means anything that’s important for running your Quality Management System (QMS) – whether it’s digital files, printed manuals, or even labels and signs. These documents aren’t just for show; they’re the backbone of your QMS, helping you prove you’re meeting quality standards when it’s time for an audit.

To stay compliant, your organization needs a solid plan to manage all of this information. We’re talking about making sure documents are approved, reviewed, updated, and properly protected so nothing gets lost or messed with. You’ll also need to decide who gets to see certain documents and who has the power to edit them.

It’s not just about ticking boxes for ISO – it’s about making sure everyone knows what documents matter, why they matter, and how to handle them right. Managers need to promote good document practices, and employees need to be on top of how they manage, store, and dispose of their info.

While you don’t technically need a formal document control procedure, having one keeps everything organized and ensures you’re ready to roll when audits come around. It’s all about staying consistent and efficient, so your team can crush quality goals while keeping everything in check.

Clause 7.5.2 of ISO 9001 focuses on the proper creation and updating of documented information to ensure that everything is accurate, controlled, and up-to-date. When your organization creates or updates documents, you need to make sure they are appropriately identified, reviewed, and approved before use. This means assigning clear titles, dates, authors, and version control to make sure everyone is working with the latest and most reliable information.

Every document must be properly formatted and understandable for the people who use it. It’s not just about having the information – it’s about making sure it’s presented clearly and in a way that anyone can easily access and understand. Whether it’s a new procedure, a revision to a policy, or an update to records, transparency and accuracy are key to maintaining the effectiveness of your Quality Management System (QMS).

In short, Clause 7.5.2 ensures that every piece of documented information is treated with care, keeping your organization compliant, consistent, and ready to roll when it comes to quality control.

Clause 7.5.3 of ISO 9001 is all about keeping your documented information safe, organized, and accessible. It ensures that organizations have a solid process in place to control documents and records throughout their entire lifecycle – from creation to disposal. This includes making sure that documents are easy to find, protected from loss or unauthorized changes, and that only the latest versions are in use.

To comply with this clause, organizations must control access (who can view and edit), distribution (who receives copies), storage (where it’s kept), and retention (how long documents need to be kept). Additionally, outdated or obsolete documents must be handled properly, ensuring they’re not mistakenly used. Whether it’s physical files or digital records, your document management system needs to prevent chaos and confusion, keeping everything streamlined and ensuring that your Quality Management System (QMS) stays effective.

In short, Clause 7.5.3 helps you keep your docs locked down, organized, and in check, so that your team always has the right information at the right time.