ISO 22301 Clause 7.5.3 Control of Documented Information (2024)

FAQs

What is part of Clause 7.5 3 Control of documented information? ›

To control documented information, you will need to organize and collect necessary information regarding various processes. From this information, you must develop simplified, diversified materials that can be applied to different departments and organizations.

All the documented information that forms part of the QMS has to be controlled in accordance with clause 7.5 Documented information.

The term “documented information” in ISO 9001 refers to all of the important information within a business that must be kept organized and controlled. It is basically a combination of: Documents; and. Records.

Clause 7.5. 3 – Control of documented information for ISO 27001. At the heart of the ISMS is the Confidentiality, Integrity and Availability principle for the information.

There are two main types of controlled documents: management and operational documents. Management documents are typically high-level documents that provide an overview of your QMS. These could include your quality policy, objectives, and scope.

Clause 4 Context of the Organization. You must establish the aim of your organization, nature of business, and even identify the strengths, weaknesses, threats and opportunities. Organizations are to assess both internal and external influences in formulating and implementing a quality management system.

6. Organizational Knowledge. The organization should determine the knowledge necessary for the operation of its processes and achieve conformity of products and services.

Internal audits must be carried out to a procedure according to requirements given in clause 9.2 of ISO 9001:2015. The procedure must address the responsibilities for conducting the audits, ensuring independence, recording results, and reporting to management.

What is considered document control? ›

Document Control Definition

Document Control is a document management profession whose purpose is to enforce controlled processes and practices for the creation, review, modification, issuance, distribution and accessibility of documents.

Examples of controlled documentation in the company

Most often they are: company policies, work procedures. guidelines, datasheets, manuals, product documentation.

Document control is the process used to maintain documents that control the design, operation, maintenance, and configuration of the site. Records management is the process for providing evidence of those activities.

Answer: "Documented information" is the term that covers both documents and records and there is a little hint on how to determine whether the standard is requiring a document or a record.

Clause 7.1. 5 states: The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. The organization shall ensure that the resources provided: a.

3 Infrastructure. You should seek and record evidence to confirm that your organization has provided the infrastructure necessary for the effective implementation of the QMS and for the operation and control of its processes.

3 Review of the requirements for products and services: Before committing to supply products and services to a customer, the organisation must ensure that it has the ability to meet the requirements to be offered.

The constitution of a closed-loop control system is discussed in chapter 1; the basic system is defined in terms of three elements, the error detector, the controller and the output element.

An uncontrolled document is a document that is accurate at the time it is printed, but is not reviewed or updated. Uncontrolled documents do not have a traceable distribution, so there is no knowledge or record of where they are kept.

What is the difference between maintain and retain documented information? ›

In order to clarify in the ISO 14001 standard what type of “documented information” is required, the standard uses “maintain” where the intent is that a document (e.g. documented procedure) is needed and uses “retain” where the intent is that a record is needed.

This clause notes that your organisation should now be ready to develop, then adopt, manage and continuously improve, a BCMS. You'll need to think through the processes you'll need to put in place to do that, and you should make sure they interact with each other in constructive ways.

The documentation pertaining to the execution and results of audits; The communication of the results of audits to the top management.

The people clause (7.1. 2) ensures that the organisation determines and provides personnel to implement a QMS and to operate and control its processes. The infrastructure clause (7.1. 3) ensures that the organisation determines and provides infrastructure for the operation of processes and to achieve conformity.

To meet this requirement, you should ensure that your organization has established effective arrangements for providing customers with product information, a means of handling inquiries and orders and a method for handling customer comments – both compliments and complaints.

The auditor should form an opinion on the effectiveness of internal control over financial reporting by evaluating evidence obtained from all sources, including the auditor's testing of controls, misstatements detected during the financial statement audit, and any identified control deficiencies.

Types of Internal audits include compliance audits, operational audits, financial audits, and an information technology audits.

Clause 9.2 of ISO 9001: Internal Auditing.

What is the difference between document control and documentation? ›

What is document management vs document control? Document management is about storing, sharing, and tracking documents to improve the efficiency of your operations. But document control is about marshalling the flow of knowledge and data in your organisation.

The document owner is usually a manager with accountability for the process the document covers or a subject matter expert with responsibility for the technical accuracy of the information presented in the document.

To control documented information, you will need to organize and collect necessary information regarding various processes. From this information, you must develop simplified, diversified materials that can be applied to different departments and organizations.

An uncontrolled document is a document that is accurate at the time it is printed, but is not reviewed or updated.

Documented information is broken up into two types, documents and records. A form is a kind of document. When the form is filled out it becomes a record. Quality manual, policy, procedure or work instructions are other kinds of documents.

ISO 22301 is divided into 10 main clauses and has adopted the high-level structure and standardized text set out by Annex L. The standard is divided as follows: Scope. Normative references.

ISO 9001 2015 Clause 7 – Support. No business can succeed without some form of support. This clause is directly relating to the resources and support a business requires to achieve their goals.

The purpose of this procedure is to ensure control over the creation, approval, distribution, usage and updates of documents and records (also called: documented information) used in the QMS (Quality Management System).

What is clause 7.1 4 of ISO? ›

All employees must: Protect themselves and co-workers who may be affected by their actions and behavior; Use appropriate personal protective equipment (PPE) and/or clothing provided; Report any unsafe acts or conditions and follow procedures and work instructions.

This clause talks about the criteria you need to determine when selecting and evaluating external providers, the type and extent of control needed as well as the information to provide to these external providers.

ISO 9001:2008: Design and development verification 7.3. 5 (superseded) Design verification basically means that the product can be produced as designed and that the output meets the intended input requirements.

Clause 7.3: Awareness. As outlined in the sister standard ISO 9000 Quality Management Systems - Fundamentals and Vocabulary, “awareness is attained when people understand their responsibilities and how their actions contribute to the achievement of the organization's objectives.”

The process of monitoring and measuring resources for ISO 9001 ensures conformity for all products and services. This includes making sure that all equipment is valid, up to date, calibrated and working properly. All measurements that are taken must be accurate and recorded for monitoring purposes.

ISO 9001:2015 Clause 7 Support. Key Requirements: Providing necessary monetary and physical assets, resources and systems (such as personnel, plant/office, logistics, working conditions, etc.) Providing and maintaining monitoring and measuring resources (i.e. calibrated equipment)

3 Control of Documented Information. ISO 9001:2015 states that documented information required by the management system, must be controlled to ensure: Availability and suitability for use, where and when it is needed, Adequate protection.

In this clause, you are required to identify and trace the product and service you deliver. Then you'll need to check the status of product or service (for instance, does it pass or fail), to ensure that you deliver acceptable product to the customer.

Clause 8 Intellectual Property

To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries; ArtI. S8.

Documented information

This clause requires that the organisation identify and maintain documents required for the effective working of the quality management system. Methods should be put in place to ensure confidentiality, integrity is maintained and improper use for documented information is prevented.

Which of the following are 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.

Operational procedures, work instructions, flow charts, process maps, signs, placards, container markings, labels etc. are all examples of 'documented information'. Documented information can be in any format and media and from any source.

What is the difference between a record and a document? A document is a unit of recorded information. It becomes a record when it is used in pursuance of legal obligations or in the transaction of business.

The organization shall retain documented information on the release of products and services. The documented information shall include: a) evidence of conformity with the acceptance criteria; b) traceability to the person(s) authorizing the release.

Clause 7 on Support sets out how companies are to deal with identifying resources, determining competence, raising awareness, and documenting information.

ISO 9001 2015 Clause 7 – Support. No business can succeed without some form of support. This clause is directly relating to the resources and support a business requires to achieve their goals.

For example, if your company relies on Dropbox, or FTP servers to keep backup versions of documents, you can use those apps instead of Google Drive. The result, in disregard of the article, will be controlled documents.

Document control can be defined as a series of practices that ensure that documents are created, reviewed, distributed, and disposed of in an organized and verifiable manner. You might also use the term “document management”. While these terms are closely related, they are not interchangeable.

Document control is the process used to maintain documents that control the design, operation, maintenance, and configuration of the site. Records management is the process for providing evidence of those activities.