ISO 9001 7.5 Documented Information
In ISO 9001 7.5 Documented Information focuses on outlining the requirements for creating, updating, and controlling documented information within a quality management system. (QMS). 7.5 ensures that organizations maintain accurate records of necessary documents to support operations and compliance with the ISO 9001 standard.
Clause 7.5 is divided into three sub-clauses:
· 7.5.1 General Requirements
· 7.5.2 Creating and Updating Documented Information
· 7.5.3 Control of Documented Information
· The importance of Clause 7.5
International Organization for Standardization. ISO 9001:2015 Quality Management Systems – Requirements:
7.5 Documented information
7.5.1 General
The organization’s quality management system shall include:
a) documented information required by this International Standard;
b) documented information determined by the organization as being necessary for the effectiveness of the quality management system.
NOTE The extent of documented information for a quality management system can differ from one organization to another due to:
— the size of organization and its type of activities, processes, products and services;
— the complexity of processes and their interactions;
— the competence of persons.
7.5.2 Creating and updating
When creating and updating documented information, the organization shall ensure appropriate:
a) identification and description (e.g. a title, date, author, or reference number);
b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic);
c) review and approval for suitability and adequacy.
7.5.3 Control of documented information
7.5.3.1 Documented information required by the quality management system and by this International Standard shall be controlled to ensure:
a) it is available and suitable for use, where and when it is needed;
b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).
7.5.3.2 For the control of documented information, the organization shall address the following activities, as applicable:
a) distribution, access, retrieval and use;
b) storage and preservation, including preservation of legibility;
c) control of changes (e.g. version control);
d) retention and disposition.
Documented information of external origin determined by the organization to be necessary for the planning and operation of the quality management system shall be identified as appropriate, and be controlled.
Documented information retained as evidence of conformity shall be protected from unintended alterations.
NOTE Access can imply a decision regarding the permission to view the documented information only, or the permission and authority to view and change the documented information.
7.5.1 General Requirements
This section establishes the fundamentals required for documented information. The organization’s QMS must include the following:
1. Documents required by ISO 9001: These include policies and procedures as well as work instructions and forms that are necessary to meet ISO 9001 requirements.
2. Documents determined by the organization as necessary: Any other documents that the organization considers important for ensuring effective operation and process control.
Examples of documented information are:
· Work instructions – detailed guidelines for specific tasks
· Records – evidence of activities performed and compliance
· Policies and procedures – such as a quality policy or quality manual
7.5.2 Creating and Updating Documented Information
This section ensures that when an organization creates or updates documented information, it must follow a structured approach.
These key requirements include:
1. Appropriateness: The information must be suitable for its intended purpose and user
2. Accuracy: The content should be verified before use
3. Adequacy: The information should be complete and correct
4. Review and Approval: Documents must be reviewed and approved by authorized personnel before distribution.
Some key elements in document creation and updating
1. Identification & Description: Title, date, version number, or reference
2. Format & Media: Paper-based, digital files, databases, etc.
3. Review and Approval: Ensuring documents are reviewed and approved before being issued
7.5.3 Control of Documented Information
This section focuses on maintaining the integrity, availability and confidentiality of documented information. The organization must ensure the Control Measures:
1. Availability and Accessibility:
2. Protection:
3. Version Control:
4. Storage and Retention:
5. Deposition:
Requirements for External Documents
· If external documents such as customer specifications and supplier manuals, are necessary for the QMS, they must also be controlled.
The importance of Clause 7.5
The top 4 importances of clause 7.5
1. Ensures consistency in the process and operations
2. Provides traceability and accountability through records
3. Prevents errors and miscommunication by using up-to-date documents
4. Ensures compliance with regulatory and customer requirements
In conclusion Clause 7.5 Documented Information, by effectively managing documented information, organizations can enhance efficiency, ensure compliance, and improve overall quality performance. In the next blog post we will be diving deeper into Clause 8 Operation.
Related blog posts –
ISO 9001 7.4 Communication
ISO 9001 7.3 Awareness
ISO 9001 7.2 Competence
ISO 9001 7.1 Resources
ISO 9001 – 7 Support Overview Clause 7: 7.1 – 7.5
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