Meaning of External Documentation Control in ISO 9001 Accreditation

Imagine a customer suing your company because you sold them a product that claims to meet the ISO 9001 accreditation requirements, but it does not match up with the latest version of the standard.


External documentation control aims to prevent this type of issue.


In clause 7.5.3, ISO 9001 states that organizations shall control their documented information to ensure they are available, suitable for use, and adequately protected.


The clause highlights the factors organizations shall address to control documentation, including externally originated documentation.


But what does externally originated documentation really mean? How can you identify and control them?


Today’s blog aims to help you get the answers to these questions.


So, continue reading!


What is External Documentation Control According to ISO 9001 Accreditation Experts?


ISO 9001:2015 quality management system standard requires organizations to determine, identify, and control documented information of external origin.


To control the documented information, the standard suggests addressing the:


• Distribution, access, use, and retrieval of documentation

• Storage and preservation of documentation

• Control of changes in documentation

• And retention and disposition of documentation


So, what is externally originated documented information?


It’s a type of documented information that’s relevant to your quality management system. Issued by an external entity, external documented information can be produced by customers, regulators, suppliers, legislators, business partners, or standardization bodies.


The older version of ISO 9001 accreditation divided documented information into two categories: records and documents.

Records refer to the documented information that organizations must retain, while documents are the documented information that companies must maintain.


Records issued by an external party can be customer orders, maintenance reports, or calibration certificates. Documents of external origin can be related to product specifications, material safety data sheets, logistics specifications, legislation permits, platform rules, standards, and work instructions.


Determining and Surveilling External Documents


To control external documented information, your organization shall determine what externally originated documents are relevant to its quality management system.


You may use a register for each relevant document. The register may contain columns for recording the name, issuing date, updated version, internal distribution, and owner of the document.


Ask yourself the following questions to set up methods for controlling external documents:


• How do you know if the document is updated?

• What are the implications of changes in the documents?

• Is your organization implicating the documentation changes into their practices?

• Who will investigate those implications?

• How should you keep track of new versions and documents?


Besides coming up with answers to these questions, you shall keep relevant parties under surveillance and check if the document issuer has made any changes to existing documents or issued new documents.


Some external parties might be responsible for information and sending documentation-related updates to you, such as work instructions from contractors. It’s essential to identify these parties to ensure they are doing their part.


What Else Should You Know About External Documentation Control for the ISO 9001 Accreditation?


When identifying, maintaining, and controlling external documented information, ensure your quality management system is aware of:


• The relevant documents of external origin

• The person responsible for checking the documents and with what frequency

• What actions to take in case new documents are released, existing documents are modified?

• Who is responsible for overlooking new documents or changes in existing documents?

• How will you get new versions or new documents, update the register, distribute new versions or documents, and check their applicability?

• How will you handle changes and implementation of modifications, and confirm that your QMS has implemented the changes?


Bottom Line


Effective external documentation control is essential for meeting the ISO 9001 accreditation requirements as well as avoiding unpleasant surprises like product recalls, dead inventory, complaints, and reworks. So, follow this guide and ensure your management knows the best ways to deal with external information documentation control

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