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Document control and ISO 9001

by | Mar 17, 2016 | Document Control, News and Events

In order to achieve compliance to the ISO 9001:2008 standard, companies are required to produce certain documents including a quality manual, a quality policy, and six specified documented procedures to meet ISO standards. Control of documents is one of these documented procedures. Of course, your company might need to provide additional documentation but these are the minimum standards specified by ISO.

From ISO 9001:2008:

“Documents required by the quality management system shall be controlled.”

With the introduction of ISO 9001:2015, documented procedures are not required but there are three pieces of documented information that must be maintained:

  • the scope of the quality system
  • your quality policy
  • your quality objectives

The other big changes with ISO 9001:2015 include placing greater emphasis on senior management’s involvement in the process, introduction of a risk-based approach and the adoption of a High Level Structure similar to other ISO standards.

Companies who are ISO 9001:2008 certified have a 3 year transition period to move to the 2015 version of the standard.

While the newer ISO 9001:2015 standard is largely focused on internal documents – it does also specify external documents that you receive and bring into your system (see below) – and while DocBoss helps you manage documents that you submit externally to your customers, the standard offers some great guidelines for documentation professionals. Whether you’re working towards ISO 9001 certification or simply want to better your documentation practices, let’s look at the 7 controls that ISO 9001:2008 specifies and how DocBoss can help:

1. To approve documents for adequacy prior to issue.
2. To review and update as necessary and re-approve documents.
3. To ensure that changes and the current revision status of documents are identified.
4. To ensure that relevant versions of applicable documents are available at points of use.
5. To ensure that documents remain legible and readily identifiable.
6. To ensure that documents of external origin determined by the organisation to be necessary for the planning and operation of the quality management system are identified and their distribution controlled.
7. To prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

You’ll notice that the focus is on documentation accuracy, reporting and tracking. There has to be a clear trail of who changed, reviewed and approved each document, how revisions are shown and stored, how  documents are updated, etc. When you do this work manually with an application like Excel, the risk for errors, lost documents, forgotten revisions, etc is great.

Final Thoughts

DocBoss focuses on tagged equipment and helps process equipment suppliers deliver custom documentation to their EPC customers as needed. While DocBoss is not ISO-certified, DocBoss helps you control documentation in a way that is similar to what is prescribed with through ISO or other compliance-related topics such as Germany’s VDI 2770.

DocBoss on the other hand minimizes the manual work required to deliver project documentation. DocBoss tracks individual document history and reverts to previous versions when necessary. The document register along with the history of the changes a document has gone through are tracked in real time.

DocBoss creates and tracks all of your document submittals. The document register is kept up to date automatically. The history of the transmittal number, who it was sent to, dates, etc are all automatically tracked. Dashboard alerts and reminder emails inform the appropriate user that there is some action needed on the document. Comments can be entered to further explain the actions. Once marked complete, the document immediately becomes available for resubmission to your customer.