The most crucial part of the ISO 9001 quality management system is document control. It is necessary for organizations to ensure that they have control over their documents, both in terms of creating and updating them while ensuring their accessibility and traceability.
ISO 9001:2015 makes it mandatory to have control over documented information to ensure the quality of your end products. This standard requires document access and change control procedures to be established properly, so that it can protect the integrity of the data you use to build products that can meet customer expectations.
In this blog, we will provide insights about ISO 9001 document control and how controls can be imposed most efficiently for businesses.
Need of ISO 9001 document controls
Organizations need to provide evidence of effective implementation of a quality management system (QMS) if they want to demonstrate conformity with the requirements of ISO for certification, registration, contractual obligations, or other reasons.
These organizations should provide objective evidence of the effectiveness of processes and the overall quality management system. The objective evidence that the organizations need to provide can be obtained through observation, measurement, tests, or other means.
6 mandatory document controls in ISO 9001
ISO 9001:2015, till now has mentioned six mandatory components that are needed for your document control procedure.
. Document Approval
You must have thought about the set process for getting your new documents approved before they are introduced. This provides consistency and ensures that all the documents are properly approved by relevant people, with a full audit trail, prior to use. All you need to do is outline who will review it, the order of review, and who has approval rights.
Make sure that you can evidence this. You can also use a document management system that automates the process as much as possible. For example, you can set rules for someone who has to review specific documents based on their content, deadlines for approval, and workflows around the order of reviewers.
. Document updating and reapproval of amended documents
It is highly recommended that you review your documents regularly and ensure that they are up-to-date, suitable, and still showcase your practices and current legislation. If the process of how you operate has changed or is changing, then you will need to update relevant documents and go through the approval cycle once again.
You can use the right document management system, which will help you make this process seamless and easily auditable. Search for the one who can automatically flag documents that need to be reviewed, and also sends them to the reviewers by email and then collates the updates, ready for re-approval. Make sure you record all the staff who were involved in the document development in the document history, including the timeline.
. Identify changes
If you simply retain the final version of a document, then it will remove the audit trail around its creation and any changes that are made. Hence, the ISO 9001 standard clearly states that all the changes that are made to the documents can be easily identified, including who made them and when they were made.
Use different colors or fonts within the document itself or mention specified numbering or date systems for drafts of the same document to easily identify the changes that are made to the document.
. Make documents available where they are needed
The primary purpose of ISO 9001 document control is to transfer documents to the people that need them in a clear, auditable way. Make sure you have notified the relevant people such as reviewers, of the changes you did in the document.
. Control documents of external origin
Several organizations rely on documents created, supplied, or updated by external partners. It is crucial that document control is extended to cover these details as well as homegrown ones.
Look for the best document management system that offers a variety of user rights from admin to general user. This will ensure accountability and put limitations on the access of an external partner, no matter if they are customers or suppliers.
. Avoid inadvertent use of obsolete documents
If any staff accidentally uses obsolete documents, then this can cause major compliance issues. However, if you delete the old documents completely, then it will cause gaps in audit trails. Also, if circumstances change, then some documents may move from being obsolete to being current again.
So, implement a system that will make it easier for you to mark documents as obsolete and hide them from normal users so that only the latest, approved version is available to them. You can also store the older versions and make those available to selected users, and don’t forget to mention clearly that they should no longer be used.
Standard ISO 9001 documentation requirements
Below mentioned is an overview of the general documentation requirements of the ISO.
. Documented quality policy and objectives
ISO mentioned that the quality policy is itself a document and all the requirements and objectives of the quality policy.
. Quality Manual
The quality manual is also a document that must be controlled. ISO has specified the minimum content for a quality manual. However, the structure and format of the manual can vary depending on the needs of the organization.
It means a small organization can include the description of its entire QMS within a single manual, but a large organization may require several manuals and a more complex hierarchy of documentation.
. Documented procedures
ISO needs documented procedures that must be controlled, which include:
- Control of documents
- Control of records
- Internal audits
- Control of nonconforming product
- Corrective actions
- Preventive actions
Documents that are needed for effective planning, operation and control of processes:
Additional documents that must be controlled are needed to demonstrate an effective QMS. These documents include;
- Quality policy
- Quality objectives
- Quality Manual
- Process maps, process flow charts and/or process descriptions
- Organization charts
- Work and/or test instructions
- Documents containing internal communications
- Production schedules
- Approved supplier lists
- Test and inspection plans
- Quality plans
According to ISO, there are additional documents that might also be required to elaborate conformity of processes, products, and the quality management system. ISO mandates that these documents must be controlled as well, even if the requirements for the control of such records are different from other documents.
Effective document control is the key to have ISO 9001 compliance and successful quality management. ISO 9001 document control allows organizations to establish consistency, and standardization, while promoting continuous improvement and alleviating risks.
From this blog, you can clearly see that ISO 9001: 2015 needs a successful QMS to have robust document controls. Be aware that various types and sizes of organizations have different requirements and resources available to them and still need to be compliant to them.
In present times, smaller, and more agile digital businesses add extra value and innovation to a global marketplace. Hence ISO 9001 allows businesses to create QMS solutions which can help them pay attention to quality outcomes instead of prescribing specific quality processes and procedures that might limit their commercial flexibility.
Visit KSQA to create ISO 9001 certification without any hitch.