When reading through the current version of ISO 9001:2015 standards, I noticed that the section about creating and updating documented information can be rather vague. So, I decided to do some more detailed reading on the topic to come up with a comprehensive guide on this clause within the ISO 9001 guidelines.
What is creating and updating documented information for ISO 9001? Creating and updating documented information is the process of recording valuable data in a defined and clear manner. In doing this, all specifications must be outlined and identified for monitoring and future reference.
Creating and updating documented information for ISO 9001 is a very detailed process that put include a variety of specific points and characteristics. If you were just as confused about this clause the first time you read the ISO 9001 standards as I was, allow me to explain the exact meaning of this clause.
Keep reading to find out everything you need to know about creating and updating documented information for ISO 9001.
|ISO 9001:2015||ISO 9001:2008||Summary of Changes|
|7.5||Documented Information||4.2||Documentation Requirements||Title only.|
|7.5.2||Creating and Updating||4.2.3||Control Of Documents||This requirement is comparable to the requirements from ISO 9001:2008 Clause 4.2.3 – Document Control|
|7.5.3||Control Of Documented Information||4.2.4||Control Of Records||This requirement is comparable to the requirements from ISO 9001:2008 Clause 4.2.4 – Control of Records.|
When documented information is created and updated, there are a few main points that must be considered and followed in order to be compliant with ISO 9001 guidelines. In this section, we will be going over the general meaning of creating and updating documented information, as well as the main requirements in doing so.
Creating and Updating Documented Information Requirements:
The first and most important thing to keep in mind when creating and updating information for ISO 9001 is that all identifications and descriptions that are being recorded should be clearly defined.
Ideally, these records will be as detailed and specific as possible for monitoring purposes. If the documentation is created in a manner that is vague or unreadable, it will have virtually no use to the company after it has been completed.
In order to create and update clear and concise documents for ISO 9001, credentials such as the date, time, title, author, and reference number should be indicated directly on the document.
Next, all documentation must follow the correct formatting requirements. Since there will be several different types of documents filled out and used throughout the course of any business, there will also be a corresponding format for each of these documents.
In order for the documentation to be considered accurate and effective, it must be following the indicated format for the type of document that it is considered. Along with the proper formatting techniques, the appropriate media must be maintained for the documentation in question.
Before any documented information can be considered adequate along ISO 9001 guidelines, it must be properly checked and reviewed. This reviewing process should go over the clarity of the document, the formatting, media, and contents of the actual record itself.
Once this has been reviewed by someone of the proper authority to make the decision, the document can be approved and considered adequate documentation.
When a document is created following all of the specified ISO 9001 guidelines in terms of detail, format, and approval, the documentation process is not over.
Although documentation and records are an important part of any business that should be accurately and efficiently kept, these documents must also be frequently updated to maintain the accuracy that they were created with.
For instance, if a business has created a document in relation to a product that they are developing, there should be detailed information within that document that describes the progress and current standing of the product in question.
However, if there are any changes made during the design and development process, the initial documentation will no longer be accurate. Take, for example, the design and development of a functional product.
During the design and development stages, there is a step toward the end of the process that includes creating the first prototype of the product. This step, also referred to as “verification” in terms of ISO 9001, will give the organization the chance to test the product and make any necessary changes.
So, if the initial prototype of the product in this stage is not carrying out the function that it is supposed to, the company will be forced to take necessary action to make sure that the problem has been solved. This, of course, will involve making changes to something on the product.
With these changes taking place, the documentation that was first created about the design of the product will not be accurate anymore, and must be updated.
Whenever an ISO 9001 document is updated, it must follow the same exact steps as when it was created as far as detail and accuracy.
When a document is updated in ISO 9001, it must still adhere to the guidelines that are set in place for the creation of a document. All updated information must also be clearly defined and written, with specific dates, times, title, author, and reference number indicated within the document for future reference.
Besides being clear and detailed, the indicated format must also be adhered to, with appropriate media maintenance. All updated documents should go through the review and approval process before they are considered to be adequate and usable.
Basically, the updating of ISO 9001 documentation should be as detailed and thorough of a process as the first time the document was written.
Please click here to find ISO Templates that are proven to work.
Along with the creation of documentation in ISO 9001 as described in the previous section, these documents must also be identified. To be more specific, there must be some kind of written explanation of what the created document is and what it contains in order to be able to easily identify it.
All documents created against ISO 9001 guidelines must be identified with a name, identification number, or another unique way to tell it apart from other documents. As a result, all company personnel who have access to the document in question will know exactly what it is and what to do with it.
To get a better understanding of the identification of documentation for ISO 9001, take a look at the list below.
Identifying and Describing Documents:
The identified documents listed above are very general, but will be sufficient to hold up during an ISO audit. Just for the purposes of an example, these are the most basic identifications of documentation for ISO 9001.
These documents can include, but are not limited to, a procedure document, work instructions, and activity documents.
The procedure document will describe a certain process within the business in detail, while the work instructions document will describe the performance of an activity. Activity documents, on the other hand, will describe activities and evidences.
With the proper identification of ISO 9001 documentation, all documents and records that are kept within the organization will be organized and easily locatable when they are needed during business operations.
To conclude, the creating and updating information clause within the current ISO 9001 guidelines is a very detail-oriented process that requires a lot of specific steps to be followed.
From the initial creation of any document that can be used throughout the organization, formatting and clarity requirements must be strictly abided by in order for the document to be considered adequate.
Additionally, and updates that are given to the first documents must also follow the exact same guidelines in order to make it through the approval process, keeping an organized and efficient business.
The term document control in ISO 9001 refers to the control of documented information that is required by the standards and guidelines. Along with putting these standards in place, the documents themselves should be controlled to fit the specified requirements. This procedure must also be documented according to ISO 9001.
A quality management system (QMS) is a system that helps an organization to document the operations and procedures that go on within the business. The specific documents that describe the QMS system serve the purpose of identifying how the system works and what it does.
A Quality management system (QMS), such as ISO 9001, is a compilation of specific business procedures and processes that help an organization to meet the needs of their customers and ensure that they are satisfied. With very tight guidelines, quality management systems essentially keep a business in line with quality standards.
Written: 24th July 2019
Author: Richard Keen
Richard is our Compliance Director, responsible for content & product development.
But most importantly he is ISO's biggest fanboy and a true evangelist of the standards.
Learn more about Richard
Don’t Try to Manage It All Alone!
Our ISO Auditors and Quality Manager Trainers have been in this industry for years, and since 2002 we’ve been providing thousands of small businesses and large corporations with the tools they need to get certified.
Instead of trying to create everything you need to follow this process from scratch, use ours. We have procedures, templates, checklists, process maps, forms and gap analysis tools to help you control your documented information without missing a single input or output.
Before you invest all the hours reinventing the wheel, before you spend countless dollars outsourcing the task — try our templates.
Control of Documented Information Procedure- view sample
The purpose of this procedure is to ensure that all relevant documented information and organizational knowledge which forms an integral part of our quality management system is managed under controlled conditions and that all documented information is reviewed and approved by authorized personnel prior to issue.
Includes Process Activity Map and 3 forms.
Documented Information Template
Pay by Credit Card, Debit Card, PayPal or Apple Pay.
Bought by Small Businesses and Large Corporations our templates have been sold online and CD since 2002.
The Templates are used by first timers following our step-by-step, clause-by-clause guidance documents; and experienced Quality Managers wishing to streamline and improve their existing documentation.
The application of our templates is scalable and generic; regardless of the size and type of organization. The elements that form the quality management system are the same.
1. Our customizable templates save you time and money by offering a streamlined process to create your quality documentation
2. They’ve got everything you need in one simple template
3. Proven to work our templates have helped thousands of businesses big and small achieve certification
4. Documents use styles to make reformatting and rebranding a breeze
5. Our templates are generalizable for any industry or sector. The application of our templates is scalable and generic; regardless of the size and type of organization.
Please view our Client list.
Please use the chatbox on the bottom right for any FAQs about:
Or, email firstname.lastname@example.org or call us on 0845 054 2886 if you have any questions about our Templates and how they can help you.