ISO 9001 processes and procedures are integral to managing the requirements needed to meet the criteria outlined in the ISO 9001 management Standard. There are subtle differences in how your business can demonstrate a commitment to effective document control. But, making sure your business has transparent processes and procedures that are defined and aligned with your overall policies and business goals remains key.
With so many similar words and definitions, it can become a little confusing to understand each term and the roles they play in meeting ISO 9001 requirements. We’ve put together this handy blog post to help make it much easier for you to understand exactly what is meant by ISO 9001 processes, procedures and work instructions and how they can help documentation control for your business.
Why is ISO 9001 document control important?
Updates to ISO 9001:2015 set out the need to control documented information that ensures quality throughout your business services and product offerings. Document control is important to keep things organised and implemented sufficiently for any management system. ISO 9001 document control helps to establish access to documents and change control procedures that help protect the use of data so you can develop products and services that meet and exceed customer expectations.
Document control is a specific requirement to gain ISO certification and meet the quality management ISO 9001 principles. You need to know what documentation you have that affects how you deliver your product or service to customers. ISO 9001 requires that organisations control creating and updating all documents needed for the quality management system.
Efficient control of your documents allows you to monitor the effectiveness of your documentation and highlight the areas they should be focused on. Generally, all of your controlled documents should be;
- Identified for use
- Suitable for their intended purpose
- Available to review
- Protected from damage
- Confidential (where applicable)
- Stored properly
- Destroyed safely and correctly
Applying a method to control documented information properly ensures you have a process that helps you correctly identify, review and approve documents to help run your business. Having a written format that’s clear and concise will help your employees access and identify this information easily too.
The benefits of ISO 9001 document control
So, now we know the importance of controlling documentation and what needs to be considered, it’s time to look at the tangible benefits of ISO 9001 document control. Below are five benefits that will help elevate the processes and procedures within your business.
- You can review the effectiveness of your processes through data within the documentation, helping you to understand any changes in the data and make appropriate adjustments where necessary.
- Keeping incorrect or historical documents increases the chances of errors, so having a controlled documentation system allows you to monitor this.
- Documented plans and processes give good guidance and can increase efficiency, which will only help your business to thrive.
- The documentation states the correct way of delivering products or services.
- Document control provides evidence of work carried out for future reference.
Efficient document control will help your ISO 9001 processes and procedures be successful and transform your business operations. It also helps demonstrate compliance across your organisation so that you can reap the many benefits of ISO 9001.
What is the ISO 9001 documentation hierarchy?
As there is no definitive structure with which your business should follow for ISO 9001 documentation, you can adapt how you perform your documentation control to suit the needs of your business.
Detailed action levels are frequently developed in the form of processes, procedures, and work instructions to regulate the outcome of the ISO 9001 quality management system. These are often used to help meet the requirements of the ISO 9001:2015 Standard.
Each business will have different requirements that are determined by the size and structure of the company. To make it easier for you, we’ve outlined the three main aspects that should be considered to ensure your document control is airtight. These are:
- Work instructions
So, what is meant by these terms? Well, one thing to note is that they all work in conjunction with each other to form a strong hierarchy to achieve effective control of documents.
ISO 9001 processes
An ISO 9001 process sets out what’s required and the reasons why. You might deploy an activity or a series of tasks that help processes inform other processes to ensure inputs are transformed into outputs. Using a process approach ensures your organisation has a series of processes that can be applied across the whole business rather than just by specific teams or departments.
A robust process should be regarded as a strategic method of control that provides a good summary of the defined objectives and any specifications or resources needed to achieve this. By embedding processes that are followed consistently and improving any areas within those processes, your business will benefit from a well-managed document control system that’s streamlined and functions well.
A strong ISO 9001 process equals strong results, which is, of course, the primary goal for any business. This means also having processes that interact well with other processes to help achieve the purpose of successfully turning inputs into outputs. An example of this could be a process for hiring contractors or managing when annual risk assessments should be carried out and how.
ISO 9001 procedures
An ISO 9001 procedure adds a little more depth to the process method, detailing how a process should be carried out and the reasons why. A suitable approach should highlight exactly what is required. For example, are there any specific tools or resources needed and what are they?
Typically, a procedure should outline the following details to support the processes you have implemented;
- The reason for implementing a particular procedure.
- What the task or action needs to be and a detailed explanation of the method required to reach the goal.
- Any specific roles and responsibilities that need to be performed and by who.
- Details of any tools, information or resources required to carry out the procedure.
- A summary of any related inputs and outputs.
Whilst there have been changes to the ISO 9001:2015 Standard that removes the need for specific procedures to be in place, there’s still a need to implement procedures where necessary within your organisation. Certain areas may not require uniform procedures (such as hiring employees), so a process may suffice. Procedures often provide the bulk of core ISO 9001 documentation that provides clarity that helps the broader benefits of your quality management system.
ISO 9001 work instructions
The third piece of ISO 9001 documentation is work instructions. A work instruction details how a procedure should be carried out, with specific guidelines that help the person or persons carrying out the work know exactly what is required.
There is a similarity between procedures and work instructions in that elements of the procedure will often be repeated, such as the purpose and requirements of a procedure. Adding a work instruction to your document hierarchy allows you to expand on this, providing additional detail and a breakdown of the necessary actions that should be taken to achieve the desired goal.
An ISO 9001 work instruction is organisational and self-explanatory and helps to guide the user in carrying out the action to reach the desired outcome easier.
Detailed instructions and guidance may be required in specific sectors more than others. For example, trade businesses often have many different work instructions that help employees carry out performative tasks. An ISO 9001 work instruction may have a step-by-step guide that’s exclusively related to a specific function but will have limited scope, meaning a new procedure is only sometimes necessary.
ISO 9001 doesn’t mandate the creation of work instructions. However, it’s important to consider their effectiveness by including them in your ISO 9001 documentation to illustrate your commitment to clear, concise quality management outcomes.
Managing your ISO 9001 Standard with Citation ISO Certification
Now you’re up to speed with all the requirements of ISO 9001 documentation; we want to help your business achieve ISO 9001 certification. By partnering with Citation ISO Certification, you’ll gain access to our bespoke Atlas Hub management system. You can use it to store, view, update and manage your documented processes with an easy-to-use modern interface tailored to your business requirements.
We’re here to help your business achieve ISO certification with our simple, cost-effective process.
As one of the UK’s leading ISO certification bodies, we’re here to help businesses establish and improve their ISO 9001 processes and procedures. We’ll help you secure more contracts and success when bidding for work.
So, why not request a quote today, or contact our friendly, professional team to discuss your options at 0333 344 3646? Let Citation ISO Certification manage your ISO documentation effectively and elevate your business!
To learn more about the ISO 9001 Standard and the benefits of a documented management system, why not check out our blog posts below?