Login 
ISO 9001 processes and procedures are integral for meeting the requirements of the ISO 9001 management Standard. While businesses might approach document management slightly differently, the goal is the same: to show a clear commitment to effective document control. The real key?making sure your business has transparent processes and procedures that are defined and aligned with your overall policies and business goals.
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 to maintain quality across your products and services. . Document control is important to keep things organised and running smoothly 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 document control helps you monitor the effectiveness of your documentation and identify areas that need attention. In general, all 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 real 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:
- Processes
- Procedures
- 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 outlines what needs to be done and why it’s important. It could involve activities or tasks that connect with other processes to turn inputs into outputs. By using a process-based approach, your organisation ensures that these processes work together across the entire business, not just within specific teams or departments.
A robust process acts as a strategic tool to outline key objectives and the resources or requirements needed to achieve them. By embedding clear, consistent processes and refining them where needed, your business can create a streamlined, well-managed document control system that runs smoothly and effectively.
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 put in place:
- 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, providing clarity that supports 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.
Mandatory procedures for ISO 9001:2015
Although ISO 9001:2015 has no required procedures, unlike the 2008 version, it’s still crucial to consider these. Let’s take a look.
1. Control of documents
The aim of this procedure is to make sure that all the documents related to the QMS are managed properly, including creating, reviewing, updating and approving documents to make sure all the necessary information is available when needed. Documents no longer in use should be clearly marked to avoid them being used. The control of documents also covers the distribution and storage of these documents, making sure they are accessible to those who need them while protecting their confidentiality.
2. Control of records
The control of records is another crucial procedure for ISO 9001 compliance. Records provide evidence of the effective operation of the QMS and the quality of products or services. This procedure involves the identification, storage, protection, retrieval, retention, and disposal of records. By controlling records, businesses can make sure they have accurate and reliable data to highlight their compliance with the ISO 9001 mandatory procedures and requirements.
3. Internal audit
Internal audits are a key component of the ISO 9001 Standard. This procedure involves regularly assessing the QMS to ensure it meets the ISO 9001 requirements and is effectively implemented and maintained. An ISO 9001 audit helps organisations identify areas for improvement, potential risks, and non-conformities so they can address issues before they escalate. The internal audit procedure should outline how audits are planned, conducted, reported, and followed up on.
4. Corrective action
The corrective action procedure is essential for addressing non-conformities in the QMS. Why? Because when a non-conformity is identified, the business needs to take action to correct it and prevent it from happening again. This involves getting to the bottom of the causes, and then implementing corrective actions and regularly reviewing their effectiveness. By doing this, organisations can completely eradicate the root problems and improve the quality of their products and services.
For more on this, take a look at our blog ‘What is Corrective Action’.
5. Preventative action
Preventative action focuses on identifying potential non-conformities before they happen and taking steps to stop them from happening again. This mandatory procedure for ISO 9001 involves analysing processes, identifying potential risks and implementing measures to mitigate those risks.
6. Control of non-conforming products
It aims to make sure that products or services that don’t meet specified requirements are identified, controlled, and prevented from being delivered to customers. Businesses must determine how non-conforming products are handled, whether they are corrected, reworked, or disposed of. This procedure also includes documenting the non-conformity and any actions taken. Controlling non-conforming products is crucial for maintaining the purpose of the QMS and ensuring that customers receive products and services that meet their expectations.
ISO 9001 documentation
Here are the records that an organisation needs to retain to be able to provide evidence of the result achieved, provided by ISO itself, meaning your ISO 9001 document control is managed effectively.
– Documented information to the extent necessary to have confidence that the processes are being carried out as planned (clause 4.4).
− Evidence of fitness for purpose of monitoring and measuring resources (clause 7.1.5.1).
− Evidence of the basis used for calibration of the monitoring and measurement resources (when no international or national standards exist) (clause 7.1.5.2).
− Evidence of competence of person(s) doing work under the control of the organisation that affects the performance and effectiveness of the QMS (clause 7.2).
− Results of the review and new requirements for the products and services (clause 8.2.3).
− Records needed to demonstrate that design and development requirements have been met (clause 8.3.2)
− Records on design and development inputs (clause 8.3.3).
− Records of the activities of design and development controls (clause 8.3.4).
− Records of design and development outputs (clause 8.3.5).
− Design and development changes, including the results of the review and the authorisation of the changes and necessary actions (clause 8.3.6).
− Records of the evaluation, selection, monitoring of performance and re‐evaluation of external providers and any and actions arising from these activities (clause 8.4.1)
− Evidence of the unique identification of the outputs when traceability is a requirement (clause 8.5.2).
− Records of property of the customer or external provider that is lost, damaged or otherwise found to be unsuitable for use and of its communication to the owner (clause 8.5.3).
− Results of the review of changes for production or service provision, the persons authorising the change, and necessary actions taken (clause 8.5.6).
− Records of the authorised release of products and services for delivery to the customer including acceptance criteria and traceability to the authorising person(s) (clause 8.6).
− Records of nonconformities, the actions taken, concessions obtained and the identification of the authority deciding the action in respect of the nonconformity (clause 8.7).
− Results of the evaluation of the performance and the effectiveness of the QMS (clause 911)
− Evidence of the implementation of the audit programme and the audit results (clause 9.2.2).
− Evidence of the results of management reviews (clause 9.3.3).
− Evidence of the nature of the nonconformities and any subsequent actions taken (clause 10.2.2).
− Results of any corrective action (clause 10.2.2).
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 0330 828 4755? 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?
