What Are the Requirements for ISO 9001?
- ISO 9001
If you’re unsure about the requirements for ISO 9001 certification, this guide will provide you with all the necessary information to prepare for certification to the Quality Management Standard.

Understanding ISO 9001 requirements
The ISO 9001 standard requires documentary evidence of your processes and procedures rather than dictating how to implement them. This approach allows you to tailor your Quality Management System (QMS) to suit your organisation’s unique operations.
- Key ISO 9001 documentation
Not all documentation within the ISO 9001 framework is mandatory, but having comprehensive records can greatly assist in implementing an effective QMS. Below, we discuss the essential ISO 9001 requirements and how to address them.
- Scope of the QMS
Define the scope of your QMS, detailing the types of operations, products, and services your organisation provides, and the boundaries of the QMS. Specify which parts of your organisation the QMS will cover, including processes, sites, departments, and divisions.
- Quality policy
Outline your organisation’s quality goals and commitment to meeting applicable requirements. The quality policy should demonstrate your dedication to improving the effectiveness of your QMS and providing excellent service to your customers.
- Quality objectives and plans
Set specific, measurable quality objectives for your organisation. Outline realistic and achievable plans for reaching these objectives, including assigning responsibilities, allocating resources, and developing actionable roadmaps.
- Procedure for control of externally provided processes, products, and services
Develop a procedure to assist in monitoring the quality of processes, products, and services provided by third-party suppliers. Document criteria for evaluating, selecting, monitoring, and re-evaluating suppliers to maintain high standards.
- Maintenance and calibration records
Keep records of the maintenance and calibration of any equipment used, to monitor or measure your products and processes. Ensure these records demonstrate compliance with recognised standards and include details of the approved laboratories used.
- Competence records
Maintain detailed records of the training and competence levels of all employees. Document any additional training required for quality management to ensure the right personnel are in place for each role.
- Product/service requirements and review records
Record all requirements for your products and services, including any changes or new requirements. Ensure these records reflect customer feedback, purchase orders, and tender requests to maintain high-quality standards.
- Design and development records
Document all inputs, controls, outputs, and changes in the design and development process. Ensure records show that design processes meet defined results and requirements, and that any evaluations of changes are properly documented.
- Evaluation of external providers
Regularly assess and document the performance of your suppliers. Include details of evaluation criteria, results, and ongoing performance monitoring.
- Product/service characteristics
Document the conditions and characteristics of your products and services to assist in managing quality control. Record evidence of how your organisation manages these conditions to meet quality standards.
- Customer property records
Maintain records of how you handle customer property, including details of storage, usage, and any damage that occurs while in your possession. This demonstrates the level of care provided to third-party property.
- Production/service changes
Document any unplanned changes to your products or services. Include evidence of the impact of these changes, the process for handling them, and necessary authorisations.
- Evidence of product/service conformity
Provide evidence that your products and services meet specified requirements. Document the individuals responsible for authorising the release of products and services.
- Nonconformity records
Record any instances of non-conformity in your products or services, along with the actions taken to address them. Ensure there is clear evidence of how conformance is restored following corrective actions.
- Monitoring performance information
A key aspect of ISO 9001 is its emphasis on continual improvement. Document procedures to monitor the performance and effectiveness of your QMS. Keep records of evaluations and evidence that your organisation considers what to measure, how, and when, ensuring appropriate process control.
- Internal audit programme and results
Conduct regular internal audits to assess the effectiveness of your QMS and overall organisational performance. Document the audit programme and results, including any identified issues or opportunities for improvement.
- Management review results
Senior management should regularly review the QMS to ensure its continued effectiveness. Maintain records of these reviews, including minutes, policies, objectives, targets, audit results, and progress towards meeting objectives and numeric targets.
Preparing for ISO 9001 certification
You don’t need all the documentation ready before starting the certification process. An initial audit will help identify areas needing attention. However, preparing as much documentation as possible in advance will facilitate a smoother certification journey.
By ensuring these documents and processes are in place, you’ll be well-prepared to achieve ISO 9001 certification and demonstrate your commitment to quality management.
Recording requirements
Requirements can take various forms, such as purchase orders, customer feedback, or requests for tender. Document these requirements in a manner that suits your organisation, ensuring the quality of your products or services is maintained.
Design and development inputs record
Developing products or services involves considering numerous requirements and demands. These inputs might be recorded in your product/service requirements review record but can also include other crucial elements not explicitly listed as requirements. For instance, while the material used in manufacturing a photocopier might not be a direct requirement, it is vital for the design process.
Record these inputs to demonstrate that your products or services are designed with all necessary considerations in mind.
Record of design and development controls
This record should detail controls over the design and development process, ensuring:
- Clear definition of desired results
- Proper execution of reviews to assess design and development outcomes against requirements
- Verification that design and development outputs meet input requirements
- Checks that products and services meet application and usage requirements
- Resolution of any identified problems
Design and development outputs record
Design and development outputs provide a clear description of the product or service, including detailed information for production or operation. Typical records include model drawings, process instructions, and assembly instructions. Ensure these outputs are verified against the inputs to confirm their alignment.
Record of design and development changes
Document any changes to the design and development process, including:
- Description of changes
- Evaluations of the impact of changes and their results
- Authorisation for implementing changes
- Actions taken to mitigate adverse impacts
Record of evaluation of external providers
As part of controlling third-party suppliers, regularly evaluate them. Document the timing of these evaluations, the criteria used, and the results of ongoing performance assessments.
Record of product/service characteristics
Maintain records that document how you control the production or provision of products and services. Ensure you have evidence that your organisation manages the conditions under which products or services are provided, defining their characteristics clearly.
Record of changes on customer’s property
Handle customer, supplier, or third-party property with the same care as your own. Document details of the property, its owner, storage, usage, and any damage incurred while in your possession.
Record of changes in production/service provision
Document any unplanned changes to your products or services, including evidence of:
- Evaluating the impact on work in progress or delivered products/services
- Updating control documentation as a result of changes
- Authorisation of changes, including responsibilities
- Source of changes and necessary actions and authorisations
Evidence of product/service conformity
Maintain a record demonstrating that processes are in place to monitor and verify that products and services meet requirements. Provide evidence of conformity and identify individuals responsible for authorising product or service releases.
Record of nonconformity
Document any non-conformities discovered in products or services and the actions taken. Ensure there is clear evidence of how conformance is restored following corrective actions. The record should:
- Document non-conformity details
- Describe actions taken
- Detail any concessions obtained
- Identify responsible individuals
Internal audit programme and results
Conduct regular internal audits to assess the effectiveness of your QMS and overall organisational performance. Document the audit programme and results, including any identified issues or opportunities for improvement.
Management review results
Senior management should regularly review the QMS to ensure its continued effectiveness. Maintain records of these reviews, including minutes, policies, objectives, targets, audit results, and progress towards meeting objectives and numeric targets.