ISO Purchasing Process
The Purchasing requirements in the ISO 9001 standard help to ensure that the products and services you purchase from various suppliers fully meet your needs so that you can, in turn, satisfy your customers. The disruption and cost to your organization stemming from supplier problems can impact your customers and your bottom line.
So, having processes in place that prevent problems and provide consistency within your supply chain is a key focus of your ISO quality management system (QMS).
With a successful strategy, you’ll be able to move your operations forward to meet industry standards and prevent complex compliance issues in the future. As you navigate critical requirements for your industry, you need to have processes ready to address operational needs and seamlessly navigate your business needs. Consider how to approach ISO 9001 purchasing requirements and get the most value from your business’s QMS.
Controlling What Is Not Under Your Direct Control
It is surprising how many times a ‘supplier problem’ actually has its root cause in your own organization stemming from internal miscommunication, inaccurate information or other mishaps that lead to ‘mistakes’ made by a vendor.
Your Purchasing Power
While your suppliers’ operations are not under your direct control, your purchasing power can give you significant influence over which suppliers you do business with and how they meet your needs. This influence starts with you having a clear understanding of what your needs are regarding purchased materials and services. These needs then must be translated into criteria for choosing suppliers and requirements for them to meet. Without this clarity, neither you nor your suppliers will know what to expect, which will inevitably lead to problems down the road.
Controls are put in Place
The ISO 9001 requirements for Purchasing (section 8.4) itemize basic processes that will put you and your suppliers on the same page. Your ISO QMS then begins with you firming up your own purchasing processes to improve the information suppliers will rely on to meet your requirements. Then, controls are put in place to monitor supplier performance and to take corrective action, if needed. By establishing strong internal procedures for purchasing, you’ll more easily exert the influence needed to assure quality coming into the loading dock.
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ISO Purchasing Requirements
When considering ISO 9001:2015 purchasing, you’ll need to keep some critical information in mind to obtain what you need for your business. It’s important to ensure you’re using the product correctly to get the most value for your purchase. With each step in the process, you want to remain aware of your goals and critically evaluate your options.
To help your organization grow and succeed, you need a product that seamlessly works with your unique operational needs.
The Product you are Purchasing Must Comply
You must ensure the product you purchase will comply with regulations while also fitting your applications. According to ISO 9001 standards, you’ll need to follow some key requirements to purchase a fully compliant product.
The purchasing requirements begin with a recognition that your company is responsible for ensuring that purchased products meet the criteria set forth by ISO 9001.
Establish Controls for your Suppliers
To do this you’ll establish controls for your suppliers and your purchased product that are appropriate based on how the supplied product might impact your products and/or services delivered to your customer. If a supplied part is critical, you’ll exert more control than if a part is less important to your company’s output quality.
Start with Suppliers you Depend on the Most
This control begins with selecting suppliers that you’ll depend on to meet your own customers’ requirements. You’ll implement processes for initially qualifying suppliers based on appropriate criteria such as cost, quality, and delivery requirements. The criteria you establish should make sense for your business.
Records for the selection, evaluation, and re-evaluation of your suppliers must be maintained.
Communication is the Key
How you communicate with your suppliers has a direct impact on their ability to meet your requirements. Your documented purchasing requirements define the target they must hit when delivering their products or services. The accuracy, clarity, and level of detail provided in your purchasing documents must be ensured through good internal administrative processes.
You Must Communicate Clearly to Your Suppliers.
You must ensure that you provide clear information to your suppliers. Section 8.4.3 states that you must communicate the requirements for:
- The processes, products, and services needed.
- The approval of products, services, methods, processes, equipment, and release.
- Competence and qualifications.
- Interaction with your organization
- Control and monitoring of external provider performance by your organization.
- Verification/validation activities to be performed on an external provider’s premises.
Make sure the Details have Adequate Descriptions
On purchase orders or other documentation, be sure that the details adequately describe the product or service you require, including technical specifications, packaging and delivery requirements, and special requirements for your supplier’s internal processes. Again, depending upon the type of product or service purchased, the information will include more or fewer details. Your internal procedure should ensure that all purchasing information is reviewed before being sent to your supplier.
Making Sure It’s Right
Verify Orders Fully Meet Your Requirements
The next purchasing process to address is how you verify that the received material and services are what you ordered and that they fully meet your requirements. This verification may be through a simple confirmation when the product is received or may involve formal inspections or testing.
Designate qualified and trained personnel to check the product and confirm it fits your standards. If necessary, you may even want to verify the product before it is shipped or allow your customer to do so, by visiting your supplier’s facility for an inspection.
If this is required, you’ll need to specify this in your purchasing documentation when the order is placed or the contract is signed. Ensuring the product is fully compliant with standards will allow you to proactively meet requirements and seamlessly transition into implementation.
A Step-by-Step Approach
As you prepare to implement an ISO 9001-compliant purchasing process, you might want to follow this six-step process:
Step 1. Define Criteria for Suppliers
Consider on what basis you will choose your suppliers or what minimum requirements they must meet. Develop a plan to evaluate suppliers, confirm their compliance with requirements, and ascertain that they follow any criteria you establish.
Step 2. Evaluate Current Suppliers
Which of your current suppliers meet your minimum requirements and which need to improve to remain qualified? The list of criteria you have developed to evaluate your suppliers will help you identify how your current suppliers measure up to standards.
Step 3. Establish Qualification Process for New Suppliers
How will you identify, evaluate, and qualify new suppliers? How will these qualifications be recorded? Develop a clear strategy for qualifying new suppliers and ensuring they continue to meet any criteria you have established.
Step 4. Set up Supplier Performance Monitoring Process
Figure out the best way to track supplier performance, including who will review the data and when action will be taken. Determine how you will monitor and track performance and designate trusted personnel to review data and follow up with any questions, considerations, or action steps.
Step 5. Review Purchasing Communication Process
How are your requirements documented for your suppliers? How do you ensure it is accurate, clear, and detailed enough to communicate what is ordered? Review your communications with suppliers from your audience’s point of view and evaluate your documents’ effectiveness in detailing orders and standards.
Step 6. Review Purchased Product Verification Process
What procedures are needed to confirm that you received what you ordered? When might a visit to a supplier’s facility be needed to verify a shipment? Establish the protocol you will follow to ensure the products you order fit the standards you have set.
For many organizations, bringing your purchasing processes up to ISO 9001 standards is an investment of time and effort that must fit into an already busy schedule. This effort will support your ISO initiative and lead to fewer interruptions and unnecessary costs resulting from poor supplier performance.
Post Purchase Steps
Identify any Gaps
After you’ve made your purchase, you’ll need to begin the implementation process. Take the time to evaluate your requirements, identify any gaps between your current and desired state, and make an action plan to reach your objectives. After you’ve begun working toward meeting compliance standards, you can get a certified auditor to assess your progress and determine your eligibility for the ISO certification.
If you’re successful, you can move forward with maintaining and updating your organizational quality management system.
You can focus on continuously improving your system and staying up-to-date on the latest regulations. You need to recertify your business every three years to ensure you continue to meet certification criteria.
About Scott Dawson
Since 2010, Scott Dawson, President of Core Business Solutions, has been an active voting member of the U.S. Technical Advisory Group (TAG) to ISO Technical Committee 176 (TC 176). TAG 176 members meet to discuss and develop U.S. positions for Quality Management standards, including ISO 9001:2015, which will be revised in 2026.
Optimize ISO 9001:2015 Purchasing With Core Business Solutions
At Core Business Solutions, we offer trusted solutions to help you navigate key requirements for your business. With extensive expertise in the industry, we provide trusted resources and guidance to help your small business navigate complex ISO 9001 requirements. If you’re interested in getting more information, request a quote from us today.
