ISO 9001 Operational Planning and Control
Clause 8.1 provides a high-level overview of the ISO 9001 operational planning and control requirements. Operations is a big umbrella term that covers the core of what an organization does to provide some product or service to its customers. This includes sales, marketing, design and development, order management, production, delivery, service, etc. It is the processes and activities that comprise the main value chain within the organization.
The ISO 9001 operational planning and control clause states that an organization must provide adequate planning and controls over operational activities. Most of these requirements reiterate and point back to other clauses within the organization:
- Determine the requirements for products and services: see clause 8.2 and 8.3,
- Establish criteria for processes: See clause 4.4, 8.2, and 8.3,
- Establish criteria for the acceptance of products and services: See clauses 6, 8.2, 8.3 and 9.1,
- Determine resources needed for operations: See clauses 4.4, 5.1.1, 7.1.2, and 7.2,
- Implementing control of processes: See clause 4.4, 8.4, 8.5, 8.7, and 9.1,
- Maintained and retained documented information: See clauses 4.4.2 and 7.5,
- Planning suitable for the organization: See clauses 4.1, 4.2, 4.4, 6.1, and 6.2,
- Control of changes: See clauses 4.4, 6.3, 8.2.4, 8.3.6, and 8.5.6.
Ensuring that processes and documentation are established for the above referenced clauses of the ISO 9001 standard will go a long way towards meeting the requirements under clause 8.1. The remainder of this article will break down and explain the requirements for products and services (clause 8.2).
ISO 9001 Requirements of Products and Services
ISO 9001 provides some requirements which define how we are to interact with customers and manage customer orders. A good name for this process might be Customer Order Management as it defines and describes the process and activities for receipt, review, conformation, and control of customer orders.
Requirements for products and services should not be confused with the product requirements defined by the Design & Development Inputs process, however, product and service requirements determined in this process may become part of or influence design and development inputs for new product development initiatives.
Let’s take a closer look at each of the ISO requirements for this clause.
Customer Communication (ISO 9001:2015 – 8.2.1)
- Providing product and/or service information: We are going to assume that you already provide the world with information about your products and services through various sales and marketing activities. Just ensure that your different product and service communication activities provide all the information (specifications, features, how to purchase, etc.) needed by your customers. Also, as needed, establish processes to ensure product information is revised and updated when your products and services change.
- Enquiries, orders, and changes: This seems basic, but make sure you have established clear processes for your customers to seek information about products, place orders, and when needed, make changes to orders. If you have limits or stipulations concerning changes to orders, make sure that information is clearly communicated and available to customers.
- Customer feedback and complaints: Customer feedback and complaints provide invaluable information about your customer’s perception of your products and services along with great inputs to your improvement activities. Make sure you have easy methods for your customers to submit feedback information to your organization. Also make sure you have a well-established process for evaluating, investigating, and responding to feedback and complaints.
- Controlling customer property: Establish a process for controlling and protecting property that customers have consigned or provided to you.
- Requirements for contingencies: This is an extension of your risk management process and activities. Consider what could go wrong with a customer order or interaction and where warranted, establish contingency plans. This might include things like delayed shipments and deliveries, union issues, weather crisis, etc.
Determining Requirements for Products and Services (ISO 9001:2015 – 8.2.2)
ISO 9001 requires that the requirements and/or specifications for your products (and services) be defined. Depending on what products your organization provides and how they are delivered to the customer will determine how you satisfy this ISO requirement. This will look completely different for an online distributor versus a custom engineering services company. This is also a two-way street. Make sure that product information (requirements, specifications, etc.) provided through various sales and marketing activities is accurate and complete. On the flip side, when you receive or take an order from a customer, take the necessary steps to fully capture and understand the customer’s requirements and expectations for the product.
Consider how you receive sales orders and what actions are taken or should be taken to ensure the customer’s requirements and expectations are clearly known and understood. Orders can be received through numerous ways such as phone, fax, email, in-person, website/internet, etc. and can be a simple order for a box of pencils to a lengthy contract to develop and manufacture a complex piece of custom machinery. You need to establish a process for taking or receiving orders in a manner that ensures all order and product requirements are clearly defined and which suits your products and customers.
When determining product requirements, first consider those specified by the customer. This might include things such as quantity ordered, pricing / cost, shipping & delivery, packaging, follow-up services, installation, returns, size, color, warranty claims, or any other requirements needed to complete the order and satisfy the customer. For orders associated with website or catalog items, the customer may simply reference a product item number and quantity desired. For custom products or services, the customer will most likely have additional requirements and specifications. No matter what is ordered, how the order is received, or the format of the order, just be sure that the information is clearly defines and captures what the customer wants and expects. It’s hard to imagine a situation where this information isn’t retained (Documented Information) in some manner, whether on a paper order form, work order, electronic order system, etc.
Statutory and Regulatory Requirements: Where relevant and applicable, make sure any statutory (laws) or regulatory requirements are understood, applied, and fulfilled with the order. This might include the collection of sales or other taxes or requirements for specific industries (banking, pharmaceuticals, medical devices, guns and ammo, etc.). Also consider laws and regulations of other countries if you provide international shipments or services.
Requirements Considered Necessary By The Organization: Many times the customer doesn’t know enough to communicate all the product requirements. You are the product or service expert and have the knowledge and understanding to define requirements unknown to the customer. These are often detailed performance or functional requirements that must be fulfilled. These requirements should already be available through internal specifications, instructions, policies, and processes.
Product / Service Claims: Any time you stipulate or publish product or service claims, make sure that you can substantiate and support those claims. This means that your products can truly perform as advertised or that you can deliver the services as documented on your website or marketing literature. In some cases, you might need to verify or validate these performance or feature claims. Just be sure that you aren’t making inaccurate or false statements that your products or services can’t fulfill.
Review of the Requirements for Products & Services (ISO 9001:2015 – 8.2.3)
This section of the standard requires you to perform some level of review and verification of the order before committing to fulfill the it. This is just a double-check to make sure the order is correct and understood, and to help prevent delivery of incorrect products or services. You most likely have some process to check an order and enter it into your order fulfillment or production system. In some cases, this check can even be automated and completed by computers, especially for items ordered via online and websites. Computers can even send automated order conformations back to the customer requesting that they verify and confirm order accuracy. In the end, just confirm that you have correctly received and understood the order, and that you can adequately fulfill the customer’s needs, requirements, and expectations. If not, then resolve any issue with the customer before committing and processing the order.
This verification should also ensure that you are aware of all customer and order requirements and that you can meet those requirements. Be sure to consider all the different requirements, including those for:
- Packaging & labeling,
- Shipping & delivery,
- Certificates of conformance / compliance (CoC),
- Data, reports, or other documentation,
- Product servicing,
- Installation activities,
- Warranty and guarantee provision,
- Other requirements and specifications.
Also review requirements that have not been expressed by the customer but which are still applicable to the order. We discussed some of these above and they might include statutory or regulatory requirements, internal requirements or specifications, or things that the customer overlooked. Consider product capabilities, capacities, and constraints, raw material procurement, external services that might be needed, etc.
When requirements have changed or are in conflict with each other, make sure that these requirements are resolved and confirmed with the customer during the review process. This is especially important when the customer has communicated through different channels or with multiple people within your organization. For complex or custom products or services, this review may involve several different functions with the organization and take days or weeks to complete.
You need to determine what this process looks like and how it is accomplished based on the products or services you provide, their complexity, inherent risks, customer expectations, etc.
The order and associated requirements must be confirmed with the customer prior to accepting and fulfilling the order. Physical receipt of an order from the customer fulfills this requirement and no additional conformation is needed, unless changes or issues with the order need to be resolved. When the customer doesn’t provide any type of order documentation, you must take action to confirm the order with the customer. This can be via phone, fax, email, or any other method that works for you.
The final part of this ISO clause indicates that you must retain documented information supporting the results of your review activities. This should include some indication that the review was completed along with documentation of any changes, issues, or other requirement information gained or addressed through the review process. This can be as simple as initials or a stamp on a basic order form or as complex as an executed contractual services agreement including an attached statement of work. You decide what works for your organization.
Changes to Requirements: (ISO 9001:2015 – 8.2.4)
This clause is very straightforward. If requirements change after the review and commitment process is complete, then make sure you revise all necessary documentation and ensure that all applicable and affected personnel (including the customer) are made aware of the changes. We recommend that the changes and reconfirmation of the changes with the customer be documented.
Having effective ISO 9001 operational planning and control processes is imperative to ensuring that products and services delivered to customers conform to specifications and requirements. This ensures customer satisfaction and continued growth and prosperity for the organization.
Before starting any production activities, be sure to determine and review all requirements for the product or service to be provided, especially those requirements dictated by the customer. Also, be sure to identify those requirements not defined by the customer. One you review and verify that the product or service requirements can be met, it is time to move forward with production activities.