ISO9001 in 2021 Week by Week - Week 28 - 8.2.2, 8.2.3, 8.2.4 Requirements for products and services

This is a 52 week discussion of ISO9001:2015. Each week, we discuss a specific clause of the ISO9001:2015 standard in detail and look for ways to trim the fat. (As a member of TAG/TC176, the committee responsible for review and revision of ISO9001, (possible revision in 2023), I’ll keep you posted on what I learn all year!)

(It is strongly recommended that you purchase a copy of ISO9001:2015  for reference).  And, be sure to do your homework!

Last week, we established our methods of communication with customers and soliciting input regarding their needs.  Now it’s time to talk about understanding and reviewing those needs in order to fulfill them.

This section breaks down the concepts into three very distinct areas.  Let’s have a look at each requirement individually.

8.2.2 Determining the requirements for products and services

“When determining the requirements for the products and services to be offered to customers, the organization shall ensure that:

a) the requirements for the products and services are defined, including:

            1) any applicable statutory and regulatory requirements;

            2) those considered necessary by the organization;

b) the organization can meet the claims for the products and services it offers”

This section is focused first on what the organization would like to offer their customers, in terms of sales and marketing.  This occurs before any customer inquiry or customer contact.  This is the intentional consideration of what products and services (and capabilities) the organization will purport to be able to provide.

When creating marketing materials and sales materials (and training for sales personnel), it is required that all requirements be known, both those relative to statutory and regulatory, but also those required by the organization.  In many cases, this can mean the “application”.  There are many products which, on their own, may seem attractive to a customer in terms of fit or function, but in the wrong application, may not be suitable.  And the organization must determine those requirements so that the most appropriate solutions can be offered.

8.2.3 Review of the requirements for products and services

“8.2.3.1 The organization shall ensure that it has the ability to meet the requirements for products and services to be offered to customers.  The organization shall conduct a review before committing to supply products and services to a customer, to include:

a)  requirements specified by the customer, including the requirements for delivery and post-delivery activities;”

This is a general statement by the customer of what they’re looking for.  It may be in the form of a request for quote, inquiry, or even skipping right to the chase and right to a purchase order.  In any case, it’s the first step in understanding the customer’s requirements.  Some companies accept verbal inquiries and orders.  In this case, the organization should be sure to have a very robust process to ensure all necessary information is gathered proactively.  Regarding “delivery and post-delivery activities”, this requirement is designed to ensure all requirements are clearly understood by both parties prior to entering into a contract.

“b)  requirements not stated by the customer, but necessary for the customers’ specified or intended use, when known;”

This is a real trick bag!  So, the customer may or may not state a requirement, and the onus is on the organization to solicit needs on behalf of the customer, whether or not the customer knows their own requirements.  It’s important that when we are in the role of customer, we be a “good customer’ and know what we need and communicate it clearly to a supplier so that a contract can be successfully executed.  However, not all customers rise to this challenge, and a supplier bears a responsibility for doing their best to understand the customer’s intentions and then make their best recommendation for the customer’s approval.

“c)  requirements specified by the organization;”

This is in support of item “b” above – the organization should have their own set of parameters the customer must provide in order to clearly understand their needs.

“d)  statutory and regulatory requirements applicable to the products and services;”

Again, there is a great deal of responsibility on the part of the supplier to understand their industry and the requirements applicable to the products they’re selling, and also, all potential applications of their products and the impacts of associated statutory and regulatory requirements.

“e)  contract or order requirements differing from those previously expressed.”

(and)

“The organization shall ensure that contract or order requirements differing from those previously defined are resolved.”

This requirement is intended to make both parties responsible for stating and reviewing contract requirements which may become important later.  Buyers and sellers should clearly state, negotiate and agree upon all requirements and expectations.

Also, this area is a risk point where companies tend to fall back on “cut and paste” or repeat orders.  Sometimes, there are small differences that do not get properly carried over when this practice is used.  A robust review should catch these errors and should be resolved prior to accepting an order.

“The customer’s requirements shall be confirmed by the organization before acceptance, when the customer does not provide a documented statement of their requirements.

(and)

“NOTE:  In some situations, such as internet sales, a formal review is impractical for each order.  Instead, the review can cover relevant product information, such as catalogues.”

This gives the organization the ability to take “verbal” or internet orders without a formal review on an order-by-order basis, but an order confirmation stating the requirements so that some form of contract can be established is key.

“8.2.3.2  The organization shall retain documented information, as applicable:

1. on the results of the review;
2. on any new requirements for the products and services.”

This is really puts a stake in the ground that makes verbal and handshake orders difficult to be considered compliant to the standard.  It’s a good requirement that any and all exceptions should be expressly noted and settled, rather than arbitrary substitutions.  And the requirement of “documented information” pretty much requires that all orders be documented.  That is not to say that verbal orders may not be accepted, but they must be documented by someone (perhaps with a simple order acknowledgement)? 

“8.2.4  Changes to requirements for products and services

The organization shall ensure that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products and services are changed.”

This is perhaps the most important requirement of them all.  Typically, taking an order and fulfilling it is the easy part.  Changes after the order is accepted is what can trip us up.  If a customer makes modifications to their requirements, for even something as simple as quantity or delivery date, the changes must be carefully controlled, communicated and executed.

All in all, this section is very clear and easy to understand.  In fact, it is clearer and more detailed than some of the other sections.  As I noted last week, there is some repetition and weird structure here, but the content is easily understood and therefore, easy to meet.

THIS WEEK’S HOMEWORK

What is your customer order review process?  Does your organization proactively solicit all necessary information to fulfill your customers’ requirements (stated and unstated)?  Does your organization maintain “documented information” about these reviews?  Be sure your organization has these bases covered and you will have confidence in your compliance.

You’ll note that this is a key area for the quality management system, but the traditional “quality” department has nothing to do with this on a daily basis.  This is typically firmly in the hands of the outside and inside sales departments with support from engineering, operations and purchasing (in determining what can be offered and provided to customers).  Be sure that this process is clearly owned and operated by the appropriate group to get the best result for your quality management system.

Good luck!

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Watch this 3-minute video about another great resource to accompany this series.   Get the self-directed, on demand, online learning series  ISO9001 in Plain English, today and you'll get:

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