ISO 9001:2015 – Newsletter – Issue 77

Clause 8.1  Operational planning and control:  If you are serious about “controlling” your processes then this first Clause is the best way to start.  Clause 8.1 asks you to address all of the basics, from knowing what output is required from your process; to deciding what is considered good vs bad output; to installing controls to catch poor output; to making sure the process has enough resources to run properly; and to maintaining records to prove the process did what it was supposed to do.  You also want to manage the risks associated with “changes” you make to any process, which means having action plans ready to mitigate any adverse effects from those changes.  Finally, if you decide that it makes better business sense to outsource (or contract out) the whole process, then make sure you have a way of keeping your outside Vendor/Supplier accountable for all of the things you expect from them.

Clause 8.2  Requirements for products and services:  This Clause contains four (4) sub-clauses, Sub-Clause 8.2.1 (Customer communication), Sub-Clause 8.2.2 (Determining the requirements related to products and services), Sub-Clause 8.2.3 (Review of requirements related to products and services), and Sub-Clause 8.2.4 (Changes to requirements for products and services).  This Clause builds on the previous one and drills deeper into completing understanding exactly what is required of the product or service (the output from your process) that you are providing either to an internal customer or to an external Customer.  Including how you plan to communicate with your Customer; how you will review the requirements to make sure your process can meet them; and how you will handle any changes that arise.  “Changes” is one of the biggest challenges affecting whether you can maintain control over a process… but if you can figure it out, then you can satisfy your Customers all day long!

Clause 8.3  Design and development of products and services:  This Clause contains six (6) sub-clauses, Sub-Clause 8.3.1 (General), Sub-Clause 8.3.2 (Design and development planning), Sub-Clause 8.3.3 (Design and development inputs), Sub-Clause 8.3.4 (Design and development controls), Sub-Clause 8.3.5 (Design and development outputs) and Sub-Clause 8.3.6 (Design and development changes).  Every product or service (output from your process) at one time or another needed to be designed so that it could satisfy what your Customer needed.  In some companies, this “design” activity was only required once, and not for every Customer Order, so it would be a N/A requirement (Not Applicable).  However in other organizations, every Customer Order that comes through needs to be “designed” before it can be produced (or supplied, in the case of a service), and that’s where Clause 8.3 becomes useful in laying out all of the steps you’ll need to follow if you want to control this “design” process.

Clause 8.4  Control of externally provided processes, products and services:  This Clause contains three (3) sub-clauses, Sub-Clause 8.4.1 (General), Sub-Clause 8.4.2 (Type and extent of control) and Sub-Clause 8.4.3 (Information for external providers).  Even though the word “purchasing” is no longer found within the ISO 9001:2015 Standard, the main focus of this Clause is really about “purchasing”, so think first about “suppliers and vendors” when you see the term “external provider”.  Ever heard of the acronym GIGO?  What it stands for is “garbage in, garbage out” which if you are trying to control a process means wrestling with poor quality coming in which puts added pressure on your process to transform that poor input into a good quality output.  This Clause wants you to look upstream of your process and install the right controls to prevent poor quality from ever reaching your process.  Once you control the goods and services that you “purchase” from Vendors/Suppliers, then you need to look at a broader scope since this Clause encompasses many more activities, with many more players, regardless of whether money actually changes hands (i.e. Corporate Headquarters; Sister Plants/Facilities; Shared Services; Other Depts; Joint Ventures; Associations; etc).  The reason why you’ll want to look at all of these other players is because GIGO is still a big factor when trying to control a process, whether you paid for it or not!

Clause 8.5  Production and service provision:  This Clause contains six (6) sub-clauses, Sub-Clause 8.5.1 (Control of production and service provision), Sub-Clause 8.5.2 (Identification and traceability), Sub-Clause 8.5.3 (Property belonging to customers or external providers), Sub-Clause 8.5.4 (Preservation), Sub-Clause 8.5.5 (Post-delivery activities) and Sub-Clause 8.5.6 (Control of changes).  During my training sessions I usually refer to Clause 8.5 as the “heartbeat” of the Standard because it’s where the action happens… when you finally get to produce your product or provide your service.  The theme throughout this Clause is how to “control” your process and it says so in the very first opening sentence: “The organization shall implement production and service provision under controlled conditions“, which it then proceeds to tell you how to do that.  Like all of the previous Clauses, there are far too many “requirements” to discuss them all here in detail.  As a Manager, all you really have to know is that all of the ingredients needed to “control” these critical processes are clearly spelled out in Clause 8.5, so if “controlling processes” is important to you then dive deeper into the words inside this Clause and see what you need to do.