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Operational Procedures
for ISO 9001:2015
Requirements
By Luke June 29, 2021

ISO Certification could easily be described as the most

important step you’ll ever do for your business. By Creating
Operational Procedures for ISO 9001:2015 certification
requirements, you are sure to cater to the most critical elements
of your core activities. In turn, by taking a deep dive into these
key activities, you are bound to find areas for improvement that
will have a long-lasting effect on your business – which is just 1
of the benefits of ISO Certification.

Overview of
requirements
In a previous post, we have already discussed the requirements
of the standard, by translating each of the ISO 9001 Clause into
plain English. In this post, we will however take a deep dive into
what we’ll need to do to meet the Operational Procedures for ISO
9001:2015 Requirements.

As an overview of the requirements, we will need to:

1. Operational planning and control

2. Control of production and service provision
3. Identification and traceability
4. Property belonging to customer or external providers
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5. Preservation of product
6. Post-delivery activities
7. Control of changes
8. Release of products and services

The above 8 points are all mentioned within Clause 8. This

Clause is the most important clause within the standard, as it
speaks about the actual operation of the business. Moreover, it is
the most detailed clause. In this post, we will only be covering
the Operational Procedures for ISO 9001:2015 Requirements, and
therefore, we will not be discussing the Sales procedure,
the design & development procedure, or the purchasing
procedure. These procedures are requirements of Clause 8 too.

Documenting a process
The first thing that we have to do is to create the interaction of
processes – how the individual processes relate to one another,
from customer requirements to customer satisfaction.

The key clause relating to processes is Clause 4.4.1:

1. determine the inputs required and the outputs expected

from these processes;
2. determine the sequence and interaction of these processes;
3. determine and apply the criteria and methods (including
monitoring, measurements and related performance
indicators) needed to ensure the effective operation and
control of these processes;
4. determine the resources needed for these processes and
ensure their availability;
5. assign the responsibilities and authorities for these
processes;
6. address the risks and opportunities as determined in
accordance with the requirements of 6.1;
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7. evaluate these processes and implement any changes

needed to ensure that these processes achieve their
intended results;
8. improve the processes and the quality management system.

Input, Process & Output = The Fundamentals of any Process

The desired result is achieved more efficiently when activities
are related resources are managed as a process.

 Input – what will start the process

 Resource – what resources people (skills), software, tools
etc that are needed to get the work done. Who is
responsible for this process?
 Control – how will we make sure that our process is running
correctly – process KPIs. For example, defects in product,
time to complete. Is there any work instruction on how work
has to be carried out?
 Output – the expected result from our process

Change Management
This is one of the new requirements of the standard. Let’s take
an example, many people from construction people – purchasing
manager stated that PO before 1pm will be processed on the
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same day. This change was not communicated to the project

managers. So, they will not get the material in time. And this
change in one of the processes, is having an effect in other
processes. By considering the clauses relating to the change, we
are going to ensure that all implications are taken into
considerations:

 6.3 – as per this clause, the organization shall consider:

 the purpose of the changes and their potential
consequences;
 the integrity of the quality management system;
 the availability of resources;
 the allocation or reallocation of responsibilities and
authorities.
 8.5.6 – the major difference of this clause from 6.3 is that
there the standard is asking for documented information,
describing the results of the review of changes, the
person(s) authorising the change, and any necessary
actions arising from the review.

Key processes
Clause 8 talks about the key activities are done by the company,
as are split by the following departments:

 8.2: Sales & marketing, Business development

 8.3: R&D (design & Development), engineering department
 8.4: purchasing/procurement department
 8.5: service provision/manufacturing
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Operational Procedures
for ISO 9001:2015
Requirements
So without further ado, let’s start discussing each of the
requirements in the level of detail that is required for this
standard. Below is an example of a procedure for a fictitious
company.
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Operational Procedures for ISO 9001:2015 Requirements

As can be seen above, the different roles for the different people
have been highlighted in a different colour. This makes it easier
for each person to quickly identify their role within the
management system. It is interesting that in this particular flow
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chart, on person (the operations manager) is most involved in the

work that needs to be done.

Moreover, it is good to note that more often than not, there needs
to be more than one flow chart created to accurately describe
each of the requirements that are going to be defined below.

Having said that, it probably doesn’t make sense to create a flow

chart, or procedure for each of the requirements defined below.
Therefore an element of judgment is required by the person in
charge of creating the quality management system.

Operational planning and

control
In Clause 6, we would have defined the internal & external
issues relating to the company and would have come up with a
list of risks and opportunities relating to the ISO 9001
management system.

Here, the standard asks us to ensure that our procedures cover

the actions determined in Clause 6. The extent, and the level of
detail to which we are to create operational Procedures for ISO
9001:2015 Requirements, depends on the risks inherent in the
type of company. And this will be highlighted in an example
below.

Control of production and

service provision
Here, primarily we are to ensure that the product/service meets
the state/unstated needs of the customer. Now, depending on the
product/service being sold this can mean many things.

Let’s take 2 examples of widely different companies.

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 A manufacturer of airplanes
 A supermarket

Needless to say, both companies sell critically important

products – and both must ensure that their company offers a top-
quality product to its clients.

Naturally, both are procuring external products from external

providers. And therefore, Clause 8.4 is relevant for both – which
asks to ensure that we ensure that the products, processes and
services that we procure from external providers are of the
desired quality.

However, in the case of the manufacturer of the airplane, given

that they are changing the raw materials, or sub-assemblies, into
a different product – further checks and balances are required.
This is needed to ensure that the parts have been assembled
correctly and that the new finished product is capable of meeting
the customer requirements.

Identification and traceability

There are certain industries where this is more important than
others. For example, importers and distributors of medical
devices must ensure the full traceability of their products.

Naturally, all efforts are taken to ensure a good quality product,

including good distribution practices, however, some mistakes
happen. And a great system for identification and traceability is a
must for Operational Procedures for ISO 9001:2015
Requirements.

Property belonging to customer

or external providers
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Part of ensuring a great quality product and service given to

customers is to ensure that we safeguard property belonging to
customers/suppliers.

Doing an excellent job, but damaging any type of property of the

customer will still result in customer dissatisfaction. By
customer property, we refer to the actual premises, to physical
goods, reputation, information, or any other tangible/intangible
asset.

Preservation of product
Care during transportation has already been mentioned in GDP
Certification, as per above. The standard here simply asks us to
ensure that once the product has been completed, we preserve
the state of the production/service during provision.

Post-delivery activities
As the name implies, post-delivery activities refer to the
activities that we need to do after we have successfully
delivered the product/service to the client. And here, the
standard prescribes exactly what we will need to consider:

 statutory and regulatory requirements

 the potential undesired consequences associated with its
products and services
 nature, use, and intended lifetime of its products and
services
 customer requirements
 customer feedback

These activities include actions required under warranty

provisions, maintenance agreements, and even the possibility of
being involved in the end-of-life disposal of a product.
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Control of changes
No matter how much we plan ahead and follow rigid systems,
change is the only constant. And change might be driven by the
customer, and therefore we would not be in full control of such a
change.

And therefore, the standard asks us to consider what would

happen in the case of a change. Such a case is very common in,
for example, companies involved in the construction industry.
Variations are the norm. A clear definition is required to define
when a new request is to be logged, or when a change on a
previous confirmed job is to be registered.

Release of products and

services
The release of the product might not necessarily happen at the
last stage (when there is the physical handover of the product).
But it may very well be staggered into steps.

Conclusion on the
Operational Procedures
for ISO 9001:2015
Requirements
The above points have covered all the Operational Procedures for
ISO 9001:2015 Requirements. Given that each company must
look at these requirements in a different way, and that every
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company must consider their risks when defining which

procedure to include, we could not go down into details relating
varying companies.

Having said that, we hope that you found this useful.

Should you be interested in getting more specific help relating to

your business, feel free to ask for help. Our dedicated team
of ISO consultants are here to help.