0 steps to a successful ISO

9001:2015 implementation and

certification.
4 years ago
by Sree vidhya
Irrespective of the size of your organization, or what type of products or services
you deliver, ISO 9001 accreditation has huge advantages that will help you manage
the organization better, while at the same time fostering a culture of continued
improvement. Being ISO 9001 accredited does not simply give you bragging rights,
but defines a solid framework and structure based on management principles that
will not only enable the company to operate efficiently, but will also drive continual
improvement in all aspects.

To help you get started in implementing ISO 9001:2015 and get certified, we
describe 10 steps that will help you manage the process effectively.

1.     Identify the reasons why you want to become ISO 9001 accredited
Deciding to go for ISO 9001 accreditation simply because some of your customers
demand it, or because someone in management thinks it might be a good idea, is
not good enough and will likely lead to failure.

For an ISO 9001 implementation to be successful, it is critical that top management

understands ISO 9001 and the very real benefits it can provide from a business
point of view, and that overall business efficiency would be improved by
implementing a Quality Management System (QMS). The 2015 version of the
standard in fact requires that top management demonstrate to all interested
parties that the organization is committed to quality.

Key drivers for implementing a QMS typically includes improved awareness of key
processes’ performance, the need for continual improvement and meeting any
specific customer requirements.
2.     Purchase a copy of the standard
You will need to purchase a copy of the standard to determine the exact
requirements. The ISO standard is universal to all industries, so there is no need to
search for a specific sector. If your country has a standards authority, there might
be a version of ISO 9001 specific to your country. These normally use the ISO
standard as a basis, but might have some minor changes to cater for specific
legislation.

While being accredited to a country’s ISO standard will not present problems if you
only trade in that country, it might not be acceptable if you trade internationally in
multiple countries. In that case, the standard of one country might not be
acceptable in another and customers might require that you either be certified to
their country’s standard, or the original ISO standard. If this differentiation exists in
your business, you also need to take care in selecting the certification body you’ll
use, as they will be accredited to certify companies to specific standards.

3.     Strategy definition
The first step in the actual implementation is for top management to define and
write a formal document containing the Quality Policy and Objectives as per the
requirements of the ISO 9001:2015 standard. The requirements of the quality policy
must be measureable so that you can demonstrate continuous improvements.

4.     Planning resources
Resources should be made available and realistic timelines set to ensure that the
QMS can be implemented within a reasonable time. Responsibilities should be
shared within the organization and as top managements is ultimately responsible,
it’s a good idea that they are made responsible for some of the functions within the
QMS. Although a formal implementation project plan is not required by ISO 9001, it
is a logical method to identify needs and check implementation progress.

You could decide to implement the QMS using in-house resources, hire a
consultant or use a software system such as MyEasyISO. Each of these approaches
have their own pros and cons. When using MyEasyISO, the major benefit is the
reduced time and effort required, which will in turn lead to a substantial cost
saving. This does not only apply to the initial implementation, but also to the
subsequent maintenance of the system.
While the system is developed, the implementation project plan should be
reviewed by senior management regularly.

5.     Identify your processes

A key requirement of IS0 9001 is that you need to follow a process based approach.
In order to do this, you need to describe the interaction between the processes
within you organization. A simple process map specific to your company can be
used for this.

For each key process, it’s a good idea to identify the controls, resources, records
and documentation needed to meet requirements. Validate this process map
across the complete business to ensure no interactions or areas are missed. This
process map should be used, reviewed and updated during all stages of
implementation and should eventually be included in the Quality system.

6.     Training needs
ISO 9001 requires that awareness, competence and training needs for employees
coming within the scope of the Quality Management System, need to be identified.
This will require internal or external training. There are many courses, workshops
and seminars available to meet these needs. It is also a good idea not to wait until
the QMS has been fully developed and implemented, before starting with training.

Employees need to be aware of what is happening, how it will affect their job, and
what the consequences of non-compliance will be. Training on these aspects
should start sooner rather than later, as this will ease the actual implementation
process.

You also need to make sure that you will be able to demonstrate the effectiveness
of training, so give some thought to how this can be achieved.

7.     Develop documentation
ISO 9001:2015 requires controlled documentation of the Scope of the Quality
Management System, a Quality Policy, Quality Objectives and a Procedure for the
control of outsourced processes.

While these four documents are specifically required by ISO 9001:2015, there will
be a number of others deemed to be necessary by the organization. ISO 9001 also
requires that numerous different types of records be kept. When developing
documentation, it’s always a good idea to involve the employees that will ultimately
be responsible for maintaining the documentation and records.

When using MyEasyISO to implement ISO 9001:2015, this step becomes very easy
as all the required documents and records have already been defined within the
software. It simply becomes a matter of completing the supplied templates with
you company specific data.

8.     Implementing the QMS

Once the QMS has been developed, it should be implemented. It should be noted
however that these two steps don’t necessarily have to run consecutively, i.e. you
don’t have to develop the complete system before implementing it. As you
complete the development of certain sections, start training and implementing it
immediately, while development of the other sections continue.

By doing it this way, you will shorten the overall project time. Another advantage is
that you will begin generating records sooner, and will be able to quickly identify
any areas that are not working as they should, or identify gaps if any exist.

Implementation of the standard’s requirements should be checked by doing

internal audits. It’s a good idea to make the internal audit process one of the first to
be implemented, together with non-conformances and corrective action. A
management review could also be done to ensure the system’s adequacy,
suitability, and effectiveness, although this only makes sense one the full system
has been implemented and running for a while.

9.     Pre-assessment audit
Although this is not a requirement of ISO 9001, a pre-assessment audit by the
certification body will enable you to identify any gaps between the requirements of
the standard and your existing processes. This audit can be done at any stage and
does not form part of the certification process.

10.  Get certified
You need to identify and contact a nationally accredited certification body to
perform the actual certification. If possible, select a body that has experience in
your industry as they will be able to share the experience they’ve had with similar
companies.