Statutory and

Regulatory
Requirements in
Quality Management
System

DRIVING WORLDWIDE
BUSINESS EXCELLENCE

Not less than thirteen times the

term statutory and regulatory
requirements has been stated in
the ISO 9001:2015 QMS Standard
including the Introduction and
Annex
attempt

A.

This
to

article

understand

is

an
the
Senior Consultant
Omnex India Pvt. Ltd.

meaning of the term, and how

organization needs to comply it.

The term statutory and regulatory

requirements can be expressed
legal requirements; as clarified in
Note 2 under the clause 1.1
(General) of ISO 9001:2015 - QMS
Standard.

sentence for the person or persons

responsible or organization for such
failure.

Statutory refers to laws passed by a

state

and/or

central

government,

This term expresses two types of

while regulatory refers to a rule issued

requirements:

by a regulatory body appointed by a

(i) Statutory requirements

state and/or central government.

(ii) Regulatory requirements

Both statutory requirements and

regulatory requirements are those
requirements that are required by
law. These requirements are nonnegotiable and must be complied
with. Failure to comply a legal
requirement may result in a fine or
penalty and possibly a custodial

Statutory requirements are those

requirements which are applicable
by virtue of law enacted by the
government. These are enacted by
passing the law in the legislative
assembly
or
parliament.
A
regulatory requirement can be
termed
as
administrative
legislation that constitutes or
constraints rights and allocates
responsibilities. It is somewhat
different
from
the
statutory
legislation and there can be
following types of regulations
applicable on an organization:
-

Legal

restrictions

or

responsibilities declared by a
government authority
- Self regulation by an industry
through trade association
A simple

example

for Educational

Institution:
a. Educational System developed and
passed in parliament of India is a
statutory requirement.
b. Controls applied by Directorate of
Controller

of

institutions

Examinations
are

example

for

regulatory

automotive

industries:
a. Companies Act 2013 (amendment
bill 2014) and Motor Vehicles Act
1988 (amendment bill 2015) are
statutory requirement.

(Automotive

Research

Association of India) is a regulatory

body

responsible

for

the

car

mileage figure in India.

ISO 9001:2015 QMS Standard

requires
an
organization
to
determine and control the statutory
and
regulatory
requirements
applicable to the organizations
products and services. It is the
responsibility of the organization to
demonstrate compliance within its
quality management system. On
perusal this ISO 9001: 2015 QMS
Standard,
we
find,
in
the
introduction part of the standard
indicates that this standard, can be
used by internal and external
parties. So it is imperative for the
organization to be aware of the
general and specific statutory and
regulatory requirements applicable
to the product and services within
the
scope
of
the
quality
management system.

to

requirement.
Another

b. ARAI

The term statutory and regulatory

requirements has been used in 0.1
General of this standard, which
states, The potential benefits to an
organization of implementing the
quality management system based
on this international standard are i)
the ability to consistently provide
products and services that meet

the
customer
and
applicable
statutory
and
regulatory
requirements.
In Clause 1 - Scope of the
standard, it has been used three
times to emphasize the importance
of meeting and conforming to
applicable
to
statutory
and
regulatory requirements.
Clause 4.2 uses the statutory and
regulatory
requirements,
while
understanding the needs and
expectations of the interested
parties.
As a demonstration method for
Leadership and Commitment by
Top Management, statutory and
regulatory requirements are to be
determined, understood and met.
In Clause 8.2.2 and 8.2.3.1,
while determining and review of
the
requirements
related
to
products and services.
During the determination of design
and development inputs in Clause
8.3.3, statutory and regulatory
requirements are addressed.
In Clause 8.4.2, statutory and
regulatory requirements need to be
considered while applying type and
extent of control on externally
provided processes, products and
services.
Clause 8.5.5 requires statutory
and regulatory requirements to be
considered in determining the

extent of post-delivery activities

required.
Annex A provides the clarification
on
statutory
and
regulatory
requirements for understanding the
needs
and
expectations
of
interested parties.
Accordingly,
should have
place
(i)

for
and

the
organization
a methodology in

determining,
updating

statutory

all

and

maintaining
applicable
regulatory

requirements,
(ii)

for

communicating

applicable

statutory

all
and

regulatory requirements within

the organization.
(iii)

The organization should ensure

that determined statutory and
regulatory

requirements

are

utilized as process inputs.

(iv)

The organization should monitor

process

outputs

for

compliance with statutory and

regulatory requirements.

In this regard, it is suggested to

have a team in place, having legal
knowledge.
The team should
determine the applicable statutory
and
regulatory
requirements
related to the product and services
of
the
organization.
The
responsibility
of
personnel/functions
in
meeting

these requirements should be

determined and implemented.
Team members may also study the
best
practices
prevailing
in
industries to gain ideas about
smooth implementation of such
requirements. The team should
ensure
communication
of
determined
statutory
and
regulatory requirements to the
personnel/functions concerned with
a copy to the top management. Top
Management should demonstrate
the leadership & commitment by
ensuring the compliance to the
requirements.
It should be the responsibility of
the personnel/functions concerned
to
meet
these
determined
requirements.
The
top
management should also review at
defined
intervals
meeting
applicable statutory and regulatory
requirements.
The

internal

audit

process

can

support
the
compliance
and
demonstration through assessment
of the statutory and regulatory
requirements. It will be a good
idea that the auditor during the
audit preparation phase obtains
relevant information from internal
as well as external sources with
respect to the applicable statutory
and regulatory requirements of
products and services.
Through these methods the quality
management
system
can
demonstrate the compliance to
statutory
and
regulatory
requirements of products and
services.