Quality Progress - November 2014 - (Page 56)
BY R. DAN REID
Catch My Draft?
Dissecting the ISO 9001:2015 draft international standard
AS YOU probably know, ISO 9001, the fun-
The purpose of this support was to
go that far. Without an effective process
damental international quality management
drive standardization among new or
to determine customer requirements-
system (QMS) standard, is being revised. It is
revised ISO management system stan-
the quality policy-effectiveness of the
at the draft international standard (DIS) stage
dards, such as those related to quality,
QMS is compromised. The quality policy
at the time of this column's publication and
the environment, and occupational health
is intended to drive conformance with
due to be released in September 2015. Figure
and safety. The adopted proposal has
specified requirements, as well as drive
1 shows the revision timeline.
been incorporated into the ISO directives,
continual improvement of the QMS.
known as Annex SL, and also requires
This article discusses some content in
Note that in ISO 9001, continual
the current draft, but remember that chang-
use of some common text under the
improvement of products and services
es still may be forthcoming, so you should
required clause structure.1
is not required because it would be dif-
not proceed too far with implementation of
Some carryover content between the
ficult-if not impossible-for regulated
ISO 9001:2008 and ISO/DIS 9001:2015 has
industries to meet that requirement under
to do with the clauses involved in vertical
the current regulatory environment. Con-
alignment (Figure 2). Many organiza-
tinuing suitability of the quality policy
It's important to realize not everything in the
tions, including those that certify and
is to be reviewed in formal management
new version of ISO 9001 is changing. The
implement QMSs, do not understand the
2012 global user survey that was conducted
critical role and linkage of the clauses as
to determine whether a revision to ISO 9001
intended by the standard writers.
new content in the standard at this time.
The first process is to determine
was needed indicated a majority of users
Quality objectives are to be established and
believed the standard was acceptable as-is or
customer needs and expectations, which
to be consistent with the quality policy. The
with slight modification.
is located in two clauses of the new draft
DIS defines an objective as a result to be
titled, Clause 4.2-Understanding the
achieved. Objectives start at the enterprise
within the International Organization for Stan-
needs and expectations of interested
level to address the external specified re-
dardization (ISO) community, when a small
parties, and Clause 5.1.2-Customer
quirements, such as regulatory and custom-
task force recommendation to use a new and
focus. There are three sources of specified
er-related ones. There are generally five to
mandatory clause structure was supported by
requirements for organizations:
10 high-level objectives.
the ISO technical management board.
1. Internal (for example, engineering).
The support for change came largely from
More detailed objectives, however, are
2. External (statutory and regulatory).
3. External (customers).
Timing of ISO 9001
revision / FIGURE 1
to be deployed to relevant levels and functions within the organization to support
The DIS addresses the external require-
the enterprise-level objectives, which are
ments in these clauses, which are then
meant to drive conformance with require-
input for the quality policy. There are
ments. Objectives are required to be
requirements for top management related
relevant to product and service conformity
to the quality policy in ISO 9001-one of
and to the enhancement of customer satis-
which necessitates a commitment to meet
faction, and they must be measurable.
applicable specified requirements.
Draft international standard
W. Edwards Deming said management
Objectives are part of planning the QMS,
but after objectives are met, they should
commitment to quality is insufficient
Final draft international standard
Published international standard
Note: Original revision timing subject to change.
56 QP * www.qualityprogress.com
be revised to drive continual improvement.
without its also knowing what must be
The need for adjustment of the objectives
11 12 1
done to achieve quality. With ISO 9001
also should be evaluated in the manage-
being the minimum set of requirements
ment review process. The current stan-
for a functional QMS, the QMS does not
dard lists the clauses in this order, but the
Table of Contents for the Digital Edition of Quality Progress - November 2014
Mr. Pareto Head
Bank on It
The System Is the Solution
Quality in the First Person
One Good Idea
Quality Progress - November 2014