Quality Progress - November 2014 - (Page 56)

STANDARDS OUTLOOK 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- Vertical alignment 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 review meetings. 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 Objectives 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- Committee draft which necessitates a commitment to meet faction, and they must be measurable. May 2014 applicable specified requirements. 2013 2014 2015 June 2013 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 July 2015 Final draft international standard 10 9 September 2015 Published international standard Note: Original revision timing subject to change. 56 QP * www.qualityprogress.com 8 be revised to drive continual improvement. 2 without its also knowing what must be The need for adjustment of the objectives 11 12 1 3 4 done to achieve quality. With ISO 9001 7 5 6 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 http://www.qualityprogress.com

Table of Contents for the Digital Edition of Quality Progress - November 2014

Up Front
LogOn
Expert Answers
Keeping Current
Mr. Pareto Head
Finding Harmony
Multipronged Approach
Bank on It
The System Is the Solution
Innovation Imperative
Quality in the First Person
Career Corner
Statistics Roundtable
Standards Outlook
QP Toolbox
QP Reviews
One Good Idea

Quality Progress - November 2014

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