Web-based news outlets and press release distribution sites are packed with announcements from companies boasting their recent completion of ISO 9001:2008. A quality management system centered on helping organizations better meet the needs of their customers and other stakeholders, the ISO family of standards is viewed as an effective way to validate a company’s commitment to quality.
As one of the components of the ISO 9000 standards, ISO 9001:2008 replaced the previous ISO 9001:2000. Its objective is to provide quality management systems that will benefit the certified organizations, help those entities manage business more effectively, and also put in place best practice methodology. Some of the benefits that ISO 9001 affords its recipients include improved customer satisfaction, more motivated employees, and continual improvement.
Swift corrective actions
Scott Fricke, director of corporate quality for Hotenda Corporation in Thief River Falls, Minn., sees ISO certification as necessary for any organization operating in the electronics sector.
“It is almost a given that you be certified if you want to be in this business at all,” says Fricke, who views ISO standards as a framework for creating checks-and-balances within an organization. “It’s particularly relevant for manufacturers that want to make sure they are using top-quality tools, processes, and standards.”
For electronics buyers, ISO helps ensure that the right parts get to the right location at the right time.
“It is almost a given that you be [ISO] certified if you want to be in this business at all,” says Hotenda’s director of corporate quality Scott Fricke.“When you go through ISO, an independent third party certifies all the processes behind those key steps to make sure that they are consistent and correct,” Fricke points out. “Once that’s completed, the systems will be in place to identify problems and take the corrective actions quickly.”
What’s on tap for 2015?
A new version of ISO 9001 is expected to be introduced in 2015. The standards are currently under review, according to Charles Corrie, BSI Secretariat of ISO/TC 176/SC2, which is a quality system standard. BSI is his firm, and it's a standards consultancy that offers standards, training, testing, assessment and certification. The proposed revision has reached the “committee draft stage” and has been circulated for review and a ballot. Corrie says this stage will be completed by the time of the planned meeting of ISO/TC 176 in November, when the preparations for the Draft International Standard (DIS) will start.
“The current work program expects the DIS to be circulated around April 2014,” Corrie says, “and the next stage after that (the Final Draft International Standard) to be available around July 2015, with publication expected around September 2015.”
Key changes to come
If you’re wondering how the revised ISO standards will affect your procurement organization, Corrie provided a brief outline of the key changes (per the current Foreword to the Committee Draft). Here they are:Annex SL
ISO/IEC Directives, Part 1, Consolidated ISO Supplement, 2013, Annex SL, Appendix 2 sets out the high level structure, identical core text and common terms and core definitions that are to form, when possible, the nucleus of future and revised management system standards such as ISO 9001.
All MSS [Management System Standards] (whether they are Type A or Type B MSS) shall, in principle, use consistent structure, common text, and terminology so that they are easy to use and compatible with each other. The guidance and structure given in Appendix 2 to this Annex SL shall, in principle, also be followed (based on ISO/TMB Resolution 18/2012).
Accordingly, ISO/CD 9001 has adopted the structure, common text, and terminology provided in Annex SL, Appendix 2 as the nucleus of this revision. Annex SL, Appendix 2 allows discipline-specific additions to the core text, and this has been utilized for the following:
Specific quality management system requirements considered essential to meet the scope of the standard;
Requirements that may appear to be generic but are considered essential to reflect use of the Quality Management Principles that form the basis for the quality management system standards within the ISO 9000 family;
Requirements and notes that enhance or clarify the core text.
Redrafting to make the standard more generic and more easily applicable by service industries.
Continued omission of specific reference to “services” was considered to be unsustainable if relevance to the service sector was to be enhanced. On that basis, “product” has been replaced by “goods and services” when specifically referring to the deliverables for the customer. This proposed change will be subject to a specific briefing note and a request for ballot input from ISO/TC 176/SC 2 member bodies.
Where possible, clauses of the standard have been revised to reduce the prescriptive nature of some requirements which were originally derived from practices for the hardware sector, in particular clauses 7.1.4 Monitoring and Measuring Devices and 8.5 Development of Goods and Services.
Context of the organization
Annex SL, Appendix 2 High Level Structure and core text has introduced two new clauses relating to the context of the organization, 4.1 Understanding the Organization and its Context and 4.2 Understanding the Needs and Expectations of Interested Parties. Together these clauses require the organization to determine the issues and requirements that can impact on the planning of the quality management system and can be used as an input into the development of the quality management system.
Although there is now reference to determining the requirements of relevant interested parties there is no new requirement to ensure goods and services meet the needs and expectations of external parties other than those already identified in ISO 9001:2008, i.e. customers, regulators, etc. Such a change would require a change to the scope of the standard, which is not permitted by the design specification for the revision.
ISO 9001:2008 promoted the adoption of a process approach when developing, implementing, and improving the effectiveness of a quality management system. This proposed revision to the standard makes this more explicit by including clause 4.4.2 Process Approach—specifying requirements considered essential to the adoption of a process approach.
Risk and Preventive Action
Annex SL, Appendix 2 High Level Structure and core text does not include a clause giving specific requirements for “preventive action.” This is because one of the key purposes of a formal management system is to act as a preventive tool.
Consequently, the High Level Structure and Identical text require an assessment of the organization’s “external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended outcome(s)” in clause 4.1.
The Annex SL Appendix 2 clause on Documented Information has been adopted without significant change or addition. Where appropriate, text elsewhere in the standard has been aligned with its requirements. Consequently the terms “document” and “record” have both been replaced throughout the requirements text by “documented information.”
Control of external provision of goods and services
Clause 8.6 Control of External Provision of Goods and Services addresses all forms of external provision, whether it is by purchasing from a supplier, through an arrangement with an associate company, through the outsourcing of processes and functions of the organization, or by any other means. The organization is required to take a risk-based approach to determine the type and extent of controls appropriate to each external provider and all external provision of goods and services.