In 2015, the new ISO 9001:2015 standard will be published. Early feedback indicates this will be a major overhaul that will significantly impact businesses using ISO 9001.
Significant Changes
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 On that basis, “product” has been replaced by “goods and services” when specifically referring to the deliverables for the customer.
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 organisation they are looking at introducing two new clauses relating to the context of the organisation, 4.1 Understanding the Organisation and its Context and 4.2 Understanding the Needs and Expectations of Interested Parties. Together these clauses require the organisation 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.
Process approach 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 the 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.
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 organisation, or by any other means. The organisation 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.
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