Rutherford, NJ — Over 1 million organizations worldwide are certified to the ISO 9001 standard, many in North America. The standard provides a framework for organizations wishing to implement a quality management system, and often is a requirement to doing business with larger corporations. The standard is currently undergoing a revision process. It is important for organizations that are certified or plan to become certified to this standard to understand the changes being proposed.
The latest stage in the ISO 9001 revision process arrived with the issue of ISO/DIS 9001 (Draft International Standard) on 8thth May 2014. This first formal draft describes the potential requirements of the revised version of ISO 9001; this is not the final version. However, it does at least give an indication on what might be included and we need to be aware of its content. Further changes are, of course, possible before final publication of ISO 9001:2015 currently scheduled to be released in Q4 2015.
The main areas of changes proposed in ISO/DIS 9001 are:
- Structure and terminology, including incorporation of Annex SL frameworkThe wider internal and external context of a organisation’s Quality Management Systems (QMS) (Clauses 4 and 6)Detailed Quality Management System (QMS) requirements’ (broadly clauses 5 & 7 – 10).
DIS adopts Annex SL, notable changes in terminology. ISO/DIS 9001 adopts the clause structure specified in Annex SL which is now the required framework for all new and revised ISO Standards. The stated reason for this is to ensure that the final version of ISO 9001 is aligned with other management systems standards. Utilizing the Annex SL structure will present QMS requirements in a more consistent, rational manner and not simply offer a template for elements of an organisation’s QMS.
Compatibility with other standards
Many organizations are certified to other management system standards in addition to ISO 9001, such as ISO 14001 (Environmental Management Systems) and OHSAS 18001 (Occupational Health and Safety Management Systems). The current changes to the ISO 9001 standard aims to re-arrange the standard in a logical order that is consistent with an organization’s planning and process management. The clauses of standard are defined in order i.e. Understanding of organization context, Leadership, Policy and responsibilities, Process for planning and consideration of risks, Process for support including resources, People and information, Operational processes related to customer and product and services, Process for performance evaluation and Process for improvement.
Plan-Do-Check-Act
The Methodology known as Plan-Do-Check-Act still remain the key principal to apply to all Quality management processes.
Terminology
ISO/DIS 9001 contains some notable changes in the terminology used in ISO 9001:2008:
All of the key words and Terms have been clearly defined with clear definitions, so that will improve the clarity in term of application and interpretation for implementation with some of the change in definitions.
In addition, there would no longer be any requirement to identify any ‘Exclusions’, i.e. QMS requirements that could not be applied due to the nature of the organisations business (clause 1.2 in ISO 9001: 2008).
ISO/ DIS 9001 requires any organisation establishing a QMS to determine relevant internal and external issues, understand the need and expectations of interested parties, specify the scope of applicability of the Quality System and consider these aspects together in order to properly understand the opportunities and risks they represent.
The proposed change in methodology requires a move away from a purely inward-focusing approach to QMS development and implementation to one wher external or ‘outside’ factors
have a greater influence on the way in which the QMS is focussed and prioritised; to be as effective as possible in meeting key internal and external objectives. An organization seeking to implement a QMS would need to determine the interested parties relevant to its QMS and their requirements.
Closely aligned to the context of an organization is the adoption of a risk-based approach when developing and implementing its QMS.
Risk based Approach
Risk assessment has been applied in some industries as a common practice, wher the risk in the business is considered as the effect of uncertainty on an expected result of the business processes. based on the objective of the organization and its customers’ expectations, risk identification will be part of planning and management to ensure that that effect of uncertainty to achieve the company objective is controlled through establishment, implementation, evaluation and the continual improvement of Quality management processes.
Numerous changes to QMS RequirementsBelow is a summary of other changes to QMS requirements:
Leadership has replaced the clause previously named Management responsibility. There are additional requirements related to leadership and commitment. Some of the new requirements are include Quality Policy and Objectives which are to be compatible with the Strategic direction to the context of the organization. There are more specific Customer Focus statements. There is some adjusted wording for the Quality Policy requirement i.e. commitment to satisfy applicable requirements, and available to interested parties.
Planning of Quality management system defines the frame work to support the alignment of an integrated management system and apply Risk based planning process. This clause has been reworded with the consideration to add the Risk based Quality planning concept “Action to address Risk and Opportunity”. Some new statements have been added i.e. give assurance, prevent and reduce undesired effects, action to address these risks etc.
Competence: Any organization implementing a QMS would have to identify the competence necessary for personnel doing work that affects its quality performance, as well as ensuring that those personnel are competent to do so.
Monitoring and Measuring Resources is the rewording of the existing clause for Control of monitoring and measuring equipment. This clause’s requirements are more generic so that they can applied to all integrated management system disciplines wher monitoring and measurement resources are applicable in the management processes.
Organization Knowledge is the rewording of the clause that replaces the Human Resources general requirement. The content of the competencies is similar with the additional specific clause for Awareness. It defines the requirements related to awareness such as Quality Policy, Quality Objective, contribution to the effectiveness of a Quality Management System and implication of not conforming to Quality Management System requirements. There remains a requirement to identify and maintain the knowledge needed to ensure that it can achieve conformity of products and services.
Operation Planning: the clause planning of product realization has been reworded to Operation Planning and Control, however the content of the requirement is similar to the existing version.
‘Preventive action’ is no longer a specific clause in ISO/ DIS 9001 as it is a primary objective of a QMS in addition the risk-based approach.
ISO/ DIS 9001 more directly expects organisations to apply a process approach when planning, implementing and developing their QMS. The version also includes a list of requirements identifying the essential elements of such an approach. The intention is to ensure that organisations systematically define and manage not just their processes, but also the interaction between them.
How can SGS help?
SGS can provide awareness training to help our prospects and clients understand the requirements of ISO/ DIS 9001. A checklist will be developed to be able to offer gap assessments against the requirements of ISO/ DIS 9001. A free overview on Annex SL could be found on www.sgs.com/ISO9001.
Future updates
A copy of the ISO/DIS 9001 standard can be purchased.
The official ISO 9001:2015 working group (ISO/TC 176/SC 2) responsible for the development and publishing of the ISO 9001:2015 standard will develop a matrix showing a correlation between the clauses of ISO9001:2008 and ISO/DIS 9001:2015, which will be available shortly at www.iso.org/tc176/sc02/public.
Further information and updates on the development of ISO 9001: 2015 and its publication schedule will be issued by SGS as they become available.
More Articles from the Productivity Centre
