DIS ISO 9001.2014 published
ISO 9001, the globally leading standard with more than 1.1 million certified organizations, is currently being revised for the fourth time. The purpose is to create a user-friendlier standard and adapt it to a changed business world.
On the one hand, the first public draft offers organizations more flexibility in designing their management system, on the other hand it demands dynamic adjustment to changes within the organization and its environment. Quality Austria is offering support in the form of information events, workshops und delta-audits for the evaluating the status of your management system with regards to the new requirements.
SO 9001 is making progress
The current revision is to be completed in the second half of 2015. Its objective is to adapt the standard to the changed conditions of an increasingly dynamic and compex business world while making it user-friendlier. The simultanous application of several management standards (integrated management systems) should be facilitated. For this reason the structure of the standard has been changed. It now adapts to the harmonized structure going to be applied on all management system standards. The draft supports management systems adjusting to current challenges organizations face in today's business world.
Some crucial changes in comparison to ISO 9001:2008 are listed below. This short list of topics is intended to make a first reading of the standard easier. By no means can it substitute a detailed analysis of the standard tailored to your organization's needs.
The following table is a comparison of DIS ISO 9001:2014 and the still valid ISO 9001:2008.
Please find below remarks to each chapter of the current draft.
0 Introduction: The introduction discusses some main aspects of the standard such as process approach, context of the organization or risk-based thinking. It contains new graphical models and shows the connection to other management system related standards in the area of quality and others.
1 Scope: The scope has not changed. Applicability is now dealt with in a separate clause (4.3).
2 Normative references: none
3 Terms and definitions: The current draft contains definitions from both the harmonized concept of management system standards and the current ISO 9000:2015 draft.
4 Context of the organization: The understanding of the internal and external context of the organization is a key element in designing flexible customized management systems. The determination of these issues is a new requirement of ISO 9001. In addition, the determination of requirements of relevant interested parties is a newly incorporated requirement.
Exclusions of requirements in clause “product-realization” are no longer possible. The scope has to be determined and made available as documented information, this being one of the few new requirements on documentation.
The process approach, which newly entered ISO 9001 in the year 2000, has been defined more thoroughly, some additional requirements (responsibilities, inputs/outputs, evaluations, etc.) have been included.
5 Leadership: Commitment of top management is of crucial importance for the success of a quality management system. This is reflected in the draft.
The requirements towards top management concerning leadership, communication and securing effectiveness of the quality management system have definitely been enhanced in comparison to ISO 9001:2008.
Responsibilities, which are summarized in ISO 9001:2008 under the title “management representative” have been amended (key words: customer focus , process results, change management).
6 Planning of the quality management system: The essential new element concerning planning is the adressing of risks and chances.
Clause 6.1 contains the core of the risk-based thinking in the context of a quality management system. Risks and opportunities shall be determined.
The requirements for quality objectives have been strengthened. (cp. 5.4.1. ISO 9001:2008). Specific action plans are now required. Changes are to be planned and implemented systematically.
7 Support: The clauses on “resources” from ISO 9001:2008 have been broadened into a chapter “support”. The topics competence, awareness and communication have been integrated with separate headings as well as increased in importance.
Resources, apart from infrastructure and the environment for operating processes, contain monitoring and measurement resources, organizational knowledge and people.
Requirements regarding monitoring and measurement resources have been changed. Measurement resources, which can also be user surveys or empirical methods in the service sector, must ensure valid and reliable results. Organizational knowledge is a new requirement. Identification, maintenance, distribution and acquisition of knowledge are specifically addressed.
Requirements on documentation are now also found under the heading “resources” (cf. 4.2 ISO 9001:2008). The term “documented information” summarizes the previous terms “document”, records, documented procedure etc., the focus is on adequacy.
8 Operation: In the clause “operation” all the requirements concerning the specific processes for manucacturing products resp. the provision of services are contained: planning, determination of product requirements, design and development, external provision, production, product approval and non-conforming process outputs, products and services.
Requirements on planning have been made more specific, especially with regard to criteria to be determined for these processes, as well as their control.
There have been changes in structure and text in the area of design and development. Some detailed requirements on reviews, verification and validation of development and control of changes in development have been dropped.
A development process has to be established where specifications have not been established by customers or relevant interested parties.
“Purchasing” and “outsourcing” are summarized under the term “external provision”.
Type and extent of controls depend on the potential impact of the externally provided processes, products and services on the organization’s ability to consistently meet requirements and the perceived effectiveness of the controls applied by the external provider.
9 Performance evaluation: There are now stronger requirements on monitoring and measurement: it has to be determined what has to be measured, when, and by which methods. Moreover, it has to be determined when the results are to be analyzed and evaluated.
Documented information is to be saved as evidence of the results.
Separate clauses for monitoring and measurement of products and processes are not longer contained in the standard.
10 Improvement: Preventive actions are no longer part of the standard. The system itself, being based on a risk-based approach has a preventive impact.
Improvement is not merely limited to continual improvement reached by respectively established processes. The organization must react to changes including one-time changes, if necessary.
News & Events
The basis for long-term success!
QMD Services obtains designation as a Notified Body for in vitro diagnostic devices
Milestone for the Medical Device IndustryLearn more
Christian Matzku (50) takes over the Management of “Sales Steering” at Quality Austria
Sales professional starts at certification organizationLearn more
The new EU Guideline on the implementation of Food Safety Management Systems published
New developments for Food BusinessesLearn more
New cooperation with ENFIT for highest standards
HQF Certification in supply chains acc. to the ENFIT StandardLearn more
The five stumbling blocks you should dodge on your way to a management system
Mind the step!Learn more
25th anniversary of successful cooperation in certification
Alkaloid celebrates 25 years of successful cooperationLearn more
IFS Food Version 8 – first DRAFT version published
What changes and new features are comingLearn more