Tuesday, 28 May 2013

ISO 9001 UPDATES: Part I

As I said one month ago in my ISO 9001:2015 post, most people are aware that ISO 9001 is in the process of being revised, with a planned release date of some time in 2015. Reactions from users range from mild curiosity to extreme trepidation.

ISO 9001 hasn't had a significant makeover since 2000, and a lot has changed in our world since then. Supply chains now routinely span the globe. Vast quantities of information can be transmitted virtually instantaneously. Environmental concerns are now incorporated into most organizations’ strategic plans. The evolution of ideas and technology has exploded and our ability to manage it all has become increasingly critical. It is in this tumultuous environment that the most popular standard ever published by the International Organization for Standardization (ISO) is being revised.

More than three years ago, anticipating the eventuality of a revision, members of ISO Subcommittee 2 (SC 2) began conducting an extensive user survey. It was important to solicit the kind of information the market could provide to ensure that this document remained relevant and beneficial to the users.

Feedback was sought from every industry and sector, from users of other management system standards, and even from those who have chosen not to implement an ISO 9001-compliant quality management system (QMS). More than 10,000 responses were received from around the world. Many contained comments that needed to be translated. All these data were collated, reviewed, and analysed.

Overall, the consensus from respondents was that they felt the standard is good as it is, but it needs to be revised. There seemed to be little support for wholesale changes, or creating a hierarchical or tiered set of requirements standards similar to Capability Maturity Model Integration (CMMI) or the old ISO 9001/ISO 9002/ISO 9003 scheme. There is also little support for withdrawing ISO 9001.

ISO 9001 user survey’s most common comments

The most commonly received comments from the extensive survey that SC 2 sent to ISO users related to the following: 
  • Requests to include requirements relating to risk management, financial management, and change management. 
  • Requests for clarification of existing requirements relating to outsourcing, product realization, and the distinction between verification and validation. 
  • Some respondents voiced concern about the ease of use for service and software industry. 

Concepts and ideas for a future ISO 9001 revision

While the user survey was being conducted, a task group was established to explore “concepts and ideas for a future revision of ISO 9001.” Over the course of several meetings, the technical experts explored the significant global changes and evolving concepts vis-à-vis the standard to decide which ones might be relevant to any future revisions. Some of the concepts that were discussed included: 
  • Risk management approach 
  • Financial resources of the organization 
  • Time, speed, agility 
  • Process management 
  • Knowledge management 
  • Maintenance of infrastructure 
  • Competence 
  • Product and service life-cycle management 
  • Supply chain management (and outsourcing) 
  • Expanding the concept of customer 

This list represents only a small subset of the original plethora of ideas that were advanced. 

It should be noted that inclusion on this list, in the survey results, or in any other document does not guarantee that the concept will find its way into the newly revised standard. Although it’s likely some of the ideas will be incorporated, many others will continue to be perceived as outside of the scope of ISO 9001. It’s important to remember that ISO 9001 is a generic requirements document and that the requirements must be applicable to the broad and diverse spectrum of users. It is not a “how to” guide nor is it an encyclopedia of tools. 

Based on the work of the task group, several white papers were generated elaborating the justification for possible inclusion of some of the concepts. 

— Sources: QualityDigest, International Organisation For Standarisation.

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