Anxiety Issues With ISO 9001:2015

November 9th, 2015

Survey Says-Quick Poll Results

What gives you the most anxiety about implementing ISO 9001:2015? j0182833

#1 – 36.5% Enhancing leaderships role in quality

#2 – 34.1% Adopting risk-based thinking

#3 – 12.1% Understanding the new clause structure

#4 – 9.7% Dealing with documentation

#5 – 7.3% Defining the context of the organization

Source: Quality Progress Magazine, October 2015

Over 70% of survey participants have anxiety about increased top management involvement, and the new risk-based thinking approach and requirements.

Will the ISO 9001:2015 standard make a real difference in promoting leadership involvement? Yes, we certainly think so, but it will require increased discussion and integration of the quality group and the leadership team. Having accountability requires this. Meaningful involvement and learning from the quality group for top management will be required in the early stages of this transition—a top priority and an essential step.

Adopting risk-based thinking, although new to the standard should not be difficult for the organization. Management decision making as to whether to provide a product or service, comes into question on a regular basis as to do we have the capability, resources required, capable personnel, outsource requirements? The ISO 9001:2015 standard does however, link risk based thinking with organizational planning, context, and needs and expectations of interested parties. This type of thinking will be foreign to some, but can be achieved with proper training and understanding of what direction is necessary.

Tell us your thoughts on this subject! Are you suffering from the same anxiety??

ISO 9001:2015 Standard Now Official

September 24th, 2015

    Close up on a file tab with the word ISO 9001 focus on the main text and blur effect. Concept image for illustration of Quality Standards

The latest edition of the ISO 9001 quality management systems standard has just been published. This concludes over three years of revision work by experts from nearly 95 participating and observing countries to bring the standard up to date with modern needs.

ISO 9001 helps organizations demonstrate to customers that they can offer products and services of consistently good quality. It also acts as a tool to streamline processes and make them more efficient. ISO 9001:2015 replaces previous editions and certification bodies will have up to three years to migrate certificates to the new version.

ISO 14001:2015 Environmental Management System Published  

ISO 14001:2015 specifies the requirements for an environmental management system that an organization can use to enhance its environmental performance. ISO 14001:2015 is intended for use by an organization seeking to manage its environmental responsibilities in a systematic manner that contributes to the environmental pillar of sustainability.

ISO 14001:2015 is applicable to any organization, regardless of size, type and nature, and applies to the environmental aspects of its activities, products and services that the organization determines it can either control or influence considering a life cycle perspective.

Purchase these standards at / /

ASQ 24th Annual Internal Audit Conference

September 16th, 2015


American Society for Quality
October 29 & 30, 2015
Peppermill Resort & Casino, Reno, Nevada

Sustaining Edge Solutions is a Gold Sponsor & Exhibitor at the 24th Annual Audit Division Conference!  As a past company conference sponsor, we have continuously found that the Audit Division Conference is an exceptional event with a wealth of information and top notch value delivered. The Peppermill Resort is a great location. With the publication of the ISO 9001:2015 Standard on September 23, 2015, this will be the first conference to address the new standard requirements and internal auditing effectiveness.

Looking forward to seeing you there!

Conference Overview: With the publication of the ISO 9001:2015  Standard-new methods to achieve effective results, auditors are expected to influence managerial decision making with their audit findings.  This conference focuses on the auditor’s role in identifying quality system issues to improve  performance & processes,  revenue, and customer satisfaction, including management planning and the decision making process.

Conference sessions include:
  • ISO 9001:2015: How Will it Change Your Internal Audits?
  • Effective Risk Assessment Auditing
  • Closed-loop Risk Based Audit Program Model
  • Advanced Interviewing Techniques for Audits
  • Internal Audits Using Six Sigma-DMAIC Process

Tutorials: One, two and three day pre-conference tutorials will be conducted on October 26, 27 & 28, 2015.

Conference Registration Here

Visit us at our exhibitor booth! We will be offering valuable information and methods for effective ISO 9001:2015 Quality Management Systems Auditing. Don’t forget the free swag too.  This will include discounts on all our business management systems services, training courses and more!

Annex SL – Changes for ISO Standards

August 18th, 2015

The final draft international standard (FDIS) of ISO 9001:2015 has been released in July, and the revised standard is slated for publication in September. Based on Annex SL of the “Consolidated ISO Supplement,” some elements of the standard will be restructured to allow for easier integration of multiple management systems.

Integrated management systems generally refers to integrated processes that result in one management system to implement such as ISO 9001, ISO 14001, and OHSAS 18001.

Annex SL consists of 9 clauses and 3 appendices. This annex has been developed primarily with ISO technical committees who develop management system standards.  The impact of Appendix 2 of Annex SL will be felt by all users of management system standards in the future.

Appendix 2 is in three parts:

* high level structure,

* identical core text,

* common terms and core definitions.

Future management system standards will need to have these elements. In addition, there will be less confusion and inconsistency because common terms will all have the same definition and there will be common requirements across all the management system standards, for example the requirement to establish, implement, maintain and continually improve the management system.

High level structure

The major clause numbers and titles of all management system standards will be identical They are:

  1. Scope
  2. Normative references
  3. Terms and definitions
  4. Context of the organization
  5. Leadership
  6. Planning
  7. Support
  8. Operation
  9. Performance evaluation
  10. Improvement.

All future ISO MSS should be consistent and compatible, and will have the same look and feel. At this time, it is questionable whether ISO 13485 Medical Devices Standard will utilize Annex SL.  We are hoping that this could be the beginning of the end of the conflicts, duplication, and misunderstanding arising from precisely different requirements across the various MSS.

ISO 9001 Moves to Final Draft International Standard (FDIS)

July 14th, 2015

On July 9th 2015, the ISO/FDIS 9001:2015 was issued in 28 pages, the last stage in the ISO 9001 revision process. This is the last formal draft before final publication scheduled on September 23, 2015. ISO member countries have about 2 months to vote on the latest draft of the standard before the September 9, 2015 deadline.

ISO/FDIS 9001:2015 positions the new version of the standard as an integral part of an organization’s efforts with leadership enhancement for development, and promotes it as a tool for improving an organization’s overall performance. It drives more internal and external stakeholder focus as part of the adoption of a risk-based approach to quality management and emphasizes the importance of adopting a quality management system  as a strategic direction for the organization.

In addition to renaming and repositioning some QMS activities, other significant new requirements have been introduced.

Based on our review of the FDIS, and compared to the DIS, changes are relatively minor. The most extensive ones have been to the Introduction and Graphic Figures, which have been simplified, with explanations being moved to an informative Annex. The terms and definitions have now been removed from the standard and added to ISO 9000.

Organizations that are already certified to ISO 9001:2008 will have three years from formal publication of ISO 9001:2015 in September to transfer to the new version of the standard. The  transition period will end in September 2018.

If interested, you can purchase the ISO/FDIS 9001:2015 at the ASQ Website.   FYI:  The ISO 14001:2015 Environmental Management System Standard FDIS has also been released for voting.