May 16th, 2016
The AS9100D:2016 Aviation, Space and Defense Standard was projected since the publication of ISO 9001:2015 last September to be released in April 2016. As of this post, the standard has not been released. The following is the latest information from the IAQG Website.
“The International Aerospace Quality Group (IAQG) has agreed to align transition to the forthcoming revised 9100:2016 series standards with the International Accreditation Forum’s (IAF) Resolution 2013-15, which requires transition to the ISO9001:2015 quality management system (QMS) standard no later than 15 September 2018.
The 9100:2016 series of standards will be published concurrently across Americas, Asia-Pacific, and European sectors. The timing of this concurrent release will result in the 9100:2016 publishing starting in October 2016, 9101 and 9110 in November 2016 and 9120 in December 2016; given a worst case scenario. Efforts are being made to shorten the publication time spans and publish concurrently as soon as possible”.
If the revised standard release remains with October 2016, the current requirement of all AS9100C organizations to transition NLT September 2018 will most likely have to change. Especially considering that all certification body auditors will have to be formally trained prior to performing any transition audits. Stayed Tuned – we will keep you informed!
April 17th, 2016
AS9100 certified organizations must transition by June 2018. AS9100D:2016 is scheduled for release in April 2016. This also includes standards AS9110 Aviation Maintenance, and AS9120 Stockist Distributors.
A primary difference between the ISO 9001:2015 and AS9100D standards is the timeline for transition.
Certification body auditor training will be completed in August 2016. This provides less than 24 month window to transition to the new standard. Current AS9100 companies must also communicate to their certification body their transition plans by January 2017; and no certification body audits will be conducted to the current versions after June 15, 2017.
Based on current information, a Quality Manual will still be an AS9100 requirement. Also, unlike ISO 9001:2015, the requirement of a specific Management Representative remains. It is also unclear whether specific procedures will be required.
Some other changes include:
- Operational Planning and Control adds requirements for FOD and product obsolescence
- Clause 8.1.1 is changed to “Operation Risk Management” and clarifies that risk in this specific clause is only related to products and services
- New clause 8.1.4 on Prevention of Counterfeit Product. We have discussed this future requirement in past newsletters
- Maintained language about special processes
- Internal auditing now indicates that “performance indicators” can be used to assess QMS effectiveness
March 13th, 2016
ISO 13485:2016 establishes the requirements for a quality management system specific to the medical devices industry. It has been revised to respond to the latest developments in quality management, technology and regulatory requirements that relate to the industry.
Improvements in the new version of the standard include broadening its applicability to include all organizations involved in the life cycle of the product, from concept to end of life, greater alignment with regulatory requirements and a greater focus on post-market surveillance including complaint handling.
There is also a greater emphasis on having the appropriate infrastructure, particularly for the production of sterile medical devices, and more focus on risk management.
Some of the changes to the new standard avoid the ISO 9001:2015 standard new requirements. Examples include:
- No alignment to high level Annex SL
- No requirement for Context of the organization
- Emphasizes risk-based QMS, but not “risk-based thinking” as ISO 9001:2015
- Requires a Quality Manual
- Avoids the confusing term “documented information,” retains documents and records
- Maintains approach to preventive action
- New “design and development transfer” clause added
- Additional language on complaints handling and regulatory communication
The ISO 13485:2016 Standard is available for purchase through the ANSI Website
. Contact us with questions and for further information on how we can support your future ISO 13485:2016 Transition Needs.
January 7th, 2016
Inaccessible for 35 years, this documentary can now be viewed free of charge.
In June 1993, I had the privilege of attending Dr. Edwards Deming three-day seminar. At 93 years old, I was amazed this quality giant was still presenting his message of quality. Being a Deming Disciple (you seasoned quality people understand) I am excited to announce this documentary opportunity.
On June 24, 1980, Americans widely viewed a NBC documentary called “If Japan Can… Why Can’t We.” The program, part of NBC’s white paper series, prominently featured W. Edwards Deming. Produced by Clare Crawford-Mason and narrated by Lloyd Dobyns.
This compelling documentary, about the ever-increasing industrial competition between the United States and Japan, introduced Deming to Americans. For the first time, they learned of the then 80-year old American who was widely credited with the Japanese industrial resurgence after World War II. Soon the icons of American industry, such as Ford Motor Co., General Motors, Dow Chemical Co., Xerox, and Hughes Aircraft were asking for his help.
To view the entire NBC documentary video that started it all, visit the Deming Institute Website.