AS9100D:2016 Aviation, Space and Defense

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

ISO 13485:2016 Medical Devices Standard Published

March 13th, 2016

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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.

 

ISO 9001:2015 Guidelines for Application

February 10th, 2016

 A new standard, ISO/TS 9002, Guidelines for the application of ISO 9001:2015, is being developed to assist users in implementing an ISO 9001-based quality management system.

The Technical Specification (TS) is intended to be informative and provide guidance on the requirements in ISO 9001, with a clause by clause correlation to clauses 4-10 in ISO 9001.

ISO/TS 9002 will not add new requirements to ISO 9001. However, it will give examples of what an organization can do. These examples will not be definitive and only represent possibilities, not all of which are necessarily suitable for every organization.

ISO 9001 contains requirements that can be objectively audited or assessed. ISO/TS 9002 will include examples, descriptions, and options to help implement a quality management system and to strengthen its relation to the overall management of an organization.

While the guidelines in ISO/TS 9002 will be consistent with the ISO 9001 quality management system model, they are not intended to provide interpretations of the requirements in ISO 9001 or be used for audit purposes.

ISO/TS 9002 is currently at the Committee Draft level.

We will keep you informed of the publication timeline. 

 

Deming Documentary: If Japan Can…Why Can’t We?

January 7th, 2016

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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.

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??