Standards Transition Current Update

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Our newsletters provide information on business management systems and process improvement methods. These systems include ISO 9001 QMS, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental Management Standard, and others. Subjects include performance improvement methods such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

Do You have a Subject of Interest for a future 2016 Newsletter?  Please let us know.

Standards Transition Current Update

Last week we attended the National Quality Assurance (NQA) Teaming Conference in Los Angeles, California. NQA is a major global QMS certification body.  One of the conference objectives was to update third party auditors, consultants and NQA clients on the latest information regarding QMS standards in transition.

The following is information we want to share with our readers which was collected based on our very fast note taking. We do want to note here that this information may be subject to change based on the parties responsible for the standards transition process.

Transition Timelines

  • AS9100D:2016 Aviation, Space and Defense-To be released April 2016.  This includes AS9110 and AS9120.
  • ISO 13485:2016 Medical Devices – Released February 2016
  • ISO/TS 16949 Automotive – To be released mid 2016.
  • TL 9000 Telecommunications – To be released June 2016
  • ISO 45001 Occupational Health and Safety- To be released October 2016.

We should all be aware that the ISO 9001:2015 and ISO 14001 EMS Standards were both released in September 2015. All transitions must occur before September 14, 2018.  The opinion is that 75-80% of certified companies will follow the transition process with a re-assessment and the rest will transition during a surveillance audit.  The biggest concern of all certification bodies is resources, specifically the impact on third party auditors and transition scheduling.

Transition Audit Certification Expectations include:

  • Updated QMS with expanded requirements
  • Completed internal audit to new requirements
  • Conducted a management review meeting
  • Focus on any new or enhanced requirements/themes

Addressing the new requirements, for example can include context of the organization, risk, organizational knowledge, leadership, change control, and external providers. The onsite transition time for a third party auditor will be increased to half-day / full day based on the size of the organization.

We will continue to keep you informed of new information. Look for further details in future newsletters. Contact us for all your transition needs.

 

AS9100:2016 Aviation, Space and Defense

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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.

AS9100 certified organizations must transition by June 2018.

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, it is not clear whether 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

We will dive into further AS9100D requirements in our next newsletter. Contact us with questions and assistance with your AS9100D:2016 transition needs.  

 

ISO 13485:2016 Medical Devices

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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 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.

ISMS Common Terminology Revised

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All information held and processed by an organization is subject to the risks of attack, error and natural disaster, and other vulnerabilities inherent to its use. Information security is therefore at the heart of an organization’s activities and focuses on information that is considered a valuable “asset” requiring appropriate protection, for example against the loss of availability, confidentiality and integrity.

The recently revised ISO/IEC 27000:2016, Information technology – Security techniques – Information security management systems – Overview and vocabulary, gives a comprehensive view of information security management systems covered by the ISMS family of standards, and defines related terms and definitions.

Information security management systems (ISMS) lets organizations develop and implement a robust framework for managing the security of their information assets, including financial data, intellectual property, employee details, and information otherwise entrusted to them by customers or third parties.

The standard lays down the key factors of a successful implementation and the numerous benefits of using the ISMS family of standards. It provides an understanding of how the ISO/IEC 27001 family fits together through its multi-faceted approach, clarifying the standards’ scopes, roles, functions and relationship to each other.

In addition, ISO/IEC 27000 gathers in one place all the essential terminology used in the ISO/IEC 27001 family

The ISO/IEC 27000:2016 Standard can be purchased through the ISO Store.

 

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In the News
March and April 2016 – ISO 9001:2015 Internal Auditor Course  

Subject: ISO 9001:2015 Internal Auditor Training

Date: March 15-16, 2016
Location: Marriott Residence Inn 3021 E. Banner Gateway Drive Gilbert, AZ
Date: April 6-7, 2016
Location: University of Phoenix Southern Arizona 300 S. Craycroft Road Tucson, AZ

We are conducting two ISO 9001:2015 Internal Auditor Course in March in Gilbert, and April in Tucson, Arizona.

Click on link for course description, registration and payment method -10% off with Promo code SE2016. 
Students receive a comprehensive binder, and a certificate of training completion.  Lunch is included.  Contact us for group discounts and any questions.  If interested in onsite auditor team training, let us know.

 

Congratulations to our Client, Granite Mountain Design for a successful recertification to AS9100C!
 

Since 1985, Granite Mountain Design specializes in precision machining, sheet metal and welding. The company  is also fully equipped for painting, plating and assembly services.

Sustaining Edge Solutions worked with the management team improving documentation detail and process controls, including personnel training and internal auditing services. The recertification audit was highly successful and the improved process controls has enhanced system effectiveness.

For more information about Granite Mountain Design, please visit the company website.

 

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Don’t see a course or schedule that fits your needs?  Contact us.

 
Survey Says-Quick Poll Results 
What gives you the most anxiety about implementing ISO 9001:2015?
#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

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

We can reduce that anxiety!  Contact us to help your organization be successful with any of the standards in transition.   

 

Best Regards,

Walter Tighe and SES Team
Sustaining Edge Solutions, Inc.
Toll Free 888-572-9642

 

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