IATF 16949 - Section 6.1.2.2: Preventive action

on . Posted in IATF 16949

Here is a brief overview of the changes to Preventive Action in the new IATF standard. Click play to hear Brandon Kerkstra explain.


  bullet green arrow 25 Actions to eliminate the causes of potential nonconformities to prevent their occurrence

bullet green arrow 25Appropriate to the severity of the potential issues.

bullet green arrow 25Process to lessen the impact of negative effects of risk including the following:

astricks 20Determining potential nonconformities and their causes;

astricks 20Evaluating the need for action to prevent occurrence of nonconformities;

astricks 20Determining and implementing action needed;

astricks 20Documented information of action taken; reviewing the effectiveness

astricks 20Utilizing lessons learned to prevent recurrence in similar processes

   
   

8.3.1.1 Design & Development of Products and Services

on . Posted in IATF 16949

The requirements of ISO 9001, Section 8.3.1 applies to product and manufacturing process design and development and focuses on error prevention rather than detection.

Documented design and development process is required.  In the past is was not required, but it is now.

Many organizations are overlapping design and production because a need for speed to market.  This means it is critical to document the process.

When planning the Design & Development, consider these ISO requirements:
  • Nature, duration and complexity
  • Required process stages including reviews
  • Required verification and validation activities
  • Responsibilities and authorities
  • Internal and external resource needs
  • Controlling interfaces
  • Involving customers
  • Requirements for manufacturing/service delivery
  • Level of control expected by customers...
  • Documented information needed to demonstrate requirements have been met

IATF 16949 Required Documentation For Transition

on . Posted in IATF 16949

Karl Dorr, ASR Quality Manager

iatf 16949 standards news auto industry word cloudIncluded with this note is a table (see page 2 / 3) that lists the documentation that is required for the implementation of a conforming system under the IATF 16949 Standard.

For the transition of your system to the new Standard there will need to be evidence that these documentation requirements have been met. The table is divided into three sections.
  • Section 1 lists the Required Documentation,
  • Section 2 lists the Required Records and
  • Section 3 lists the Required Documented Processes.

In each Section the clause of the Standard and topic of the requirement are listed. During the initial transition audit to IATF 16949 there will be an off-site review which will assess readiness of your system for transition.

ISO/TS 16949:2009 vs (ISO 9001:2015 & IATF 16949)

on . Posted in IATF 16949

This comparison matrix can be used by iso ts 16949 130646813An organization as a gap analysis for their QMS.

This is a +100 page document. If it was published on Amazon, the price would be hundreds of dollars.

Bart Solomon created this to help our clients and help any professional needing to understand and implement these standards.

pdfClick here to download the document.

You do not need to be a client to benefit from ASR's committment to excellence.

ISO/TS 16949 Certs. Expire Sept 14, 2018 November 2016

on . Posted in IATF 16949

ISO/TS 16949 certificates expire Sept 14, 2018 and the push is on as automotive suppliers work to upgrade their quality management system before the deadline. Since IATF 16949:2016 consists of only automotive requirements, suppliers  need a copy of ISO 9001:2015 to fully update their QMS.

ASR is reaching out to its clients to schedule transition audits.  A transition audit replaces a client’s regularly scheduled recertification or surveillance audit.  The transition audit is equivalent to a recertification audit which is a full system audit addressing all requirements of IATF 16949:2016 and ISO 9001:2015 and begins a new three-year audit cycle.

IATF Strategic Focus

on . Posted in IATF 16949


IATF-Strategic-Focus-DefinedThe International Automotive Task Force (IATF) is an "ad hoc" group of automotive manufacturers and their respective trade associations, formed to provide improved quality products to automotive customers worldwide. Specifically, the purposes for which the IATF was established are:
  1. To develop a consensus regarding international fundamental quality system requirements, primarily for the participating companies' direct suppliers of production materials, product or service parts or finishing services (e.g. heat
  2. treating, painting and plating). These requirements will also be available for other interested parties in the automotive industry.
  3. To develop policies and procedures for the common IATF third party registration scheme to ensure consistency worldwide.
  4. To provide appropriate training to support ISO/TS 16949 requirements and the IATF registration scheme.
  5. To establish formal liaisons with appropriate bodies to support IATF objectives.

IATF 16949 Now Released

on . Posted in IATF 16949

October 2016

Automotive suppliers can begin upgrading their quality system as the revised standard IATF 16949 is now available from AIAG. Clients will also need a copy of ISO 9001:2015 as IATF 16949 consists of only automotive requirements.

Existing ISO/TS 16949 certificates expire Sept 14, 2018. ASR is in the process of reaching out to its certified clients to schedule transition audits.

A transition audit replaces a client's regularly scheduled certification or surveillance audit. The transition audit is equivalent to a recertification audit which is a full system audit addressing all requirements of IATF 16949:2016 and ISO 9001:2015 and begins a new three-year audit cycle.

A key transition point for clients is a requirement to submit updated QMS documents to ASR prior to the start of the transition audit for an off-site documentation review. These documents include quality manual, updated/new procedures and evidence about conformity to IATF 16949. Failure to do so will result in an additional 4 hours to the site's audit to allow the auditor time to collect and review the requested documents.

Valuable information addressing the IATF 16949 transition process can be found by going to www.aiag.org and click the International Automotive Task Force (IATF) transition strategy document.

Contact ASR if your organization has any questions regarding the revised IATF 16949 standard or the transition process.


ASR's 2nd Party Auditing Service

on . Posted in IATF 16949

Did you know that ASR provides second-party auditing services?


Audit services include internal auditing, gap analysis, pre-assessments, IATF 16949
supplier audits, and the CQI customer specific audit series including 8, 9, 11, and 12. Click here for a complete list of the special process assessments.

Share your needs and request a quote from ASR's sales team at This email address is being protected from spambots. You need JavaScript enabled to view it. or call (888) 891-9002.

Special Process Assessments:

  • CQI-8 Process Layered Audit (Special audit system for all company levels)
  • CQI-9 Heat Treat Assessment (Assessment of heat treatment systems)
  • CQI-11 Plating System Assessment (Assessment of systems for galvanic surface treatment)
  • CQI-12 Coating System Assessment (Assessment of surface coating systems)
  • CQI-14 Consumer Centric Warranty Management (Guideline for warranty management for end user)
  • CQI-15 Welding System Assessment (Assessment of welding processes)
  • CQI-17 Soldering System Assessment (Assessment of soldering processes)
  • CQI-19 Sub-Tier Supplier Management Process Guideline
  • CQI-20 Effective Problem Solving Practitioner Guide
  • CQI-21 Effective Problem Solving Leader Guide
  • CQI-22 Cost of Poor Quality Guide
  • CQI-23 Molding System Assessment
  • CQI-27 Casting System Assessment


ISO/TS 16949 Revised, Renamed, Released in October

on . Posted in IATF 16949

TS clients are strongly encouraged to immediately begin transitioning to the revised ISO/TS 16949 standard now called IATF 16949.

While IATF 16949 will be released next month, the updated standard aligns with        ISO 9001:2015 so clients can begin now to change their QMS.

The following summarizes important client transition information and dates:  

Transition and alignment of ISO/TS 16949 to ISO 9001:2015 continues to progress.  At a recent meeting with the IAOB additional information and clarifications on timing was presented.  Below are the estimated dates for release of information and transition requirements for both ASR and all certified clients.

  • October 2016 - Standard Release –  New name is IATF 16949
  • November/December 2016 – Third Party Auditor Training available
  • October 1, 2017 – No more audits to ISO/TS 16949:2009, All audits to be conducted to new standard
  • September 15, 2018 – All transition audits must be completed, certification decisions made and audit data and certificates uploaded to the IATF database.
  • There is an allowance for the certificate to expire and a new certificate to be issued so long as it occurs within 120 days of end of the transition audit.
  • Each transition audit will require an off-site documentation review in advance to determine readiness for transition.
  • If the off-site documentation review information is not provided or readiness is not evident a minimum of .5 audit days will be added the transition audit.
  • Transition audits will be conducted on your regular audit schedule with audit time equivalent to recertification.  This will start a new three-year certificate cycle.  
The overall theme presented from the industry stakeholders was that certified clients should get started now on upgrading their internal systems to the requirements in ISO 9001:2015 as the new standard is using the new structure.  ASR also recommends beginning the process now as the transition timeline is very short and the entire industry will be challenged to get all clients upgraded prior to September 15, 2018.  

If your normal audit cycle is during the months of January – July it is possible that you will be able to transition in 2018. However, if your current audit cycle is August – December you will be required to transition in 2017. If you have any questions or want additional information, please contact ASR (This email address is being protected from spambots. You need JavaScript enabled to view it.) and we will be happy to discuss any concerns. The full transition document is also available on the IATF website at www.iatfglobaloversight.org

New 2016 Automotive and Aerospace Standards - ISO/TS 16949

on . Posted in IATF 16949

aviation Rolls Royce Jet Engine quality ts 16949New 2016 Automotive and Aerospace Standards Set for 4th Q 2016 Release


ISO/TS 16949 – IAOB announced in a recent meeting with Certification Bodies (registrars) that the new standard should be available this October instead of December.  The October release will add a couple extra months to the automotive community’s implementation timeline.

ASR is advising its TS 16949 clients to acquire a copy of the standard just as soon as it is available to ensure there is sufficient time for a system upgrade.  ASR is hopeful of conducting upgrade audits by early April 2017.
 
AS9100:2016 Series - 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) requirement to transition to the ISO 9001:2015 quality management system (QMS) standard no later than September 15, 2018.  AS9100:2016 is based on ISO 9001:2015.

IAQG has told Certification Bodies (registrars) their plan is to publish concurrently the 9100:2016 series of standards across Americas, Asia-Pacific, and European sectors beginning in October 2016 with AS9101, AS9110 in November 2016, and AS9120 in December 2016. However, IAQG is making efforts to shorten the publication time spans and publish concurrently as soon as possible.

ASR is also advising aerospace clients to acquire a copy of the standard just as soon as it is available to ensure sufficient time for a system upgrade.


IATF 16949 2016 Revision Update

on . Posted in IATF 16949

The IATF 16949:2016 issued a supplemental bulletin on August 9th informing the community that the new revision "Rules for achieving and maintaining IATF recognition" is scheduled for releas in November of 2016.

pdfClick here to read and download the bulletin.

The ISO has also sent a press release about this with more information.  pdfTheir press release titled, "A New Evolution for Quality Management in the Automotive Industry" can be read or downloaded - by clicking this link.


New ISO/TS 16949 Expected Dec 2016 – Upgrade Time Short

on . Posted in IATF 16949

ISO/TS 16949 is being revised with an expected December 2016 release date for the new standard. All existing certified ISO/TS 16949 clients will need to transition and recertify by September 14, 2018 to maintain an active certificate. This gives the entire automotive supply chain less than 2 years to implement changes and recertify to the newly rewritten ISO/TS 16949.

ISO 16949 Revisions Automotive IndustryRecently, all IATF Certification Bodies (CBs) attended a required global conference to provide feedback and discuss the release of the new version of ISO/TS 16949. The new standard will incorporate content and structure from ISO 9001:2015 and specific automotive requirements.

Each section of the standard was reviewed in detail with small groups of CB representatives and selected suppliers. Concerns and feedback were shared with OEMs and IATF representatives and will be taken into consideration for the second revision of the standard. This second rewrite is expected to be complete by July 2016.

IATF is expected to release the final version of ISO/TS 16949 in December 2016 along with a new revision to the TS Rules. Changes to the Rules will be minimal and likely only include all existing sanctioned interpretations and FAQ's.

Once the standard is released, all certified clients will need to immediately begin implementation of the new requirements in preparation for the upgrade audit. Transition requirements for upgrade will require all ISO/TS 16949 certified sites to conduct the upgrade audit and acquire a new certificate prior to September 14, 2018.
As we learn more about the final release dates and if any of these transition requirements change, ASR will communicate this to you. If you have any questions, please contact Tom Droog (This email address is being protected from spambots. You need JavaScript enabled to view it.) at the ASR office.

Revised ISO/TS 16949 Certificate Coming

on . Posted in IATF 16949

ASR will begin issuing revised ISO/TS 16949:2009 certificates reflecting an expiration date of September 14, 2018. This action is the result of a directive to all Certification Bodies from the International Accreditation Forum (IAF) and the ISO Committee on Conformity Assessment (CASCO). These two groups set the governing rules for the certification industry.

ISO 9001:2008 is the basis for the ISO/TS 16949:2009 QMS and TS certificates must run concurrent with the expiration of ISO 9001:2008. Transition period to ISO 9001:2015 is three years from the publication release date or September 15, 2018. IAF and CASCO notified Certification Bodies that ISO/TS 16949:2009 certificates will expire September 14, 2018.

ASR's TS client contacts will also receive notice of the certificate expiration date change via e/mail.

Contact ASR if you have questions concerning your ISO/TS 16949 certificate and continue to monitor ASR's web site for soon to be released transition plans to ISO/TS 16949.

ISO/TS 16949 Registrar

on . Posted in IATF 16949

What is ISO/TS 16949?
ASR, An ISO/TS 16949 Registrar Answers

ISO-TS-16949-standard-for-automotive-by-ASRISO/TS 16949 is a Technical Specification not an ISO standard.

It specifies the Quality Management System (QMS) requirements for the design, the development, production, installation, and servicing of automotive products.

The International Automotive Task Force (IATF), which consists of an international group of vehicle manufacturers, wrote ISO/TS 16949 in conjunction with the International Organization for Standards (ISO). This specification aligns existing American, German (VDA6.1), French (EAQF) and Italian (AVSQ) automotive quality systems standards within the global automotive industry.

Together with ISO 9001, ISO/TS 16949 specifies the quality management system requirements for the design/development, production, installation and servicing of automotive products.  In addition, there are customer specific requirements that are required by individual subscribing vehicle manufacturers. ISO/TS 16949 does not replace the existing quality system requirements.

Some of the benefits of the IATF registration scheme include:

  • better product and process quality
  • improved positioning in the market of global sourcing
  • common quality approach in the supply chain for development and product consistency
  • reduction in multiple registrations
The IATF developed a common registration scheme for supplier 3rd party registration to the ISO/TS 16949. ASR is a trusted ISO/TS 16949 registrar.

For further information on ISO/TS 16949 visit the IAOB website at www.iatfglobaloversight.org.

Click here for a quote from ASR or call directly toll-free at 888-891-9002 or 616-942-6273.
Request a quote for a review or an ISO standards audit
Click Here to view ASR's IATF Recognition Certificate.

What are the benefits to being ISO/TS 16949?

on . Posted in IATF 16949

Ability to Enter Auto Manufacturing Market

Most auto/vehicle manufacturers, require ISO/TS 16949 certification because it is internationally recognized – this will help you on a global scale.

Improve Productivity, Reduces Waste and Reduces Defects

Because the standard is based on ISO 9001:2008, it promotes a process approach. By using the process approach, increases understanding of the inter-relationship of processes.  This improves the product and quality process and avoids problems in the supply chain.

Works Within Your Organization and can be Adaptable

If your organization is certified to ISO 9001, implementing the ISO/TS 16949 is much easier.  It can also be integrated with ISO 14001 Environmental and OHSAS 18001 Occupational Health and Safety. It also coexists with other business improvement tools, like PPAP, Six Sigma and FMEA.

Improve Your Reputation

Certification can provide additional confidence and consistency to all interested parties in global sourcing, enabling greater business opportunities, and attracting more investment prospects.

Tips for implementing ISO/TS 16949

on . Posted in IATF 16949

How does my company implement ISO/TS 16949?

  • Be sure your organization is committed to the effort of ISO/TS 16949 certification.
  • Ensure you have good communication within your business and supply chain.
  • Perform a Gap analysis that compares an existing Quality Management System (QMS) with the ISO/TS 16949 requirements.
  • Perform a survey with your stakeholders and supply about the current quality processes.
  • Organize an implementation team.
  • Delegate the roles, responsibilities and timesframes.
  • Implement the basic principles of the ISO/TS 16949 standard to your organization.
  • Train your staff.
  • Perform internal audits regularly to review your ISO/TS 16949 system.Request a quote for a review or an ISO standards audit

A quotation for registration to ISO/TS 16949:2009 can be provided by clicking the "Request a Quote" link or calling ASR at: 888-891-9002.

ISO/TS 16949 Rule Changes

on . Posted in IATF 16949

Here are some important rule changes:
  • The Pre-Assessment auditors are not able to perform the registration audits
  • Pre-Assessment on-site time is limited to 80% of Stage 2 on-site time
  • Corporate quoting methodologies are permitted for manufacturing or value added organizations. Corporate refers to the quoting scheme only. Each value added site must have a separate audit report and a separate certificate
  • Sampling sites is not allowed
  • Each subsequent recertification and surveillance cycle, different auditors must be used
  • Corrective action responses must be in the Seven- or Eight-Discipline method, depending on the customer
  • For Major (Hold) corrective actions, the client must determine root cause and implement correction within 20 days from the end of the site audit and an on-site Special audit for verification is required
  • Surveillance events must be of equal duration
  • Renewal Audit must occur within 3 years of the previous initial or re-registration (renewal) event and well before the certificate expiry date to prevent a certification lapse (that would require a full registration re-assessment)
  • The certificate must be issued within 120 days of the last day on site at the initial or renewal event

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Automotive

  • IATF 16949
  • Intl. Automotive Task Force
  • BS 25999
  • OHSAS 18001

Medical Devices

  • ISO 13485
  • Product Safety
  • Device Recalls
  • Emergency Situations

Aerospace

  • AS9100
  • AS9110
  • AS9120
  • SAE Technical Standards

Environmental

  • ISO 14001
  • EPA Regulations
  • EMS Tools
  • Emergency Preparedness