Automotive ISO/TS Standard Update

This Month

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ISO 9001:2015 Standard – What’s It All About? August 11, 2016 ASQ Phoenix Chapter Meeting.  Speaker: Walter Tighe. Free and Open to the Public.

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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.

Automotive ISO/TS Standard Update

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The Automotive Industry QMS Standard, ISO/TS 16949 is in the process of transitioning to the ISO 9001:2015 requirements and more. The transition project is on schedule to have the revision completed by the end of Q4 2016.

The Automotive Industry Action Group (IATF) is the recognizing body for ISO/TS 16949 accreditation worldwide. Since 2008, the standard has undergone a 59% growth in global certification volume with the top five being- #1 China, #2 Korea, #3 India, #4 USA, and Germany #5.

The reasons for the automotive industry having its own QMS standard include:

  • High volume manufacturing
  • Technologically advanced products
  • Driven across a wide variety of operating conditions
  • Significant increase in regulatory/statutory requirements – regional, international and global
  • Consumer expectations for a heighten culture of product quality, reliability and safety

 

Some of the revision focus areas include:

Revision Focus Areas Revision Team Approach
Safety-related parts and processes Requirements for special treatment of safety related products
Product traceability requirements Risk based approach, data retention and accessibility requirements
Products with embedded software Addition of automotive SPICE requirements
Warranty management process Requirements for addressing NTF and reference to automotive industry guidance documents
Sub-tier supplier management and development requirements Both operational performance development and QMS development required
Quality Manual Continued the requirement for a Quality Manual. Flexibility in format and structure

Strengthening the Audit Process

 
The IATF is “raising the bar” regarding expectations for audits to reflect systematic weaknesses that affect performance. Increased focus during audits on operational performance and customer feedback (scorecards and metrics). Expectations are that poor performing suppliers should not be ISO/TS certified.

An improvement we are also glad to see is a common architecture for future Customer Specific Requirements (CSR’s) aligned with the revised standard. For example, GM and Ford have released their new CSRs following the common architecture.

 
All organizations currently certified to ISO/TS 16949:2009 are required to complete the transition process by September 14, 2018. With the revised standard being published at the end of this year, it will be essential that current certified organizations begin planning and executing in a timely manner.

Seeking more information on the future revision? Contact us, and we are here to support all your future ISO/TS 16949:2016 transition training and consulting needs.  

Where is Risk Addressed in ISO 9001:2015?

 

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The concept of risk-based thinking is explained in the introduction of ISO 9001:2015 as an integral part of the process approach.
ISO 9001:2015 uses risk-based thinking in the following way:

 

Introduction – the concept of risk-based thinking is explained.

 

Clause 4 – the organization is required to determine its QMS processes and to address its risks and opportunities.

Clause 5 – Top management is required to:

  • Promote awareness of risk based thinking
  • Determine and address risks and opportunities that can affect product / service conformity
Clause 6 – the organization is required to identify risks and opportunities related to QMS performance and take appropriate actions to address them.

 

Clause 7 – the organization is required to determine and provide necessary resources (risk is implicit whenever “suitable” or “appropriate” is mentioned).

 

Clause 8 – the organization is required to manage its operational processes (risk is implicit whenever “suitable” or “appropriate” is mentioned).

 

Clause 9 – the organization is required to monitor, measure, analyze and evaluate effectiveness of actions taken to address the risks and opportunities.

Clause 10 – the organization is required to correct, prevent or reduce undesired effects and improve the QMS and update risks and opportunities.

 

Why use risk-based thinking?
 
By considering risk throughout the system and all processes the likelihood of achieving stated objectives is improved, output is more consistent and customers can be confident that they will receive the expected product or service.

Risk based thinking:

  • improves governance
  • establishes a proactive culture of improvement
  • assists with statutory and regulatory compliance
  • assures consistency of quality of products and services
  • improves customer confidence and satisfaction    
Looking for more information or assistance on the standard risk based requirements? Let us know. 

Pharma Sector Gets New ISO Tool
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With hundreds of thousands of prescription drugs on the market, the pharmaceutical sector faces an increasingly complex and risky challenge. Rapid growth in the number of available medications may be contributing to increased uncertainties. That is where the new ISO IDMP (IDentification of Medicinal Products) series comes in.
Up until now, there was no means of identifying medical substances on a global basis. This led to numerous challenges when adverse reactions to medicinal products were reported in one country and had to be interpreted by others. Greater co-ordination among drug regulatory authorities and increased transparency in reporting suspected adverse drug reactions was needed to improve current decision-making processes.

ISO IDMP is a collection of five ISO standards, which together form the basis for a system of unique, global identification of medicinal products. It is designed to enable cross-border healthcare delivery, particularly the exchange of electronic prescriptions and safe dispensation of prescribed medicinal products. IDMP will impact many key areas within a pharmaceutical company, from registration with an authority, research and development, to manufacturing, distribution and product safety.

 

Dr Herman Diederik, one of the foremost experts on the subject, explains: “Implementation of the ISO IDMP standards will enable scientists around the world to collaborate by delivering high-value substance descriptions. It will become a reference document for scientists and IT experts alike, a kind of unique sum of intelligence and IT architecture.”

According to ISO, the standards will “specify definitions in terms for all data elements required to uniquely, and with certainty, identify medical products for human use”.
The five standards in the IDMP series include:
  • Substances – ISO 11238
  • Pharmaceutical dose forms, units of presentation, routes of administration, and packaging – ISO 11239
  • Units of measurement – ISO 11240
  • Regulated medicinal product information – ISO 11615
  • Regulated pharmaceutical product information – ISO 11616

 

The ISO IDMP standards are being adopted globally by health authority agencies and organizations such as the World Health Organization.

 

Environmental Management Systems
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The third edition of ISO 14004 has been published with a new title, “Environmental management systems – General guidelines on implementation”. It replaces ISO 14004:2004 that had the title, “Environmental management systems – General guidelines on principles, systems and support techniques”.

ISO 14004:2016 provides guidance for an organization on the establishment, implementation, maintenance, and improvement of a robust, credible, and reliable environmental management system (EMS). The guidance provided is intended for an organization seeking to manage its environmental responsibilities in a systematic manner that contributes to the environmental pillar of sustainability.

ISO 14001:2016 helps an organization achieve the intended outcomes of its EMS, which provides value for the environment, the organization itself, and interested parties. Consistent with the organization’s environmental policy, the intended outcomes of an EMS include:

  • enhancement of environmental performance;
  • fulfilment of compliance obligations;
  • achievement of environmental objectives.
ISO 14004:2016 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.
The ISO 14004:2016 guidance can be used in whole or in part to systematically improve environmental management. It serves to provide additional explanation of the concepts and requirements.

 

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In the News
SAE Publishes New Standard for Aerospace Supply

SAE International’s G-14 Americas Aerospace Quality Standards Committee (AAQSC) announces the publication of the new technical standard, “AS9117: Delegated Product Release Verification.”

AS9117 specifies requirements for Delegated Product Release Verification (DPRV) to establish common product/service requirements for use at all levels of the supply chain.
The process for DPRV varies from one organization to another. Implementation of a standard process reduces the risk of escapes in the aviation, space, and defense industry supply chain, when the organization’s product release verification has been delegated to a supplier.

This new standard will apply when an organization elects to delegate product release verification by contractual flow down to their supplier (reference 9100 and 9110 standards); to perform product acceptance on their behalf.

To learn more about or to purchase “AS9117: Delegated Product Release Verification,” visit the SAE Website.

Free and Open to the General Public: ISO 9001:2015 What’s it all About?

Walter Tighe, President/Owner of Sustaining Edge Solutions, Inc. will be presenting valuable information on the ISO 9001:2015 Standard at the Phoenix Chapter Meeting of the American Society for Quality (ASQ) on Thursday, August 11, 2016. The meeting will be held at the Edward Jones Training Facility 8333 S. River Parkway Tempe, Arizona at 6:00 p.m.

 

Training Courses
 
All courses can be delivered at your company or at our training centers.  We do provide training beyond our home state of Arizona. Click on the course title for description, schedule, registration and payment. Group discounts are available. We also provide custom designed training to fit your specific needs. All training is fully documented for your training records and certificates of training are awarded.
 

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

 
Survey Says-Quick Poll Results 

What is the most important element of risk management?

#1 – 45.1% Fully understanding a risk potential consequences
#2 – 32.2% Knowing which risks to accept, transfer or mitigate
#3 – 22.5% Ensuring correct data are used in risk analysis

Source: Quality Progress Magazine, June 2016

With the new risk management requirements, Quality Managers and/or Quality Departments cannot do this on their own. Top management personnel must be involved, and this must be viewed as a top priority and an essential step for transitioning success.

 

Best Regards,

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

 

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