Responsible Care® RC14001:2015 Technical Specification

Responsible Care® is the chemical industry’s global initiative for managing and improving environmental, health, safety and security performance. Since 1988, Responsible Care has helped American Chemistry Council (ACC) member companies significantly enhance their performance, reveal new business opportunities, and improve employee health and safety. In addition, the health and safety of the communities in which member companies operate are improved, and our environment as a whole is more sustainable. The wide acceptance of the Responsible Care® initiative is a testimony to its recognition and effectiveness.

Responsible Care® 14001 (RC14001) and Responsible Care Management System® (RCMS) are performance improvement Standards launched by the ACC to ensure that the chemical industry makes health, safety, security and the environment top priorities. The RC14001 Technical Specification, since its initial release, has been modeled around the ISO Standard for environmental management systems, ISO14001. With recent updates to ISO14001 in 2015, the RC14001 Technical Specification has also been

updated. Its structure is identical to ISO 14001, and in most cases, simply expands an environmental requirement into an EHS&S requirement.

RC14001:2015 Update

The current version of RC14001:2013 has now been updated to RC14001:2015. This revision closely follows the 2015 revision of ISO14001, which was a substantial change to the previous structure of the Standard and includes some new requirements. The new High-Level-Structure (HLS) is now integrated for all ISO Standards, as well as RC14001:2015. The HLS brings a

(welcomed) standardized format for all new and revised ISO Standards. Along with the new HLS is a new approach to thinking about management processes and integrating management concepts

throughout an organization. This integration starts with determining the strategic direction of the organization and then considering the environmental, health, safety and security impacts associated with that direction. Once a strategic direction is established, then management processes are put in place to plan and implement appropriate goals for improving EHS&S performance.

Context of the Organization

RC14001:2015 brings us challenges with its restructured framework, along with some new requirements and considerations. High on the list of requirements is the new “Context of the Organization” concept. The intent of this new requirement is to assure that there is a high-level understanding of important issues that can have an effect on an organization’s EHS&S responsibilities. This could be thought of as an “initial review” in the process of defining the management system. Included in this initial review are internal and external issues affecting EHS&S performance and identifying relevant interested

parties.

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RC 14001:2015Page 1

AS9100:2016 ChangesPage 2

2016 Quarter 2

ISO 13485:2016 UpdatePage 3

AIAG Quality Summit

Don’t miss this opportunity to hear Cindy Soltis-Stroud (Lead Auditor for DQS, CEO Cogent Global Performance Solutions) speak at the AIAG Quality Summit September 2016. She specializes in the ISO/TS 16949 “Automotive” standard as well as ISO 9001. Cindy will be presenting “The Trouble with Corrective Actions”.

Cindy has developed her presentation based on common issues and concerns observed with corrective action processes based on experience with over 1000 audits. As an auditor for DQS, she

is responsible for the evaluation of implementation and effectiveness of organizations’ corrective action systems. She has identified key weaknesses from Top Management engagement to standard practice and implementation. The corrective action process is one of the key processes that determine the health and viability of your business management system. This process is at the heart of your business system. Good corrective action systems are not just about how you respond to customers, but how you address concerns within your own internal systems.

Businesses cannot afford to have a weak corrective action system. Weak systems cost the organization more money than just the resources that manage them. A

poor corrective action system is truly the definition of insanity. Insanity: Doing the same things over and over and expecting different results. Poor systems are nothing more than resource vampires. Sucking the life and energy from your resources as well as developing a poor attitude toward the importance of your corrective action system.

Cindy is a dynamic speaker with methods based on participation and engagement from her audience. She has presented to organizations such as Ford Motor Company, GM and other professional organizations. Please join her at the AIAG Quality Summit in September 2016. For more information on the AIAG Quality Summit and presenters, visit www.AIAG.org.

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UPDATES TO STANDARDS

2016 Quarter 2

AS9100:2016

Within the past year, we have witnessed a lot of change from various standards, and the Aerospace industry will be no exception. The new AS9100:2016 is expected to be released by October, and the updates for AS9101, AS9110, and AS9120 are expected to be released shortly thereafter.

Though the updated standards have not been published yet, the industry has shared what is expected to be the significant changes to the standard. Below are the anticipated key changes for AS9100:2016:

• Product Safety- added in a separate clause and in selected areas

• Human Factors- added as a consideration in non-conformity /corrective action

• Risk- merged current AS9100 requirements with the new ISO requirements and placed an emphasis on risks in operational processes

• Counterfeit Parts Prevention- added in a separate clause and in selected areas

• Configuration Management- clarified and improved considerably to address stakeholder needs

• Awareness- reinforced requirements for awareness of individual contribution to quality

AS9100, AS9110 and AS9120 will all be based on ISO 9001:2015. In addition, the AS91XX series will also adopt the 10 clause structure, including the following: Scope, Normative Ref, Terms and Definitions, Context of the Organization, Leadership, Planning for the QMS, Support, Operation, Performance Evaluation, and Improvement.

DQS Inc. is committed to ensuring we help our customers prepare for these changes and keep them updated as information is released. We are expecting audits to the 2016 revision to start in Quarter 1 2017 but will keep customers updated through our newsletters and direct communications.

Michelle BartonDirector of Aerospace Program

2016 Quarter 2

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UPDATES TO STANDARDS

ISO 13485:2016 Update

2016 is a year for change! On March 1, we welcomed the new revision of ISO 13485. It had been 13 years in the making and finally arrived. Unlike other standards that have changed recently, ISO 13485:2016 did not convert to the new high level structure like ISO 9001:2015. The new ISO 13485 is now based on ISO 9001:2008.

There were a number of factors that influenced that final release of ISO 13485:2016. The technical committee had a daunting task to update the standard and continue to have it applicable and useable by the industry. Some of the considerations that went into the new version include: regulatory requirements in the countries that recognized ISO 13485:2003, continued emphasis on risk management, need for additional supplier controls and clarifications of definitions and requirements within the standard.

One of the significant changes in the 2016 revision of the standard is the further clarification of what types of organizations can apply ISO 13485. ISO 13485:2016 can be used by any organization that is involved in one or more stages of the life-cycle of a medical device. The stages of the life-cycle are defined as:

• Production

• Storage and distribution

• Installation

• Servicing

• Final decommissioning and disposal of medical devices

• Design and development, or provision of associated activities (e.g. technical support)

The standard can also be used by suppliers or another external party that provides products (e.g. raw materials, components, subassemblies, medical devices, sterilization services, calibration services, distribution services, maintenance services, etc.) to organizations described above. The supplier or external party can voluntarily choose to conform to the

requirements of ISO 13485 or can be part of contractual requirements.

ISO 13485:2016 has also added more emphasis on the use of the process approach that was introduced as a part of ISO 9001:2008. This approach identifies that any activity that has an input which is converted to an output is a process, recognizing that a quality management system functions based on the links between numerous processes. The process approach within a QMS considers the importance of:

a) Understanding and meeting requirements;

b) Considering processes in terms of added value;

c) Obtaining results of process performance and effectiveness;

d) Improving processes based on objective measurement.

Unlike its predecessor, ISO 13485:2016 offers additional flexibility in the application of particular clauses of the standard. In the 2003 version of the standard, only clauses within section 7

could be considered as not applicable to a quality management system. In the 2016 standard, clauses from sections 6, 7 and 8 can be considered as not applicable based on the activities of the organization or the nature of the device that is being produced under the quality management system. Records of justification for deeming clauses as not applicable do of course have to be maintained.

The 2016 standard also made several changes and additions to the overall requirements of a quality management system under ISO 13485. An overview of these changes was presented as a part of an informational webinar. A recording of that webinar can be found on the DQS Inc. website, www.dqsus.com, if you go to Resources on the main menu and choose Events and Webinars. Under Webinars, click on the link for Recorded Webinars to see all of our past webinars, including the

ISO 13485 revision webinar.

Certification Upgrade Timelines

It has been recommended by TC 210 that there be a three year transition period from the date of issuance of the standard to upgrade to the 2016 version.  Generally, for clients that are on an annual surveillance cycle, this would include two surveillance audits and a recertification audit to upgrade, depending on where the organization is within its certification period. Organizations on a biannual audit frequency will generally have additional surveillance assessments to make this transition based on the frequency of audits.

The timelines for transition to ISO 13485:2016 based on the recommendation of TC 210 are:

- 2 years after publication (March 1, 2018), all newly issued accredited certificates will be to ISO 13485:2016

- 3 years after publication (March 1, 2019), all ISO 13485:2003 certificates will no longer be valid

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2016 Quarter 2 www.dqsus.com

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UPDATES TO STANDARDSContinued from page 3

If your organization has a current ISO 13485:2003 certificate, the upgrade to the 2016 standard should take place no later than December 1, 2018. This gives the necessary time for review and closure of any nonconformances that may be identified, as well as completion of required post-audit reviews.

At this time, DQS Inc. is in the process of confirming these plans with our

accreditation body and will communicate certification arrangements in the near future. DQS Inc. cannot provide any accredited certificates until such time that our accreditation body grants the authority to issue them. However, DQS can provide initial gap assessments of your quality management system.

Gap Assessments

DQS also offers an optional gap assessment service including a report of known areas

where the management system is not yet in conformance with the new requirements of ISO 13485:2016.  Gap assessments can be performed sequentially with any regularly scheduled audit or at a specially requested time. Please contact your Customer Service Professional to schedule.

Rick BurgessMedical Program Manager

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Procurement, Outsourcing and Lifecycle Perspective

RC14001:2015 has retained the requirements to manage EHS&S aspects. These aspects are associated with the organizations procured goods and services. Organizations will now need to extend their level of control and influence on the EHS&S impacts associated with product design and development and address each stage of the life cycle.

Newly expanded requirements are applicable to the acquisition of raw materials, product design, production, transportation/delivery, use, end-of-life treatment and final disposal. An organization must now give serious

consideration to what actual or potential impacts happen upstream and downstream of an organization’s processes. There are also requirements for the control of planned changes and the review of unintended changes when these occur. Another key change is that the Standard now requires that outsourced processes be controlled or influenced. Some help is provided by having a clear definition for outsourced processes.

Some additional changes in RC14001:2015 include:

• An increased alignment with the strategic direction of the organization;

• Greater protection for the environment, with a focus on proactive initiatives;

• More effective internal and external communication, driven through a communications strategy;

• A greater commitment from Leadership;

• Life-cycle thinking, considering each stage of a product or service, from development to end of life; and

• An emphasis on performance and measurement.

Gary McRaeEHS and Energy Program Manager

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