TL 9000 R6 Updates

QuEST Forum has released the TL 9000:2016 (R6) standard. This standard has been updated based on the new ISO 9001:2015. The measurement handbook R5.0 is not changing right now, and the new standard will be effective from September 15, 2016. The organizations those are currently certified to the TL 9000, R5.5 will have time until September 15, 2018 to upgrade to the new standard. This is the same timeline for transition to the ISO 9001:2015.

The Integrated Global Quality (IGQ) work group of the QuEST Forum was responsible for this standard upgrade. To be consistent with the new ISO 9001:2015, TL 9000 R6.0 has also introduced conceptual changes like risk-based thinking, more emphasis on process approach, no mandatory procedures, no requirement for quality manual and management representatives. IGQ

members also took this opportunity to simplify adders and notes based on the feedback received from the members. TL 9000, R5.5 has 92 adders and 45 notes; the R 6.0 has 84 adders and 41 notes. Also, eight adders have been deleted from R5.5. Deleted adders are:

• 5.2. C.1 – Customer relationship development

• 6.4.C.2 – Work area• 7.1.V.1 – Service delivery plan• 7.2.2.C1 – Closure tracking• 7.3.2.S.1 – Identification of

software requirement• 7.5.1.C.1 – Customer service

resources• 7.5.1.S.1 – Replication• 8.5.1.C.1 – Continual

improvement program

R6.0, however, introduces new adders:

• 9.1.3.C.3 – Sustainability assessment: The organization should assess the status of its sustainability efforts as appropriate to its organization, products, and services. QuEST Forum has also provided a sample sustainability assessment model in the TL9000 website (tl9000.org).

• 9.2.2.C.1 – Internal Audit Program Planning: Internal audit program shall include all applicable Requirements and Measurement Handbook requirements. This has been an implicit requirement till now, but this adder made it explicit.

R6.0 also simplified adders by combining the R5.5 adders of similar intents. Below table provides the list of combined adders:

R5.5 adders7.3.1.HS.2 – Design and development process quality measurement planning and implementation7.2.3.HS.2 – Design and development process quality measurements data reporting7.3.2.H.1 – Content of requirements7.3.2.C.2 – Design and development requirements7.5.1.S.1 – Patching procedure7.5.1.S.2 – Patch documentation8.4.HS.1 – Field performance data8.4.V.1 – Service performance data

R6.0 adders8.3.2.HS.3 – Design and development process quality measurement planning and implementation8.3.3.C.2 – Design and development requirements8.5.5.S.1 – Software patching information9.1.3.C.2 – Performance data

Overall, practitioners should find reduced requirements and simplified language in TL9000:2016 (R6.0). QuEST Forum has also released the upgrade training module for the auditors. DQS will be ready to start offering upgrade audits from October 2016.

TL 9000 R6Page 1

Food Safety UpdatePage 2

2016 Quarter 3

ISO 45001 and AS9100DPage 3

Food Safety Updates

The FDA Food Safety Modernization Act (FSMA), was signed into law by President Obama on January 4, 2011. Rules for third party accreditation of manufacturers, including this initiative, were proposed in January 2013. Last month, August 2016, the FDA issued a final rule that extends and clarifies the compliance dates for suppliers beginning in September 2016.

SQFI contracted The Acheson Group (TAG) to compare the elements of SQF Level 2 Certification (specifically Modules 2 and 11) to the FDA FSMA Final Rule requirements. The analysis examined two major aspects of the Final Rule: the new preventive controls requirements that the industry must comply with in order to implement the requirements of Section 103 of FSMA, and the updated current Good Manufacturing Practices (cGMPs) (current 21 C.F.R. Part 110 now re-designated as Part 117). SQF FSMA applications are more specific than the FDA for environmental monitoring of high-risk processes and incoming goods and raw material safety. SQF Level 2 and a HARPC-focused food safety plan will put a company in a good position for FSMA readiness. SQF Edition 8, set for release Fall of 2016, will include further clarification of FSMA application for the SQF standard.

To assist all BRC Food certificated sites, BRC Global Standards commissioned The Acheson Group (TAG) to assess the BRC Global Standard for Food Safety Issue 7 against the final rule for Preventative Controls for Human Food. The results of the analysis show that certification to

the BRC Global Standard for Food Safety Issue 7 is almost in complete alignment with the expectations of FSMA. There is also a Voluntary Module, 15 FSMA Preventive Controls Preparedness Module now available on BRC Participate. You may choose this as addendum as an add-on for your next BRC Recertification audit with DQS Inc.

FSSC introduced their latest standard revision in February 2016. This update allowed suppliers to include quality

analysis by adding the option of a voluntary ISO 9001:2008 module. This combined FSSC 22000 and ISO 9001 certificate allows suppliers using FSSC 22000 certification an opportunity to integrate food quality management in the scope of their certification. As of March 2015, FSSC 22000-Q Module certification is available for organizations wishing to integrate food quality management into their certified food safety scope. The Module includes: ISO 22000:2005 in combination with ISO 9001:2008 + applicable technical specification for sector PRPs (food) + FSSC 22000

requirements. This add-on module is available for your next FSSC Surveillance. Please note, only organizations that are FSSC 22000 certified can integrate ISO 9001 and acquire a FSSC 22000-Q certificate. Alternatively, suppliers may still choose to continue carrying a separate ISO 9001 certification.

DQS is committed to ensuring we help our customers prepare for these changes, please reach out to myself or your Regional Account Manager to inquire about your company’s preparedness for FSMA Preventative Controls for Human Food and which avenue would suit your company’s continual food safety pursuit.

Josey Byrne

DQS Inc. Food Safety Program Manager

2

UPDATES TO STANDARDS

2016 Quarter 3

AS9100D is Published

We are excited to announce that the AS9100D (AS9100:2016) has been published. The standard can be purchased at: http://standards.sae.org/as9100d/

Please note revisions of AS9101, AS9110, and AS9120 are underway and expected to be released later this year. We will continue to provide transition plan updates within the coming weeks as the accreditation application and IAQG transition rules become finalized. Below are some initial important dates and activities to be aware of during the transition to the revised standards:

• March 1, 2017 – all currently

certified organizations must have communicated with their CB to establish a commitment date for standard transition readiness

• Jun 15, 2017 – all audits

started after this date must be to AS9100/9110/9120:2016

• Jun 15, 2018 – all currently

certified organizations must have completed their transition audit

• Sep 15, 2018 – all existing certificates to AS9100/9110/9120:2009 that have

not completed the transition to AS9100/9110/ 9120:2016 will no longer be valid. The certification will no longer be eligible for transition, and an initial certification audit will be required.

2016 Quarter 3

3

UPDATES TO STANDARDS

ISO 45001 Advances to 2nd DIS

Standard (DIS) for Occupational Health and Safety, ISO/DIS 45001, has failed to gain the necessary votes needed for approval. The development of ISO 45001 will now advance to a second DIS, which is expected in December 2016 or early 2017.

Following the publication of the first DIS in February 2016, the International Committee met in Toronto in June 2016 to discuss over 3,000 comments that had been submitted during the ballot. It was agreed at the closing plenary session

to move to publication of a second DIS.

The next Project Committee meeting, which is scheduled for October 2016, will review the remaining comments submitted during the first DIS ballot and also finalize the content for the second DIS. The

final standard publication is now anticipated to be released in the second half of 2017.

We will continue to bring you further information and updates on the development of ISO 45001 and its publication schedule as it becomes available.

2016 Quarter 3 www.dqsus.com

4

UPDATES TO STANDARDS