Occupational Health and Safety Management Systems – ISO 45001 update

For those of you eagerly awaiting an update on the Occupational Health and Safety Management – ISO 45001 standard, here it is.

The most recent round of voting on the ISO DIS 45001.2 has resulted in majority approval and can move forward towards publication.   The ballot indicated 57 votes of approval, 7 votes of disapproval and 8 abstentions.

The next step will take place in September of 2017, when the PC 283 committee meets in Malaysia to review the approximately 1630 comments received on the Draft International Standard (DIS).    At that time, the committee will determine if the standard will be moved directly to publication, which would mean potentially by the end of 2017, or if an FDIS (Final Draft International Standard) will be necessary.   If an FDIS is deemed necessary, it would delay publication until 2018.

It is intended that the ISO 45001 standard will help organizations reduce the burden of occupational injuries and diseases by providing a framework to improve employee safety, reduce workplace risks and create better, safer working conditions, all over the world.

Currently, many organizations use OHSAS 18001 for minimum requirements for occupational health and safety management best practice. The intention is that OHSAS 18001 will be replaced by ISO 45001 when published.

DQS Inc. is closely monitoring the development of this standard and is preparing to apply for accreditation as soon as the opportunity is available as well as preparing to offer certification services.

More to come on the progress of this standard after the September meeting!

Candace Orbaugh

Source: ISO.org

DQS Inc. Attains ISO 13485:2016 Accreditation

ISO 13485:2016 was released February 25, 2016, and DQS Inc. is proud to say that as of January 18, 2017, we have attained accreditation to offer certificates to this updated standard.
Clients currently certified to ISO 13485:2003 are required to have their current certificate transitioned to ISO 13485:2016 by March 1, 2019.  All remaining ISO 13485:2003 certificates will be withdrawn on that date.  To complete this, all upgrade audits must be completed by December 1, 2018.
Customers may upgrade during their regularly scheduled recertification or surveillance audits or during a special audit. Stage 1 audits are not required for the upgrade, but we can conduct an optional Stage 1 or gap assessment if requested.  The certificate renewal date will not be reset upon renewal unless it is done during a recertification audit.
The number of audit days required for the upgrade audit is as follows:
·      Recertification audit:  Recertification time with no reductions.
·      Surveillance audit or special audit:  Annual surveillance time with no reductions plus one day
·  If conducted at the same time as an ISO 9001:2015 S1/S2 upgrade/ recertification audit with same scope and same or lower employee count, no additional time for ISO 13485:2016 upgrade is required.  Scopes that differ only by clarifying it is  “for the medical device industry” or similar wording with same or lower employee count will also not require additional time for ISO 13485:2016 upgrade.   Other scenarios will be reviewed on a case by case basis to determine if additional time is needed.
Please contact your Customer Service Professional with any questions or to start scheduling upgrade audit activities. You can also review our recorded ISO 13485:2016 revisions webinar for additional information. We look forward to continuing to work with you during this transition.

IATF 16949 Revision

IATF 16949 available for purchasing; deadline for transition is 14 September 2018

IATF 16949 was published on October 3, 2016. From now on, organizations will need to adjust to the new requirements and start on their implementation.

The International Automotive Task Force (IATF) further confirmed September 14th, 2018 as the deadline for transition to the new standard in accordance with the new ISO 9001:2015. This implies that by that date at the latest, all ISO/TS 16949 certificates shall have been transferred to the new standard.

Based on this and with respect to the tight timeline, we would like to give you some additional information regarding the transition process as defined by IATF.

Transition Process

The Transition Process includes the following steps:

Time of Transition

Voluntary transition may be scheduled at the next planned surveillance or recertification audit any time between 1 January and 30 September 2017. Starting 1 October 2017, all audits shall be conducted to IATF 16949.

Audit Duration

According to IATF, the transition audit shall be the duration of a re-certification audit as given in IATF Rules, Table 5.2. If document review has to be conducted on-site due to documentation not being submitted in advance, an additional 0.5 days minimum will be carried out prior to the preliminary meeting.

Main Content Changes

In addition to ISO 9001:2015, we expect the following new/changed requirements:

DQS Recommendation for Transition

Even though the deadline is September 14, 2018, the Transition Audit should be finished by June, 2018, in order to allow the passing of a certification decision as well as issuance of the new certificate well before the current certificate expires.

Keeping in mind the short timeline, DQS recommends any organization currently certified to ISO/TS 16949:2009 and needing to transition to define their own schedule for the Transition Audit by the end of December 2016 already. This will give you ample time to clarify the amount of additional on-site audit time based on know-how, experience and size of your organization, supporting functions on-site or remote) as well as the complexity of processes and existence of a corporate scheme.

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:
R6.0, however, introduces new adders:
R6.0 also simplified adders by combining the R5.5 adders of similar intents. Below table provides the list of combined adders:
R5.5 adders
R6.0 adders
7.3.1.HS.2 – Design and development process quality measurement planning and implementation
7.2.3.HS.2 – Design and development process quality measurements data reporting
8.3.2.HS.3 – Design and development process quality measurement planning and implementation
7.3.2.H.1 – Content of requirements
7.3.2.C.2 – Design and development requirements
8.3.3.C.2 – Design and development requirements
7.5.1.S.1 – Patching procedure
7.5.1.S.2 – Patch documentation
8.5.5.S.1 – Software patching information
8.4.HS.1 – Field performance data
8.4.V.1 – Service performance data
9.1.3.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.

DQS Now Accredited to Offer RC 14001:2015

RC14001® Technical Specification (2015 edition) was published and released in late 2015 and is now available for companies to be registered to this updated Standard! DQS Inc. is proud to say we have now attained accreditation to offer RC 14001:2015 accredited certificates, effective April 4, 2016. We are one of the first Certification Bodies to be accredited by ANAB for this service.

The new RC 14001:2015 Standard combines elements of the American Chemistry Council’s (ACC) Responsible Care® initiative with those of ISO Standard 14001:2015 “Environmental management systems – Requirements with guidance for use”.  The new High-Level-Structure of RC14001:2015 is aligned with other ISO management system Standards for clause numbering and section content and so is highly suitable for integrating management system components.

The ACC is allowing a three-year period for transitioning to the new Standard, from the September 15, 2015 official release date, and so this timing is also aligned with ISO14001:2015 transition timing requirements.  DQS Inc. will be providing additional guidelines that include specific information for optimal timing of your transition to the revised Standard.  This is important because all organizations are required to be transitioned to the new Standard by September 15, 2018 to retain their certification to RC14001.

There are many benefits of certification to RC14001 and the new 2015 revision.  A key benefit is that it provides a company, through an application and audit process, a certification that its management system conforms to both the ISO 14001 and RC14001 requirements.

As in past versions of RC14001, the Technical Specification has two components. The first is the actual text of ISO 14001:2015, which specifies requirements for an environmental management system in support of a sustainable environmental commitment.  The second component includes requirements stated within corresponding text-boxed areas.  These are the additional Responsible Care elements required under an RC14001 scope.

RC14001 is one option that ACC members and Responsible Care Partners may select to meet their Responsible Care management systems certification requirements. RC14001 is also available to non-ACC organizations that are interested in certifying a comprehensive management system covering the environment, health, safety, security, product stewardship and outreach activities. RC14001 audits are conducted by certification bodies, such as DQS Inc., who are accredited by the ANSI-ASQ National Accreditation Board.

ISO 13485:2016 Update

The long awaited ISO 13485:2016 update is finally here! For the first time since 2003, there is a new revision of the ISO 13485 standard, as of February 25, 2016. This is the 3rd edition of this standard.

Unlike ISO 9001:2015, ISO 13485:2016 has not transitioned to the high level structure. The new version is based on ISO 9001:2008. It has been recommended by the technical committee that there be a three year window from the issuance of the standard to upgrade to the 2016 revision.  For most clients on an annual surveillance cycle, that may include at least two Surveillance audits and a Recertification audit to upgrade. Organizations on a biannual audit frequency will have a few more Surveillance audits to make this transition possible.

Considering the release date of the standard, the three year certificate upgrade window will run until February 25, 2019.  Any certificate that is not upgraded by that time to comply with the requirements of the 2016 revision will be withdrawn on the effective date of February 25, 2019.

If your ISO 13485 certification also includes ISO 9001, the timing for the upgrade should coincide with the September 2018 requirement for ISO 9001:2015.

Current certifications may be upgraded to ISO 13485:2016 at any time during the registration cycle.  It may be done as part of the Recertification audit, regularly scheduled Surveillance audits, or by having a Special audit done at the organization’s preferred time.

DQS Inc. will be planning webinars in the near future to go over the changes in ISO 13485:2016 and integration with ISO 9001:2015. Webinars and updates will provide additional information for the upgrade process and will be coming soon.

We look forward to helping you prepare for your 2016 revisions!

First DQS Inc. Customer ISO 9001:2015 Certified

DQS Inc. is proud to say that we have had our first customer successfully upgrade to ISO 9001:2015. Congratulations to Extron, Inc.! Please see their statement on the upgrade below.


 

Extron, Inc. is proud and excited to be the first DQS customer to be certified to the new ISO 9001:2015 Standard.  This would not have been possible without the effort of all Extron employees and the auditing staff provided by DQS-US.

Extron, Inc. is a leading ISO 13485 & ISO 9001:2015 certified high-tech manufacturer offering solutions designed to improve supply chain cost, flexibility and risk exposure. Extron’s 120,000 sq. ft. facility is located in Milpitas, CA, producing product for Fortune 100 companies in the medical, aerospace, defense, technology, communications, medical, and automotive sectors. Extron provides on-demand product configuration in close proximity to distribution channels, helping its clients reduce manufacturing costs, maintain control of IP, respond faster, and reduce risk. Extron also provides returns management solutions, systems integration services, and is the North American source for Knurr mobile electronics carts, consoles, and custom racks and enclosures. Visit http://www.extroninc.com for details.

Extron’s ISO 9001:2015 certification updates the company’s ISO certification and extends the company’s position as a leader within the high-tech manufacturing industry, as it demonstrates Extron’s high levels of quality management and operational excellence.  Across the wide range of industries that Extron supports, the certification inspires confidence in Extron’s ability to consistently meet customer, statutory, and regulatory requirements.

Aspects of the New Standard by DQS Lebanon

We are thrilled to be able to share with you the below article written by Edward Grissom, General Manager at DQS Lebanon. In the article Grissmon shares a conversation he had with one of their customers about transitioning to ISO 9001:2015 and shows the evolving opinion the customers can have about it when they are more informed about how it effects them.


 

“What happened to ‘Say what you do, and do what you say’? I have a million things to juggle, and I don’t have time to re-work our manual”. This was Jamil’s response to our conversation regarding the new ISO standard 9001:2015. His response is typical among our customers. Jamil is the owner and general manager of a successful family owned SME and aspires to greater growth. He appreciates the benefits that come with ISO certification; however, at times he feels the requirements go

beyond what he really needs. He was not convinced that he would actually benefit from having to update his QMS in order to comply with the new standard.

He listened as I explained the process ISO goes through in order to review and update one of its standards. We discussed market changes worldwide, changes in customer expectations, technological advances, changes in sector specific requirements and new organizational knowledge. Jamil said it was interesting. We further the discussed the process of the review, modification and approval of the new standard—including the amount of time and money invested, the type of experts that participate and the sources of input which comes from varying markets around the world. Jamil was impressed. However, he still was not convinced. His mood did change, however, as we began to discuss some of the details in the actual standard. The real value for him and his company began to become clearer: The new standard provides understanding, tools and vocabulary that moves his decision making process and his company’s control of its work from the intuitive to the analytical.

Jamil did not really understand my explanation of “Understanding the Context of the Organization”, until he realized that he had considered external and internal issues when he took over as General Manager from his father. Office and factory space are found only at a premium in our area. Inevitably, the most practical location for his business is the one that he inherited from his dad.  He would have preferred to have rented a new space and built a factory from scratch, but given the company’s history, that was not possible. He said that the company name goes back a long time, and customers feel comfortable knowing that his products and service have a long history. He added

that had he moved to a new space, he also would have faced unwanted issues with his top managers’ commitment to the company. We expanded this discussion to incorporate other internal issues that Jamil had thought relevant, but had never considered such as updating equipment, the role of tradition regarding his brand and the challenge of increasing his work force with younger, more open-minded employees. Suddenly, understanding the context of his understanding by realizing internal issues he had already considered wasn’t so foreign. We experienced the same pattern regarding external issues. Immediately, he began to complain about the political deadlock in our country—there has been no trash service for 3 months. Although, trash is being picked up in his area, the government hasn’t resolved the issue. The government hasn’t appointed a president in

the past year. As a result, government contracts are held up and sometimes payment is slow. His list continued.

As he mentioned his problems with municipalities, we naturally began talking about interested parties. When he has looked over the standard himself, he admitted that he didn’t see any value in making his intertied parties. “I already know them.” Of course, the municipalities would be one, and I know what they want”, he said. However, after considering external issues, a light went on in his thinking. “But, that does make me think about a big problem we have. Invoices.–and not just from the municipalities. Sometimes we have outstanding invoices for months now. Folks are slower to pay, because it is taking time for them to get paid. They pay, but we need to nudge them a little.

Truthfully, sometimes we do the same thing. We have to put payment off for a week or two. Then we kind of forget. We will pay, but other things come up”. He barely finished the sentence when he looked at the QMR in his office, “We really do need a new procedure for tracking and assuring timely payment of invoices. We really didn’t need a strong procedure before. But, honestly, now we do”.

Jamil was beginning to lead part of the conversation now and even laughed when I moved on to Risk Based Thinking. Due to the unsteady security situation, he told me that he had bought an additional phone, and hired a driver to take his kids to school instead of the bus. He just felt safer having more direct contact with his kids on their to and from school. He said and it didn’t really cost that much more, because the bus wasn’t cheap as it is. A result, he started using “Whats App” texting and sending pictures to/from his kids. It was fun. He laughed because he realized he had employed “Risk Based Thinking” in his home. He wondered if there maybe some possible applications regarding the security and invoice situation in his business.

Rather than stop, I did continue on concerning the requirement of employing a process approach, and in particular, the requirement to measure whether these processes are achieving his desired results. Of course, Jamil was familiar with the process approach and did a good job of clarifying for his employees the steps needed for production and contact with customers. So, rather than explain that KPIs were needed for each process, I simply asked him what were the 3 most challenging decisions he had to make last year. Without thinking, he said, “Whether I bring on more drivers for delivery, expand our sales location into a partial production site as well, and whether I should replace one of my site managers. I’m still thinking about them, actually.” As he told me the information he was considering in order to take action of these decisions, it was clear some of the needed input would naturally be part of KPIs for certain processes. He began to appreciate that the value of the KPIs was not just making sure everything was going as planned. But, they also could provide helpful information that lead to smarter and quicker decisions.

We wrapped up our forty-minute meeting. Jamil was now looking forward to the new standard. Jamil had always been convinced that he would go forward with certification to 9001:2015, but now he was convinced that it provided specific advantages for him and his company. He no longer saw the transition from the old standard to the new as one more thing that he had to juggle, but a tool—in fact a strategic decision—to help him juggle all the things that inevitably are thrown his way.

The New ISO 9001:2015 Standard by DQS Malaysia

Following the articles we were able to share with our customers from DQS Argentina and DQS Taiwan, we are now proud to present an article by Soong KV from DQS Malaysia.

Changes of this latest version of ISO 9001 compare to its previous version of year 2008 are significant and accommodate to current management system trends. Previous focus in identifying core processes and ensuring effectiveness of these processes so as to achieve customer satisfaction, are now talking about the assessing and evaluating the risks and also opportunities of key processes in the context of each organization.  The organization is now required to determine those interested parties who are relevant to the management system and identify the needs and expectations of these interested parties.

Top management in any organization is always the key factor to drive to success. This new version therefore emphasizes active involvement and participation of top management to ensure effective implementation & maintenance of quality management system. This is clearly described in clause 5 Leadership in the new Standard. Also significant change from previous clause of 5 Management commitment and responsibility, the position of Management representative has been removed from this revised Standard. The roles & responsibilities of MR are now part of clause 5.3 of the revised Standard.

In clause 6 Planning, Risk based thinking or Risk analysis is introduced in year 2015 version. This may not be new for some organizations especially those ISO 13485, ISO/TS 16949, AS 9100, etc. certified organizations who has implemented risk management using FMEA, ISO 14971 etc. tool. But it is definitely a very significant change in the development of ISO 9001:2015. There is no requirement to have a specific tool nor method to determine the risks. However, the organization is expected to demonstrate how the risks and opportunities in all identified processes are analyzed and evaluated. In association with these identified risks and opportunities, the management shall plan relevant actions to address these risks and opportunities as well as how to integrate and implement these actions into the processes and evaluate effectiveness of these actions. As per previous versions, quality objective remains as it is and now the 4W1H approach is introduced to plan the achievement of set quality objectives.

Previous clause of 6.1, 6.2, 6.3, 6.4 & 4.2 are now restructured and rephrased in clause 7 Support. Document and record are now redefined as Documented Information. Clause 7.6 Calibration of 2008 version is now addressed in Clause 7.1.5 Monitoring & Measuring Resources.

Previous clauses of 7.1, 7.2, 7.3, 7.4 & 7.5 are now addressed in Clause 8 Operation. The revision of this 2015 Standard does not allowed any of the requirements/clauses to be excluded. Nevertheless, some of the elements in clause 8 may be not applicable to certain organization business nature.

Clauses 9 & 10 of this revised ISO 9001 are basically clause 8.1, 8.2, 8.3, 8.4 & 5.6 of 2008 version. Management Review is now under clause 9 Performance Evaluation which reflects the nature of this requirement as CHECK activity in PDCA cycle. The review inputs have been expanded to ensure items to measure effectiveness of quality management system, such as achievement of quality objectives, performance of external providers, customer satisfaction & feedback from interested parties etc., will be reviewed effectively.

With all these changes, thorough an in-depth readiness review for our existing certified clients towards smooth transition of ISO 9001:2015 is deemed necessary. Explaining to the client about this onsite readiness review will be a challenge ahead considering other certification bodies are basically reluctant to practice so. Nevertheless, as a preferred certification partner, DQS’s approach towards upgrading to this ISO 9001:2015 shall be valued. This is very much similar to patient and doctor kind of scenario. Doctors will never diagnose nor prescribe “Offsite”. He/she for sure will see the patient face-to-face (“Onsite”) to ensure clear and unambiguous information obtained to support his diagnosis and prescription. Hence DQS’s on-site readiness review for our certified clients towards the transition of revised ISO 9001 serves the same purpose.

ISO 9001:2015 from DQS Taiwan

DQS Inc. is proud to be a global company with offices all around the world. We were recently able to share an article on the ISO 9001:2015 revision from our Argentina office and are now proud to present a question and answer document from Rock Chang, Managing Director of DQS Taiwan Inc. Check out his Question and Answer document on the standard revision in his native language now.