Here’s What You Need to Know about ISO 9001:2015
Author: Joe Mansour
The ISO 9001:2015 standard was first announced in September of 2015, leaving a three-year window to update ISO 9001, but with less than six months left in that window, more and more organizations are gearing up to make the necessary enhancements, and the task of upgrading for some is becoming rather urgent.
Our transition plan is available on the DQS website and we offer a two-part upgrade process. Stage 1 is to determine the organization’s readiness, and Stage 2 is the actual upgrade audit to assess the effectiveness of the ISO 9001:2015 requirements.
Identification of Processes
ISO 9000:2015, defines “Process” as a “set of interrelated or interacting activities that use inputs to deliver an intended result.”
It may be challenging to justify the inclusion of Purchasing and Warehousing under a more extensive process, say “Fulfillment.” In most organizations, both Purchasing and Warehousing have well-defined inputs and expected outputs, with very little in common. Therefore, having both under the same umbrella may not be adequate.
However, if justification could be made that, say for a Distributor, Purchasing and Warehousing are related activities to ensure adequate stock levels at all times, then that may make it perfectly fine for the two “distinctly different” activities to be merged into one.
Based on what has been seen so far, for smaller organizations, ten or so processes may be sufficient to meet the intent of the requirements. Mid-size companies may have a bit more – perhaps 15 or so. For more substantial organizations 20-25 may be the right subscribed number. Anything more or less will have to be evaluated for adequacy.
Identification of Risks
For the identified processes, clause 4.4.1 requires that the risks be identified and managed. “Risks” should include factors that may prevent the organization from achieving its intended targets in meeting their Interested Parties’ expectations and objectives. Most organizations find the use of FMEAs suitable in addressing this requirement, but its use is not mandatory.
Establishing Goals and Objectives for all Processes
Also in 4.4.1, the need to monitor the process by use of process indicators is included as well. Please note that this requirement is not just related to the “Key Processes,” but all processes of the organization.
Our webinar webpage offers several webinars on various sections of the standard that are still available for you to access. If you have any questions about the ISO 9001:2015 update or you would like to learn more about DQS’s two-stage upgrade process, feel free to email us at [email protected] or call us at 800-285-4476.
Top 10 Challenges to Overcome for Implementing ISO 9001:2015 and ISO 14001:2015
By: Ganesh Rao, President and CEO
Certified organizations around the world are in the process of upgrading their management systems to comply with the 2015 revisions to ISO 9001 and ISO 14001 standards. Although the transition deadline of September 2018 looks far away, most organizations seek to complete the transition with their next re-certification audit or surveillance audit in 2017. The magnitude of effort to complete the transition is purely dependent on the size, maturity, and complexity of the organizations’ business processes. As always, leaders and forward-looking companies have already planned to complete the transition in 2016 to take advantage of the flexibility and business-focused requirements as a result of the 2015 revisions.
Here are the top 10 challenges organizations are facing with implementing the ISO 9001:2015 and ISO 14001:2015 standards:
- Context of the organization – requires an understanding of the external and internal factors that could impact the organization’s ability to meet its objectives.
- Identification of Stakeholders and Interested Parties – Although self-evident, the revised standards enlarge the group of stakeholders and interested parties beyond customers and owners / shareholders of the organization.
- Risk-based Thinking – An added dimension to decision making at all levels within the organization and encourages the consideration of risks and opportunities with achieving the desired objectives. Process level analysis has been present in sector specific standards; however, for many organizations the requirement to demonstrate risk–based decision making is challenging.
- Process Approach – A challenge even before the 2015 revisions. Organizations continue to address their management systems on the obsolete clause basis and are in the journey of thinking along business processes. Identifying business processes at a relevant level and assigning process indicators for effectiveness, has proven to be of great value to those organizations that have successfully made the transition.
- Out-sourced Processes – The applicability of these requirements has not changed and yet the type of control to be exercised over outsourced processes includes consideration of the environmental aspects and impacts over the life cycle of the product or service.
- Leadership and Commitment – The requirement to demonstrate commitment to the organization’s quality or environmental management systems and ensure the integration of those requirements into the organization’s business processes has drawn in executive responsibilities in the certification processes. By engaging top executive management in such decisions, organizations are now able to demonstrate the value of an effective management system in assuring business success. Complex structures and large organizations have the difficulty of assuring and demonstrating such leadership engagement and commitment for processes previously delegated to the “quality” or “environmental” department.
- Multi-Site Coordination – Larger organizations have an increased level of complexity with multiple locations and assuring consistent roll-out of business processes across the locations. Especially when the focus is in awareness, training, and competency development in the requirements such as risk-based thinking across all levels of the organization. Technology can be a great friend for such organizations in deploying the knowledge across multiple locations.
- Timing – In many large organizations, the timing decision on planning and implementing upgrades to the 2015 revision is made at a corporate or divisional level. While global or corporate processes are more conducive for changes with a short lead-time, it is often a challenge at site / plant level to deploy the information and changes with short notice. Deployment of internal assurances like internal audits, corrective actions, and management reviews requires advance planning prior to undertaking the upgrade assessments. A project plan that includes timing of awareness, education, training, and gap assessments could make the journey more predictable and less prone to risks.
- Terminology – The revised standards indeed include new terminology for business concepts currently in place. Most organizations practice some version of risk-based thinking in their decision making; however, building awareness and implementing risk-based thinking into all levels of the organization and into all the business processes is challenging. Similarly, integrating terminology such as context of the organization, stakeholder’s needs and expectations, and life cycle approach into current business practices is an evolution into the new requirements.
- Outcomes and Performance – One of the significant changes is the focus on “output matters” and “performance”. With the essential requirements for leadership commitment, risk-based thinking, and stakeholder expectations, organizations can focus on the achievement of intended results, i.e., output and performance. Organizations that have relied on volumes of procedures and documents that cover up inefficiencies may find it challenging to demonstrate the effectiveness of their business processes. The 2015 revised standards enable a strong focus on business outcomes and environmental performance such that value and return on investment in a certified management system is clearly evident.
A wealth of information is available for organizations to learn and implement the revised requirements. A staged approach that includes an in-depth understanding of the 2015 requirements and taking advantage of performing periodic gap assessments may provide increased opportunities and reduced risks for organizations.
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.
DQS Inc. Accredited to ISO 9001:2015 and ISO 14001:2015
DQS Inc.’s ANAB accreditation now includes ISO 9001:2015 and ISO 14001:2015 and can transition clients to ISO 9001:2015 and ISO 14001:2015. The transition is recognized on the ANAB website.
DQS is accredited to issue ANAB-accredited certificates following the transition requirements within ANAB’s Accreditation Rule 21.
ISO 9001:2015 is now also published!
The revision process of the ISO9001:2015 quality management standard is now finally complete. It was approved with an overwhelming majority and not a single country voted against the FDIS. Now, ISO is pleased to announce the official publication of ISO 9001:2015 on its website, and the standard can be purchased from ANSI.
For consistency, ISO has decided to make September 15, 2015 as the official publication date, which is also the publication date for ISO 14001:2015. The transition rules and deadlines for both standards will remain the same.
In comparison with ISO 9001:2008, the main changes to the standard are:
- High level structure and core text from ”annex SL“
- Increased emphasis on achieving value for the organization and its customers (“output matters”)
- Increased leadership requirements for top management commitment and involvement (Top management is accountable for the system and its performance).
- Need to understand the context of the organization and the needs and expectations of interested parties
- Emphasis on risk-based thinking
- Increased flexibility on the use of documentation
Certified companies will have a three year period to transition to the revised standard. DQS Inc. is prepared to assist all our registered organizations by way of offering informational sessions and gap assessments. Please contact your Customer Service Professional for more information.
ISO 9001:2015 Update
ISO-9001:2015 is still in Committee Draft (CD) status. The ISO member bodies did vote to move it to a Draft International Standard (DIS) once comments from the Committee Draft vote are resolved. The publication of the DIS version is anticipated in 2Q. Rest assured that UL DQS will notify our certified customers upon publication as a DIS. At that time, the draft will be far enough through the revision cycle for us to start providing customer informational sessions and offer optional gap assessments. The final publication of ISO 9001:2015 is not expected until the latter half of 2015. Once published, the International Accreditation Forum will provide requirements on the allowed transition period for upgrade of certificates to the new version. A time period of two to three years is anticipated.
You can find the latest update from ISO here: http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref1751
If an organization is interested in purchasing a copy of the Committee Draft, it can be attained at the link below. However, keep in mind that it will still need to go from CD to DIS to Final Draft International Standard (FDIS) to an ISO standard before the wording is final.
As always, we will do our best to keep you informed on the latest updates to standards. If you have any questions, please feel free to contact us.
ISO 9001:2015 Draft Standard Ready for Review
The ISO 9001:2015 draft standard is now open for public comment until July 21, 2013. Click on this link and create your free account to download the information as well as the template needed to submit any comments.