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ISO 9001:2015 Transition News

For many industries and organizations around the world, ISO 9001 has evolved to become the foundational quality standard on which their complete quality management system is built.

However, as the integration of technology has changed many aspects of systems and operations in recent years, a degree of inflexibility and rigidness in the current ISO 9001:2008 standard was exposed. This latest revision-due to be published in September, 2015-will allow organizations to be more flexible in how they apply the standards and practices of IS0 9001 in the context of their unique processes, technologies and business needs.

The following questions and answers have been chosen for inclusion in this FAQ and organized by topic to facilitate organizations’ understanding of the changes afoot and how they will impact their business.

 

Where can I learn about the new structure of ISO 9001:2015?

Quality Resource Center has produced an abundance of materials that include overviews and analysis of the new high-level structure of ISO 9001, Annex SL. Quality Resource Center offers a full suite of value added training, including on-site, web based, as well are our state of the art training facility in northern California. The materials are available on the website.

You may also contact Quality Resource Center with any questions at certification through our web portal or by simply calling 1 800 244 5409.

 

When will the final version of ISO 9001:2015 be published, and where can I get a copy?

Timeline for publication and implementation of ISO 9001:2015

  1. July- October 2014: Comments on DIS were submitted
  2. July 2015 Final Draft International Standard FDIS issued
  3. September 2015 (estimate): ISO 9001:2015 issued
  4. September 2015- September 2018: Transition period. All current registrations to ISO 9001:2008 must be transitioned to the 2015 revision by this time, or they will lapse.

 

Will there be an implementation guide published for ISO 9001:2015?

Yes. Quality Resource Center will continue to offer additional important guides and updates. We also provide ISO 9001:2015 consulting, training, and auditing for businesses in need.

 

When should I start transitioning to ISO 9001:2015, and what should I do to prepare?

It would be prudent to begin planning discussions now based on the DIS, but hold off on taking any major action until the standard is published and the transition officially begins in September, 2015. One thing you can do is start taking inventory of your current processes and comparing them to the new high level structure proposed in the Dl S.

 

How much longer will ISO 9001:2008 compliance be recognized?

Conformance to the current standard will be recognized through the end of the three-year transition period, which is due to end September, 2018. Organizations can request to be audited to the FDIS when it is issued. The issuance of certificates is an Assurance Group decision. All organizations must transit ion to the new standard by the end of the transition period.

 

Are Organizations Permitted to Upgrade During Their Scheduled Re-certifications in 2016?

Yes, as long as your systems conform to the standards set forth in ISO 9001:2015.

Our Organization is Currently Implementing or Considering Certification to ISO 9001:2008. What is the Best Course of Action?

Continue as planned; there are three full years to achieve certification to ISO 9001:2015 after its publication in September, 2015. That said, Quality Resource Center can help to familiarize Organizations with the new high-level structure, so systems designed or upgraded with an eye toward the future.

 

Will the Transition Require Additional Resources Either in Budgets or Time?

Quite likely, but it will depend upon the current status of an Organization’s management system. Areas that will be impacted include personnel time developing or modifying current systems and processes to meet the new requirements.

For more information regarding how the ISO 9001:2015 might impact your organization, Quality Resource Center offer detailed ISO 9001:2015 GAP Analysis services that can assist in identifying where the audit against the revised standard will differ from your existing programme.

 

When May I begin transitioning? Do I Need to Wait Until My Surveillance Audit?

The transition process may commence as soon as the official three-year transition begins. While it is permissible to outside of your scheduled surveillance but it is more efficient to do an upgrade audit to ISO 9001:2015 during regularly scheduled surveillance audits.

 

How can Progress Best Be Measured During the Transition Process?

Quality Resource Center works closely with Organizations to develop approaches enable progress to be tracked towards the new standard and ensure proper training, support, and execution every step of the way. If you are implementing the standard for the first time, Quality Resource Center offers full turn-key solutions that offer maximum value with minimum risk.

 

When will auditor training be available for ISO 9001:2015?

Internal auditor training and certification will be available following publication of the FDIS in 2015; the rules and requirements have not yet been finalized. If your organization has a robust Internal Audit process, the auditing techniques should not change. However, the criteria you audit against and the scope of your audits will definitely be affected.

Quality Resource Center will provide customers with additional information as it becomes available. We also have a series of interactive webinars already scheduled, and public training courses on the transition all over North America. We also have a series of interactive webinars already scheduled, and public training courses on the transition a II over North America.

 

ISO 14001 Is Being Revised Along With ISO 9001. Will the Impact Organizations Utilizing Both Standards?

ISO 9001:2015 and ISO 14001:2015 will be more closely aligned than ever, as both standards will utilize the same high-level structure defined in Annex SL. Upwards of 30% of the language in the two management system standards will be identical. ISO 14001:2015 should be issued in September 2015 along with ISO 9001:2015 if everything goes according to plan.

 

What Impact Will the Revisions Have On ISO/TS 16949:2009 Automotive Standard?

The automotive industry is not enamored with the revisions to ISO 9001. Currently they are opting out of participating in the revision process in favor of creating their own standard. While the automotive group could certainly change their position between now and when the standard is finally issued in September 2015, no definitive position has been determined.

 

We Are Certified to AS 9100C. Are there any plans to revise this standard to accommodate new ISO 9001:2015 requirements?

AS 9100 will adopt the requirements of ISO 9001:2015 when the new standard is revised in 2016.

 

Is the ISO 13485 Medical Device Standard Changing As A Result Of The Updates To ISO 9001?

The draft ISO 13485:2015 is based on the clause structure in ISO 9001:2008, not the new requirements and clause structure of ISO 9001:2015 using Annex SL.

Tables correlating ISO 9001 and the previous version of ISO 13485 have been included in the document.

Similar to ISO 9001:2015, there will be a transition period for organizations upgrading from the 2003 revision to the ISO 13485:2015 standard. The date of the ISO 13485 transition has not been announced as yet.

The supplementary Annex Z in support of the European Medical Devices Directives has been included in anticipation of the next revision of ISO 13485 being harmonized under the three Medical Device Directives.

This means ISO 13485 and EN ISO 13485 will be published in a similar timeframe. Organizations can then use the Harmonized Standard with in Europe which provides for the “Presumption of Conformity” under the applicable clauses of the Directives. This revision has also been drafted recognizing that it will have to support the existing European Medical Devices Directives and the proposed European Medical Device Regulations when they are published in the future. Some of the content has therefore been specifically drafted to accommodate this requirement.

 

Where does Plan-Do-Check-Act (PDCA) Fit In With The New Standard?

Of course. The new standard is still built around the PDCA cycle. It’s featured prominently on page 8 of the Draft International Standard.

 

Will FMEA’s and Control Plans be required under ISO 9001:2015?

Although very valuable tools, FMEA’s and Control Plans are not required by ISO 9001:2015. Your organization could apply these tools as their approach to meet the requirements. Properly developed Control Plans would satisfy many of the requirements for section 8. FMEA’s are a useful tool to identify prioritize, and mitigate areas of risk required in section 6.

 

What Is The Practical Impact Of Eliminating The Management Representative?

The management system still needs a champion and a spokesperson, but it does not automatically mean that this is the quality manager-or any one person. Optimally, these duties would be shared by a member(s) of the leadership team. Once the management system has been implemented, this person’s role should transform into being a facilitator of continual improvement.   It should be noted that while the requirement for a designated Management Representative has been removed from the DIS, the responsibilities that were attributed to this position are still retained in the standard.

 

What Suggestions Are There For Organizations Wishing To Begin Preparing For ISO 9001:2015?

  1. Have a GAP Analysis performed and review the results. Identify Actions to fill the GAP’s.
  2. Train managers that will be affected by the proposed changes. Help them gain a comprehensive understanding of the issues at hand and help them begin to strategize an action plan for implementation
  3. If you have certification to more than one standard, look at where management system integration might be possible and beneficial. Make this part of the GAP Analysis.
  4. Talk to one of our representatives and ask how we can support your organization

 

I have an integrated management system based on ISO 14001 and OHSAS 18001-how will the revisions to ISO 9001 and these standards affect me?

The changes make system integration much easier as there will be greater alignment among these standards. But with differing projected publication dates and trans-national, you should plan your transitions carefully to retain certification on each.

It may be beneficial to acquire a copy of PAS 99, It offers valuable guidance on the design and structure of an integrated management system.

 

Is There A Requirement For a Quality Manual in ISO 9001:2015?

ISO 9001:2015 does not require a quality manual. The question each organization should consider is whether or not having one is beneficial to the organization. If it is used as intended in 9001:2008-an introduction to the management system that acts as a guide or roadmap to the overall system-then by all means have one. Quality Resource Center strongly recommends the Organizations maintain a Quality Manual.

 

What Are The Guidelines Like For Internal Audits Under ISO 9001:2015?

Refer to section 9.2.2 Internal Audit –

9.2.2

“The organization shall:

  1. a) plan, establish, implement and maintain an audit programme(s) including the frequency, methods, responsibilities, planning requirements and reporting, which shall take into consideration the quality objectives, the importance of the processes concerned, customer feedback, changes impacting on the organization, and the results of previous audits;
  2. b) define the audit criteria and scope for each audit
  3. c) select auditors and conduct audits to ensure objectivity and the impartiality of the audit process”

 

These requirements have been clarified from those in 9001:2008. Audits are still required to be conducted at planned (scheduled) intervals. Organizations need to establish goals, priorities, and objectives and align them to drive their decisions with respect to the audit function. Many of factors go into the development of an audit program, risk is being only one of them. Other things to consider: complexity and current state of the process or areas involved, and potential impact on customers and the Organization.

 

What Are The Key to Requirements for Design and Development of Products and Services? Will there be Requirements for Process Design?

Much of what is now required under ISO 9001:2015was implied and would have been considered good practices under ISO 9001:2008. Section 8.3 “Design and Development of Products and Services” enhances the requirements found in section 7.3 of ISO 9001:2008, which dealt with product design.   Some of the requirements have been reorganized (i.e. verification and validation have been consolidated in one section 8.3.4 “Design and Development Controls”). Technically, manufacturing process design is not included. However, a note at the end of section 8.3.1 encourages organizations to apply these same principles to process design and development.

 

Can you summarize the new approach to Preventative Action in ISO 9001:2015?

Organizations must understand their organization’s business context (Clause 4.1) and determine the risks and opportunities that need to be addressed (Clause 6.1). One of the key purposes of a quality management system is to act as a preventive tool. Consequently, the new standard does not have a separate clause or sub-clause titled “Preventive Action.” Instead, the concept of preventive action is expressed through a risk-based approach to formulating quality management system requirements. This resulted in a reduction of prescriptive requirements, which have been replaced by performance-based requirements. Although risks and opportunities have to be determined and addressed, there is no requirement for formal risk management or a documented risk management process. The implication is the entire management system, properly implemented, should function as a preventive tool.

Does Compliance With ISO 31000 Satisfy The Risk Management Requirements in ISO 9001:2015?

Clearly an Organization could apply the requirements of a risk management system as defined in ISO 31000 and more than meet the requirements for risk based thinking in ISO 9001:2015. While the standard does not require a formal risk management approach, organizations must identify and understand their business environment in the broadest of terms and the resulting potential risks they face. Armed with this data the organization can then develop and deploy an effective management system to control, mitigate, and eliminate these risks.

 

Is there a summary of the changes between ISO 9001:2008 and 9001:2015 available?

Yes. Quality Resource Center provides this summary and has made it discuss it at our training courses, both classroom and interactive webinars

 

How can Quality Resource Center provide support through the transition process?

Quality Resource Center will have the latest up-to-date information on the ISO 9001 revision all the way up to the planned publication in September, 2015. Upon publication, we can advise you on what to do to meet the new requirements.

Ultimately, it is up to you to plan and implement the changes, but Quality Resource Center will provide all the support you need to make the best possible decisions.

 

What training will be available?

Yes, we have a series of interactive webinars already scheduled, and public training courses on the transition all over North America.

 

I have questions about my certification I need to answer right now. Who should I call?

Quality Resource Center – 1 (800) 244 5409 or e-mail us at www.QRCCentral.com

Transition to ISO 9001:2015

Quality Professionals know that there has been much discussion over the last two years regarding impending changes in the ISO 9001:2015 standard

Understanding the revised standard’s impact on an organization can be a bit overwhelming.

Quality Resource Center is committed to assisting our clients and potential clients in achieving both compliance and maximum value added in transitioning to this new standard, and thus has drafted this FAQ to address some of the essential questions and issues and present guidance on steps needed to prepare for the coming change.

Additionally, Quality Resource Center has published several articles regarding changes to ISO 9001:2015 that are currently available at www.QRCCentral.com

Quality Resource Center offers a complimentary toll free call regarding ISO 9001:2015 transitioning –

Call today – 1 800 244 5409

A – Why is the ISO 9001 Standard Changing Again?

There are a number of important objectives imbedded with this revision.

There remains an unfortunate and erroneous perception that ISO 9001 is not fully compatible with service organizations. This is key, and there has been a targeted movement to streamline language used in order to improve understanding and promote consistency between accreditation bodies, certification bodies, auditors, and clients.

Simplifying and making the process more efficient for Organizations seeking multiple certifications (such as ISO 9001 and ISO 14001) has been addressed. Many of these Organizations have felt compelled to maintain multiple sets of quality and procedures manuals, SOP’s, Work Instructions, and Forms and Records. The new revision addresses these and other concerns. Quality Resource Center has been a pioneer in the development of Integrated Management Systems, and has developed and deployed more systems of this type than any other firm.

B – Will Other Standards (AS9100, ISO/TS 16949, etc.) Should Be Updated As Well?

The major sector specific standards, including ISO/TS 16949, AS9100, and TL9000 have indicated their intentions to transition and continue their alignment with ISO 9001. Timelines for these other standard updates are not fully known at this time; that said, a 2016 publication date seems likely for all three. At present only ISO 13485 has not announced plans to maintain alignment with ISO 9001, although it is in the midst of its own update with a targeted publication of early 2016. Continued alignment is expected.

C – What Are The Critical Changes?

Quality Resource Center has conducted analysis and prepared several separate reports detailing key changes, but there are two noteworthy elements:

1 ISO 9001:2015 has eliminated the terms “Documents, “Records”, and “Procedures,”. They have been replaced with the expansive terms “Documented Information.” The reasoning here is that it offers opportunities for greater understanding and acceptance of alternative methods of controlling a quality management system. ISO is no longer concerned with a process is controlled or shown to be effective. Thus, these terms have been removed.

2 – There has been a great deal of discussion regarding the introduction of Risk Management. There are already two ISO standards (ISO 14971 and ISO 31000) and numerous other published materials on methods that can be used to design and implement Risk Management. Quality Resource Center’s analysis has concluded that at least two existing processes within ISO 9001:2008 can be applied to an effective Risk Management program. These processes are 7.1 Planning of Product Realization and 8.5.3 Preventive Action.

Formal Risk Management is now required as a system wide element of the quality management system, similar in fashion as was Continual Improvement was when ISO 9001:2000 was published).

D – What is “Annex SL” and How Does It Relate to ISO 9001?

Annex SL is part of the “ISO/IEC Directives Part 1 – Consolidated ISO Supplement – Procedures Specific to ISO” document. This standard regulates and controls the process of developing, updating, and issuing ISO published standard. Annex SL is basically a ten section template to be used for all ISO standards. It establishes common terms and core definitions for much of the language used in the ISO family of standards. The mandatory structure of Annex SL enables organizations to be better positioned to attain multiple certifications such as ISO 9001, ISO 14001, and OHSAS 18001, as each of these standards will now contain the same 10 sections and include the same core terms and definitions.

E – What is the Timeline?

The projected publication dates for the FDIS (Final Draft International Standard) and the actual ISO 9001:2015 document are July 2015 and September 2015, respectively. It is Quality Resource Center’s contention that most organizations should wait until the final approved ISO 9001:2015 standard is published to make a purchase and obtain the Standard. Once the ISO 9001:2015 standard is published, a 36 month transition timeline will begin. Thus, if the ISO 9001:2015 standard is published on September 15, 2015, the ISO 9001:2008 standard will be viable until September 15, 2018.

It is important to note that ALL ISO 9001:2008 certifications issued in late 2015 and beyond will be required to bear an expiration date that matches the cut-off for ISO 9001:2008. Companies may be permitted to transition at their own pace, and certification bodies may establish their own individual cut-off dates for ISO 9001:2008 audits. That said, Quality Resource Center has declared there will be no cut-off in our support for ISO 9001:2008 audits. Quality Resource Center will be there to support our clients as long as that support is needed.

F – Our Organization Has a Re-certification Audit in Early 2016. Should It Conducted in Accordance with ISO 9001:2015?

This is a strategic decision that each Organization must determine, but there are several key points to consider. If the Organization has had a chance to perform an ISO 9001:2015 GAP Analysis, upgrade systems to comply with the revised requirements, and has confidence in the Organization’s ability to succeed, a request that a transition audit to ISO 9001:2015 be performed can be submitted.

Coordinating the timing of the transition to the existing recertification audit is ideal, but isn’t mandatory. An Organization could certainly perform its’ 2016 Re-certification Audit to ISO 9001:2008, and then complete a transition audit to ISO 9001:2015 in 2017.

G – Our organization has been certified for quite some time and our procedures are well implemented;

Will they need to be changed?

Quality Resource Center’s analysis has concluded that for the average ISO 9001:2008 certified company, the impact of the revised standard will be varied but quite manageable. It is important to bear in mind that the ISO is seeking greater inclusion for the ISO 9001 standard. They want to see it continue to grow into new sectors and be even more user friendly than it is now. Requiring a company to aggressively overhaul their current ISO 9001:2008 system is not consistent with this objective.

H – Should Our Staff Complete Transition Training?

It depends on the extent of revisions made to your quality management system, but generally speaking – of course you will be expected to provide some form of transition training to your staff. At a minimum, Quality Resource Center recommends that awareness training of the new standard would be conducted, as well as an assessment of the new standard’s impact on the various processes and personnel. Ideally, an ISO 9001:2015 GAP analysis would be conducted by Quality Resource Center’s certified Auditors. However, it is entirely conceivable that the majority of your staff will feel no effect from your company’s transition to ISO 9001:2015.

I – Where Can Internal Auditors Obtain Complete Transitional Training and Certification?

Internal auditing remains the cornerstone of demonstrating compliance to requirements within a quality management system. Organizations remain responsible for determining what competencies are required for its internal auditors, as well as the methods to be used to achieve those competencies. Simply stated, each organization must decide the extent to which transition training is required. It is conceivable that a seasoned team of internal auditors could conduct an ISO 9001:2015 GAP Analysis and period of self-evaluation to facilitate the successful transition to auditing ISO 9001:2015. The competency of internal auditors is judged by the overall effectiveness of the internal audit process.

Over the last 25 years Quality Resource Center has trained and certified thousands of Internal Auditors.

Contact Quality Resource Center immediately to schedule your training and certification project.

J – What Immediate Steps Can Be Taken?

Preparation must include a comprehensive review of the currently available DIS, or the soon to be available FDIS. Quality Resource Center can and does provide extensive early planning assistance and analysis. Expect to see an official transition guide from the ISO itself, and likely additional written materials from other bodies such as ANAB and RABQSA. The International Accreditation Forum (IAF) has published an Informative Document (ID 9) which recommends the following steps be taken in the transition to ISO 9001:2015. A full review of the ISO 9001:2015 standard should be performed by Top Management to identify the gaps that need to be addressed. A plan of implementation should be developed with assigned responsibilities. All quality management system documents (including the quality and procedures manual (if applicable)) should be updated to reflect any new or revised processes. Necessary awareness and transition training should be completed. A full system Internal Audit followed by a Management Review should be completed. Corrective Actions for all internal audit findings should be completed.

Only Quality Resource Center offers a full suite of transition and training options, including on-site, web based, and our state of the art training center in northern California. Contact Quality Resource Center for all planning of transition arrangements and training.

 

ISO 9001:2015 & ISO 14001:2015 Upgrade and Transition Training

Is your firm currently certified under ISO 9001:2008 and/or ISO 14001:2003?

Are you wondering what will happen with ISO 9001:2015 and ISO 14001:2015?

There are some very significant and important changes heading your way…

 

Since 2012, all ISO management system standards have been in the process of being updated against the new 10-clause High Level Structure (HLS).

 

The ISO 9001 and ISO 14001 standards are undergoing radical transformation, raising questions and concerns over their new structures, revised documentation requirements, and a variety of other changes needed to comply with the new and improved standards.

 

The ISO 9001:2015 Standard will be released in September 2015.

 

ISO 14001:2015 will be released in August 2015.

 

In addition to the new structures, there are other sweeping changes.

 

The new ISO 9001:2015 and ISO 14001:2015 emphasize risk-based thinking beyond that seen in earlier versions.

 

The ISO 9001:2015 Draft International Standard (DIS) was released in May 2014 and the target is now fairly well-defined.

 

Quality Resource Center offers practical, hands-on, 1 and 2 -day courses in developing your strategy for making a seamless transition to the new requirements; Available at our world class training center, on-site at your facility, or via the internet in our popular webinar based system.

 

Pre-Requisite: Participants should be knowledgeable of the ISO 9001:2008 QMS standard.

 

Who Should Attend?

 

Any interested party involved in ISO 9001:2015 or ISO 14001:2015 quality and/or environmental management system implementation or upgrade.

 

Course Description:

 

Attendees to this important course should include, but not be limited, to all personnel within the organization, especially Top Management; such that they may all understand how to successfully implement the upcoming changes in the ISO 9001 and ISO 14001 standards.

 

The new approaches, outlined in the drafts, represent a dramatic turn in direction. There are new demands on management. Risk Analysis now takes center stage and must be considered throughout the organization. Specific documentation is no longer mandatory, but remains conspicuously implied.

 

Quality Resource Center is uniquely positioned to lead you through the twists and turns of these important revisions and the effects they may have on your business. Our seasoned team of experts has experience that dates back to the original 1994 standard, the 2000 revision, and the 2008 revision.

 

Join us as we map out the latest versions of the revisions to ISO 9001 and ISO 14001. Quality Resource Center will provide the tools and techniques to help you understand the spirit and letter of the new revisions. With QRC, you can rise above the confusion and see how to prepare your team for management-led, risk-based thinking that can best position your organization.

 

These workshops will navigate you through the maze of changes and give you the latest information available from the technical committees to help you adopt this new approach.

 

Course Objectives:

 

This workshop will enable participants to:

 

  • Understand, interpret and plan for the changes in ISO 9001:2015
  • Receive up-to-date information on the key changes in both ISO 9001:2015 and ISO 14001:2015
  • Understand the 10 (ten) clauses of the new ISO Management System Annex SL
  • Gain insight into how the revisions provide closer relationship and alignment between ISO 9001, ISO 14001, ISO 13485, R2, AS9100C, OHSAS 18001, and ISO 27001, and ISO 22301
  • Get an overview of how these changes may affect the audit process
  • Learn the best practices that can help facilitate a smooth transition
  • Prepare for the transition plan to ISO 9001:2015 and ISO 14001:2015
  • Develop a strategy for effective implementation of the changes at their organization
  • Prepare for re-certification to ISO 9001:2015 and ISO 14001:2015
  • Understand how the new global push for a risk-based approach to business will affect your organization
  • Incorporate requirements for ISO 9001:2015 and ISO 14001:2015 Internal Audits
  • Train and prepare for ISO 9001:2015 and ISO 14001:2015 Internal Auditor Certification
  • Initiate Risk Analysis techniques and programs

 

BENEFITS:

 

At the conclusion of this course attendees will have been provided with:

 

  • An understanding of the reason for and the steps associated with revisions of the standards
  • An understanding of the philosophy behind, and the project management strategy to design a successful ISO 9001:2015 and/or ISO 14001:2015 implementation process
  • An understanding of the new structure of the ISO 9001:2015 and ISO 14001:2015 standards
  • An appreciation of the impact to organizations implementing the revisions

 

CONTENT:

 

  • ISO 9001:2015 and ISO 14001:2015 – a detailed comparison between the old and new versions of the standards. Highlights of the changes, including a detailed review of the potential impacts, together with discussion of the new focus in certain areas, plus discussion of the plans for adoption by other standards
  • Implications for organizations – Examination of how implementing the revisions will affect organizations in the process of achieving compliance
  • What about Top Management? What are the new requirements for Executives?
  • Selecting a Registrar – how to make the best choice.

 

Quality Resource Center has been providing world class training and certification services in the field of ISO 9001 and ISO 14001 Quality and Environmental Systems since 1994. We can help you navigate what will surely be an uncertain transition period. We invite you visit this website regularly and to contact us today. Classes are forming and we can design a program to meet your organization’s unique requirements. Contact us today.

ISO 9001:2015 & ISO 14001:2015 Update

ISO 9001 and ISO 14001 are under revision with updated versions due by the end of 2015.

FAQ 

  • Why is ISO 9001 being revised?

All ISO standards are reviewed every five years to establish if a revision is required to keep it current and relevant for the marketplace. The future ISO 9001:2015 will respond to the latest trends and be compatible with other management systems such as ISO 14001:2015.

  • Where are we at in the revision process?

ISO 9001 is currently nearing the Final Draft International Stage (FDIS ballot expected by July), the fifth stage of a six stage process, whereby the ISO subcommittee revising the standard will now go through all the comments received during the DIS vote in order to produce a final draft which will then be put forward to all ISO members for voting.

  • What is the next step?

Once all comments have been considered a final draft will be produced and put forward to ISO members for voting.

  • When will the new version be published?

ISO 9001:2015 will be published by the end of 2015.

  • What will be the main changes to the standard?

The new version follows a new, higher level structure designed to make it easier to use in conjunction with other management system standards, with increased importance given to risk.

  • I am certified to ISO 9001:2008. What does this mean for me?

Organizations are granted a three-year transition period after the revision has been published to migrate their quality management system to the new edition of the standard.

  • How do I find out more?

Contact Quality Resource Center as soon as possible for more information on how the FDIS is proceeding.

 

TRANSITION PLANNING GUIDANCE FOR ISO 9001:2015 & ISO 14001:2015

Parties who will benefit from this guidance include but are not limited to –

  1. Organizations using ISO 9001:2008
  2. Accreditation bodies (AB’s)
  3. Certification bodies (CB’s)
  4. Training bodies and consultants

 

Changes

The ISO 9001:2015 revision introduces significant changes and will be published in September 2015. It is is based on Annex SL of the ISO Directives, a high-level structure (HLS) which standardizes sub clause titles, core text, common terms and core definitions to enhance compatibility and alignment with other ISO management system standards. Main changes in the new version of ISO 9001:2015 are:

  1. Adoption of the HLS as set out in Annex SL of ISO Directives Part One
  2. Explicit requirement for risk-based analysis to augment and improve the understanding and application of the process approach
  3. Fewer prescribed requirements
  4. Reduced emphasis on documents
  5. Improved applicability for service based organizations
  6. Requirement to define the boundaries of the QMS
  7. Increased emphasis on organizational context
  8. Enhanced leadership requirements
  9. Greater emphasis on achieving planned outcomes to improve customer satisfaction.

 

Transition

The International Accreditation Forum (IAF), which monitors certifications/accreditations, and the ISO Committee on Conformity Assessment (CASCO) have agreed to a three year transition period from the publication date of ISO 9001:2015. The transition period will begin in September 2015 and end in September 2018.

 

ISO 9001:2008 certifications will not be valid after the end of September 2018. From March 2017 all initial certifications under accreditation shall be to ISO 9001:2015.

 

Guidance for transition

The degree of change necessary for any organization will be dependent upon the maturity and effectiveness of the current management system, its organizational structure and practices. Thus, an impact assessment is strongly recommended in order to identify realistic resource and time implications prior to initiation of any changes.

 

Specific guidance for parties involved in certification and accreditation –

Organizations operating under ISO 9001:2008 are encouraged to take the following actions-

  1. Identify organizational gaps which need to be addressed to meet new requirements
  2. Design and develop an implementation plan
  3. Facilitate training and awareness for all affected parties
  4. Update existing quality management system (QMS) to meet the revised requirements and verify its’ effectiveness,
  5. Where applicable, liaise with your certification body for transition arrangements.

 

Accreditation Bodies (AB’s) are recommended to

  1. Inform CB’s about the transition process using the appropriate guidance and IAF produced documents,
  2. Plan and allocate resources for training and performing assessments to the revised standard,
  3. Verify that criteria used to assess auditor competence are adequate.

 

Certification Bodies (CB’s) are recommended to –

  1. Train and monitor auditors to ensure competence is demonstrated
  2. Interact regularly with national standard bodies
  3. Communicate regularly with AB’s
  4. Communicate with other CB’s to co-ordinate information
  5. Inform existing clients and share guidance on the transition process and arrangements for transition
  6. Plan the timing and scheduling of audit and certification activities for the revised standard
  7. Consider the stated transition period and current certification period
  8. Plan the timing of certification decisions for upgrading certificates
  9. Encourage current users of ISO 9001:2008 to implement ISO 9001:2015 at an early stage, taking account of any changes that may occur during the DIS stage
  10. Encourage new users to implement ISO 9001:2015
  11. Arrange audit schedules for existing client organizations
iso

Keep checking this website for regular updates between now and the standard’s final publication.

ISO 9001 2015 Changes

Quality Resource Center Update to Expected  ISO 9001 – 2015 Changes

An official draft of ISO 9001-2015 changes has been released for comment by interested parties and a final draft standard is scheduled for release by the end of November 2014. The new standard is expected to be published in September 2015 with March 2017 for the final discontinuance of the 2008 standard and September 2018 for all concerned to fully implement the new standard.

Until a new standard is published and officially released companies should start planning for a changeover but do nothing to specifically alter their quality systems toward the new standard. Certifying audit companies will follow the above schedule unless it changes.

The 2015 standard will differ in some formal ways and it will be structured differently. The basic areas of quality control will remain the same but with renewed general emphasis on planning and management accountability. A Quality Manual will not be a formal requirement. There will be 10 sections or clauses the last seven of which will be auditable. The reason for the new standard is to promote compatibility with other standards, to recognize the various ways management is capable of satisfying the basic requirements and to respond to quality control needs discovered over time.

The seven auditable clauses will be:

  1. Control of the organization
  2. Leadership
  3. Planning
  4. Support
  5. Operation
  6. Performance Evaluation
  7. Improvement

Risk will be better linked to prevention but no formal risk management process will be specifically required. Risk aversion will be considered an outcome of many areas of the QMS including planning meetings. The basic principles of control and process including effects on consistency and efficiency and customer satisfaction will not change but formal quality manuals or procedure manuals will not be required. The Management Representative will not be required. Permissible exclusions will be replaced by a non-applicable designation subject to validity checks at audits.

A larger emphasis in sections 4, 5, 6, and 7 will be put respectively on:

  1. Organizational purpose
  2. Management accountability and quality objective/QMS integration
  3. Risk and opportunity analysis and follow-up and
  4. Future resources planning. But, no major overhaul will be needed. All other standards will eventually incorporate new changes but the timing is as yet not determined.

In the interim it is suggested that companies can do a gap analysis of the ISO 9001 – 2015 changes and especially with respect to the above for areas to improve. It should also be noted that the auto industry has decided as a whole through its trade organization has decided not to implement the standard due to their heavy investment in the previous standard and TS16149.

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Next Steps in the ISO 9001:2015 Revision Process

Next Steps in the ISO 9001:2015 Revision Process

The DIS phase (Draft International Standard) is the first major step in the ISO publication process. The DIS ISO 9001 revision 2015 was officially issued for public comment in early May 2014. The next steps will be the review and discussion of changes before the issuance of the FDIS (Final Draft International Standard), expected in November 2014, and the publication of ISO 9001:2015 in September 2015.

The transition period for introducing and adopting the new requirements for organizations with ISO 9001 certification will start after the new version’s publication in September 2015 and organizations will have three years to implement these into their management systems.

While the DIS is not the final release, it does reflect changes to existing requirements. As the revision process goes forward, the later FDIS will likely have minor amendments included before the final revision is issued. Quality Resource Center recommends that all organizations start familiarizing themselves now with the actual requirements of the DIS version.

What are the main expected changes to ISO 9001?

ISO 9001:2015 will have a modernized approach to quality management, characterized by the following:

  • An increased emphasis on achieving value for organizations and customers. The new version will be more results- and improvement-oriented
  • The new version will also have a distinct emphasis on risk management and risk-based thinking
  • Increased requirements for feedback from all involved stakeholders and processes (not only from clients)
  • Greater emphasis on involvement of top management
  • A revised structure to align with all other ISO management system standards and facilitate integration with other management systems
  • The standard will be more readily applicable by service industries and organizations
  • More flexibility on the type and use of documentation; simplified requirements for documented procedures (no longer a “quality manual”)
  • What has not changed is that the customer remains the primary focus

Quality Resource Center will publish information on new developments on a regular basis. Our team is available to support you with this transition and can provide further information and assistance on this new draft standard.

Selecting ISO 9001 Consultants

Selecting ISO 9001 Consultants and What They Can Do For Your Organization

Utilizing a proven, successful ISO 9001 Consultant will maximize your odds of achieving success in designing and deploying an effective Quality Management system that delivers real value to your organization.

Selecting the ISO 9001 Consultant

You want someone who you are comfortable with.

  • Do they have experience? Look for companies that have a long history of success with multiple types of clients.
  • Can you work with them? Organizational chemistry is an important component of success in working with a consultant organization. Make sure you mesh with the vendor you choose.
  • Are they an individual or do they represent a firm? Check out the team you’re offered.
  • Are they “Virtual” or do they have a real brick and mortar presence? This is another way of establishing their longevity and stability as an organization.
  • Are they a “one trick pony” or do they provide the variety of complementary services that will ensure the healthy growth of your systems as your company grows? – look for vendors that can support and train your company in all the major ISO 9001 based Quality Management Systems

Implementing ISO 9001:2008 enables continual improvement of your organization’s processes and quality management systems (QMS), and improves the ability of your operations to meet customer requirements and expectations.

Demonstrating real commitment to product and service quality can transform your corporate culture because, as a result, employees understand the requirement for ongoing improvement and that will help your bottomline.

ISO 9001 Consultants will help your organization understand the essentials of ISO 9001:2008

  • Understand the benefits of a QMS
  • Know the purpose of ISO 9001:2008 and the ISO 9000 series of standards
  • Gain familiarity with the eight quality management principles
  • Know the factors that make an effective QMS
  • Understand requirements for key clauses of ISO 9001:2008 

Experienced ISO 9001 Consultants will help you understand essentials of the Quality Management Systems Auditing Process

  • Understand fundamentals of quality management systems
  • How to maximize the effectiveness of the Auditing Process
  • How to uncover and realize the value
  • How to couple Internal Auditing with Continual Improvement
  • Understand management systems
  • Gain familiarity with basic skills of the auditing process

Who Should Work With an ISO 9001 Consultant?

  • Management professionals and employees involved with the implementation of a quality management system
  • Professionals seeking to enhance their basic knowledge base, or looking   for a refresher
  • Quality Managers and Management Representatives seeking to implement ISO 9001 Quality Management Systems

What can working with the ISO 9001 Consultant help you learn and understanding ISO 9001:2008?

An experienced ISO 9001 Consultant will explain the clauses of ISO 9001:2008 in detail, and provide a foundation for understanding Quality Management Understand quality management definitions, concepts, and guidelines

  • Understand the purpose of the ISO 9000 series
  • Understand the requirements of the ISO 9001:2008 standard
  • Understand the eight Quality Management Principles
  • Understand the process approach
  • Supervisors
  • Recognize the role of management
  • Recognize the benefits of a quality management system
  • Understand how to register a quality management system
  • Laboratory quality professionals

What can working with the ISO 9001 Consultant give to the Executive Team?

Outline and demonstrate how management can support and optimize an ISO 9001 process-based quality management system, as well as the role of, and benefits to, top management members; A clear understanding of the five clauses of ISO 9001 with an emphasis on clause 5, “Management Responsibility.”

How does the ISO 9001 Consultant Assist in Implementing ISO 9001:2008

Developing the concepts needed to understand, deploy, and implement a quality management system.

  • Understand quality management definitions, concepts, and guidelines
  • Understand the purpose of the ISO 9000 series
  • Understand the requirements of the ISO 9001:2008 standard
  • Build an efficient and effective quality management system
  • Learn best practice processes to implement each clause of ISO 9001:2008
  • Learn tips for winning employee and management support
  • Prepare for an audit
  • Plan for registration

What else can my ISO 9001 Consultant do for me?

They can help you and your Organization understand why Quality Management Systems are Important as well demonstrate your organization’s commitment to quality. And you’ll discover how regular assessments ensure your organization continually uses, monitors and improves processes. You will understand how Certification has proven its potential to help boost business performance, reduce uncertainty, and increase market opportunities and profitability.

How can my ISO 9001 Consultant Help Me Build a Foundation for Effective Management, Continual Improvement and Financial Return?

Formal, internationally-accepted management system standards are critical to the profitability of many organizations.

Organizations who adopt ISO 9001 realize faster sales and employment growth, and are more likely to survive than non-adopters.

ISO 9001 is a foundation for effective management, continual improvement and financial return. As a management representative or quality manager, it is up to you to make a business case for adopting ISO 9001. Any concerns about the ROI should be dispelled when it is over. However –

If you are certified to ISO 9001 and not recognizing a ROI, an ISO 9001 Consultant can show you why – Reviewing and re-evaluating your quality management system, metrics and continual improvement process should help you realize the advantages being realized through your ISO 9001 process, and how implementing ISO 9001 solutions can improve operations, compliance and ultimately the bottom line.

Establishing a Foundation for Effective Management, Continual Improvement and Financial Return.

An ISO 9001 Consultant can help you understand PDCA –

Plan–Do–Check–Act or plan–do–check–adjust (PDCA) is an iterative four-step management method used for the control and continuous improvement of processes and products across many industries.

One of the key concepts of any Quality Management System it is addressed in Section 4 of ISO 9001. The ISO 9001 standard is based in the PDCA cycle, which is adopted by all ISO quality and environmental standards. Plan, Do, Check, Act.

Just remember to make sure you select a consultant organization that is experienced, has good synergies with your company, and can support all of your ISO certification needs.

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Considering ISO 9001:2008 or ISO 9001:2015 Certification? we invite you to contact Quality Resource Center for a complimentary consultation Toll Free at (800) 244-5409 or Email Us.

What Are RIOS and EHSMS?

What Are RIOS and EHSMS and How Do they Inter-Relate?

R2:2013 requires that electronics recyclers possess and use an Environmental, Health and Safety Management System (EHSMS) and that the management system be certified to an accredited management system standard (e.g., RIOS or a combination of both ISO 14001 and OHSAS 18001).  The ISO and OHSAS certification bodies lack a single standard appropriate to fully certify an EHSMS at an electronics recycling facility.  The Institute of Scrap Recycling Industries (“ISRI”) responded by developing the Recycling Industry Operating Standards (“RIOS”), which incorporate the industry-relevant EHSMS elements found in the ISO 9001 (quality), ISO 14001 (environment) and OHSAS 18001 (health and safety) standards, while eliminating the overlap that would occur if all three standards were adopted.  The RIOS standard is based on the plan-check-do-act model for continual improvement that forms the basis of the ISO 9001 standard.  Rather than incorporate parts of three different standards, scrap recyclers save time and money by adopting the single RIOS standard.  R2:2013 has approved RIOS to certify EHSMS for purposes of its R2:2013 Standard.

The Standard requires all recycling facilities to abide by applicable health and safety laws.  This includes implementation of appropriate ventilation engineering controls and the development of facility-specific occupational health and safety risk assessments. Additionally, many of the health and safety measures required by R2:2013 go over and above measures that may be required by applicable laws.  For example, the Standard requires the implementation of engineering controls including, where appropriate, dust control and capture, and ventilation controls.  The Standard also requires a facility-specific identification and assessment of occupational health and safety and environmental risks, including risks associated with exposures to substances.  Indeed, the Standard notes that such facility assessments should take into account the unique risks posed by exposure to substances in the recycling industry and lists substances of note (e.g., mercury, lead, beryllium, cadmium, and PCBs).  All of these requirements are in addition to blanket protections recommended under the Standard, including safe work practices and medical surveillance.

What are the R2:2013 Focus materials?

What are the R2:2013 Focus materials?

The R2:2013 standard requires recyclers to document any movement of used and end-of- life equipment that is likely to qualify as a Focus Material or hazardous waste. The R2:2013 Standard identifies as Focus Materials any end-of-life electronic equipment and/or electronic assemblies that contain hazardous materials:

A. Polychlorinated biphenyls (PCBs)
B. Mercury
C. CRT glass (with some exceptions)
D. Batteries
E. Whole or shredded circuit boards containing lead solder

In several important respects, R2:2013 adopts more detailed obligations exceeding the Basel Convention or national legislation in many countries. For example, R2:2013’s broad references to PCBs, mercury, and batteries in the definition of Focus Materials are broader than the component listings identified in the Basel Convention A1180 listing.

Also, R2:2013 removes some of the ambiguity related to the Convention’s non-hazardous waste listing for waste electronics by designating circuit boards containing lead as Focus Materials requiring more stringent management and export controls. (The Convention lists printed circuit boards under the non-hazardous B1180 waste entry in Annex IX – presumptively non- hazardous.)

R2:2013 also imposes requirements for recyclers to document the legality of importing or exporting Focus Materials contained in so-called “untested or non- functioning equipment.” As noted further below, untested used equipment destined for repair, refurbishment and reuse is generally viewed as non-waste that is outside the Basel Convention, although this issue is the subject of ongoing discussions among governments. Obligations to assess untested or end-of-life equipment containing Focus Materials apply to shipments for recycling within the Organization for Economic Co-operation and Development (OECD) area, despite the fact that the Basel Convention does not apply to such shipments, and OECD countries may not regard some of these materials as wastes subject to stringent regulation.

Furthermore, R2:2013 mandates that an electronics recycler “comply with all applicable environmental, health and safety . . . legal requirements . . .” This broad requirement ensures legal compliance includes consideration of differing approaches governments have taken to the classification and control of e-waste shipments, including imports and exports.

In conclusion, certification to R2:2013 requires recyclers to document the legality in the importing, exporting and transit countries of any movement of used and end-of- life equipment that is likely to qualify as an A1180 hazardous waste. The R2:2013 Standard’s special attention and obligations for importing and exporting Focus Materials correctly directs the attention of recyclers to those materials often regarded as “hazardous wastes” under the Basel Convention. The more general obligation to comply with applicable legal requirements ensures that in those instances where a government may choose to regulate a broader universe of used or end-of-life equipment as hazardous, such requirements are identified and addressed.

R2:2013 Regulation of Used Equipment Movement

Update: R2:2013 Regulation of Used Equipment Movement?

A multitude of governments have expressed concern over the movement of e- waste materials across country bounders for recovery under the auspices of repair or reuse.  While the approach of individual governments may vary, the Standard takes a practical approach to promoting the responsible reuse of equipment and components even as governments continue to debate the need for additional controls and transparency requirements for such shipments at the international level. R2:2013’s approach to managing used equipment for reuse is fully consistent with the requirements of the Basel Convention and establishes important documentation and assurance mechanisms that go beyond the obligations set forth in the original Convention.

  • Equipment and Components that are Fully Functional.  Tested and “fully functional” equipment that is ready for use out of the box is not subject to international waste controls under the Basel Convention.   As a treaty governing the transboundary (across country borders) movement of “hazardous waste” destined for materials recovery or final disposal, the export of functioning used equipment is clearly outside the scope of the Convention. Nonetheless, R2:2013 mandates specific testing, quality assurance and product return requirements that will reduce the risk of improper movements of end-of-life equipment and components.  These requirements apply regardless of where the equipment is managed, if it is being exported, or the country of export.
  • Equipment Tested for Key FunctionsR2:2013 Standard imposes similar requirements and documentation on proposed shipments of used products for resale that are tested for “Key Functions.” R2:2013 requires recyclers shipping equipment and components that contain Focus Materials to implement and document test methods confirming that “Key Functions” of the equipment or components are working properly, disclose to buyers the functions that are not working properly and describe the condition of the equipment, implement a Product Return Plan and policy and ensure the equipment and components meet the specifications of the recipient vendor or end user.
    • At the international level, governments have yet to adopt final guidance under the Basel Convention on the question of how the functionality of a used product is to be defined for purposes of demonstrating legitimate reuse.  The proposed definition in the pending draft Technical Guidelines on E-waste (slated for possible adoption in 2015) focuses on “essential key functions” which are defined as “the originally intended function(s) of a unit of equipment that will satisfactorily enable the equipment to be reused.”
    • This current definition in draft Basel Technical Guidelines is comparable to the current R2:2013 Standard’s focus on Key Functions: “’Key Functions’” are the originally-intended functions of a unit of equipment or component, or a subset thereof, that will satisfactorily serve the purpose(s) of someone who will use the unit.”
    • R2:2013 Standard is also in line with the approach for determining functionality reflected in the recently released European Union WEEE Recast.
  • Evaluated and Non-Functioning Equipment.  Finally, even with regard to the management of equipment that is non-functioning but suitable and intended for repair, the R2:2013 Standard again imposes documentation, tracking, recordkeeping and auditing requirements to ensure that such shipments are for legitimate repair rather than materials recovery.
    • As a rule of thumb, used equipment destined for legitimate reuse, including reuse following repair or refurbishment, does not qualify as a waste under the Convention.   While many governments support the movement of used products for legitimate repair and refurbishment as “non-wastes”, others have expressed concerns with the potential for illegal or undocumented movement of e-waste for materials recovery under the guise of repair.
    • Parties to the Basel Convention are currently negotiating whether or not to adopt a new and more expansive reading of the Convention to control certain transboundary movements of used equipment destined for repair or refurbishment, although currently there is no consensus on an approach and negotiations are expected to continue well into 2015.
    • Among the concerns raised is that new restrictions on legitimate shipments for repair could have the unintended consequence of accelerating the generation of e-waste by prematurely diverting reusable equipment to recycling rather than repair and continued use.

In summary, the Standard incorporates measures aimed at ensuring that shipments of used equipment for reuse or repair are legitimate and environmentally sound while ensuring they are practical and economically sound.

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