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Improving performance, reducing risk
ISO 9001:2015 and ISO 14001:2015
Transition deadline quickly approaching
Since the publication of the revised international Quality Management System (QMS) and Environmental Management System (EMS) standards – ISO 9001:2015 and ISO 14001:2015, organizations all over the world have transitioned to the revised standards.
If your organization is yet to begin this process, these FAQs will give you the information you need to get started.
Frequently asked questions
When is the deadline for transition?September 14, 2018 is the deadline for transition to ISO 9001:2015 (Quality Management System) and ISO 14001:2015 (Environmental Management System). On this date certificates for ISO 9001:2008 and ISO 14001:2004 will become invalid.
The deadline also applies for many standards based on ISO 9001, including AS91XX:2016 for the aerospace industry and IATF 16949:2016 for the automotive industry.
How long does the transition take?The degree of change necessary will depend on how an organization has developed and uses its existing management system.
A Gap Analysis will help you identify areas within your business to focus on and will help your assessor to estimate realistic timescales for the transition assessment.
What happens if I don’t transition in time?The implications of failing to transition to 2015 versions of the standards by this date are that:• Your organization may no longer claim
to be approved by your respective certification body.
• You may no longer accept orders in which your approval is a condition of contract and you must notify customers with whom you have contracts for which approval is a contractual requirement, that your approval is no longer valid.
• You may no longer promote your certification and you must withdraw from circulation any documents bearing your certification body’s approval mark.
When should I book my transition audit?Speak to your client services team today to book your gap analysis and transition audit. This is particularly important if you want a specific auditor as their diaries will be booking up fast as the transition deadline approaches.
If any non-conformities are discovered during the transition audit, you need to allow enough time for corrective actions to be implemented and reviewed.
Timescales
Improving performance, reducing risk
ISO 9001:2015 Overview and Comparison
The purpose of this handout is to share LRQA insight into the newly revised of the international Quality Management System (QMS) Standard ISO 9001:2015, which was published on September 15, 2015.
Organizations certificated to ISO 9001:2008 will have three years following publication of ISO 9001:2015 to transition to the revised standard. As a result, LRQA recognizes that there will be ongoing demand for knowledge of ISO 9001:2008 at least until September 2018.
Introduction
Improving performance, reducing risk
ISO 9001:2015 Analysis and Transition Guide
An LRQA perspective
ISO 14001:2015 Overview and Comparison
Improving performance, reducing risk
The purpose of this handout is to give insight into the newly revised international Environmental Management System (EMS) Standard ISO 14001:2015, which was published on September 15, 2015.
Organizations certificated to ISO 14001:2004 have three years following the publication of ISO 14001:2015 to transition. As a result, LRQA recognizes that there will be ongoing demand for knowledge of ISO 14001:2004, until at least September 2018.
Introduction
Improving performance, reducing risk
ISO 14001:2015 Analysis and Transition Guide
An LRQA perspective
Improving performance, reducing risk
ISO 9001:2015 and ISO 14001:2015 – One year to go
things that you can do now that will make your transition easier
8
Focus on the areas that are completely new or have been revised. Those are the areas that are likely to be included in your transition plan. Also, make sure that quality managers and internal auditors understand the differences that Annex SL (common text and structure) will bring to the design, operation and performance of your QMS and any other management system standards in your organization.
Engage with your assessor or client services team to find out how a gap analysis and training on specific areas of the revised standards can benefit you personally, as well as your organization. Begin formalizing a transition plan and process and ensure that top management is involved from the start.
As well as reading the standards, there is a wealth of information available through LRQA that can provide you with a good understanding of the revisions and the transition process.
The documents below are a good starting point.
What are the best steps for me to take to transition?
• 8 things that you can do now that will make your transition easier
• ISO 9001:2015 Overview and Comparison
• ISO 9001:2015 Analysis and Transition Guide
• ISO 14001:2015 Overview and Comparison
• ISO 14001:2015 Analysis and Transition Guide
Is it too late to think about training?It’s never too late to understand the topics that can make your management system more effective and provide even greater benefit for your organization.
The revisions to ISO 9001 and ISO 14001 bring the requirements up-to-date with good management practice. Training provides a deeper understanding of the requirements; is the fastest way to get up to speed; and can ensure that the objectives and requirements are understood, particularly in relation to individual roles and responsibilities.
LRQA offers a range of training courses to suit all levels of knowledge and experience – from a half-day awareness briefing to transition training for lead auditors. We also offer topic specific courses to help organizations address the most relevant areas for them.
Do you have a specific course to engage top management/leaders?Yes – we offer a half-day leadership workshop, which gives an overview of the new and changed requirements for leaders in relation to the revised ISO management systems standards and how you can incorporate them into your existing leadership processes.
We can also deliver topic-specific training on risk-based thinking, process management and context of the organization.
If I have an existing lead auditor qualification, do I need to re-sit the 5 day course for ISO 9001:2015?It is not necessary to re-sit the 5 day course. We offer Lead Auditor Transition Training for both ISO 9001:2015 and ISO 14001:2015. This is a two-day course for Auditors or Lead Auditors who want to upgrade their knowledge in line with the revised standards. It will give you a detailed understanding of the changes in the revised standard, how they may impact an organization, and how to audit the new and changed requirements effectively.
Training
What evidence will an assessor look for to prove that I am a competent auditor?Our assessors will always look for objective evidence to confirm that the internal auditing is effective. The organization will need to demonstrate that their auditors are competent to undertake the requirements of their designated roles and functions in relation to the 2015 standards.
This includes the audit function itself, knowledge of the 2015 standard, understanding of the new requirements, the management system and the audit of these. This may be through information or records of training delivered or by other means that demonstrate achievement of the required competence and records of the audits conducted to demonstrate that they achieve the expected outcomes for an effective internal audit.
What do I need to do to prepare for the transition audit?The transitional assessment will look to see that your management system has addressed all of the new and changed requirements of ISO 9001:2015 and ISO 14001:2015. As an organization, you need to understand the revised standard or standards and be ready to demonstrate how you meet the requirements. Training and Gap Analysis can help you to develop your transition plan so that you are confident that you have addressed everything.
What will the assessor be looking at?In brief, our assessors will focus on the main challenges facing organizations:• Context of the organization and
stakeholder needs• Leadership• Planning• Performance (includes measurements,
analysis, self-governance and improvement).
Our assessors will be looking for application of risk-based thinking, process management, alignment to strategic direction and business objectives and the general application of the Plan-Do-Check-Act (PDCA) cycle throughout the whole assessment.
Transition auditsWho needs to be present for the transition audit?The assessment needs to involve the key people in the organization with responsibility for the management system. The plan for the transition assessment would include the top management representative, which could be a face-to-face meeting or by remote means. If the top management team are based in another country and they are within the scope of the management system, we would expect them to be part of the audit.
If not, then we would expect to see the interface between them and the local management team.
How many days will the transition audit take?That depends on the scale, size and complexity of the organization. LRQA’s approach is that the time needed for the transition assessment should not be taken from the man-days required for maintenance of the existing certification assessment program. The requirements for conducting an effective transition assessment would be reviewed on an individual basis by the assessor or office and confirmed with the client before planning the transition visit. Typically, this would be at least one day per standard but it could be more.
What site or sites will need to be visited on a multisite audit?The approach to multi-site assessment has not changed and the assessor will be responsible for determining the number of sites and duration of the transition audit for a multi-site management system. For example, an organization that uses the same management control system for all activities throughout its organization could have a high level of control. So, if very little was affected by the new requirements operationally, then a site review may not be needed.
However, if the client or assessor identify elements, during the transition assessment planning, that have significant effects in the field operations, then a site evaluation would be needed and this would need to be factored into the transition time.
What is Annex SL? And what does it mean for my management system?
Annex SL is the High Level Structure applicable to ISO Management System Standards (MSS). It features 10 clauses as well as common terminology and definitions. It presents an opportunity for those preparing for their transition to integrate their QMS and EMS now and complete their transitional assessment at the same time. This common structure means that it is now far simpler for management system controls on disciplines such as occupational health and safety, and information security, to be integrated into a single ‘business management system’.
Annex SL has led to changes in relation to the term ‘Documented Information’ rather than procedures or records. In addition, Annex SL will lead to the incorporation of management systems into the strategic thinking of the organization and increased responsibilities on top management.
How will the changes impact smaller organizations?The approach to a management system varies more in small companies, however, the intent and outcome expected remains the same i.e. that the requirements are met and that the organization is demonstrating continual improvement.
Typically, the leadership of smaller organizations tends to be closer to their activities, so they will have a much clearer idea as to the context in which the organization operates, who their interested parties are and what they wish their QMS and/or EMS to deliver.
About the new standards
Do the revisions affect organizations in exactly the same way – irrespective of their size or geographical location?The potential organizational impact of the revisions is dependent upon the organization and their individual management system.
Factors such as the maturity and complexity of their existing management system, the existence of other management systems and the organization’s current evaluation and management of risk will heavily influence the degree of change that an organization will need to undertake to meet the requirements.
What are the new and revised areas in ISO 9001:2015?Annex SL is the single biggest change within ISO 9001:2015. Other topics that are new to ISO 9001 include: a) organizational context (clause 4)b) knowledge (clause 7)c) the control of externally provided
products and services (outsourcing, clause 8)
d) the formal introduction of a risk based approach (several clauses)
Among the areas of the standard that have been revised or now contain more specific information, organizations should pay attention to: a) increased emphasis on top
management engagement with ISO 9001 (clause 5)b) managing change (clause 6)c) performance and evaluation (clause 9)d) management review (clause 9)e) repeat references to the process
approach (several clauses).
Who in my organization needs to know about the revisions to ISO 9001?There are a number of key stakeholders who need to be aware of and understand the ISO 9001 revisions: • With the removal of the designated
management representative, responsibilities still remain and can be delegated by Top Management to the System Manager.
• Top Management need to understand and engage with the leadership elements of the revised standard.
• Process Owners need to understand their obligations to managing their defined processes and associated indicators.
• Internal Governance teams such as Internal Auditors and Audit Program Managers need to ensure that they understand specific requirements around context, leadership and performance.
Who are the most important internal interested parties in relation to the ISO 9001 revision?Probably the most important internal interested party is top management. ISO 9001:2015 requires greater understanding of the external environment, addressing risk and greater top management ‘quality leadership’ responsibility tied to closer links between the management system and product/service quality. There is more emphasis on their direct involvement or oversight for the design, implementation, structure and performance of the organization’s management system and to ensure the QMS is an integral part of the organization’s business processes.
When this is done well, the QMS provides a valuable mechanism for top management to meet their responsibilities for internal governance and control as well as providing an excellent source of performance data for use in decision making.
ISO 9001:2015
LRQA offers a range of services to help you transition to the revised standards.Find out more at www.lrqausa.com or email [email protected]
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ISO 14001:2015What changes have the ISO Technical Committee introduced?Most of the changes enhance the processes by which an organization protects the environment using their EMS. The committee drafted the clause on environmental policy that now requires that an organization should commit to protecting the environment.
This is an expansion over previous policy commitments, which were limited to prevention of pollution and compliance with legislation and is now a generic term that encourages organizations to look at protecting their overall environment rather than just the pollution they or their products and services may cause.
ISO 14001:2015 introduces the concept of life cycle perspective, which requires organizations to look at their products and services from the beginning to the end of their life cycle.
This incorporates how they control outsourced processes. To do this, organizations need to determine what they can control and/or influence, and then apply the appropriate controls or influence through their management system. They also need to look at the end of life treatment and the disposal of their products or of their service.
This will extend into areas such as design, because when they are designing new products, they will need to consider its design to see how they can improve environmental performance.
Another area which is important within ISO 14001 is in the area of communication – both internal and external. While this was covered in ISO 14001:2004, within ISO 14001:2015, the organization needs to develop a process by which they will determine what they will communicate, when they will communicate and to whom they will communicate. Another change that has occurred as a result of Annex SL is that the Plan, Do, Check, Act model within ISO 14001:2004 was redrawn to reflect the Annex SL structure.
What impact does ISO 14001:2015 have when considering interested parties?Annex SL introduces a section on context of the organization (clause 4) that means a company has to have a process in place to identify internal and external interested parties.
This includes recognizing the views that are key to the environmental performance of the organization and take those into account when they are looking at designing their EMS. As a result, this has become an important part of the new requirements.
