 Hello everyone! This is an A to Z of ISO 9001 QMS Transition Tutorial video. In this video, we are going to talk about transition and upgradeation from ISO 9001-2008 to ISO 9001-2015. We will discuss changes in the QMS standard, new requirements and expected compliances you need to implement and demonstrate. All this with an absolutely simple approach and a language all of you can understand, non-technical and free of management jargons. A no-nonsense, practical and simple representation of changes in ISO 9001-2015 over ISO 9001-2008, which you must know for a successful, easy, effective and result-oriented transition. We will not bombard with clause numbers and other technical stuff as you see in other videos and training tutorials. This video is for you to understand what has changed in ISO 9001-2015 standard and what you as a user need to do to migrate successfully. Let's get started. A. Quality Management Principles In ISO 9001-2008, we had 8 management system principles. These are replaced with 7 quality management principles in ISO 9001-2015. B. Integration with other ISO standards is now simple and easy. As per ANIX SL framework, ISO 9001-2015 has 10 clauses with compliance requirements covered by clause 4 to clause 10. This makes integration with ISO 14001-2015, ISO 27001-2013 and ISO 400001 very easy and effective because they follow the same framework. This realignment also ensures a better structured PDCA approach being applied to ISO 9001-2015 standard. C. Exclusion ISO 9001-2008 uses the word exclusion while ISO 9001-2015 uses the phrase requirements that cannot be applied. As per section 1.2 of ISO 9001-2008 standard, an organization may exclude or ignore product realization requirements section 7 if they cannot be applied and if doing so doesn't interfere with its ability or responsibility to meet customer and legal requirements. ISO 9001-2015 standard also has a similar approach but instead of stricting this only to one clause, this thinking is applied to all requirements of ISO 9001-2015. D. Fewer prescribed requirements and simple documentation. ISO 9001-2015 is no longer a document-oriented approach. The focus is on performance and achievement of the intended outcome of QMS. Quality manual and six documented procedures required in ISO 9001-2008 are not mandatory now. You decide the level and complexity of your QMS documentation. E. Top management Involvement of top management is essential and critical as per ISO 9001-2015 standard. Policy, objectives, communication, processes, risk and opportunity, internal audits, management reviews and evaluation of QMS effectiveness and efficiency are some of the areas where you will need to demonstrate involvement, participation and engagement of top management. Top management takes accountability for QMS and its effectiveness. F. Management representative MR or management representative is no longer a mandatory position. Intent of the standard is to have participation from everyone from the organization in implementation and maintenance of an effective QMS with top management accountability. In ISO 9001-2008 standard, the MR or management representative is used to manage QMS. And this in most of the cases resulted in limited participation from other employees in the organization. ISO 9001-2015 standard removes this position with an anticipation of all employees being involved in design, execution and improvement of an effective QMS. Organizations can still retain the earlier position of MR if they wish, but now you have to ensure either top management takes this responsibility and delegate to someone and you involve the rest of the employees as well. G. The context of the organization A strategic alignment between the organization and its QMS is required and can be established through newer requirements related to the context of the organization. Consider your vision, mission, strategic direction and intended outcome of your QMS. Make sure QMS is a tool which is a strategic fit to your organization and aligns closely with your organization. ISO 9001-2015 standard now needs a unified management system instead of QMS being looked as a standalone and separate project. Identify context of your organization and scan your business environment. Use SWAT and PESTEL analysis if required. H. External issues and internal issues Identify all challenges and issues relevant to your organization. These can either be external to your organization or internal to your organization. Any challenge or issue which you feel is going to impact the performance of your organization, business continuity, customer satisfaction, product, service quality can be considered. Once you identify these issues, you need to determine how they impact your business and are they risks or opportunities related to these issues? You need to regularly review these issues to ensure they are current and relevant. I. Interested parties Identify all interested parties and stakeholders in your business. Determine their needs and expectations and impact on your business if these needs and expectations are not fulfilled. You can also identify relevant risks from these. Regularly monitor them and review at a regular interval to ensure they are current and relevant. J. Quality policy Quality policy is to be made available to relevant interested parties. Your existing quality policy still needs to be communicated to your employees and management has to be sure they are understood by employees. You need to make this quality policy also available to relevant interested parties. You can determine the method for this communication. K. Quality objectives Quality objectives must include objectives covering process, service, product nonconformity and customer satisfaction. Planning for the achievement of the quality objectives is emphasized and required in ISO 9001-2015 standard. Continue with your smart, specific, measurable, achievable, realistic and time-bound quality objectives determined at relevant functions and levels within the organization. You need to ensure there is a detailed plan to achieve these objectives and regular tracking of these objectives. L. Mandatory procedures and SOPs Six mandatory documented procedures required in the old standard are not required as mandatory documentation. The organization can decide if they want to retain them. In ISO 9001-2008, there were six procedures to be documented mandatorily. They were control of documents, control of records, control of nonconformity, internal audit, corrective actions ISO 9001-2015 removes this restriction to have them documented as procedures. It is up to your organization whether you want to continue having them as documented procedure or not. Take a justified call. If you feel these procedures are required and adding value to your business, continue having them. Still, you need to retain relevant records to demonstrate they are executed effectively, irrespective of whether these procedures are documented or not. M. Quality manual The quality manual is not required as mandatory document. Organization can decide if they need to have one. ISO 9001-2015 has removed the requirement of having a quality manual. The objective is to ensure documented oriented approach is replaced with a performance oriented approach. If your quality manual is a dead document in terms of its use and is only open during your ISO 9001 certification audit, you may decide if you want to do away with the quality manual. But if your quality manual is a live document with employees using it as a document to plan, review, and improve your QMS, you can retain it. Modify your existing quality manual if required to add additional components as per ISO 9001-2015 standard. But remember having a quality manual is optional now. N. Documented information Control of documents and control of records of ISO 9001-2008 are now combined as documented information. Standard talks about maintaining documented information and retaining documented information. No major change in the expected compliance though. A documented procedure is not mandatory, but you can decide if it is required. Ensure vision control on documents, control on creation, approval, distribution, and changes of documents. Identify retention period, location, disposal, or archival mechanism of records, etc. Risk and opportunity Risk-based thinking is in with identification of risks and opportunities, planning, and review. This is a major change in the ISO 9001-2015 standard. Standard requires an organization to identify risks and opportunities from various sources covering context of the organization, internal issues, external issues, interested parties, processes, internal audit, suppliers, changes, etc. There is no explicit requirement to do a formal risk assessment and risk management and records of risk and opportunity. But we will suggest a simple risk repository to capture various risks, simple assessment covering probability, and impact to identify risk level. Later you can identify actions to mitigate these risks, review the actions taken, and ensure they are effective. P. Preventative actions are no longer required. Preventative actions created a lot of confusion with correction and corrective actions for users in the ISO 9001-2008 standard. In the new standard, the concept of preventive actions is removed and is replaced with risk-based thinking as discussed a while ago. Broadly risk identification and preventive actions address the same issue, identification of potential problem, nonconformity, and future problem. Q. Knowledge management Knowledge management is covered in the ISO 9001-2015 standard with reference to the knowledge required is identified and made available. Formal knowledge management is not required, but you must identify what knowledge is required across the organization. Various processes and effective execution of your QMS. Identify knowledge, make it available to employees, and keep it current. R. Process approach Ensure you implement process approach effectively. In ISO 9001-2015 QMS, process base management gets more prominence with the identification of processes in the organization. For each process, you must identify process input, responsibility, authority, accountability, required knowledge, procedure, execution steps, process output, identification of process effectiveness, evaluation parameters, monitoring of those parameters, indicators, and risks related to the process. You have the liberty to determine how many processes you want to document as procedures. Irrespective of you documenting a process or not documenting a process, relevant employees must be aware of specific processes. There is a greater emphasis on the achievement of the desired outcome for enhanced customer satisfaction. S. Change management Ensure you have a planned approach to executing any change in the organization. Changes that affect your product or service quality, customer satisfaction, or business performance must be executed under a controlled environment. Change management gets prominence in the ISO 9001-2015 standard. Uncontrolled change may pose a risk to the organization, and you need to ensure risks to the organization from the changes are identified and managed effectively. T. Suppliers The supplier has been replaced with a new terminology of external provider and includes outsourced processes as well. No major change in existing compliance except the change in terminology. Any outsourced services are also covered under this compliance, covering supplier or external provider selection, initial evaluation, approval, control, communication, and reevaluation. U. Outsourced Processes Service Providers More control and evidence of the effectiveness of outsourced service providers, selection, monitoring, control, and reevaluation. Ensure you exercise effective control on your outsourced service providers. Cover information like selection, monitoring, evaluation, and reevaluation of the performance of these outsourced service providers. V. Work Environment In the old standard, only physical work environment was considered. But now, standard talks about other two work environment factors as well. A. Social Example, non-discriminatory, calm, non-confrontational. B. Psychological Example, stress-reducing, burnout prevention, emotionally protective. W. External Property External property replaces earlier customer property clause, and it now also includes supplier, service provider property, along with customer property. External property is to be handled carefully to prevent it from any damage and records to be retained in case it is found unsuitable for use. X. QMS Awareness Your organization shall ensure employees are aware of A. The Quality Policy B. Relevant Quality Objectives C. Their contribution to the effectiveness of the quality management system including the benefits of improved performance. D. The implications of not conforming with the quality management system requirements. Y. Design and Development No compliance change, but this clause has been simplified to have design review, design verification, and design validation, all three clubbed under design control. Z. Management Review Meeting Becomes Management Review This makes the process to review suitability, adequacy, the effectiveness of the QMS and alignment with the strategic direction of the organization, better and value-adding. A formal meeting is not always required. Management review can be done online, in several smaller reviews, or another format as appropriate and practical for your organization. These are all the changes you should know as a user and professional responsible for ISO 9001 QMS for your organization. Use MyEasyISO to address all these changes and make your ISO 9001-2008 to ISO 9001-2015 migration and transitions simple, easy, effective, time-saving, employee-friendly, and always audit ready. Remember, it is your QMS and we want you to be in control of your QMS with MyEasyISO. Visit www.myeasyiso.com to get started now.