ISO 9001:2015 and Risk Management

Though ISO 9001 does promote risk based thinking, it does not provide any risk methodology. The organizations can freely adopt their own approach. The adopted approach should be proportionate to the possible impact on customer satisfaction and the desired results of the quality management system, should the opportunity or risk is realized.

After completing the first step of identifying the risks and opportunities, it must then determine how these need to be addressed. Any action taken to address these risks and opportunities should be matched to the possible impact of the opportunity or risk on the ability of the organization to achieve the set objectives of the QMS.

This also includes avoiding risk, eliminating the source of its occurrence, changing the consequence and sharing the risk. It must be noted that not all risks require an action. An organization may even chose to take a risk in order to pursue an opportunity.

Organizations can train themselves as per ISO 31000 which is a standard for Risk Management. The training will act as a useful resource for those who wish to implement a more formal risk management approach in their organizations.

Eurotech, an IRCA approved training partner (ATP), conducts ISO 9001:2015 Quality Management Trainings. These training will help you better understand the concept and importance of a quality management system, while encouraging risk-based thinking in your organization. To know more about this training, visit our website, drop a mail at trg@eurotechworld.net or call us at +91 9316744482 or 0172 - 4191128.

Topics Covered Under ISO 9001:2015

ISO 9001:2015 is based on Plan-Do-Check-Act methodology. It provides a process oriented approach to document and review the responsibilities, procedures and structure required to achieve a productive quality management in the organization. Some of the topics covered in the standard are:

  • Requirements of the QMS, including documented info, determining and planning process interactions.
  • Management responsibilities
  • Managing resources as well as organization’s work environment
  • Steps involved in product design to its delivery
  • Improving, analyzing and measuring the Quality Management System through corrective and preventive actions and internal audits

ISO 9001:2015 Training provides an opportunity to apply the quality management principles in your organization. Professionals who are responsible to develop, implement, audit and manage a QMS should take ISO 9001:2015 training along with organizations seeking to improve the performance of its employees. Also, employees who wish to continually improve will also find our trainings relevant.

Eurotech ACSPL is an IRCA approved training partner (ATP) and conduct ISO 9001:2015 Quality Management System Trainings and Certifications. We provide both in-house as well as open-house trainings at reasonable fee. To know more about these trainings, drop a mail at trg@eurotechworld.net or call us at +91 9316744482 or 0172 - 4191128.

8 Basics of ISO 9001:2015

The 8 basics of ISO 9001:2015 are based on the quality management principles which enable the organizations to consistently embed quality in their products and create value for their customers. These 8 basics are:

  • The customer is the center of it all: The first and foremost focus of Quality Management System is to meet and exceed customer expectations. You’ll begin to see ISO 9001 at work when you observe an expansion of your customer base with new customers and increased repeat business from the loyal customers.
  • Leaders at all levels need to ensure unity of direction and purpose: Leaders don’t have to order, tell or command employees to do something. True leadership requires developing a work culture in which people know and do what needs to be done under a unified direction and purpose. A leader also needs to improve communication and coordination among all the functions in the organization to meet the desired quality objectives.
  • Engaged employees are productive employees: People being an organization’s most important asset, when employees are engaged, they become more empowered, competent and dependable to deliver value. Engaging people means giving them recognition for their work, constantly communicating with them, respecting them as individuals and enhancing their personal and professional development.
  • Understand the process approach: Leaders need to understand that each activity they do is part of a system which should be linked together with other sub-system to form one cohesive system. Employees, machines, leaders and processes don’t each work in lone. Their individual activities should be managed as interrelated processes to meet one objective. This helps to achieve more consistent and predictable results and also enhances the ability of people to focus their efforts on key areas.
  • Keep Improving: Organization, with a positive outlook on improvement, can better react to changes in the external and internal environments if necessary. For example, technologies evolve too quickly or become obsolete. To prevent the organization from its negative effects, employees at all levels need to be trained on how to apply new methodologies and tools.
  • Decisions based on evidence: Decision making is a complex process which involves multiple inputs and their interpretations. All the data required by the decision makers should be accurate, secure and reliable and should be evaluated by competent people using suitable methods.
  • Foster relationships with relevant partners: Here partners may include customers, employees, resellers, investors, suppliers and the community.
  • Implement a system approach: The process approach is part of the system approach. This means that analyzing, understanding, and managing interrelated processes help in creating a coherent system that contributes to effectiveness and efficiency in attaining organizational objectives.

Eurotech ACSPL is an IRCA approved training partner (ATP) and conduct ISO 9001:2015 Quality Management System Trainings and Certifications in Delhi, Mumbai, Chandigarh, Chennai, Lucknow and Ahmedabad. We provide both in-house as well as open-house trainings at reasonable fee. To know more about these trainings, drop an email at trg@eurotechworld.net or call us at +91 9316744482 or 0172 - 4191128.

Implementing ISO 9001:2015

Deciding to develop and implement a new or improved QMS is one of the strategic decisions of the organizations. For this, efforts should be made for identification and minimizing the risk while meeting or exceeding the requirements of customers and goals of the organization.

The organizations should make a commitment towards:

  1. Recognizing customers, direct as well as indirect, who receive value from the organization
  2. Understanding the current as well as future expectations and needs of the customers
  3. Establishing a link between the organization’s goals and customer’s expectations and needs
  4. Ensuring that the customer’s needs and expectations are communicate throughout the organization
  5. Planning, designing, developing, producing, delivering and providing support for goods and services keeping in mind the customer’s perception of the same.
  6. Keeping a tab on customer satisfaction and measuring the same for taking required actions
  7. Determining and taking action on the needs and expectations of the interested parties that can affect customer satisfaction
  8. Active management of the relationships with customers for a sustained success.

Eurotech ACSPL is an IRCA approved training partner (ATP) and conduct ISO 9001:2015 Quality Management System Trainings and Certifications in Delhi, Mumbai, Chandigarh, Chennai, Lucknow and Ahmedabad. We provide both in-house as well as open-house trainings at reasonable fee. To know more about these trainings, drop an email at trg@eurotechworld.net or call us at +91 9316744482 or 0172 - 4191128.

ISO 9001 and Benefits to Government Department

Implementation of ISO 9001 training in Government Department and Ministry has following benefits:

Benefits

  1. ISO 9001 enable the departments to develop SOPs (Standard Operating Procedures) for carrying out its activities and functions.
  2. Helps in benchmarking and comparing these SOPs with other similar organizations.
  3. Helps in identifying areas for improving the functions of the departments.
  4. Codification of personal and institutional experiences and memories for future generations.
  5. The department is always on its toes through annual third party’s audits.ISO 9001 training
  6. Enables the department to audit itself against ISO 9001 standard.
  7. The possibility of losing ISO 9001 certification during the audit every year forces the system to sustain itself over time.
  8. It brings accountability and transparency in operations of the Government machinery.
  9. Allows the Head of the Department to give more attention to strategic issues.

We are an IRCA approved training partner (ATP) and conduct ISO 9001 Training and Certification in Delhi, Mumbai, Chandigarh, Chennai, Lucknow and Ahmedabad. To know more about these trainings, drop an email at trg@eurotechworld.net or call us at +91 9316744482 or 0172 - 4191128.

Core Elements of Quality Management System

The ISO 9001 standard is intended to help the organizations achieve excellence through improved performance in business and stronger customer focus. The basis of ISO 9001:2015 are the seven principles, namely: Leadership, Customer Focus, Improvement, Process Approach, Engagement of People, Evidence Based Thinking and Relationship Management.

In line with these principles, there are some core elements that make up the overall quality program. These elements are:

  • Improve Customer Focus: As per the revised standard, the main focus of any organization’s quality management program is to meet customer requirements and exceed their expectations regarding quality of the products and services. Organizations will do well if they comprehensively research, analyze and understand their current and future needs and adjust their processes and programs to fulfill the same. Also, it is important that the organizational objectives are in line with the market trends and are also communicated across the organization.
  • Enhance Leadership Involvement: ISO 9001:2015 lays emphasis on leadership involvement in quality management. The leader and his team should be highly committed to strengthen the outcome of the quality management program. It is their duty to ensure that every business unit in the organization accepts and understands the changes brought about by the revised standard to ensure a unified commitment to quality. The team has to understand the expectations of any party involved or affected by the quality management. The leaders should encourage and recognize people’s contributions and should provide the required training and resources to improve quality.elements of qms
  • Improve Engagement of People: The new standard states that all people should be competent engaged and empowered in delivering value. It is expected of the organization to provide clarity of job expectations, enhance employee communication, have regular feedback and motivate employee’s contribution in organization.
  • Adopt Process Based Approach: Organizations have to adopt process based approach that includes documenting and implementing processes, resources, controls and methods to demonstrate compliance with ISO 9001 standard. This approach also includes defining quality objectives and integrating quality management requirements with business processes.
  • Enable People and Process Improvements: Only those organizations are successful that have a continuous focus on improvement in terms of organizational effectiveness and efficiency. Organizations need to implement a consistent approach to train people in how to utilize the tools and methods for improvement. They should also focus on the growth of every individual in the organization.
  • Facilitate Evidence Based Decision Making: The decisions based on analysis and evaluations are more likely to produce the desired results. The organizations should restructure their QMS to support evidence gathering through observations, tests and measurements, or by using inspections and audits. The evidence should be accurate and easily accessible to those who require it for decision making.
  • Ensure Relationship Management: By managing their relationships with third parties, organizations can easily ensure high standards in quality and sustained growth. Sharing of values, knowledge and vision between the organizations and third parties enhance their relationship. It is important to identify and select the right suppliers and to determine the improvement plans.
  • Establish Systematic Approach to Risk Management: The main focus of ISO 9001 standard is to incorporate risk management into organization’s day-to-day activities. Risk has always been implicit in the standard (ISO 9001), but ‘risk based thinking’ is now explicitly defined, hence making preventive action a part of the daily routine.The standard now requires organizations to support implementation and creation of preventive as well as corrective actions.elements of qms
  • External Provisions-Manage Third Part Risks: There are certain requirements which an organization needs to fulfill before outsourcing goods and services. They need to adopt risk based approach and define processes and controls for suppliers. This will enable them to compare supplier scores and monitor them, thus benchmarking supplier performance. Organizations need to check supply chain risks by identifying high risk suppliers, assess the impact of risk, and track their risk profiles.
  • Enable Knowledge Management: The organizations need to be assured whether they have the required knowledge to carry out the activities necessary for compliance with ISO 9001 standard. Also, training for third parties and employees on changing policies and standards should be arranged.

Eurotech, an IRCA approved training partner (ATP), is conducting ISO 9001:2015 Quality Management System Trainings in your city. To know more about this training, drop an email at trg@eurotechworld.net or call us at +91 9316744482 or 0172 - 4191128.

Documentary Control in ISO 9001

Even though, according to the new revision of ISO 9001 standard, there is no requirement of a documented procedure for control of documents, there is still a need to control the documented information. This is to ensure that the quality of the documents affecting the work related activities is protected. Document control is an important aspect of compliance and auditing verification.

Following guiding questions can be used to ensure proper ISO 9001 documentary control:

  1. Protection:
    • Is the documented information well protected against tampering, damage and unapproved changes?
    • Who is authorized to access the information?
    • Whether there are appropriate safeguards in place to prevent misuse of information?
  2. Availability:
    • Does the documented information exist where it is supposed to?iso 9001 documentary control
    • Whether the available information is suitable to fulfill the intended need?
  3. Distribution:
    • How can the information be received by the employees?
    • Are they facing any struggles in retrieving the information?
    • Can the information be retrieved within a reasonable time?
  4. Storage:
    • Where is the information being stored?
    • Is there a periodic backup and monitoring of the information to ensure its continuous legibility?iso 9001 document control
  5. Change Control:
    • How does the organization ensure the correctness of the information?
    • How are the revisions tracked?
    • How can the employees be kept from using incorrect or obsolete information?
  6. Retention:
    • For how long the records are to be kept?
    • How long is the retention time?
  7. Disposition:
    • What happens with the information after the retention time?
    • How are the documents and records disposed off?

To know more about documentary control as a part of ISO 9001, you can join our ISO 9001 Training Courses. We are an IRCA approved training partner (ATP) and conduct ISO 9001:2015 Quality Management System Trainings in Delhi, Mumbai, Chandigarh, Chennai and Ahmedabad. To know more about these trainings, drop an email at trg@eurotechworld.net or call us at +91 9316744482 or 0172 - 4191128.

Benefits of ISO 9001:2015

There are many benefits of implementing QMS in your organization. Some of the ISO 9001 benefits are:

  • It helps in assessing the overall context of the organization to distinguish who is affected by your work and what are their expectations from you. This enables in stating the objectives clearly and captures new business opportunities.iso 9001 benefits
  • Establishing a QMS in the organization puts your customer first, resulting in consistently meeting their needs and exceeding their expectations. This leads to repeating customers, increased new clients and business for your organization.
  • It increases the working efficiency, for all processes are aligned and made understood to everyone in the organization. Thus, it leads to increased efficiency and productivity resulting in overall reduction in internal costs.
  • It helps in fulfilling all the legal and statutory requirements.
  • Implementing quality management system in the organization helps in extending business in new markets, for some clients and sectors require ISO 9001 before doing business.
  • It helps in identifying and addressing the risks associated with our organization.

Eurotech, an IRCA approved training partner (ATP), is conducting ISO 9001:2015 Quality Management System Trainings in your city. To know more about this training, visit our website, drop an email at trg@eurotechworld.net or call us at +91 9316744482 or 0172 - 4191128.

Interested Parties

The first question that should arise in your mind is, ‘Who are the interested parties?’ The second question should be, ‘Why is it important to understand the needs and expectations of the interested parties?’

For example: When you enter a showroom, you enter it with an expectation that the store will provide you with what you are looking for. You become an interested party as soon as you take a step in the store, and the store has to do its best to fulfill your requirements. However, they can satisfy your needs only if they understand your requirements.

Continuing with our example, if a customer is new to your store, you will use a different tactic to sell the products than the one you use for selling your products to your regular/old customers. This is called ‘understanding the expectations and needs of the interested parties.’

According to ISO 9001:2015, the organizations have to determine their interested parties and their requirements that are relevant to the QMS.

An organization along with identifying its interested parties, should also understand their needs and expectations relevant to the functions for effective stakeholder management.

There are various ways in which the organizations can conduct stakeholder analysis. Some of these are ranking the stakeholder’s needs based on the power of their influence, addressing stakeholder’s needs based on their impact on the organization and stakeholder cycle.

Every interested party poses a risk to the organization’s ability to provide its products and services that meet the requirements of the customer as well as statutory and regulatory requirements. It is also to be noted that not all interested parties pose the same sort of risk or have same type of expectations every time. Their expectations keep on changing over time.

In the end, it is for the organization to decide if a particular requirement of an interested party is relevant to its QMS or not.

Eurotech, an IRCA approved training partner (ATP), is conducting ISO 9001:2015 Quality Management System Trainings in your city. To know more about this training, drop an email at trg@eurotechworld.net or call us at +91 9316744482 or 0172 - 4191128.

Risk Based Thinking In ISO 9001:2015

Risk is the effect of uncertainty on the expected result, which encompasses any deviation whether it is negative or positive. The intent is for an approach to risk based thinking which promotes continual improvement and is proactive rather than reactive.

Risk based thinking is an important concept that forms the basis of ISO 9001:2015. This concept may seem to be new, but it has always been a part of ISO 9001 and at the same time, done by many organizations.

Any reference to ‘preventive action’ is removed but the concept of identifying and addressing potential mistakes before they occur remains the same.

ISO 9001:2015 requires an organization to determine the risks and opportunities affecting products and services, processes and the QMS as a whole and to take necessary action to address them.

Risk based thinking is determining the risk in qualitative terms as well as quantitatively defining the degree and rigor of formality needed to plan and check the quality management system and its activities.

Different processes have different levels of risk in terms of impact on customer satisfaction and results of the QMS. Also the results of non conformities are different for different organizations.

Risk-based thinking is prominent in Clause 6.1. The clause requires an organization to consider its context when planning the Quality Management System.

Eurotech, an IRCA approved training partner (ATP), is conducting ISO 9001:2015 Quality Management Trainings in your city. These training will help you better understand the concept and importance of a quality management system, while encouraging risk-based thinking in your organization. To know more about this training, drop an email at trg@eurotechworld.net or call us at +91 9316744482 or 0172 - 4191128.