What is ISO 9001:2015 Certification?
ISO 9001:2015 certification is a very important topic for those who own business in product manufacturing or providing services. ISO 9001:2015 certification is a standard decided by a group of experts for various business sectors regardless of its type or size, or the products and services it provides determines the requirements necessary for ensuring a quality management system. This certification is an internationally recognized certification which ensures quality of products and services of a company. ISO 9001:2015 certification is very important for those who are asking for how to improve the quality of their products and services and simultaneously and consistently meet their customer’s needs.
ISO 9001:2015 sets criteria for a quality management system and is the standard in the 9000 family that can be certified. It can be used by any organization regardless of field, large or small. There are over 1 million companies and organizations in over 170 countries certified to ISO 9001. These ISO standards are based on a number of quality management principles like customer focus, leadership, improvement and engagement of people. It ensures that customers get good quality products and services, in return business also gets benefits. This certification undergoes a well ordered review every five years to decide whether it is still valid or needs update. This is important to ensure that standard still meets the needs of its customers. Latest version of ISO still provides much value to those implementing the standards as it was last updated in 2015. ISO 9001:2015 acts as the standard benchmark. Know more about ISO 9001 from the best ISO 9001 Consultants here.
What is ISO?
ISO stands for International Organization for Standardization. Is a platform providing ISO 9001:2015 certification. ISO develops and publishes International Standards in all technical and nontechnical fields. ISO is a standard development organization that includes representatives from national standard organizations of member countries. ISO was founded on 23 February, 1947 at London, UK. It is headquartered in Geneva, Switzerland, currently working in 167 countries. Official languages of ISO are English, French and Russian. The main goal of ISO is to develop worldwide standardization by adoption of international quality standards. By implementing these standards the barriers of trade get eliminated. ISO standards support worldwide trade that leads to equal economic growth of countries, also promotes health and safety and innovation to achieve a sustainable future. ISO provides a platform where experts from various countries come together to develop standards and agree on them.
International Organization for Standardization
The International Organization for Standardization is an independent Non-Governmental Organization, composed of members of different national standards bodies. Currently there are 167 members representing ISO in their country, each country having only one member. ISO has 804 technical committees and subcommittees responsible for standards development. As of April 2022, the ISO has developed over 24,261 standards, covering everything from products manufactured and food safety, agriculture, healthcare and technology.
ISO 9001:2015 Quality Management Systems
It is the internationally recognised standard for Quality Management Systems. The main goal of these standards is to monitor performance of businesses so business owners can continuously improve quality of product or services. ISO 9001:2015 standards also accentuate a risk based approach encouraging businesses to analyze the potential threat to quality of product or services. These standards are implemented by over millions of companies and organizations globally, ISO 9001:2015 certification adopted by any company regardless of size, type, sector to any business.
ISO 9001:2015 describe concepts of quality management which are globally applicable for following:
- Companies seeking sustained success or growth through implementing these standards and confidence in their supply chain that their product and service requirements will be satisfied.
- Customers seek trust in a company’s ability to provide product and services as per their requirement.
- Company looking to improve communication through understanding of the vocabulary used in quality management.
- Company performing conformity assessments against the requirements of ISO 9001:2015.
ISO 9001:2015 state requirements for a quality management system when a company or organization needs to demonstrate its ability to provide products and services that meet customer requirements and aim to intensify customer satisfaction through the application of the system ensuring improvement in system and assurance to customer and requirement.
Requirements of ISO 9001:2015 Certification
As per ISO 9001:2015 a company needs to demonstrate its capacity or ability to provide product and services to meet customers requirement. Requirements of ISO 9001:2015 are categorized into 10 main clauses. Following clauses help you truly understand the actual requirements of the standards.
- Scope
- Normative References
- Terms and Definitions
- Context of the Organization
- Leadership
- Planning
- Support
- Operation
- Performance Evaluation
- Improvement
1. Scope
Requirements of ISO 9001:2015 are planned to be applicable to any company regardless of its size or type or kind of product and services it provides. It is the first clause in the ISO 9001:2015 standard. This clause is only informative and does not have any requirement that needs to be covered. This clause covers QMS (Quality Management systems) requirements. Companies must aim to enhance customer satisfaction through effectively using the standard for improvement of the QMS.
2. Normative References
The supporting standard referenced in ISO 9001:2015 and is essential for its application is ISO 9000:2015 which covers terminology, fundamentals and vocabulary.
3. Terms and Definitions
Terminology used for this standard comes directly from ISO 9000:2015 QMS. General terminology and process is an important part of this standard.
4. Context of the Organization
When you are implementing your QMS, the first step for ISO 9001:2015 requirements is to thoughtfully align your business objectives. Determine external and internal issues, the needs and expectations of interested parties, QMS scope and its processes. As per ISO 9001:2015 Standard the this clause has four sub-clauses:
- Understanding the organization and its context
- Understanding the needs and expectations of interested parties
- Determining the scope of the quality management system
- Quality management system and its processes
5. Leadership
This clause of the ISO 9001:2015 requirements covers leadership responsibility. Top management must show leadership and establish quality policy and ensure responsibilities and authorities are assigned. Further this clause has three sub clauses:
- Leadership and commitment: Top management shall signify leadership and commitment with respect to the QMS.
- Policy: Top management shall establish and maintain the quality policy. It is relevant to the objective of the company. Quality policy includes continual improvement of QMS and provides a framework for setting quality objectives.
- Organizational roles, responsibilities and authorities: Ensuring that QMS keep to the requirement of ISO 9001:2015. Top management shall ensure that processes are delivered there expected outputs also promote customer focus.
6. Planning
This clause of the ISO 9001:2015 requirements cover organizational QMS planning to address quality objectives, opportunities, risks and changes. This clause has three sub clause:
- Action to address risk and opportunities: Risk and opportunities that need to be addressed to give assurance that QMS can achieve its expected results, enhance desirable effects and reduce undesirable effects to achieve improvement.
- Quality objectives and planning to achieve them: Organization shall establish quality objectives at relevant functions, levels and processes needed for the QMS. The organization shall maintain documented information on the quality objectives. Quality objectives are to be consistent with the quality policy, be measurable, take into account applicable requirements, be relevant to conformity of products and services and to enhance customer satisfaction, be monitored, be communicated and be updated as appropriate.
- Planning of changes: Analyze the need for change to QMS and these changes must be carried out in planned manner. The planning needs the purpose of changes and their consequences, availability of resources and allocation of responsibilities and authorities.
7. Support
This clause of the ISO 9001:2015 requirements cover the resources needed for the QMS, ensuring employees are competent and aware and have documented information to support your QMS. This clause further has five sub clauses.
- Resources: Organization shall provide resources that are required for maintenance and improvement of the QMS. Resources like labor, infrastructure, machines, equipment, transportation. Equipment must be calibrated or verified, able to be identified and safeguarded.
- Competences: Determine the proficiency of a person doing work. Ensure these persons are competent on the basis of appropriate education, training or experience. Keep documented information as proof of competence.
- Awareness: The person doing work is aware of the quality policy, relevant quality objective and their contribution to effectiveness of QMS, including benefits of improved performance.
- Communication: Determine the internal and external communication relevant to QMS, including on what it communicates, when to communicate, with whom to communicate, how to communicate and who to communicate.
- Documented Information: DI required by QMS and ISO 9001:2015 shall be controlled to ensure that it is available, suitable for use and where and when it is needed. QMS must include things to consider at the time of Creating and updating are Identification and description, format, review and approval and control of documented information.
8. Operation
This clause covers the plan and control processes needed to meet the requirements for products and services which are:
- Operation planning and control
- Requirement for product
- Design and development of product and services
- Control of externally provided processes, products and services
- Production and service provision
- The release of product and services
- Control of nonconforming outputs
9. Performance Evaluation
ISO 9001 requires your organization’s QMS to monitor, measure, analyze and evaluate your quality management system. Clause 9 further has three sub clauses.
- Monitoring, Analysis, Measurement & Evaluation: The organization shall determine what needs to be monitored and measured and the methods for it and evaluation needed to ensure valid results. The organization must retain appropriate documented information as evidence of the results. Organization shall monitor customer’s perceptions of the degree to which their needs and expectations have been fulfilled. The results of the analysis shall be used to evaluate conformity of product and services. The degree of customer satisfaction, performance and effectiveness of the QMS, effectiveness of actions taken to address risks and opportunities and performance of external providers.
- Internal Audit: Organization must conduct internal audits at planned intervals to provide information on whether the QMS Conforms to organization’s requirements for its QMS, requirements of ISO 9001:2015 is effectively implemented and maintained. Organization shall Plan, establish, implement and maintain an audit program including the methods, responsibilities and planning requirements. Organization shall take appropriate correction and corrective actions without delay.
- Management Review: Top management shall review the organization’s QMS at planned intervals to ensure its continuing suitability, effectiveness and alignment with the strategic direction of the organization. Management review Inputs – the status of actions from previous management reviews, Customer feedback from relevant interested parties, corrective actions, audit results, the performance of external providers, adequacy of resources. Management review outputs – Opportunities for improvement, any need for changes to the QMS, resource needs, retain documented information as evidence of the results of management reviews.
10. Improvement
ISO 9001:2015 requirements for clause 10 are based around continual improvement. Select opportunities for improvement, take action against non-conformities, implement corrective actions as necessary and improve your quality management system. This clause further has three sub clauses.
- General: Improving products and services to meet requirements as well as to address future needs. Correcting and reducing undesired effects. Improving the performance and effectiveness of the QMS.
- Non-conformity & corrective action: The organization shall take action to control and correct it, deal with the consequences, reviewing and analyzing the nonconformity, determining the causes of the nonconformity, determining if similar non-conformities exist or could potentially occur, Corrective actions shall be appropriate. Retain documented information as evidence of the nature of the non-conformities and action taken and the results of any corrective action.
- Continual Improvement: The organization shall continually improve the Quality Management System.
8 principles of ISO 9001:2015
ISO has developed standards to protect society from potential errors. The most current version of ISO 9001:2015 adopted to fulfill regulatory requirements and customer needs by improvement of system quality. The standards apply globally with confidence in an organization’s capability to provide conforming products. The ISO 9001:2015 standard contains standardized language based on the eight major quality management principles. These principles were developed in the mid 1990s by a group of experts who were familiar with teaching and philosophies of well known quality gurus of the last century. The eight principles are:
1. Customer focus
Organization or company should understand and meet their customer’s current and future requirements.
2. Leadership
Leaders should establish and maintain an environment in which employees can become involved in achieving organization objectives, then only organizations get benefited.
3. Involvement of people
Organizations grow when employees are competent, encourage them for enhancement of their knowledge and skill and empower them.
4. Process approach
When leaders maintain and control processes, organizations enhance their performance.
5. System approach to management
Organizations sustain success when processes are managed as one coherent quality management system.
6. Continuous improvement
Organizations will maintain current levels of performance, respond to changing conditions and explore new opportunities.
7. Factual approach to decision making
Organizations succeed when they have established an evidence based decision making process, identifying facts, analyzing data, examining cause or effect and considering consequences.
8. Mutually beneficial supplier relationships
Organizations that manage their relationship with suppliers can nurture productive involvement and feedback from those suppliers.
Steps to Get ISO 9001:2015 Certification
1. Allocate Resources for the Certification
Allocating resources for the QMS development can be the first step to get ISO 9001:2015 certification. Allocate resources to the project means you’ll need to decide whether to use a consultant or do it by yourself. For an ISO 9001:2015 certification requires the correct allocation of resources. Appoint someone senior to manage the project helpful to big organizations or companies. The organization must assure that all responsibilities are shared within all levels and provide resources such as budget and impose timelines. You will have to understand whether you will have enough resources to do it yourself or take the help of a consultant. For big organizations, it would be great to hire a consultant so you can do it without errors.
2. Do a gap analysis
Gap analysis is very important to understand your baseline status of organization. To get an ISO 9001:2015 certification, you must check where your organization currently stands and the gaps that you need to fulfill to get certified. This means you systematically assess the status of your current system and decide what needs to be done. Find your baseline and estimate the scope of work. Use the results of the gap analysis to identify your gaps and what is needed to do to fill these gaps. Pre-assessment is important to compare the current quality management system in comparison to the ISO standard. Gap analysis report will identify which ISO 9001:2015 requirements your organization is already meeting. As different organizations have different sizes, people and working environments, there is no single way to do gap analysis. Any gaps that exist between the current processes of your organization and the standard requirement can help in the creation of a project plan.
3. Develop and internally audit the system
To get the certification you will need to develop your system and processes up to the level of ISO 9001:2015 standards. Review your system and processes to see how well they are working. Do internal audits to see if you’re doing what you think you are. This means developing new processes, quality controls and organizational policies according to the ISO 9001:2015 standards. Before letting a third-party audit your system, you have to be sure that it fulfills the ISO 9001:2015 certification standards. This is why internal auditing is an important step before applying for the certification.
4. Take a formal training on ISO 9001:2015
If you are doing the certification process on your own, it is good to have a clear understanding of all the requirements for an ISO certification. ISO 9001:2015 requires proper identification of competence requirements for staff. Employees, leaders and internal auditors all need to undergo seminars, workshops and courses in order to meet the requirements of competence. External training can provide assurance and authentic skills to help the execution process. An organization must also define how to demonstrate the effectiveness of training.
5. Choose an accredited auditor
You need to get your organization’s quality management system checked by an accredited auditor to get the ISO 9001:2015 certification. There are many accredited certification bodies that provide the certifications. Check out which one is popular and suit your resources. Then undergo the external audit. Choose a certifier and agree dates for the external audit. These auditor bodies will assess all the areas in your quality management system and will let you know if any more gaps need to be filled. External auditor will audit the organizational quality system against all of the specific requirements of ISO 9001.
6. Get the certification
When the auditor feels that your quality management system is as per the requirements of the ISO 9001:2015 standard, you will receive the certification. This certification is valid for three years and you will have to maintain the processes and system to renew the certification. Even after getting the certification, you need to continually improve the processes so that it continually fulfills all the requirements.
Benefits of ISO 9001:2015 Certification
Now let’s discuss the benefits if you get ISO 9001:2015 certification.
ISO 9001:2015 is an internationally recognized certification which ensures quality of products and services of a company or organization. Being ISO 9001:2015 certified has lots of benefits to the company. When you choose to become certified, It provides support for your staff and customer satisfaction. There are many benefits of this Certificate, Some of these benefits are:
1. Increased Efficiency of Organization
Once an organization achieves ISO 9001:2015 certification, the standard processes are established. For that companies have done extensive research on the processes they are following and how to maximize quality and efficiency. Manual work is reduced with process integration and process automation. Organizational efficiency and effectiveness is improved by using data and evidence to inform decision making.
2. Increased Credibility and Recognition
ISO is recognized worldwide as the authority on quality management. Having ISO 9001:2015 certification increases the value of your company against your competitors as well as increases your status among your clients.
3. Increased Revenues
ISO 9001:2015 certified companies have shown improvements in the field of productivity and financial performance as compared to the uncertified ones. Company is ISO certified, it means that quality has been testified. So you can use this as an advertising plus point and price your products accordingly. More quality products will help you gain more customers.
4. Increased Customer Satisfaction
Customers will know that your products and services will always have quality. Companies can gain the confidence of clients easily because the ISO is a universally accepted standard. You will have what customers expect from you. You will get less complaints and more satisfied customers. ISO 9001:2015 QMS certification ensures efficiency, consistency and quality service by the companies thereby ensuring the satisfaction of the customers.
5. Consistency
As standard processes are implemented so there is a minimum scope of errors. That’s why services and products are delivered consistently. ISO 9001:2015 helps you increase the control of your business processes, the more your consistency increases. Customers will get the same service or same products every time they are making business with you.
6. Empowered Employees
ISO 9001:2015 certification requires the training and development of your staff being maintained. It provides the necessary tools for them to do their jobs. Employees will be more knowledgeable of what they are doing and since they will keep getting trained, their careers will improve.
How to Maintain ISO 9001:2015 Certification
Achieving ISO 9001:2015 certification is important to certify to the level of quality management, but it is even more important to maintain certification. It is essential to carry out the maintenance of ISO 9001. At the end of a year, it is obligatory to submit the company to a new assessment whether or not it offers recertification. There are some methods to maintain ISO certification.
Decide the right implementation method for your organization
Maintaining ISO 9001:2015 requires a series of activities that need to be closely monitored. Each company has its own needs and uniqueness that’s why it is essential to define which implementation method is the most suitable for your company.
Perform diagnostics and planning
It is also important to carry out internal diagnostics, based on the implantation method. From these diagnoses, it is possible to identify which are the most problematic processes. With planning, it is possible to define what are the necessary actions to achieve the maximum result in quality.
Attend training cycles
After obtaining ISO 9001:2015 certification and during the maintenance period, new market needs, technologies and standards are likely to emerge. It is essential that employees follow all these changes. It is recommended that employees go through at least one or two training cycles during this maintenance period.
Involve employees in this maintenance
In addition to being continuously trained, employees also need to be involved. There is no quality without the participation of those who most influence the processes, so it is necessary that everyone is aware of the importance of this maintenance. This involvement generates a commitment to maintaining the quality levels corresponding to ISO 9001:2015, which favors recertification at the end of the period.
Perform internal audits
Internal audits point out which are the critical points that are still out of the standard or that need to be monitored. It is important to carry out internal audits as a way to identify which points may impair maintenance.
Consider the assistance of a software planning and development company
Technology plays an important role in achieving ISO 9001:2015 and in maintaining it. With the use of software, it is possible to perform integrations between processes and get better results. Therefore, it is essential to consider having the support of a company specialized in developing solutions of this type in order to maintain the certification. The maintenance of this certification in your company is possible if there is a focus on planning, recognition of results, involvement and training of employees and use of technology. It is also essential to have a specialized company focused on developing solutions and software aimed at quality management.
Conclusion
ISO 9001:2015 certification is a very authentic document that every company or organization must register for and get certified. Getting certified is better, more better if you maintain it for a long period of time. It shows that your company is providing products or services that customers expect. Certification to the ISO 9001:2015 standard can enhance a company’s accountability by satisfying customers with needed products and services. In some industries, certification is required or legally mandated. So, their quality of products and services are maintained. There are several different documents in the ISO 9000 family of standards, but ISO 9001 is the only standard in the 9000 series that requires certification. This certification does not matter what size your organization is and does not matter what kind of industry it is. Getting certified with ISO 9001:2015 certification is beneficial for customers as well as the company. So what are you waiting for? Do get ISO 9001:2015 Certification in India today! Connect with the best Quality Management Certification Consultants for ISO here.
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FAQ’s
Ques 1. What are the major clauses of ISO 9001:2015?
Answer: Scope, Normative References, Terms and Definitions, Context of the Organization, Leadership, Planning, Support, Operation, Performance Evaluation and Improvement.
Ques2. What does ISO stand for?
Answer: ISO stands for International Organization for Standardization.
Ques 3. What are the 8 principles of ISO 9001?
Answer: Customer focus, leadership, involvement of people, process approach, system approach to management, continuous improvement, factual approach to decision making and mutually beneficial supplier relationships.
Ques 4. What is the cost of getting ISO 9001:2015 certification in India?
Answer: ISO 9001:2015 Certification Cost approx. RS.3000 to RS.8000 which depends on the Agency.
Ques 5. What is ISO 9001 quality management system?
Answer: ISO 9001 is the internationally recognized Quality Management System (QMS) standard that can benefit any size organization or company.
