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ISO 9001 Certification

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Evolution of ISO 9001 Certification

The latest version of ISO 9001 Certification is known as ISO 9001:2015 Certification. It was first published in 1987 and last revised in the year 2015.

What is ISO 9001:2015- Quality Management System?

ISO 9001:2015 certification is a quality management standard that demonstrates the organization’s ability to provide products and services that meet customer and legal requirements. It is a set of policies, procedures, and processes to implement and maintain a quality management system within the organization.

 

ISO 9001 standards provide management tools and techniques to improve customer satisfaction and assist organizations in increasing efficiency. Quality management functions to achieve Quality Assurance and Quality Control.

 

Quality Assurance aims to design processes to produce products and services of appropriate quality and focuses on every aspect of the system, including suppliers and customers.

 

Quality Control focuses on operations related to producing the product or services and intends to eliminate factors that might cause undesired outputs.

Importance of ISO 9001:2015 Certification

ISO 9001 Certification is a universal standard for Quality Management System and one of the most used ISO standards.

 

  • Over 1.1 million certificates have been issued in 178 countries.

 

  • 85% of the certified organizations report benefits, such as higher demand for products and services, increased market share and improved business operation.

 

  • Organizations with ISO 9001 Certification are more competent and pay 7% more on average.

 

ISO 9001 certification is the only standard in the ISO 9000 family of standards that requires certification. An entire organization seeks Certification, but the scope of the QMS can be accommodated to improve performance at a particular facility or department.

ISO 9001:2015 Quality Management and its All Major Aspect in a Business

Quality management is a key to success, when we talk about business growth and its performance. That promotes client relations and plays a role for the wellbeing of business. To ensure the success in a business the quality of products and services will be maintained to all levels. This includes the planning, decision, and quality of procedure.

 

Quality is not only about ensuring the final product but also includes the process and the efforts behind the result.

 

Higher profitability is a crucial part of great quality. Higher the quality promotes higher profits. And for this it requires a high investment in a market. Minor failures in a company translate into the company’s manufacturing and service cost. And earning from this prevented the company’s expenditure and increased the market share and sales.

 

Efficient management grows the business and makes it more sustainable and promotes the productivity. This will help to make the changes with competitor’s business. and promotes customer satisfaction.

 

Customers expect the standard of product from the company they purchase, without the quality the customer will deny purchasing from you, because nowadays customers keep quality over quantity and don’t waste their hard earned money on the things which aren’t worth the same. Keep quality a priority that is maintained in each and every substance in a company and enhances customer peace of mind.

 

Higher standards of a product attracts the customer to purchase back, and for this the crucial part to make essential changes, improves the quality, update product as the time and affordable, this has resulted in the customer loyalty and customer come back to you for other products.

What is ISO 9001 and its principles?

The ISO 9001 Certification places the concept of process management at the heart of the standard. It consists of eight core quality management principles that act as a common foundation for all standards relating to quality management.

 

These are the eight principles :-

1. Customer focus – It evaluates the organization’s objectives and initiatives to meet customers’ needs and requirements. The principle focuses on product performance and customer service.

 

2. Leadership – This principle aims to establish a quality-minded culture. The top-level management plays a crucial role in establishing and maintaining work environments that engage people and achieve quality objectives.

 

3. Engagement of People – It is one of the essential principles of ISO 9001 certification and focuses on making employees more competent, dependable, empowered, and better. It helps in the personal and professional development of the employees by establishing effective communication within the organization.

 

4. Process Approach – It focuses on linking all the business processes in a single system and helps in achieving more predictable and consistent outcomes. It helps an organization to focus on operations that need improvement.

 

5. System Approach to Management – The process approach is a part of the system approach. It focuses on developing a cohesive system and improving individual performance by understanding, analyzing and managing interrelated business processes.

 

6. Continual Improvement – Improving business operations is an on-going process. It requires an organization to identify potential risks and opportunities and formulates strategies to eliminate risks and reap opportunities.

 

7. Evidence-based Decision Making – It follows an evidence-based approach to the decision-making process. It evaluates all the data and implements appropriate tools and methods. The importance is given to understand the cause-and- effect relationships and potential unintended consequences.

 

8. Relationship Management – Establishing good relations with relevant partners, business associates, vendors, stakeholders, and investors is significant for an organization to ensure the continuity of the supply chain. Sustained success is more likely to be achieved when the organization manages relationships with all of its interested parties to optimize their impact on its performance.

Checklist for ISO 9001:2015 Certification

ISO 9001 certification is an internationally accredited standard for Quality Management System. It requires an organization to establish effective quality management, and here is a checklist of 12 key steps that will guide you to achieve ISO 9001:

Step: 1- Leadership

Step: 2- Perform a Gap Analysis

Step: 3- Defining the scope

Step: 4- Implementation of Quality Management and Creating Quality Management System Manual

Step: 5- Establishing effective communication within the organization

Step: 6- Creation of an audit plan

Step: 7- Determining and assigning roles and responsibilities

Step: 8- Evaluating the Quality Management System and taking the corrective-actions

Step: 9- Conduction of an internal audit

Step: 10- Apply for stage-I audit

Step: 11- External audit

Step: 12- Successfully completing the Certification process

Cost of ISO 9001 Certification

The cost of ISO 9001 Certification varies from one organization to another. ISO 9001 standards apply to any industry, large and small, irrespective of nature and location. The cost of ISO 9001 certification depends on the certification body you choose. It also depends on many factors, such as:

  • Size of your organization
  • Number of employees in the organization
  • The number of branches your organization has and many more.

PDCA Cycle

  • Plan – to think that what do we need to achieve in our organization
  • Do – to execute a planned action which will help us achieve the required objective
  • Check – monitor against the standards) (policies, objectives, requirements)
  • Action – finally implementing what has been rechecked.

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Boosting the image of your organization – ISO 9001 certification by a credible certification body enhances your reputation in the eyes of customers, clients, and other stakeholders regarding your capabilities to deliver quality products and services.

Meet customer’s expectations – ISO 9001 aims at meeting the requirements as well as expectations of customers in terms of quality. This helps in enhancing your customer base as well as retaining your old customers.

Integration of processes – the High-Level Structure of ISO 9001 enables the integration of various management systems within the organization. This helps in recognizing the area of improvement as well as resource conservation within your organization.

Evidence-based decision making – The key to an effective QMS lies in evidence-based decision-making that can take into consideration the identified risks and ensure appropriate action for an efficient QMS.

Continual improvement – the culture of continual improvement in your organization enables your staff in improving the processes that they are directly responsible for. This helps in saving a good amount of time, costs, and other resources.

Involvement of the workforce – Who the framework of ISO 9001 ensures the engagement of the entire workforce for the betterment of the processes that keeps them motivated, which ultimately benefits of Being ISO 9001 Certified for your business.

The structure of ISO 9001 consists of 10 sections, out of which the first three are introductory in nature, whereas the last seven specifies the requirements of QMS, against which ISO 9001 certification performed.

Clause 4: Context of the organization – This section deals with understanding the uniqueness of your organization and customizing ISO 9001 in order to implement a QMS that is most suitable for you.

Clause 5: Leadership – It underlines the importance of top management in implementation of QMS by proper risk assessment, planning actions, and assigning roles and responsibilities to the relevant staff.

Clause 6: Planning – through analysis of the risks and opportunities, the top management is expected to design a plan that enlists the quality objectives for your organization.

Clause 7: Support – It points out all the resources, such as human resources, infrastructure, and others that are required for an effective QMS. This section also deals with the requirements around competence, awareness, communication, and controlling documented information.

Clause 8: Operation – this section deals with the execution part of the planning for QMS. It includes product requirements review, keeping a check on external providers, reviewing the product before release, and so on.

Clause 9: Performance evaluation – This section deals with the ways by which you can ensure an effective functioning of your QMS. It involves regular management reviews, monitoring and measurement techniques, etc.

Clause 10: Improvement – this section ensures that your QMS is upgraded and able to meet the current market requirements. It involves regular reviews to identify gaps and performing corrective actions to close those gaps for continual improvement

Gap Analysis

  • Understand the prerequisites of ISO standards by analyzing each clause thoroughly.
  • Analyze your system for any shortcomings.
  • You may take help from any ISO consultant to get you through this stage.

Implementation

  • Prepare the required documents, records, and policies
  • Perform internal audits and management review to understand gaps and practical realties
  • Perform corrective actions to confirm conformities

Certification

  • Fill the application form provided by the certification body
  • Invite the auditors from certification body for audit and certification
  • Get your management system ISO certified.
  • Stage One (documentation review) – At this stage, the auditors from the certification body verifies that your documentation meets the requirements of ISO 9001.
  • Stage Two (main audit) – In this stage, the realities of your processes are matched with your statements in the documentation for their compliance to the requirements of ISO 9001 standard.

the certification process goes further. Click here to view the next steps to the ISO certification process

Make Sure

Quality manual procedures need to be preferably performed by the company, noncompliance of procedure can result in losing the certificate (quality manual is different form system procedure can be given to customer on demand)

Work instruction manual includes step by step carrying out of procedures, forms, quality records, specification, master lists, need to be properly maintained and if not it may become a major problem in ISO 9001 implementation

Quality management principles is a comprehensive and fundamental rule/belief, of leading grand operations of an organization, aimed at consciously improving performance over the long term by focusing on customer while addressing the needs of all other stakeholders

How can I get an ISO 9001 certificate?

Achieving ISO 9001 Certification is not a big deal in today’s upgraded systems. The basic steps to become ISO 9001 Certified are listed below:
  • Firstly, you need to prepare all the relevant information about your company in a systematized way (It is always best and safe to hire a legal consultant.)
  • Secondly, you need to document all the relevant information about your business.
  • Thirdly, you have to implement all the documented information in your organization.
  • Fourthly, get ready for the internal audits which are performed first during the certification process and then periodically after.
  • Lastly, if the certifying body approves your management system then you will be awarded the required ISO standard.

How much does it cost for ISO 9001 certification?

The cost of ISO 9001 certification varies from one organization to another. Basically, when you approach an internationally accredited certifying body for ISO Certification and they approve your management systems and all your processes, they will then quote an amount for the certificate. Moreover, the cost for achieving ISO certification depends mostly on your organization, such as the no. of employees in your organization, No. of branches your organization has, and many more.

How long is an ISO 9001 certificate valid for?

Basically, an ISO Certificate is valid for three years. And during this time period of three years, a surveillance audit is conducted on an annual basis to ensure that ISO quality standards are being maintained by the organization.

How do I maintain ISO 9001 certification?

Just because you received an ISO 9001 certification, your task is not complete. For proper functioning of the management system, you need to maintain the ISO 9001 certification. For that, your company has to continually undergo an annual surveillance audit for the period of three years. After completion of the validity period, you need to get recertified.

Is ISO 9001 certification right for me? / Why become ISO 9001 certified?

Having an ISO 9001 certification is important for any organization because it helps you to lower your cost amount, maximize your profits ability in the organization. The benefit of a quality management system also helps you to earn new customers and retain those customers for a long period.

How can I apply for ISO 9001:2015 for my company for quality?

  • First of all, you need to choose an internationally accredited certification body meeting all the requirements of IAS Accreditation such as SIS CERTIFICATIONS.
  • Then an application shall be created, where all the rights and obligations will be included and will be confidential between both the applicants and the registrar.
  • After that, the ISO auditor will review the relevant documentation related to various procedures followed in your organization.
  • The auditors will identify gaps, and if there are any gaps you have to prepare an action plan in order to remove these gaps.
  • Then, there will be initial certification audits which will be followed by:
    • Stage I – where the auditors will check the changes made in your organization according to requirements.
    • Stage II – where the auditor will do their final audit for the certification.
  • As the auditors will approve all your processes then they will make a report and send it to the registrar. They will then grant you the ISO 9001:2015 certification.

What is the aim of ISO 9001 Certification?

ISO 9001 Certification is a globally recognized standard for Quality Management Systems (QMS) which basically aims to cut costs and optimize all the processes operating in your organization and helps your organization to meet all the requirements of the customers and other stakeholders.

What is the latest version of ISO 9001 Certification?

The latest version of ISO 9001 Certification is ISO 9001:2015 Certification, published in the month of September 2015. It basically aims to meet and enhance customers’ and other stakeholders’ satisfaction through effective application of the processes and also any organization regardless of its type, size, or products and services it provides, can apply for it.
ISO 9001 Benefits

Boosting the image of your organization – ISO 9001 certification by a credible certification body enhances your reputation in the eyes of customers, clients, and other stakeholders regarding your capabilities to deliver quality products and services.

Meet customer’s expectations – ISO 9001 aims at meeting the requirements as well as expectations of customers in terms of quality. This helps in enhancing your customer base as well as retaining your old customers.

Integration of processes – the High-Level Structure of ISO 9001 enables the integration of various management systems within the organization. This helps in recognizing the area of improvement as well as resource conservation within your organization.

Evidence-based decision making – The key to an effective QMS lies in evidence-based decision-making that can take into consideration the identified risks and ensure appropriate action for an efficient QMS.

Continual improvement – the culture of continual improvement in your organization enables your staff in improving the processes that they are directly responsible for. This helps in saving a good amount of time, costs, and other resources.

Involvement of the workforce – Who the framework of ISO 9001 ensures the engagement of the entire workforce for the betterment of the processes that keeps them motivated, which ultimately benefits of Being ISO 9001 Certified for your business.

ISO 9001 Requirements

The structure of ISO 9001 consists of 10 sections, out of which the first three are introductory in nature, whereas the last seven specifies the requirements of QMS, against which ISO 9001 certification performed.

Clause 4: Context of the organization – This section deals with understanding the uniqueness of your organization and customizing ISO 9001 in order to implement a QMS that is most suitable for you.

Clause 5: Leadership – It underlines the importance of top management in implementation of QMS by proper risk assessment, planning actions, and assigning roles and responsibilities to the relevant staff.

Clause 6: Planning – through analysis of the risks and opportunities, the top management is expected to design a plan that enlists the quality objectives for your organization.

Clause 7: Support – It points out all the resources, such as human resources, infrastructure, and others that are required for an effective QMS. This section also deals with the requirements around competence, awareness, communication, and controlling documented information.

Clause 8: Operation – this section deals with the execution part of the planning for QMS. It includes product requirements review, keeping a check on external providers, reviewing the product before release, and so on.

Clause 9: Performance evaluation – This section deals with the ways by which you can ensure an effective functioning of your QMS. It involves regular management reviews, monitoring and measurement techniques, etc.

Clause 10: Improvement – this section ensures that your QMS is upgraded and able to meet the current market requirements. It involves regular reviews to identify gaps and performing corrective actions to close those gaps for continual improvement

ISO 9001 Process

Gap Analysis

  • Understand the prerequisites of ISO standards by analyzing each clause thoroughly.
  • Analyze your system for any shortcomings.
  • You may take help from any ISO consultant to get you through this stage.

Implementation

  • Prepare the required documents, records, and policies
  • Perform internal audits and management review to understand gaps and practical realties
  • Perform corrective actions to confirm conformities

Certification

  • Fill the application form provided by the certification body
  • Invite the auditors from certification body for audit and certification
  • Get your management system ISO certified.
  • Stage One (documentation review) – At this stage, the auditors from the certification body verifies that your documentation meets the requirements of ISO 9001.
  • Stage Two (main audit) – In this stage, the realities of your processes are matched with your statements in the documentation for their compliance to the requirements of ISO 9001 standard.

the certification process goes further. Click here to view the next steps to the ISO certification process

Make Sure

Quality manual procedures need to be preferably performed by the company, noncompliance of procedure can result in losing the certificate (quality manual is different form system procedure can be given to customer on demand)

Work instruction manual includes step by step carrying out of procedures, forms, quality records, specification, master lists, need to be properly maintained and if not it may become a major problem in ISO 9001 implementation

Quality management principles is a comprehensive and fundamental rule/belief, of leading grand operations of an organization, aimed at consciously improving performance over the long term by focusing on customer while addressing the needs of all other stakeholders

ISO 9001 FAQs

How can I get an ISO 9001 certificate?

Achieving ISO 9001 Certification is not a big deal in today’s upgraded systems. The basic steps to become ISO 9001 Certified are listed below:
  • Firstly, you need to prepare all the relevant information about your company in a systematized way (It is always best and safe to hire a legal consultant.)
  • Secondly, you need to document all the relevant information about your business.
  • Thirdly, you have to implement all the documented information in your organization.
  • Fourthly, get ready for the internal audits which are performed first during the certification process and then periodically after.
  • Lastly, if the certifying body approves your management system then you will be awarded the required ISO standard.

How much does it cost for ISO 9001 certification?

The cost of ISO 9001 certification varies from one organization to another. Basically, when you approach an internationally accredited certifying body for ISO Certification and they approve your management systems and all your processes, they will then quote an amount for the certificate. Moreover, the cost for achieving ISO certification depends mostly on your organization, such as the no. of employees in your organization, No. of branches your organization has, and many more.

How long is an ISO 9001 certificate valid for?

Basically, an ISO Certificate is valid for three years. And during this time period of three years, a surveillance audit is conducted on an annual basis to ensure that ISO quality standards are being maintained by the organization.

How do I maintain ISO 9001 certification?

Just because you received an ISO 9001 certification, your task is not complete. For proper functioning of the management system, you need to maintain the ISO 9001 certification. For that, your company has to continually undergo an annual surveillance audit for the period of three years. After completion of the validity period, you need to get recertified.

Is ISO 9001 certification right for me? / Why become ISO 9001 certified?

Having an ISO 9001 certification is important for any organization because it helps you to lower your cost amount, maximize your profits ability in the organization. The benefit of a quality management system also helps you to earn new customers and retain those customers for a long period.

How can I apply for ISO 9001:2015 for my company for quality?

  • First of all, you need to choose an internationally accredited certification body meeting all the requirements of IAS Accreditation such as SIS CERTIFICATIONS.
  • Then an application shall be created, where all the rights and obligations will be included and will be confidential between both the applicants and the registrar.
  • After that, the ISO auditor will review the relevant documentation related to various procedures followed in your organization.
  • The auditors will identify gaps, and if there are any gaps you have to prepare an action plan in order to remove these gaps.
  • Then, there will be initial certification audits which will be followed by:
    • Stage I – where the auditors will check the changes made in your organization according to requirements.
    • Stage II – where the auditor will do their final audit for the certification.
  • As the auditors will approve all your processes then they will make a report and send it to the registrar. They will then grant you the ISO 9001:2015 certification.

What is the aim of ISO 9001 Certification?

ISO 9001 Certification is a globally recognized standard for Quality Management Systems (QMS) which basically aims to cut costs and optimize all the processes operating in your organization and helps your organization to meet all the requirements of the customers and other stakeholders.

What is the latest version of ISO 9001 Certification?

The latest version of ISO 9001 Certification is ISO 9001:2015 Certification, published in the month of September 2015. It basically aims to meet and enhance customers’ and other stakeholders’ satisfaction through effective application of the processes and also any organization regardless of its type, size, or products and services it provides, can apply for it.

Is ISO 9001 Certification mandatory or a legal requirement?

Since ISO 9001 certification is proof of your commitment to the quality of your products or services, it becomes a priority for your clients to do business with you. Also, you may find those suppliers trustworthy who are certified with ISO 9001. Thus, ISO 9001 certification is not a mandatory requirement, but it sure is a preferable one. In addition to that, ISO 9001 is also not a legal requirement. In fact, there are many standards, based on ISO 9001, for the implementation of Quality Management systems.

 

Organizations of any size or sector of operation can apply for ISO 9001 certification. The cost of obtaining this certificate varies from organization to organization, based upon the strength of their workforce, the complexity of their processes, and many other factors. Implementing a QMS on the basis of ISO 9001 may seem like a difficult task, but with proper guidance, it becomes easier, in addition, that, ISO 9001 certification might seem challenging to many, but with an experienced certification body, like SIS Certifications, the process of certification can be made hassle-free.

 

To know more about SIS Certifications – Click Here

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