ISO 9001:2015 – Quality Management System

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ISO 9001:2015

Quality Management System

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ISO 9001 is an international standard for quality management systems and it was published in 1987 by ISO and also the first and foremost standard in the modern world.

It is designed to help an organization to meet the needs of customers and stakeholders by the consistent quality of products and/or services.

Benefits of ISO 9001.

  • Customer Satisfaction
  • Achieve Consistency
  • Work Efficient
  • Necessary Resources

Reasons to get of ISO 9001.

  • Good Marketing Opportunities
  • Get chances to win the contracts/tenders
  • It helps for continual improvement to your organization
  • It improves customer satisfaction
  • Its works operations efficiently

Principles of ISO 9001.

  1. Customer focus – The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations.
  2. Leadership – Leaders at all levels establish unity of purpose and direction and create conditions in which people are engaged in achieving the organization’s quality objectives.
  3. Engagement of people – Competent, empowered and engaged people at all levels throughout the organization are essential to enhance its capability to create and deliver value.
  4. Process approach – Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system.
  5. Improvement – Successful organizations have an ongoing focus on improvement.
  6. Evidence-based decision making – Decisions based on the analysis and evaluation of data and information are more likely to produce desired results.
  7. Relationship management – For sustained success, an organization manages its relationships with interested parties, such as suppliers.

ISO 9001 Audit Benefits

Audit plays a major role in the ISO 9001 certification process and this will help you:

  • To verify the effectiveness of ISO 9001 standard requirements.
  • To identify and analyze the issues in your organization through an ISO 9001 audit.
  • Identify the potential improvement of your management system.

ISO 9001 Requirements

Clause 4: Context of the Organization

This clause explains that the company has to identify the internal and external issues to the organization, and also identify the interested parties with their needs and expectations, the scope of the organization with strategic direction and process involved in that QMS.

Clause 5: Leadership

This clause describes that top management of the company has to implement the QMS into the organization, and give the leadership commitment to ensure the customer focus, and define and communicate the quality policy, and define and assign the job roles for the employees as designation wise described.

Clause 6: Planning

This clause says that top management has to plan the activities of the quality management system, and identify the risk and opportunities and need to address the risk with control measures and set the objective plan to achieve them.

Clause 7: Resources

This clause requires identifying the resources of the QMS process and/or activities and it includes human resources, infrastructure, work environment. And also, it covers the competence, awareness, documented information for the QMS processes.

Clause 8: Operation

This clause says that to cover all activities of planning and need to address them, and this section covers the review of the product, design, control the external providers, create and release the product or service, and controlling the nonconforming process outputs.

Clause 9: Performance Evaluation

This section describes the company has to monitor the QMS processes, and it includes the monitors of your processes, internal audit, and Management review meeting of QMS.

Clause 10: Improvement

This clause explains the company has to evaluate the corrective action for the nonconformity of the QMS processes and/or activities.

 

FAQ – Frequently Asked Questions

What is certification?

It is an official document attesting to a status or level of achievement.

What is ISO certification?

An independent body can give written assurance (a certificate) that the product, service, or system in question meets specific requirements.

What is ISO 9001?

Among all the modern management systems ISO 9001 – Quality Management System stands foremost in the world. This system enables companies to maintain excellent procedures in order to meet at the global level in terms of quality and standards.

What is the latest version of ISO 9001?

ISO 9001 current version is ISO 9001:2015; before it was 9001:2008.

My company is very small. Can I get certified?

Unquestionably. We’ve worked with companies of one or two people who decided to get certified. The processes that you’ll put in place would have the same intent as a much larger company; it’s just that the implementation will be simpler. We work with organizations to assist them in balancing the appropriate level of documentation with what’s necessary to meet requirements.

How long will it take to become certified?

ISO certification is an ongoing process, not a single event and it complies with requirements of relevant international standards. But it will take 2-3 months to achieve certification.

What is a Surveillance Audit?

It is a periodic audit performed by the ESI auditor and to verify the requirements in accordance with the quality management system.

What is a Stage 1 Audit?

Stage 1 Audit is a document review audit, which is an ESI auditor to review your documents with the requirements of ISO 9001 standards.

What is a Stage 2 Audit?

ESI team will come to your premises and conduct an audit to verify the implementation of ISO 9001 standard requirements.

What is a Recertification Audit?

Generally, the ISO 9001 certificate is valid for 3 years from the initial audit and the recertification audit means you have to undergo the same audit process without the stage 1 audit.

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