ISO 9001:2015 Quality Management Systems

ISO 9001 is an international standard that specifies the basic requirements for a Quality Management System (QMS) that an organization should possess. It is one of the most widely adopted standards globally, with thousands of certified organizations. Initially published by the International Organization for Standardization (ISO) in 1987, this standard sets the framework for an effective QMS.

Background of ISO 9001

In 1987, the International Organization for Standardization (ISO), based in Geneva and representing 91 nations, introduced the ISO 9000 series of standards. In 1994 the series was subsequently updated to ANSI/ISO/ASQ standard, allowing U.S. companies to attain certification. Earlier, ISO had three different sets of standards - ISO 9001, ISO 9002, and ISO 9003. However, in the year 2000, the latter two standards requirements were merged into the main QMS standard, ISO 9001.

The ISO 9001 Committee continually reviews all standards to ensure they remain current and serve the global needs of organizations. The most recent update to the ISO 9001 QMS standard occurred in 2015. Before this, the standard underwent three previous revisions, occurring in 1994, 2000, and 2008. The most recent edition ushered in a paradigm shift by introducing the concept of Risk-Based Thinking into ISO 9001, signifying a groundbreaking milestone in the realm of Quality management.

What are the Major Changes in the ISO 9001:2015 Version?

The primary focus was to improve the performance of businesses and streamline the documentation needs. The ISO 9001 standard is based on the seven quality management clauses/principles as follows:

  1. Context of the Organization
  2. Leadership
  3. Planning
  4. Support
  5. Operation
  6. Performance Evaluation
  7. Improvement

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Why Should I implement ISO 9001?

There are many reasons for an organization to implement ISO 9001 QMS standard. One of the main benefits of the ISO 9001 QMS standard is that it helps organizations to have an international management systems framework to adhere to. Consequently, this framework guarantees that customers can anticipate the delivery of high-quality products and services. The adoption, implementation, and maintenance of an ISO 9001 QMS represent a strategic choice that company management must make.

The standard is adaptable and does not prescribe specific operational methods. to companies. Companies can interpret the standard’s guidelines and implement a process-based system that complies with the general requirements of the standard. For further insights into the process development, you may consider enrolling in this Understanding the Requirements of ISO 9001:2015 for Quality Management Systems course. The objectives of the standard can be defined by the company that adopts the ISO 9001:2015.

How Easy is ISO 9001 Implementation and Does It Save Cost?

ISO 9001 QMS is mainly divided into 10 sections or Clauses, along with additional sub-clauses related to the Plan-Do-Check-Act system. Sections 4-10 contain requirements that are “auditable clauses”. These clauses cover requirements for any company, so it’s important that the standard operating processes are well defined and satisfy all the requirements of these clauses. To be compliant with ISO 9001, the following documents are required: a Quality Manual, Standard Operating Procedures, and Forms and Checklists. To demonstrate the system's functionality, it must maintain records of process performance as tasks are completed.

  • An effective ISO 9001 system has proven to improve the company’s business performance and establish a strong basis for a culture focused on continual improvement in the long term.
  • Implementing ISO 9001 can indeed lead to cost savings. It has been well-documented that ISO 9001 QMS boosts employee morale, enforces standardized operating procedures, enhances clarity for staff, and establishes a shared benchmark for management to assess performance.
  • ISO 9001 QMS standard can be implemented by any company, regardless of its type, size, industry, and the product and services it offers.

How Do I Get Started with Implementing ISO 9001?

You can utilize the support of certified ISO 9001 consultants for your implementation. Having said that, the ISO 9001 standard is quite easy to follow, and you may choose to implement it with your internal teams with minimal guidance from an ISO 9001 consultant. There are many implementation guides, checklists, and ISO 9001 Implementation plans that are available. For a comprehensible, step-by-step manual, you may consider purchasing this guide that we recommend how to audit ISO 9001:2015

How Do I Get My ISO 9001 Certificate?

Obtaining ISO 9001 certification signifies your organization's credibility, commitment to service, and assurance that your products and services align with customer expectations. Once you have implemented the standard, you can invite one of the Authorised Certification bodies to visit and audit your ISO 9001 QMS.

The audit is typically conducted according to your organization's size, process complexity, and the number of employees involved. Upon successfully completing the audit, the certification body will grant your organization an ISO 9001 compliance certificate.

Remember, ISO 9001 certification can be issued only to companies and not to individuals.

Individuals have the opportunity to become certified as ISO 9001 auditors. Typically, companies employ certified ISO 9001 internal auditors who periodically verify the implementation of ISO 9001 systems in your company. Additionally, individuals can also become certified as lead auditors for ISO 9001

How Can Omnex Help in Implementing ISO 9001

Omnex has been a pioneer in providing Quality Management System (QMS) services to thousands of organizations worldwide. Along with the ISO 9001 implementation, we are well-equipped to support the development of integrated systems for Quality, Health and Safety (ISO 45001, and Environment Management (ISO 14001), Business Operating Systems frameworks, disciplined Problem Solving, and of course, value-based auditing techniques.

These techniques are used to create management system architecture to drive competitive advantage. Not all methodologies are mandatory, but depending on management’s interest we can play a major role in deploying these systems and methodologies to your organization.

Omnex has worked with companies from varied industries, including Automotive, Aerospace, Medical Devices, Transportation, Engineering, and software development. We have also assisted in contracting 3rd party technical employment and training.

Omnex has a strong track record of achieving zero non-conformities during certification audits. When collaborating with your teams, we can assure the success of your ISO 9001 implementation program.

Which Training Programs Does Omnex Offer for ISO 9001

Omnex conducts regular seminar and public training programs for ISO 9001. These programs can be conducted at your premise also. There are many training programs one can choose for ISO 9001. Some of the most sought-after programs are:

Do note that some of these programs are available as E-Learning modules as well. You may click the program and view the lectures online at your leisure.

We regularly conduct Consulting, Coaching, Training, and Auditing services for QMS, EMS, and OH&S at various client locations globally.

Certified ISO 9001 Lead Auditor Exemplar Certified

Omnex follows a worldwide recognized Training Provider and Examiner Certification Scheme (TPECS) for Lead Auditor training. Courses offered by Omnex comprise of three separate Exemplar Global Competency Units with the following objectives:

  • Exemplar Global-QM (Understanding the QMS requirements)
  • Exemplar Global-AU (Understanding the Auditing requirements)
  • Exemplar Global-TL (Understanding the Lead Auditing/Team Leader requirements)

FAQ

ISO 9001 is an internationally recognized standard for quality management systems. It provides a framework for organizations to establish, implement, and continually improve processes that ensure the consistent delivery of high-quality products and services.

ISO 9001 certification is not mandatory, but many organizations choose to pursue it to improve their quality management practices and meet customer requirements.

Omnex offers a range of services to assist organizations in achieving ISO 9001 certification. Our experts can provide guidance on implementing quality management systems, conducting internal audits, and preparing for certification audits.

Yes, ISO 9001 principles can be applied to various industries, including service providers, healthcare, education, and more. It focuses on enhancing processes and customer satisfaction, which are universal goals.

The timeframe for attaining ISO 9001 certification can differ based on the organization's size and complexity. Omnex can provide a customized timeline based on your specific needs and readiness.

ISO 9001 benefits organizations by improving efficiency, reducing errors, and enhancing customer satisfaction. It benefits customers by ensuring consistent quality and reliability.

ISO 9001 certification is widely accepted and recognized across various industries globally. It's often considered a benchmark for quality management systems.

ISO 9001 certification typically remains valid for three years, subject to successful surveillance audits.

To secure ISO 9001 certification, it is advisable to adhere to these general procedures:

  1. Engage a certification body,
  2. Conduct a gap analysis,
  3. Implement necessary changes,
  4. Undergo an initial certification audit,
  5. Maintain compliance, and
  6. Participate in surveillance audits.

The prerequisites for achieving certification as an ISO 9001 auditor usually encompass the successful completion of accredited auditor training programs, the accumulation of practical auditing experience, and the passing of a certification examination to validate competency.