ISO 9001:2015 Quality Management Systems

History and Background of ISO 9001:2015

ISO 9001 is an international standard that satisfies the Quality Management System (QMS) requirements. The ISO 9001 QMS standard is very popular among the ISO 9001 series of standards and is the first Quality Management certification standard. The ISO 9001 standard was first published in the year 1987 by International Organisation for Standardization committee, the ISO. This standard specifies the requirements for an effective QMS and deals with the fundamentals of QMS. This standard was based on the BS 5750 series of standards from BSI.

In the past, the ISO had three different sets of standards namely the ISO 9001, ISO 9002 and ISO 9003. However, the latter two standards requirements are addressed into one QMS standard – the ISO 9001.

“In 1987 the International Organization for Standardization (ISO) with members from 91 nations adopted the ISO 9000 series of standards. In 1994 the series was updated to an ANSI/ISO/ASQ standard and US companies could become certified to the standard.”

Sourced from - ISO 9001 Overview

Key requirements of ISO 9001:2015?

There are numerous reasons for the global adoption of this QMS standard. The standard is flexible and does not dictate companies to employ a certain set of specific standards. Rather, the objectives of the standard can be defined by the company that adopts the ISO 9001:2015.

The major requirements for a Quality Management System (QMS) are mentioned in ISO 9001.  ISO 9001 is mainly divided into 10 sections (Clauses) along with additional sub-clauses related to the Plan-Do-Check-Act system. However, only sections 4-10 contain requirements that are auditable clauses. It is important to satisfy the requirements within clauses 4-10 as well as in order to implement ISO9001:2015, they have to satisfy by meeting customer and applicable statutory and regulatory requirements.

Below are the lists of documents required for companies to become compliant to ISO 9001:2015:

  • Scope of QMS
  • Quality Management system and processes
  • Quality policy
  • Quality objectives
  • Process and sequence interaction matrix
  • Risk and Opportunity assessment
  • Criteria for evaluation and selection of suppliers
  • Documents / records / procedures / instructions master list

Sourced from - ISO 9001 Knowledge base

These are the mandatory records that must be kept (note that records indicated with * are only required in cases when the relevant clause is not excluded):

  • Monitoring and measuring equipment calibration records* (clause 7.1.5.1)
  • Records of training, skills, experience and qualifications (clause 7.2)
  • Product/service requirements review records (clause 8.2.3.2)
  • Record about design and development outputs review* (clause 8.3.2)
  • Records about design and development inputs* (clause 8.3.3)
  • Records of design and development controls* (clause 8.3.4)
  • Records of design and development outputs *(clause 8.3.5)
  • Design and development changes records* (clause 8.3.6)
  • Characteristics of product to be produced and service to be provided (clause 8.5.1)
  • Records about customer property (clause 8.5.3)
  • Production/service provision change control records (clause 8.5.6)
  • Record of conformity of product/service with acceptance criteria (clause 8.6)
  • Record of nonconforming outputs (clause 8.7.2)
  • Monitoring and measurement results (clause 9.1.1)
  • Internal audit program (clause 9.2)
  • Results of internal audits (clause 9.2)
  • Results of the management review (clause 9.3)
  • Results of corrective actions (clause 10.2)

There also certain non-mandatory documents that might be required while certifying to ISO 9001:2015 QMS standards.

What is New in ISO 9001:2015?

The International Organization for Standardization (ISO) regularly reviews all standards, ensuring they are up-to-date, and if they serve the organizational needs and requirements. The latest revision to the ISO 9001 QMS standard was made in the year 2015. Before this, the standard was amended three times in 1994, 2000 and in 2008. The latest version included a new era of QMS that suggested “risk-based thinking” instead of the earlier “preventive actions”.

Major Change includes:

  • Adapting the Annex L -High Level Structure
  • More focus on Process Approach
  • Risk-based thinking is at the core of ISO 9001:2015
  • Focusing the leadership of your organization on customers
  • Documented Information-New terminology

The primary focus was to improve the performance of the business and streamline the documentation.ISO 9001:2015 standard is based on the seven quality management principles as follows:

  1. Customer-centric
  2. Leadership
  3. People Engagement
  4. Process Approach
  5. Through Improvement
  6. Making decisions based on evidence
  7. Relationship Management

Benefits associated with ISO 9001:2015:

The predominant benefit of the ISO 9001 QMS standard is that this standard helps organizations ensure their customers receive products and services of high/ supreme quality. It is a strategic decision to adopt this quality management system, which helps the organization to improve its overall performance and provides a solid foundation for long term development plans. Implementing ISO 9001 can save expenses, can greatly improve the process, can organize QMS efficiently and can satisfy the users. Many industries adopt the ISO 9001 QMS standard in order to become an approved supplier. To be recognized as a company means to be certified to ISO 9001 Quality Management Standard

How to Implement ISO 9001:2015:

The ISO 9001:2015 standard can be implemented by any company, regardless of its type, size, industry, regardless of the product and services it offers. You can utilize ISO 9001:2015 checklists or guidelines that help you with the steps and procedures to be followed for implementing the standard. Below is a quick 10 point checklist to help your company comply to ISO 9001:2015 QMS standards.

  1. Determine the need for implementing ISO 9001:2015 QMS standard
  2. Buy a copy of the standard
  3. Define your Strategy
  4. Plan your resources
  5. Identify your process
  6. Training requirement
  7. Documentation
  8. Implementing the standard
  9. Review and Audit

How Omnex can help with ISO 9001:2015

Omnex has been a pioneer in providing Quality Management System (QMS) services to non-manufacturing and service organizations internationally. Omnex led in developing integrated IATF 16949:2016, Advance Quality Planning, Quality/Business Operating Systems, disciplined problem solving and other advanced techniques and methodologies that are adapted to the unique needs of service providers and to create management system architecture to drive competitive advantage.

Omnex has played a major role in deploying these systems and methodologies in such varied industries as surface, air and oceangoing transportation; engineering, testing and software development; contract technical employment and training; advertising, marketing and sales/distribution, and construction.

Click here to see how Omnex can assist with Implementation Support and/or Assessments.

How to get ISO 9001:2015 certified

Getting certified to ISO 9001:2015 implies that your organisation is credible and that you value your service and also showcases that your products and services meet the expectations of the customers.

A few points to keep in mind:

  • Cost/ expenses for registrar to get ISO 9001:2015 certification
  • Conformance levels i.e. meeting the requirements of the ISO 9001:2015 standard
  • Resource allocation for development and implementation for the ISO 9001:2015 standard

ISO 9001:2015 certifications can be issued only to companies and not for individuals. However, individuals can get qualified as ISO 9001:2015 auditors that include internal and lead auditors.

  1. QMS process – The primary step in getting certified to ISO 9001:2015 is to create and implement a Quality Management System (QMS) in accordance to the latest ISO 9001 standard requirements
  2. Auditing – The next step is to have your audits assessed by a certified body or a registrar in order to determine the performance of your QMS as per the requirements of the 9001 standard.
  3. Certification – The final step is receiving the certification; after which your organisation will have to be re-certified after a period of 3 years to make sure your organisation is meeting the latest QMS requirements.

Omnex Certificate Accreditation – Exemplar Global QM, AU & TL/ Omnex

Omnex follows Exemplar Global, a worldwide recognised “Training Provider and Examiner Certification Scheme (TPECS)”, and depending on the courses and examination you have chosen to become qualified. The courses offered by Omnex comprises 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)

Omnex Methodology

Omnex specializes in Quality Management Systems methodologies such as ISO 9001, IATF 16949, QOS/BOS, APQP (new product development), SPC, MSA, and Management of Continuous Improvement. Additionally, Omnex provides extensive services in Environmental Management Systems (EMS) ISO 14001 and Safety Management Systems ISO 45001. Omnex consultants have been involved in the development and implementation of Quality, Environmental, and Safety Management Systems and methodologies at over 500 client sites. Omnex has bench marked credentials in achieving zero non-conformity certification to the standard sought.

Omnex is an Exemplar Global Certified TPECS provider for Exemplar Global QM, AU and TL Competency Units. Our seminar leaders have conducted implementation & Coaching, Training & Competency development and Auditing in QMS, EMS and OH&S at various client locations globally.

Trainings offered by Omnex

Click here to know how Omnex can help you with Implementation and Coaching support for ISO 9001.

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Integrated Management Systems

Integrated Management Systems (IMS) is the integration of QMS (Quality Management System), EMS (Environment Management System), OH&S (Occupational Health and Safety), ISMS (Information Security Management System), Social Responsibility and other regulations / standards and requirements into a single management system.

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