ISO 9001:2015
Quality Management System

What is ISO 9001

The adoption of a quality management system is a strategic move for a business that can enhance performance overall and serve as a solid foundation for efforts aimed at sustainable development.

HISTORY OF ISO 9001:2015

In 1987, the International Organization for Standardization (ISO) issued the first version of ISO 9001. ISO is an international organization made up of the national standards bodies of more than 160 countries. ISO 9001:2015 is the most recent version, having been published in September 2015.

  • The design and development control clause and other provisions were revised in ISO 9001:1994 to increase control and give more clarity. ISO 9002 and 9003 had their functions somewhat altered in the 1994 series as well. The first of these updates was made in 1994 when the ISO set out to shift the original standard’s emphasis from final product inspection to quality management systems (QMS) that monitored and checked products at every stage of the creation process. The emphasis of this shift shifted from fixing problems to ensuring quality through preventative measures. In essence, QMS shifted from a “cure” to a “prevention” mode of operation.
  • ISO 9001 was revised again in the year 2000. During this period, efforts were made to streamline processes and documentation in order to relieve businesses of the burden of quality control measures if they weren’t involved in developing brand-new items. One of the goals of this update was to get more of the company’s higher management involved in quality assurance efforts so that they could permeate the entire organization and serve as a unifying thread. The end result of these changes was an increase in efficiency through the application of process performance measures, where the measurement and tracking of customer satisfaction took center stage.
  • Issues that arose in practice during the implementation of ISO 9001:2000 were intended targets for the modification that resulted in ISO 9001:2008. Without adding any new criteria, this period in ISO 9001’s evolution saw the introduction of clearer clarifications to existing standards.

The latest version of 9001:2015

The Intent of ISO 9001:2015

An effective quality management system will allow you to:

ISO 9001 Structure (QMS)


Know all about ISO 9001

  • Quality – A quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
  • Accordance – If a business is in accordance with ISO 9001, that means that it has adequately or sufficiently conformed to ISO 9001 standards and requirements.
  • Certification – Gaining certification means that the organization has demonstrated that its QMS is in line with ISO 9001 standards.
  • Competence – Competence describes a company that’s able to meet an ISO 9001 requirement through its QMS or other processes.
  • Compliance – Similar to competence, compliance describes an organization that has successfully fulfilled a requirement for ISO 9001. Also known as conformity.

Documentation for ISO 9001 (QMS)

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If you want to meet the requirements of ISO 9001:2015, below are the forms you need to fill out. (Some of the paperwork will not be required if the company doesn’t carry out the procedures)

  • QMS Scope and Objectives
  • Insisting on a high standard of quality
  • Goals related to quality
  • Supplier evaluation and selection criteria
  • Recordings of all calibrations performed on instruments used for monitoring and measuring
  • Documentation of education, expertise, and credentials
  • Documentation of product and service requirements reviews
  • Review Documentation for Design and Development Outputs
  • The documentation of design and development sources
  • Design and development control documentation
  • Documentation of completed designs and prototypes
  • Keeping track of revisions made during the design and development process
  • Specifics on the goods and services to be manufactured and offered
  • Information pertaining to purchased goods
  • Documentation of Controlled Changes in Production/Provided Services
  • Documentation showing that a product or service meets established standards
  • Log of discarded products
  • Observational and Quantitative Findings
  • In-house Auditing Procedures
  • The findings of in-house audits
  • Findings from the management audit
  • Outcomes after implementing changes

ISO 9001:2015 Standard in PDCA Cycle/Process

Benefits of ISO 9001

Relevant Industries For ISO 9001

There are no constraints on implementing ISO 9001:2015 because it can be implemented in any industry, regardless of size. For example, the food and beverage business, the oil and gas industry, the hospitality industry, the public sector, the medical device industry, the defense industry, etc.

When it comes to providing the quality goods and services, no business or organization can afford to cut corners. It is a well-known truth that any business serious about succeeding in the market will choose ISO 9001:2015, the mother standard.

Industries That Benefit from Having ISO 9001-Certified Organizations

Who should get ISO 9001 certification, and why? Puts it plainly: becoming an ISO-certified company benefits businesses of all sizes and in all fields. However, the benefits of ISO conformity vary widely depending on the target audience. Having ISO 9001 certification helps immensely in the following industries:

Changes ISO 9001 brings in the Industrial Development in FUTURE

All ISO standards are reviewed every five years to make sure they are still current and relevant in the marketplace. That is why ISO 9001 is currently under review–at the Committee Draft stage–and an updated version is due towards the end of 2015. The Committee Draft stage is the first consultation in the development of an ISO standard, where members who have taken part in the revision will form a national position on the draft and comment on it.

Certified organizations should talk to their client managers to keep up-to-date on the proposed changes. The revised ISO 9001:2015 is much smoother,

More emphasis on leadership
ISO 9001’s coverage now further extends to senior management’s understanding of its business environment (including social, cultural, and regulatory) and its internal strengths and weaknesses. This results in the Quality Management System becoming more integrated into operational processes, quality policy, and objectives fully aligned with corporate strategy, and top management more involved in ISO 9001.

New focus on risk management
The 2015 version of the standard introduces an additional clause on risk management (clause 6.1 “Actions to address risks and opportunities”) which builds upon the ISO 9001:2008 section on preventive action. The combination of risk-based thinking and process approach refocuses the standard on performance and results, and the Plan Do Check Act cycle is employed at all strata in the organization.

Clarifications on objectives, measurement, and change
The requirements regarding quality objectives, measurement, and change are more detailed. However, this mainly involves clarifications of requirements in the 2008 version rather than new requirements.

More emphasis on communication and awareness
The two additional clauses (7.3 “Awareness” and 7.4 “Communication”) place further emphasis on these two areas.

Fewer prescriptive requirements
The new standard is less prescriptive than its predecessor and focuses more on performance and results. There are fewer explicit documentation requirements than in all previous versions, and even “quality procedures” and a “quality manual” are not even mentioned. However, the standard contains many implicit documentation requirements, which, for all practical matters, means that procedures covering most or all ISO 9001:2015 requirements should be established. Further, a so-called “Management Representative” is no longer required (though most companies will continue to assign a member of staff to fulfill this role).

New high-level structure
ISO 9001:2015 is based on Annex SL, the new high-level framework for all management systems standards, which will bring a common structure and common language to all standards. The advantage: it is now easier to integrate ISO 9001 with ISO 14001 and other ISO standards.

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