ISO 9001

About ISO 9001

This document has been prepared by the Quality Management System Committee of the International Organization for Standardization (ISO) in collaboration with Technical Committee ISO/TC 176, Conformity assessment. It represents a worldwide consensus of experts on good-quality management system requirements. 

The criteria are considered suitable for use by businesses who need to demonstrate their capability to consistently deliver product and service that meets customer and applicable statutory and regulatory requirements in order to improve client satisfaction through the effective application of the system, including processes for continual improvement of the system and assurance of conformity to customer and applicable statutory and regulatory requirements.

ISO 9001:2015 is the result of a collaboration between ISO and the International Electrotechnical Commission (IEC). It is published simultaneously by ISO and IEC, representing a worldwide consensus among experts on acceptable system requirements that can be adopted by any business, regardless of its line or size.

However, many organizations work with an extended scope than just “product". It actually deals with the aspect of ‘service’. For example, a product-oriented organization would be one that deals in manufacturing services, etc.

ISO 9001:2015 is applicable to any organization, whatever its field of activity and whether it carries out manufacture, assembly, or other operations, including service providers. It can be used by all types and sizes of organizations and for all quality management system aspects or applications within an organization. 

The requirements in ISO 9001:2015

ISO 9001:2015 defines the requirements needed to assist organizations in focusing on process performance and providing products and services that consistently meet customer requirements, helping organizations to improve their performance, efficiency, and competitive edge in the marketplace while achieving continual improvement of its processes. The requirements are based on common sense principles that guide businesses dealing with product and service provision.

ISO 9001 is one of the most popular management standards, but it can be too generic for certain industries like medical devices and pharmaceuticals. So there are also other versions like ISO 13485 for medical devices and ISO 14971 for medical devices and in vitro diagnostic medical devices.

ISO 9001:2015 sets out the criteria for a quality management system and can be used by any organization, whatever it’s a field of activity, and whether it is in the private or public sector. It is applicable to all types and sizes of organizations and is suitable for use worldwide.

PDCA Approach in ISO 9001 

A quality management system based on the PDCA cycle helps an organization to plan, do, check and act. The concept of PDCA (Plan-Do-Check-Act) has been used for more than half a century by numerous organizations throughout the world as part of their improvement strategy.

Plan: The organization’s mission, vision and goals are translated into a quality management system with processes that define how the organization will achieve its objectives.

Do: The actions defined in the plan are carried out as planned.

Check: The results of carrying out those actions are measured, analyzed and recorded to reveal whether requirements have been fulfilled. If not, further action is required.

Act: The results of checking are used to determine whether corrective or preventive actions need to be taken.

The PDCA approach focuses on achieving continual improvement using a structured method for carrying out work, analyzing processes, and taking action in order to achieve expected outcomes. A quality management system based on the PDCA cycle integrates all organizational systems so that they also support continuous improvement, and helps to achieve the organization’s strategic goals.

Standard does not prescribe how to design or operate a quality management system; it is up to each organization to determine for itself which factors are important. ISO 9001 describes processes required for an effective quality management system, including the management of resources (people, information, and financial), business planning and operational planning (including goals and plans), performance monitoring, and improvement.

ISO 9001:2015 contains:

– a generic structure that may be applied to all organizations; it represents the consensus of these different sectors on what is needed to improve processes;

– 46 requirements for an effective quality management system, including 13 that were carried forward unchanged from ISO 9001:2008;

– a detailed list of essential processes that, in order to achieve compliance with the standard, must be established and performed in a documented manner. These are called management processes ;

– basic concepts upon which improvements in an organization’s performance can be achieved;

– definitions of key terms used in the standard.

Not Applicalabilty in ISO 9001 

-ISO 9001 does not state that all processes must be documented; the requirement for documentation is linked to those process activities essential to the achievement of customer satisfaction (e.g. defining customers, their requirements, and ensuring these are met).

1) ISO 9001:2015 specifies two types of management processes:

-management processes which are required to be documented in a systematic way to provide sufficient information for repeatability and consistency of performance;

-management processes that are not required to be documented as they provide information for, or inputs to, other management processes.

2) A quality plan must address all the requirements of ISO 9001:2015 and may include any processing activity that supports the achievement of product or service conformity. All the requirements in ISO 9001:2015 must be implemented and documented, though not necessarily by means of a quality plan.

3) A management system may include elements that are not processed according to ISO 9001:2015, for example, documentation standards; this does not contradict the requirement that only management processes are to be included in a management system.

4) Quality plans and procedures are not required for all processes, but only for the management processes that must be documented under ISO 9001:2015. The absence of documents does not necessarily mean that no quality planning takes place; this would need to be determined by other evidence such as past experience or customer feedback.

5) ISO 9001:2015 does not require a quality manual or any other document to include all the requirements of the standard. A documented procedure may be used as an alternative to a management process if it provides sufficient information for repeatability and consistency of performance. Documents that are only used by one person do not need to be documented as this would be a duplication of effort.

6) ISO 9001:2015 does not require work instructions for all processes, but only for those management processes that must be documented under the standard. However, if an organization chooses to document some management processes in the form of work instructions, then these need to meet the relevant requirements in ISO 9001:2015.

7) ISO 9001:2015 does not require the standardization of all processes – only those management processes that need to be documented under the standard. The use of a similar terminology does not equate to a process being standardized.

8) ISO 9001:2015 does not require conditions, constraints or limitations of a product or service to be quantified or known before the product or service is provided.

9) ISO 9001:2015 does not state that customers must be satisfied with all products and services provided; this would need to be determined by the organization through customer feedback.

10) ISO 9001:2015 does not state that quality planning must provide sufficient information for repeatability and consistency of performance; this would need to be determined by the organization’s top management.

11) ISO 9001:2015 does not state that all processes must be documented in some way, even though it is recommended.

12) ISO 9001:2015 does not require all internal and external interfaces to be included in quality planning. It requires only those internal and external interfaces that are controlled to be included in quality planning. Consequently, documentation of these interfaces need not necessarily exist as this would be a duplication of effort

13) ISO 9001:2015 does not state that all changes to or developments of processes should be described in the quality plan; this would need to be determined by the organization’s

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