ISO 9001: Quality Management System

Study Notes

ISO 9001 is an internationally recognized standard for quality management systems.
It is part of the ISO 9000 family of standards, covering a range of quality assurance topics.
ISO 9001:2015 helps companies gain recognition for their quality management and demonstrate it to their customers.
The standard is applicable to any type of industry and organization of all sizes.
It assists in providing consistent products and services, leading to customer satisfaction, regulatory compliance, and continual improvement.

The history of ISO 9001 can be traced back to the 1950s with US and UK government departments establishing standards for military procurement.
The defence industry adopted mutual recognition of NATO AQAP, MIL-Q, and Def Stan standards.
BS5750, the first specific 'quality management system' standard, was published in 1979.
The ISO 9001 standard was developed by the International Standards Organisation (ISO) to extend the reach of quality management to an international audience.
The standard was first published in 1987 and has been reviewed and updated every 5-8 years to ensure relevance to global business.

The ISO 9000 series comprises of three standards:
- ISO 9000:2015: Quality management systems – Fundamentals and vocabulary
- ISO 9001:2015: Quality Management Systems – Requirements
- ISO 9004:2018: Quality Management Systems – Managing for the sustained success of an organisation (continuous improvement)

The PDCA cycle is a project management framework for implementing incremental change.
The cycle consists of four steps: plan, do, check, and act.
It is designed to help teams make small, incremental changes and test each step's success or failure before moving onto another one.
The PDCA cycle is a continuous improvement approach, allowing teams to achieve large-scale transformations over time.
Any department in a business can use the PDCA cycle for any incremental change, such as changes to a company's business process, product, or team culture.

An example of using the PDCA cycle is A/B split testing in marketing campaigns.
In the "Plan" stage, a team identifies a challenge or opportunity and decides to change a single element of the campaign.
The team then runs both versions simultaneously to test the change and evaluates the results.
The PDCA cycle allows teams to make incremental changes and test their success or failure before moving onto another one.

Implementing a Quality Management System (QMS) is a strategic decision influenced by the context of the organization.
The "context of the organization" is a new clause of ISO 9001, requiring organizations to consider internal and external issues that can impact strategic objectives and QMS planning.

There is no prescribed method of determining the context, but a simple four-step approach can be taken:
- Identify internal issues that can affect products, services, investments, and interested parties.
- Identify external issues that can affect products, services, investments, and interested parties.
- Identify interested parties and their requirements.
- Regularly review and monitor identified internal and external issues and interested parties.

Internal context includes the environment in which the organization aims to achieve its objectives.
Internal issues can include:
- Regulatory requirements
- Strategies to conform to policies and achieve objectives
- Relationships with staff, stakeholders, partners, and suppliers
- Resources and knowledge (e.g., capital, people, processes, and technologies)
- Risk appetite
- Assets
- Products or services
- Standards, guidelines, and models adopted by the organization
- Information systems

External context includes the social, technological, environmental, ethical, political, legal, and economic environment.
External issues can include:
- Government regulations and changes in the law
- Economic shifts in the market
- Competition
- Events that may affect corporate image
- Changes in technology

Regular reviews and monitoring of identified internal and external issues are necessary.
A PEST (political, economic, social, and technological) analysis can be used to determine factors that affect operations.
PEST factors can be classified as 'risks' and 'opportunities' in a SWOT analysis.

Interested parties include customers, partners, employees, and suppliers.
When developing a QMS, only interested parties that can affect:
- Ability to consistently provide a product or service that meets customers' needs and statutory requirements
- Continual improvement process
- Ability to enhance customer satisfaction
- Process for ensuring conformance to customers' requirements and regulations
Organizations need to identify stakeholders or interested parties relevant to their operations, including customers, suppliers, employees, regulatory bodies, shareholders, and the community.