This section of the ISO 9001:2015 standard discusses the principles behind Quality Management

It covers:

• customer focus
• engagement of people
• leadership
• improvement
• process approach
• relationship management
• evidence-based decision making

The ISO 9001:2015 standard does not deviate from the previous standard in its promotion of the process approach.

In general the Process Approach enables an organization to

• understanding and consistently meeting requirements;
• consideration of processes in terms of added value;
• the achievement of effective process performance;
• improvement of processes based on evaluation of data and information.

The Plan-Do-Check-Act cycle remains an important part of the ISO 9001:2015 standard

The PDCA cycle should be applied to all processes in your Quality Management System.

Risk is the effect of unknowns and uncertainty on an expected result.  This concept is expanded upon in the ISO 9001:2015 standard.  It becomes more explicit and becomes an integral component of every aspect of the QMS.

In the new ISO 9001:2015 standard the overall structure was changed to make it easier to implement other ISO standards within the organization.

In Annex A, the standard's structural changes are defined.

The Quality Management System Requirements for the ISO 9001:2015 are defined starting with sections 1.0 - The Scope

The scope or purpose of the QMS is for organizations that:

• must show others in its market their ability to deliver a product or service that meets a customer's or regulatory agency's requirements
• has a goal to continually improve their performance using a systematic approach

The Normative references in the ISO 9001:2015 standard simply states that the clauses contained and referenced are actually within the standard

This section (i.e. 3.1 to 3.69) specifically defines terms or words used within the ISO 9001:2015 standard.

Please review our "Glossary of Terms" to find these definitions that are consistent with the standard.

This section of the ISO 9001:2015 Standard is new from the previous ISO 9001:2008 standard.

This clause of the ISO 9001:2015 standard describes the internal versus external issues 

The definition of the "organization context" is: a combination of internal and external factors and conditions that have an effect on an organization's approach to its products, services and interested Parties".

The concept of Context of Organization also applies to Not for profit organization, public service organization and governmental organization.  Typically this is called "business environment," "organizational environment" or the "ecosystem of an organization."

Interested parties in the ISO 9001:2015 standard are those that are affected by the Quality Management System.

This clause in the ISO 9001:2015 is very important for every organization.  Within your QMS you need to define what is included and what is not.  Based on the scope you define, your QMS determines what processes and procedures are affected and fall within the bounds of the system.

The clauses 4.4.1 and 4.4.2 define what to include in your Quality Management System's handling of processes and how they are to be documented.

This clause of the ISO 9001:2015 simply requires that a QMS be used.  It goes on to itemize its components and processes that are needed.

This ISO 9001:2015 clause states that documented information must be maintained and retained if the information is relevenat to the organization's QMS.

Leadership is essential in any organization.

Leadership without commitment are clouds without rain.

This section of the ISO 9001:2015 standard includes 5.1.1 - 5.1.2

This clause of the ISO 9001:2015 standard define how leadership is demonstrated

This ISO 9001:2015 clause requires that management must meet customer and regulatory requiements; and management understands these requirements. 

It also risks and opportunities are recognized in relation to the QMS.

This clause also requires that management understands how their QMS has a focus on continually improving customer satisfaction.

This section of the ISO 9001:2015 Standard includes 5.2.1 to 5.2.3

Developing a quality policy within the scope of the QMS
Generally how this policy is communicated to all relevant parties (internally and externally).

The 5.2.1 clause of the ISO 9001:2015 standard must have these factors:

• it must be consistent with the purpose of the organization
• it must correspond to the context of the organization
• it must be used as the basis (i.e. framework) when setting the quality goals
• it must include management's commitment to meet requirements
• management must be committed to continually improve the QMS
• it must be relevant to interested parties

When the quality policy is documented in the ISO 9001:2015 standard, it must:

• be readable and available as documented information by those affected by the QMS
• it must be maintained as a document with all the controls necessary
• it must be understood and applied by members / employees

The ISO 9001:2015 standard states that management must assign roles, responsibilities and authority to:

• adhere the QMS to the standard
• ensure all outputs from relevant processes meet their intended purpose
• report QMS performance and areas for improvement to top management
• keep a customer focus throughout the organization
• keep control processes in place that maintain the Quality Management System's integrity

Note - a main change from the ISO 9001:2008 standard is no specific management representative.  This means the responsibilities can be broken up between multiple people.  This should help if people change or leave the organization.

Section 6. of the ISO 9001:2015 standard discusses planning.  Planning includes addressing Risk; how planning is addressed in the QMS and how to handle changes.

This section in the ISO 9001:2015 may have the biggest impact on an organization's Quality Management System.

Shall consider issues from the context of the organization and interested parties and determine risks and opportunities that need to be addressed to:

• Ensure the QMS can achieve intended results
• Enhance desirable effects
• Prevent or reduce undesired effects
• Achieve improvement

Remove the requirment for preventative action - but most organizations have addressed this in their continual improvement processes.

In the ISO 9001:2015 standard, the organization must take actions to address risks and opportunities

And it must document how the actions are integrated and implemented in the QMS; then evaluate their effectiveness.

The QMS must also show that the actions taken are proportionate to potential impact on the quality of the delivered product or service.

These actions can include

• risk avoidance
• risk taking to improve quality
• addressing the source of the risk
• decreasing the probility of the risk occuring
• shaing the risk
• conscious risk taking through a decision making process

By persuing opportunities, the organization could

• adopting new practices
• developing new products or new markets
• building partnerships
• using new or different techologies

The ISO 9001:2015 standard requires that organizations describe how their quality objectives are achieved.

• what will be done to achieve the objectives
• define the resources required
• document who will be responsible and what authority they have
• define how the objective is achieved (i.e. when it is completed)
• how the effectiveness is determined and evaluated

Over time the Quality Management System needs revision.  The modifications must follow the requirements stated in clause 4.4 (i.e. Quality managment system and its processes).  The changes must take into account:

• consider why you are making the change (purpose) and understand the risks
• be sure the changes do not change the fundamental purpose of the QMS
• do you have the time, money, and personnel available for the change
• review how this affects responsibilities and authorities

This section covers Resources, Awareness, Communication, and Documented Information

The resources section of the Support requirement cover, people, infrastructure, environment for the processes, monitoring, measuring, tracing, and organizational knowledge.

The catch all is that an organization must provide the resources for the care and feeding of you Quality Management System.  It must consider

• the organization's capabilities, limitations, and internal resources
• determine what the organization needs from external providers

The organization needs to provide all the personnel need to design, implement and maintain the QMS and the relevant processes.

It is imparative that the organization has the facilities and capabilities to conform to the ISO requirements including (for instance):

• buildings and utilities
• hardware, software, networks and equipment
• transportation
• communication resources (i.e. like the Ingentius Conformance Portal)

The overall environment must be implemented and maintained to conform to the standard and to achieve the desired quality of products and services.  This environment consists of both human and physical aspects:

• social environment
• mental environment for the employees
• physical environment

This clause has sub-clauses about General (overall goals & requirements) and Measurement Traceability (specific requirements).

This clause requires that an organization has the resources needed to monitor the products and services in regards to their conformance to the standard.  Further, it states the obvious that the resources to monitor are appropriate and are kept current and working.

The clause also requires that documents are kept (retained information) about the methods and types of monitoring.

When an organization measures a process, product or service using a defined piece of equipment, tool or device, it must be calibrated to operate and measure correctly.  The organization must document how the devices are maintained and how the status is obtained.

Also, the organization must show how the measuring device is "fixed" if it is shown to be faulty.

What is Organizational Knowledge?
This is the "brain trust" of the organization from the line worker to the executive board, it spans the entire organization.  Knowledge does not exist as data points or information in a vacuum.  It is the humans acting upon information and experiences then applying it to produce better product or provide improved service.

The ISO 9001:2015 standard acknowledges the necessity of organization knowledge by requiring the organization to

• maintain a form of knowledge base and provide access to it
• determine what is there and what is lacking (a kind of Gap for the knowledge base)
• provide a mechanism to update the knowledge base

In terms of Competence, the ISO 9001 standard requires four actions:

1. define what is competence for those under the Quality Management System umbrella
2. provide mechanisms to improve or maintain competence through training, education or from experience
3. evaluate the employee's retention and measure their competence
4. maintain retained information regarding the employee's competence

On an organization-wide basis, required competence levels can also be met through employment policies, reassighment and mentoring.

The awareness clause of the ISO 9001 standard requires that employees know about:

• the organization's quality policy
• the goals and objectives of the quality initiative
• how employees contribute to quality and the benefits that are derived
• what happens if the organization does not meet the goals (risk based)

Generally, the communication clause of the ISO 9001 standard is to tell everybody about the Quality Management System.

The policy should define what, when, how and with whome it is communicated.

Similar to the old standard, the new ISO 9001 standard requires that an organization keep records of their Quality Management System.

This ISO 9001 clause states the obvious - an organization must document those items that are required by the standard and anything else the organization deems necessary to manage, maintain and deploy their Quality Management System.

In your documentation, be sure to include

• Date/Time
• Author
• Title
• Reference Number
• Approval & Review designations

Also make sure you detail how, what and where the documented information is kept.

NOTE: the Ingentius portal supports all of the requirements for documented information.

Be sure you control the creation, use and revisions of the documented information in your ISO 9001 Quality Management System.

The ISO 9001 standard requires that an organization controls the documented information is

• available for use when and where it is intended
• suitable for its intend use
• protected (another risk based issue)

The largest section in the ISO 9001 standard, the Operation section covers many aspects and requirements:

• 8.1 Planning & Control,
• 8.2 Requirements for Products & Services,
• 8.3 Design & Development,
• 8.4 Externally Provided Products & Services,
• 8.5 Production & Service Provisioning,
• 8.6 Product & Service Release
• 8.7 Controlling Non-Conforming Outputs

This ISO 9001 requirement requires the organization to plan and control their operation using clause 4.4 as a guide, to conform to their stated standard using clause 6.

The organization must determine the requirements for their products and services and develop quality criteria.  It must document the resources (internal and external) needed and control the process used in the manufacture or delivery of the products and services.

Also, the organization must be able to show how the quality of a product or service corresponds to the requirements including the planning stage and the effect of risk (i.e. unintended changes).