ISO 9001 & Quality News
The first of the ISO 9001:2015 Standard's introdution discusses implementing the standard and its benefits:
0.2 Quality Mangement Principles
This section of the ISO 9001:2015 standard discusses the principles behind Quality Management
It covers:
It covers:
- customer focus
- engagement of people
- leadership
- improvement
- process approach
- relationship management
- evidence-based decision making
0.3 The Process Approach
The ISO 9001:2015 standard does not deviate from the previous standard in its promotion of the process approach.
0.3.1 General
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.
0.3.2 PDA Cycle
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.
The PDCA cycle should be applied to all processes in your Quality Management System.
0.3.3 Risk Based Thinking
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.
0.4 Relationship with other standards
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.
In Annex A, the standard's structural changes are defined.
1. Scope
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:
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
2.0 Normative references
The Normative references in the ISO 9001:2015 standard simply states that the clauses contained and referenced are actually within the standard
3.0 Terms and defnitions
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.
Please review our "Glossary of Terms" to find these definitions that are consistent with the standard.
4.0 Context of the organization
This section of the ISO 9001:2015 Standard is new from the previous ISO 9001:2008 standard.
4.1 Understanding the organization and its context
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."
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."
4.2 Undarstanding the needs and expectations of interested parties
Interested parties in the ISO 9001:2015 standard are those that are affected by the Quality Management System.
4.3 Determining the scope of 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.
4.4 Quality managment system and its processes
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.
4.4.1 QMS requirement
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.
4.4.2 Maintained documentation
This ISO 9001:2015 clause states that documented information must be maintained and retained if the information is relevenat to the organization's QMS.
5.0 Leadership
Leadership is essential in any organization.
5.1 Leadership and commitment
Leadership without commitment are clouds without rain.
This section of the ISO 9001:2015 standard includes 5.1.1 - 5.1.2
This section of the ISO 9001:2015 standard includes 5.1.1 - 5.1.2
5.1.1 General
This clause of the ISO 9001:2015 standard define how leadership is demonstrated
5.1.2 Customer focus
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.
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.
5.2 Policy
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).
Developing a quality policy within the scope of the QMS
Generally how this policy is communicated to all relevant parties (internally and externally).
5.2.1 Developing the quality policy
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
5.2.2 Communicating the quality policy
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
5.3 Organizational roles, responsibilities and authorities
The ISO 9001:2015 standard states that management must assign roles, responsibilities and authority to:
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.
- 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.
6.0 Planning
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.
6.1 Actions to address risks and opportunities
This section in the ISO 9001:2015 may have the biggest impact on an organization's Quality Management System.
6.1.1 Consider risks and opportunities during planning
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
6.1.2 What the organization must do about risks and opportunities
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
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
- adopting new practices
- developing new products or new markets
- building partnerships
- using new or different techologies
6.2.2 Quality objectives achievement plan
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
6.3 Planning of Changes
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
7 Support
This section covers Resources, Awareness, Communication, and Documented Information
7.1 Resources
The resources section of the Support requirement cover, people, infrastructure, environment for the processes, monitoring, measuring, tracing, and organizational knowledge.
7.1.1 General
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
7.1.2 People
The organization needs to provide all the personnel need to design, implement and maintain the QMS and the relevant processes.
7.1.3 Infrastructure
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)
7.1.4 Environment for the operation of processes
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
7.1.5 Monitoring and measuring resources
This clause has sub-clauses about General (overall goals & requirements) and Measurement Traceability (specific requirements).
7.1.5.1 General
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.
The clause also requires that documents are kept (retained information) about the methods and types of monitoring.
7.1.5.2 Measurement traceability
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.
Also, the organization must show how the measuring device is "fixed" if it is shown to be faulty.
7.1.6 Organizational knowledge
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
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
7.2 Competence
In terms of Competence, the ISO 9001 standard requires four actions:
- define what is competence for those under the Quality Management System umbrella
- provide mechanisms to improve or maintain competence through training, education or from experience
- evaluate the employee's retention and measure their competence
- maintain retained information regarding the employee's competence
7.3 Awareness
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)
7.4 Communication
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.
The policy should define what, when, how and with whome it is communicated.
7.5 Documented Information
Similar to the old standard, the new ISO 9001 standard requires that an organization keep records of their Quality Management System.
7.5.1 General (Documented Information)
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.
7.5.2 Creating and Updating
In your documentation, be sure to include
NOTE: the Ingentius portal supports all of the requirements for documented information.
- Date/Time
- Author
- Title
- Reference Number
- Approval & Review designations
NOTE: the Ingentius portal supports all of the requirements for documented information.
7.5.3 Control of documented information
Be sure you control the creation, use and revisions of the documented information in your ISO 9001 Quality Management System.
7.5.3.1 Documented information control
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)
8 Operation
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
8.1 Operational planning and control
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).
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).
More Articles...
- 8.2 Requirements for products and services
- 8.2.1 Customer communication
- 8.2.2 Determining the requirements related to products and services
- 8.2.3 Review of requirements related to products and services
- 8.2.3.1 Requirement review
- 8.2.3.2 Retain documented information
- 8.2.4 Changes to requirements for products and services
- 8.3 Design and development of product and services
- 8.3.1 General
- 8.3.2 Design and Development Planning
- 8.3.3 Design and Development Inputs
- 8.3.4 Design and Development Controls
- 8.3.5 Design and Development Outputs
- 8.3.6 Design and Develoment Changes