ISO 9001:2015 – Quality management systems

The ISO 9000 family addresses various aspects of quality management and contains some of ISO’s best known standards. The standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved.

ISO 9001:2015

ISO 9001:2015 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact, there are over one million companies and organizations in over 170 countries certified to ISO 9001.

This standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. These principles are explained in more detail in the pdf Quality Management Principles. Using ISO 9001:2015 helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits.

Get an overview of ISO 9001 in this PowerPoint presentation.

If you want to know more about the revision of ISO 9001:2015 see our revision page.

ISO 9001:2015 specifies requirements for a quality management system when an organization:

a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and

b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.

Sector-specific applications of ISO 9001

ISO has a range of standards for quality management systems that are based on ISO 9001 and adapted to specific sectors and industries. These include:

ISO 13485 – Medical devices
ISO 17582 – Electoral organizations at all levels of government
ISO 18091 – Local government
ISO/TS 22163 – Business management system requirements for rail organizations
ISO/TS 29001 – Petroleum, petrochemical and natural gas industries
ISO/IEC 90003 – Software engineering

 

ISO 14001:2015 – Environmental management systems

ISO 14000 family – Environmental management

The ISO 14000 family of standards provides practical tools for companies and organizations of all kinds looking to manage their environmental responsibilities.

ISO 14001:2015 and its supporting standards such as ISO 14006:2011 focus on environmental systems to achieve this. The other standards in the family focus on specific approaches such as audits, communications, labelling and life cycle analysis, as well as environmental challenges such as climate change.

The ISO 14000 family of standards are developed by ISO Technical Committee ISO/TC 207 and its various subcommittees. For a full list of published standards in the series see their standards catalogue .

ISO 14001:2015

ISO 14001:2015 specifies the requirements for an environmental management system that an organization can use to enhance its environmental performance. ISO 14001:2015 is intended for use by an organization seeking to manage its environmental responsibilities in a systematic manner that contributes to the environmental pillar of sustainability.

ISO 14001:2015 helps an organization achieve the intended outcomes of its environmental management system, which provide value for the environment, the organization itself and interested parties. Consistent with the organization’s environmental policy, the intended outcomes of an environmental management system include:

· enhancement of environmental performance;

· fulfilment of compliance obligations;

· achievement of environmental objectives.

ISO 14001:2015 is applicable to any organization, regardless of size, type and nature, and applies to the environmental aspects of its activities, products and services that the organization determines it can either control or influence considering a life cycle perspective. ISO 14001:2015 does not state specific environmental performance criteria.

ISO 14001:2015 can be used in whole or in part to systematically improve environmental management. Claims of conformity to ISO 14001:2015, however, are not acceptable unless all its requirements are incorporated into an organization’s environmental management system and fulfilled without exclusion.

Who should use the ISO 14001:2015 revision?

ISO 14001:2015 should be used by any organization that wishes to set up, improve, or maintain an environmental management system to conform with its established environmental policy and requirements. The requirements of the standard can be incorporated into any environmental management system, the extent to which is determined by several factors including the organization’s industry, environmental policy, products and service offerings, and location.

ISO 14001:2015 is relevant to all organizations, regardless of size, location, sector, or industry.

What topics does ISO 14001:2015 cover?

At the highest level, ISO 14001:2015 covers the following topics with regard to environmental management systems:

•     Context of the organization
•     Leadership
•     Planning
•     Support
•     Operation
•     Performance evaluation
•     Improvement

ISO 14001:2015 Revisions – 14001:2004 vs. 14001:2015

The 2015 revision of ISO 14001 introduces a number of changes from previous versions. A detailed explanation of the changes can be found in this ISO 14001 presentation (PDF), available in the online library of the ASQ Energy and Environmental Division. Thea Dunmire of the U.S. Technical Advisory Group to the committee working on the standard presented this update in 2014, discussing the expected impacts of the new revision’s requirements.

According to Dunmire, as part of the effort to structure all ISO standards in the same way, the revisions introduced in the 2015 version of ISO 14001 include incorporating a required high-level structure, using mandatory definitions, and incorporating common standards requirements and clauses.

Dunmire further identifies 10 major areas of impact of the 2015 revision:

    Expansion in EMS coverage and scope
    Required interactions with external parties
    New requirements for leadership engagement
    Expanded legal compliance requirements
    Need for risk-based planning and controls
    New documentation requirements
    Expanded operational control requirements
    Changes in competence and awareness requirements
    Impacts on the internal audit program
    Increased certification costs

ISO 45001:2018 – Occupational health and safety management systems

ISO 45001 – Occupational health and safety

Over 7 600 people die each day from work-related accidents or diseases – that’s over 2.78 million every year*.

The burden of occupational injuries and diseases is significant, both for employers and the wider economy, resulting in losses from early retirements, staff absence and rising insurance premiums.

To combat the problem, ISO has developed a new standard, ISO 45001, Occupational health and safety management systems – Requirements, that will help organizations reduce this burden by providing a framework to improve employee safety, reduce workplace risks and create better, safer working conditions, all over the world.

The standard was developed by a committee of occupational health and safety experts, and follows other generic management system approaches such as ISO 14001 and ISO 9001. It will take into account other International Standards in this area such as OHSAS 18001, the International Labour Organization’s ILO-OSH Guidelines, various national standards and the ILO’s international labour standards and conventions.

ISO 45001:2018

ISO 45001:2018 specifies requirements for an occupational health and safety (OH&S) management system, and gives guidance for its use, to enable organizations to provide safe and healthy workplaces by preventing work-related injury and ill health, as well as by proactively improving its OH&S performance.

ISO 45001:2018 is applicable to any organization that wishes to establish, implement and maintain an OH&S management system to improve occupational health and safety, eliminate hazards and minimize OH&S risks (including system deficiencies), take advantage of OH&S opportunities, and address OH&S management system nonconformities associated with its activities.

ISO 45001:2018 helps an organization to achieve the intended outcomes of its OH&S management system. Consistent with the organization’s OH&S policy, the intended outcomes of an OH&S management system include:

a) continual improvement of OH&S performance;

b) fulfilment of legal requirements and other requirements;

c) achievement of OH&S objectives.

ISO 45001:2018 is applicable to any organization regardless of its size, type and activities. It is applicable to the OH&S risks under the organization’s control, taking into account factors such as the context in which the organization operates and the needs and expectations of its workers and other interested parties.

ISO 45001:2018 does not state specific criteria for OH&S performance, nor is it prescriptive about the design of an OH&S management system.

ISO 45001:2018 enables an organization, through its OH&S management system, to integrate other aspects of health and safety, such as worker wellness/wellbeing.

ISO 45001:2018 does not address issues such as product safety, property damage or environmental impacts, beyond the risks to workers and other relevant interested parties.

ISO 45001:2018 can be used in whole or in part to systematically improve occupational health and safety management. However, claims of conformity to this document are not acceptable unless all its requirements are incorporated into an organization’s OH&S management system and fulfilled without exclusion.

ISO 22000:2018 – Food safety management systems

ISO 22000 family – Food safety management

The ISO 22000 family of International Standards addresses food safety management.

The consequences of unsafe food can be serious and ISO’s food safety management standards help organizations identify and control food safety hazards. As many of today’s food products repeatedly cross national boundaries, International Standards are needed to ensure the safety of the global food supply chain.

ISO 22000:2018

This document specifies requirements for a food safety management system (FSMS) to enable an organization that is directly or indirectly involved in the food chain:

a) to plan, implement, operate, maintain and update a FSMS providing products and services that are safe, in accordance with their intended use;

b) to demonstrate compliance with applicable statutory and regulatory food safety requirements;

c) to evaluate and assess mutually agreed customer food safety requirements and to demonstrate conformity with them;

d) to effectively communicate food safety issues to interested parties within the food chain;

e) to ensure that the organization conforms to its stated food safety policy;

f) to demonstrate conformity to relevant interested parties;

g) to seek certification or registration of its FSMS by an external organization, or make a self-assessment or self-declaration of conformity to this document.

All requirements of this document are generic and are intended to be applicable to all organizations in the food chain, regardless of size and complexity. Organizations that are directly or indirectly involved include, but are not limited to, feed producers, animal food producers, harvesters of wild plants and animals, farmers, producers of ingredients, food manufacturers, retailers, and organizations providing food services, catering services, cleaning and sanitation services, transportation, storage and distribution services, suppliers of equipment, cleaning and disinfectants, packaging materials and other food contact materials.

This document allows any organization, including small and/or less developed organizations (e.g. a small farm, a small packer-distributor, a small retail or food service outlet) to implement externally-developed elements in their FSMS.

Internal and/or external resources can be used to meet the requirements of this document.

 

HACCP – Hazard Analysis Critical Control Point

Hazard Analysis and Critical Control Point (HACCP) is an internationally recognized system for reducing the risk of safety hazards in food.

A HACCP System requires that potential hazards are identified and controlled at specific points in the process. This includes biological, chemical or physical hazards.Any company involved in the manufacturing, processing or handling of food products can use HACCP to minimize or eliminate food safety hazards in their product.

Why use HACCP?

Awareness of food-borne illness is increasing and concern throughout the industry is driving the use of HACCP and HACCP based certification programs.

HACCP is based on seven principles:

    Conduct a Hazard Analysis
    This is where you evaluate your processes and identify where hazards can be introduced. Hazards can be physical (i.e. metal contamination), chemical (i.e. can a cleaning product contaminate the product, are there toxins that could contaminate the product?) or biological (at what points could bacteria or virus contaminate your product?). You will need to make sure that you have the expertise to make an accurate evaluation of the hazards. This means that if you do not have sufficient expertise in your organization you will need to identify external resources that you can use to perform the hazard analysis.
    The hazard identification is done in two steps, first the identification of hazards, then an evaluation of the hazard. The hazard evaluation is a determination of the degree of risk to the user from the identified hazard. Once the hazard is identified and evaluated the team must identify critical control points. These are points where the hazard must be controlled or it will present a risk to the end user.
    Identify the Critical Control Points
    At what steps in your process can controls be applied to prevent or eliminate the hazards that have been identified? These are your critical control points. For each critical control point you will identify the preventive measure. How will you prevent the hazard?: Use of specific Temperature, ph, time, procedures?
    Establish a maximum or minimum limit for temperature, time, pH, salt level, chlorine level or other processing characteristic that will control the hazard. This is the critical limit for the CCP. If this limit is ever exceeded corrective action must be taken, and all affected product controlled.
    Establish Critical Limits
    Your next step is to establish criteria for each critical control point. What criteria must be met to control the hazard at that point? Is it a minimum temperature? Are there regulatory limits that you must meet for this control point?
    Establish Monitoring Procedures
    What will you measure and how will you measure it? You need to monitor the process at the critical control point and keep records to show that the critical limits have been met. Can you do continuous monitoring of the control point? If not, how often will the measurements need to be performed to show that the process is under control?
    The monitoring that takes place at the critical control points is essential to the effectiveness of the HACCP program. The monitoring program will be made up of physical measurement or observations that can be done in a timely manner, to provide the information in a time frame that allows you to take action and control product if an out of control situation occurs.
    Establish Corrective Actions
    You will establish what actions need to be taken if a critical limit is not met. This will be identified ahead of time for each CCP. The action must make sure that no unsafe product is released. There must also be an evaluation of the process to determine the cause of the problem and an elimination of the cause.
    The action or actions taken have two purposes, to control any nonconforming product resulting from the loss of control, and to identify the cause, eliminate it and prevent the situation from reoccurring. By identifying the corrective action before an out of control situation occurs, you are prepared to take action quickly if and when it does occur.
    Establish Record Keeping Procedures
    You will determine what records are needed to show that the critical limits have been met, and the system is in control. Address regulatory requirements and include records from the development of the system and the operation of the system.
    Establish Verification Procedures
    The HACCP plan must be validated. Once the plan is in place, make sure it is effective in preventing the hazards identified. Test the end product, verify that the controls are working as planned. Perform ongoing verification of the system. Are measuring and monitoring equipment in control? What are corrective actions showing? Are records being maintained as required?

The Food Safety Management Systems reaches beyond the hazard analysis critical control point and also incorporates management systems principles similar to those found in ISO 9001. You will be building a system to manage quality and continual improvement throughout your organization. It will reach beyond the control systems that we have discussed above and into how you plan and manage quality into your organization.

    Global market place
    Increasing incidents of food-borne pathogens
    New pathogens emerging
    Need to protect Brands, control risks

HSE – Health, Safety and the Environment Management System

On the shop floor or construction site, your employees – both staff and sub-contractor personnel – must work together using various materials and equipment. Accidents may have disastrous consequences for employees, bystanders and your organization. Our health, safety and environment management provides coordination and monitoring to ensure the health and safety of your workers and compliance with HSE construction requirements.

Why choose health, safety and environment management from EIQM?

Whether you are a building commissioner, main contractor or construction company, we can help you:

    Suggest proactive measurements that prevent incidents before they manifest as accidents
    Coordinate all health and safety aspects of your construction project
    Draft health and safety plans and verify any existing or proposed plans
    Comply with all relevant HSE construction regulations and requirements
    Ensure the health and safety of workers, decrease accident risks and improve onsite productivity
    Gain expert advice and recommendations for future safety maintenance and create a long-term safety culture
    Ensure full compliance with EU directive 92/57 EEC

World-class health, safety and environment management from the leading supplier

As a leading supplier of health, safety and environment management we offer you unrivaled expertise, resources and expertise. Plus, with our unique global reach, we can dispatch experienced and qualified safety coordinators to your building site or factory – wherever your operations are based.

Our services for health, safety and environment management include:

    Safety coordination during the design, fabrication and construction phases
    Recommendations for preventive measures
    Coordination documents
    Safety risk analysis
    Verification and development of health and safety plans
    Internal license controls
    Verification of access permits
    Access controls for designated areas
    Certificate control for cranes and operators
    Control of collective protection
    Control of personnel protection equipment (including helmets, gloves and shoes)
    Safety signaling control
    Determination of transfer/clearing routes
    Supply of external HSE coordinators
    Guidance/coordination concerning Occupational Health and Safety regulations
    Regular recording and reporting, focused on non-conformities, corrective/preventative actions and statistical data
    Safety training courses

Contact us today to find out how our health, safety and environment management can help you comply with all HSE construction requirements.

 

ISO 50001:2018 – Energy management systems

Using energy efficiently helps organizations save money as well as helping to conserve resources and tackle climate change. ISO 50001 supports organizations in all sectors to use energy more efficiently, through the development of an energy management system (EnMS).

ISO 50001:2018 – Energy Management System

ISO 50001 is based on the management system model of continual improvement also used for other well-known standards such as ISO 9001 or ISO 14001. This makes it easier for organizations to integrate energy management into their overall efforts to improve quality and environmental management.

ISO 50001:2018 provides a framework of requirements for organizations to:

    Develop a policy for more efficient use of energy
    Fix targets and objectives to meet the policy
    Use data to better understand and make decisions about energy use
    Measure the results
    Review how well the policy works, and
    Continually improve energy management.

This document specifies requirements for establishing, implementing, maintaining and improving an energy management system (EnMS). The intended outcome is to enable an organization to follow a systematic approach in achieving continual improvement of energy performance and the EnMS.

This document:

a) is applicable to any organization regardless of its type, size, complexity, geographical location, organizational culture or the products and services it provides;

b) is applicable to activities affecting energy performance that are managed and controlled by the organization;

c) is applicable irrespective of the quantity, use, or types of energy consumed;

d) requires demonstration of continual energy performance improvement, but does not define levels of energy performance improvement to be achieved;

e) can be used independently, or be aligned or integrated with other management systems.

Annex A provides guidance for the use of this document. Annex B provides a comparison of this edition with the previous edition.

 

ISO 10004:2018 – Customer satisfaction — Guidelines for monitoring and measuring

 

ISO 10004 provides guidance in defining and implementing processes to monitor and measure customer satisfaction.

In order to pursue this goal the organization should:

    identify customer expectations;
    gather customer satisfaction data;
    analyze customer satisfaction data;
    provide feedback for improvement of customer satisfaction;
    monitor customer satisfaction on-going.

The purpose and objectives influence what, when, how and from whom the data is gathered. They also influence how the data is analyzed and how the information is ultimately to be used.

For whom?

The international standard series ISO 10000 can be used by any organizations no matter what type, size or product. The focus is on customers outside of the organization, not suppliers or its personnel.

Benefits:

    obtain information on new expectation
    resolving complaints to the satisfaction of the complainant and the organization
    identify trends and therewith eliminate causes of complaints
    customer-focused approach to resolving complaints
    encourage personnel to improve their skills in working with customers
    basis for continual review and analysis of the complaints-handling process

ISO 10004:2018

This document gives guidelines for defining and implementing processes to monitor and measure customer satisfaction.

This document is intended for use by any organization regardless of its type or size, or the products and services it provides. The focus of this document is on customers external to the organization.

NOTE Throughout this document, the terms “product” and “service” refer to the outputs of an organization that are intended for, or required by, a customer.

ISO 10002:2018 – Customer satisfaction — Guidelines for complaints handling in organizations

Manage customer complaints effectively and you’ll have more chance of meeting their expectations as well. And you can quickly turn customer complaints into customer satisfaction instead – especially when you view complaints as an opportunity to improve what you do and how you do it. ISO 10002 can help you to achieve this whatever the size or nature of your business. The customer complaints management system is a basic but essential requirement for any business – especially businesses that want to become and remain successful.
What is ISO 10002 Customer Satisfaction. Complaints Handling?

Customers expect more and more from the service you provide. And your competitors are working harder to meet these expectations. You can too with ISO 10002, the international standard for customer satisfaction. It provides you with guidelines for putting in place your own complaints management system – helping you to identify complaints, their cause and how to eliminate them. ISO 10002 will also allow you to identify areas in your business where you can improve and eventually remove the cause of complaints. The standard outlines management controls and processes that help you to handle customer complaints more effectively and efficiently – making sure that more customers are satisfied with the service you provide.
What are the benefits of customer complaint management?

    Achieve operational efficiency to identify trends and causes of complaints
    Resolve more complaints by adopting a more customer-focused approach
    Engage staff with new customer service training opportunities
    Integrate ISO 10002 with ISO 9001 to improve overall efficiency
    Monitor and continually improve your complaints handling process.

ISO 10002:2018

This document gives guidelines for the process of complaints handling related to products and services within an organization, including planning, design, development, operation, maintenance and improvement. The complaints-handling process described is suitable for use as one of the processes of an overall quality management system.

NOTE Throughout this document, the terms “product” and “service” refer to the outputs of an organization that are intended for, or required by, a customer.

This document is intended for use by any organization regardless of its type or size, or the products and services it provides. It is also intended for use by organizations in all sectors. Annex B provides guidance specifically for small businesses.

This document addresses the following aspects of complaints handling:

a) enhancing customer satisfaction by creating a customer-focused environment that is open to feedback (including complaints), resolving any complaints received, and enhancing the organization’s ability to improve its products and services, including customer service;

b) top management involvement and commitment through adequate acquisition and deployment of resources, including personnel training;

c) recognizing and addressing the needs and expectations of complainants;

d) providing complainants with an open, effective and easy-to-use complaints process;

e) analysing and evaluating complaints in order to improve the quality of products and services, including customer service;

f) auditing of the complaints-handling process;

g) reviewing the effectiveness and efficiency of the complaints-handling process.

This document does not apply to disputes referred for resolution outside the organization or for employment-related disputes.