About ISO 9001
The International Organization for Standardization (ISO) develops and publishes standards, such as the ISO 9001 Quality Management System standard. Currently ISO has developed over 22,000 standards in different industries and product sectors.
The ISO 9001 standard outlines requirements for organizations to establish, implement, maintain, and improve a Quality Management System. With over a million organizations certified to ISO 9001 worldwide, the ISO 9001 standard is the largest of all ISO standards in terms of number of certificates issued, and has become the international indicator for quality and consistency.
Using a process-based approach, the ISO 9001 standard lays out tools for companies to assess, and improve their day-to-day processes that make them run. Conforming to the ISO 9001 standard can help organizations ensure that everything that reaches its customers meets their requirements and has the levels of quality desired.
ISO 9001:2015 Turnkey Consulting
By considering ISO 9001 certification, your organization is demonstrating an interest in achieving more than just the minimum customer requirements. This is a commitment towards quality improvement, greater operational efficiency, increased profitability, and a purposeful customer focus.
ISO 9001 QMS Auditing Services
As one of the most widely recognized standards around the world, Quality Management Systems certified to the ISO 9001 standard are evidently the most audited ones.
Audits against ISO 9001 focus on “Quality”, auditing the organization’s ability to provide quality products and services that meet customer’s and other requirements.
Auditors with knowledge of this standard abound, and competency is usually achieved through frequent audits. Mireaux’s Auditors are highly qualified to audit against the ISO 9001 standard and have extensive expertise to provide accurate and effective audits, based on years of experience as well as adhering to Mireaux’s own ISO 9001 certification.
The ISO 14001 standard outlines the requirements for organizations to establish, implement, maintain, and improve an Environmental Management System to enhance its environmental performance. ISO 14001 is the second largest of all ISO standards, based on the number of certificates issued worldwide which currently stands at almost 350,000.
While certain organizations may have a larger impact on the environment than others, ISO 14001 is applicable to any organization, regardless of size, type and nature. It applies to the environmental aspects of the activities, products, and services that the organization determines it can either control or influence considering a life cycle perspective.
As the population becomes conscious of the adverse effects of industrial development on the environment, “going green” has become more than just a buzzword; it’s become part of a cultural shift.
Using our Proven Consulting Approach, Mireaux has the knowledge and expertise to help organizations achieve ISO 14001 certification or integrate these requirements to an existing certification.
As good stewardship towards the planet becomes the norm, auditing of Environmental Management Systems certified to the ISO 14001 standard becomes increasingly sought out. Audits against ISO 14001 focus on the “Environment”, assessing how the organization manages its impact on the environment.
Mireaux auditors are highly qualified to audit against the ISO 14001 standard and have firsthand knowledge of the details involved in auditing an environmental management system, gained by having been in charge of these type of systems themselves.
The ISO 45001 standard “Occupational Health and Safety Management Systems – Requirements with Guidance for Use”, provides a robust and effective set of processes for improving work safety in global supply chains. Designed to help organizations of all sizes and industries, the new International Standard is expected to reduce workplace injuries and illnesses around the world.
In these times of rising awareness of the importance of occupational health and safety (OH&S), which includes increasingly strict legislation governing those areas, many organizations want to improve their OH&S practices and avoid OH&S issues. Intermittent “reviews” or “audits,” conducted on an annual or semi-annual basis, can provide a snapshot assessment of an organization’s legal and policy compliance. However, these reviews are not sufficient to provide assurance that an organization will continue to meet its legal and policy obligations. To get that kind of guarantee, companies need a structured OH&S management system that works within their organization every day, not just a few times a year.
Using our Proven Consulting Approach, Mireaux has the knowledge and expertise to help organizations achieve ISO 45001 certification for the first time, add ISO 45001 certification to an existing one, or migrate from the old OHSAS 18001 to the new ISO 45001:2018 version. If you’re looking for an ISO 45001 consultant, contact us to learn about our process.
ISO 45001 is based on OHSAS 18001, along with various other national standards. ISO 45001 replaces OHSAS 18001, the world’s former reference for workplace health and safety.
The ISO 45001 standard “Occupational Health and Safety Management Systems” provides a robust and effective set of processes for improving work safety in global supply chains. Designed to help organizations of all sizes and industries, ISO 45001 is expected to reduce workplace injuries and illnesses around the world. ISO 45001 replaces OHSAS 18001, the world’s former reference for workplace health and safety.
Mireaux Auditors are well equipped to Audit against ISO 45001, based on formal training, and experience helping organizations implement it. Our Auditors can perform well-rounded audits to better prepare you for your Registrar audit.
The ISO 27001 standard outlines requirements for organizations to establish, implement, maintain, and improve an Information Security Management System. The ISO 27001 is currently the 4th largest of all ISO standards in terms of number of certificates issued.
While the ISO 27001 standard was one of the first standards to adopt the “Common Framework” which all ISO standards are moving toward or have moved already, it is the only standard which contains a list of Control Objectives and Controls under the so-called Annex A. These 113 controls, organized into 14 clauses and security categories, are required and therefore exclusions have to be justified.
Conforming to the ISO 27001 standard and recommended controls from Annex A, can help organizations assess and treat information security risks, and most importantly prevent information security risks from materializing.
Mireaux can assist you through ISO 27001 consulting, as well as training, audits, managed services and Web QMS software for ISMS implementation.
Annex A – Control Objectives:
- Information Security Policy
- Organization of Information Security
- Human Resource Security
- Asset Management
- Access Control
- Cryptography
- Physical and Environmental Security
- Operations Security
- Communications Security
- Systems Acquisition, Development and Maintenance
- Supplier Relationships
- Information Security Incident Management
- Information Security Aspects of Business Continuity Management
- Compliance
With vulnerabilities being exploited daily and information breaches happening worldwide, by considering ISO 27001 certification for your organization, you are demonstrating an interest in securing your internal information as well as that of your clients and suppliers.
This is a high level commitment toward securing your assets, ensuring business continuity and increasing the confidentiality, integrity and availability of those assets.
As the world’s immersion into everything electronic and connected continues, issues regarding data and information security are becoming ever so prevalent. Audits against ISO 27001 standard, focus on “Information Security”, seeking to ensure the confidentiality, integrity, and availability of information assets.
Auditors with knowledge of this standard are scarce, and competency is typically achieved by working in an environment certified to the standard. Mireaux’s own ISO 27001 certification and exposure to its cloud-based Web QMS software, gives it an edge over the competition.
AS 9100 is an internationally adopted and standardized Quality Management System for the aerospace industry. The AS 9100 standard outlines requirements for organizations to establish, implement, maintain, and improve a comprehensive Quality Management System for providing safe and reliable products to the Aviation, Space, and Defense industry, as well as civil and military aviation requirements. AS 9100 builds upon the ISO 9001 requirements by supplementing them with additional quality system requirements established by the aerospace industry to satisfy organizations such as DOD, NASA, and the FAA and can be used at all levels of the supply chain by organizations around the world.
AS 9100 was released in October, 1999 by the Society of Automotive Engineers and the European Association of Aerospace Industries. AS 9100 replaced the earlier AS 9000 version and fully incorporates the entirety of the current version of ISO 9001, while adding requirements related to quality and safety. As a condition of doing business, many major aerospace manufacturers and suppliers worldwide require compliance and/or registration to AS 9100.
Nowadays, the International Aerospace Quality Group (IAQG), with representatives from aviation, space, and defense companies in the Americas, Asia/Pacific, and Europe, has been established to provide supporting information for organizations that apply the AS 9100 standard, and to provide guidance for organizations that choose to progress beyond its requirements.
Using our Proven Consulting Approach, Mireaux has the knowledge and expertise to help organizations achieve AS 9100 certification for the first time, add AS 9100 certification to an existing one, or migrate from the old AS 9100C to the new AS 9100D version. If you’re looking for an AS 9100 consultant, contact us to learn about our process.
By considering AS 9100 certification, your organization is demonstrating an interest in providing safe and reliable products, to satisfy as well as to achieve the requirements of the aviation, space, and defense industry and other applicable statutory and regulatory requirements. This standard will help position your organization above other suppliers, able to demonstrate that you can deliver products and services to multiple customers having varying quality requirements and expectations throughout the world and at all levels of the supply chain.
As with any other standard, Mireaux will help your organization implement AS 9100 with a systematic, and project-based approach; that will result not only in successful certification, but in value-added processes, reduction of costs, and improved quality and delivery performance.
The AS 9100 standard “Quality Management Systems – Requirements for Aviation, Space, and Defense Organizations” is an international standard that was created to bring consistency to the aerospace sector. The standard addresses regulatory, safety, and reliability requirements specific to the aviation, space, and defense industry.
Audits against AS 9100 focus on “Quality” and are based on ISO 9001:2015 with the addition of requirements specific to aviation, space, and defense. Our Auditors will ensure your organization is able to provide safe and reliable products, as well as to achieve the requirements of AS 9100 and other applicable statutory and regulatory requirements.
Mireaux Auditors are well equipped to audit against AS 9100, based on formal training and firsthand knowledge of the details involved in auditing in an aviation, space, and defense environment, gained by having been in charge of these type of systems themselves. Our Auditors can perform well-rounded audits to better prepare you for your Registrar audit.
Along with AS 9100, Mireaux can also provide Auditing Services for Aerospace Quality Management System standards AS 9110 or AS 9120.
This part of ISO/IEC 80079 specifies particular requirements and information for establishing and maintaining a quality system to manufacture Ex equipment including protective systems in accordance with the Ex certificate
It does not preclude the use of other quality systems that are compatible with the objectives of ISO 9001:2008 and which provide equivalent results.
It can also be used by third parties, including certification bodies, to assess the organization’s ability to meet conformity assessments system requirements and/or regulatory requirements.
The application of this standard is intended to cover both electrical and non-electrical equipment and protective systems. The detailed content (e.g. annexes) is currently more focused on the established equipment standards for electrical equipment, However, IEC sub- committee 31M has recently been formed with the responsibility for the development of standards for non-electrical equipment. It is anticipated that, where appropriate, these standards, or requirements related to them, will be referenced within this standard in the future.
The ISO 80079 Explosive atmospheres, Part 34: Application of quality systems for equipment manufacture, specifies requirements for a quality system that can be used by an organization for the production of equipment and protective systems for explosive atmosphere.
The application of this standard is intended to cover both electrical and non-electrical equipment and protective systems. Manufacturer’s quality requirements are an integral part of most certification schemes and as such this standard has been prepared with the IECEx equipment requirements in mind, is intended to support the ATEX scheme requirements for a manufacturer’s quality system, and can be applied in other national or regional certifications schemes that relate to the manufacture of explosion-protected equipment.
Auditors with knowledge of ISO 80079 are rare, and competency is usually achieved due to working knowledge of the standard. Mireaux has a limited number of Auditors qualified to audit against ISO 80079 and can help your organization achieve a fair and productive audit.
When implemented correctly, organizations stand to benefit greatly by adhering to the ISO 9001 requirements as well as its principles. Here are some of the most relevant benefits that can be gained from proper ISO 9001 implementation:
- Provides confidence to customers that the products and services delivered have an additional level of quality and scrutiny
- Helps create more efficient and consistent processes
- Increases productivity by promoting best practices and minimizing wasted effort or rework
- Increases customer satisfaction through analysis and awareness
- Empowers employees
- Creates a framework for future continual improvement
The standard as written can be applied to any type of industry or sector. If you were previously certified to the 2004 version and would like to update your Environmental Management System to the 2015 version, please Contact Us.
ISO, however, has a range of standards for Quality Management Systems that are based on ISO 9001 and adapted to specific sectors and industries. These include:
- AS 9100 – Aerospace
- TS 16949 – Automotive
- ISO 13485 – Medical devices
- ISO/IEC 90003 – Software engineering
- ISO 17582 – Electoral organizations at all levels of government
- ISO 18091 – Local government
ISO 9001 is part of ISO 9000, a family of standards that include:
- ISO 9001:2015: Quality management systems – Requirements
- ISO 9000:2015: Quality management systems – Fundamentals and vocabulary (definitions)
- ISO 9004:2009: Quality management systems – Managing for the sustained success of an organization (continuous improvement)
- ISO 19011:2011: Guidelines for auditing management systems
From this family of standards, organizations can only certify to the ISO 9001 standard. Currently in its 2015 revision, the ISO 9001 standard has been revised multiple times since its inception in 1987. Here is a brief history of ISO 9001:
Since 2001, Mireaux has helped numerous organizations achieve ISO 9001 certification. By using its proven ISO 9001 consulting approach, the Mireaux team has the knowledge and expertise to help organizations of all shape and sizes achieve this certification.
Additionally, Mireaux itself has been ISO 9001 certified since 2012 and therefore conforms to the very same requirements that it coaches its Clients to achieve.
It goes without saying that ISO 9001 is the benchmark for a Quality Management System and therefore, any organization in any industry can benefit from implementing its requirements. From manufacturing to health care, from communications to education; any organization who provides products, services, or both, can greatly benefit from this standard when implemented correctly.
The following documented information is typically requested during any ISO 9001 Audit, whether an Internal Audit, Gap Analysis, or similar audit:
- Quality Policy
- Quality Objectives
- Risk Assessment approach
- Internal Audit report/evidence
- Management Review outputs
- Information required to be retained (Records)
- Etc.
Depending on the Audit Type as well as the organization’s product or services, audits based on the ISO 9001 standard, focus on the following areas:
- Top Management
- Quality Assurance
- Document Control
- Contract Review/Sales
- Operations
- Engineering
- Purchasing
- HR and Training
Whether you are conducting an Internal Audit, Gap Analysis, or another Audit Type, an audit against the ISO 9001 standard can certainly be combined with other standards to become an Integrated Audit. Since ISO introduced the Common Framework and the High Level Structure, Integrated Audits are easier to perform.
Key benefits organizations gain from proper ISO 14001 implementation can be summarized as improved environmental performance through:
- More efficient use of resources
- Reduction in environmental impact
- Reduction in waste and waste management
- Reduction in risk of legal or regulatory penalties
- Improved corporate image among regulators, customers, and the public
- Enhanced trust from stakeholders
As in all ISO standards, the ISO 14001 belongs to a family of standards that provides practical tools for organizations of all kinds looking to manage their environmental responsibilities. The only standard that you can certify to -within this family- is the ISO 14001 standard, which was updated in 2015. Prior to this, the standard’s last version was issued in 2004.
If your organization is seeking a new ISO 14001 certification, the version that you should use is the 2015 version. If you are currently certified to the 2004 version and need to transition to the 2015 version, please contact us. In addition to ISO 14001:2015 consulting, we also provide training, managed services, and Web QMS software.
With the advent of the “Common Framework” embedded in all ISO standards, implementation of multiple ISO standards can be done easier and more cohesively. Organizations already certified to ISO 9001, ISO 45001, or other management systems need not develop a separate management system for ISO 14001. Rather, these organizations should enhance their existing management systems, building upon a good infrastructure, and strengthen it based on the changed or new requirements.
The following documented information is typically requested during any ISO 14001 Audit, whether an Internal Audit, Gap Analysis, or similar audit:
- Environmental Manual
- Environmental Policy
- Environmental Objectives
- Aspects/Impacts of the organization
- Internal Audit report/evidence
- Management Review outputs
- Information required to be retained (Records)
- Etc.
Depending on the Audit Type as well as the organization’s processes, audits based on the ISO 14001 standard, focus on these areas:
- Top Management
- EHS or HSE Department
- Document Control
- Operations
- HR and Training
Whether it is an Internal Audit, or Gap Analysis; an Audit of the ISO 14001 standard can definitely be combined with other standards in order to become an Integrated Audit. Integrated Audits are easier to perform since ISO introduced the Common Framework and the High Level Structure.
- Increases employee safety consciousness and morale
- Reduces accidents, claims, and lost work days
- Increases preparation for regulatory checks
- Reduces risk of citations and penalties
- Cuts healthcare costs through long-term prevention
- Potentially reduces insurance costs
- Improves corporate image among regulators, customers and the public
The new ISO 45001 standard was released on March 12, 2018. This standard replaces the former OHSAS 18001 standard.
Organizations already certified to OHSAS 18001 will have three years from March 2018 to comply with the new ISO 45001 standard, although certification of conformity to ISO 45001 is not a requirement of the standard. Count on Mireaux for expertise and guidance through ISO 45001 consulting, training, audits, managed services and Web QMS management system software.
The ISO 45001 standard follows the same management system approach as other ISO standards such as ISO 14001 and ISO 9001, which includes the High Level Structure and the common framework that helps with management system integration.
Based on this, ISO 45001 is indeed designed to integrate with other ISO management system standards, ensuring a high level of compatibility among them. Businesses who have implemented the ISO 9001 and ISO 14001 standards’ requirements correctly, should see an easier path for integration with ISO 45001 requirements.
When implemented correctly, organizations stand to benefit greatly by adhering to ISO 27001 requirements and principles. Here are some of the most relevant benefits that can be gained from proper ISO 27001 implementation:
- Significantly increases information security awareness throughout the organization
- Helps establish proven information security controls
- Increases employee, supplier, and customer confidence
- Ensures information assets and risks are controlled
- Improves reputation through elimination or reduction of information security incidents or events
- Creates a framework for future continual improvement
The current version of ISO 27001 is 2013. The previous version was 2005. ISO 27001 was actually one of the first standards to migrate to the Common Framework. All certifications are currently issued to the 2013 version.
Although it is easy to associate information security with data processing centers, the standard can be applied to any type of industry or sector. In fact when applied correctly, the standard itself and the controls can greatly help companies shield themselves against internal or external information security threats.
Depending on the products or services your organization offers, controls from the Annex A such as E-Commerce, may not be applicable to your company and can therefore be excluded with due justification.
Since 2004, Mireaux has been involved with the ISO 27001 standard, and has seen it evolve through the 2005 and 2013 versions. Furthermore, Mireaux has been certified to this standard since 2014, and has, as a result become an authority on it, by living the standard, and being audited year after year.
So if you are serious about implementing the ISO 27001 standard, look no further than Mireaux to help your organization achieve its certification goals. We offer expert ISO 27001 consulting and other services designed to ensure your success.
The following documented information is typically requested during any ISO 27001 Audit, whether an internal audit, or gap analysis:
- Information Security Policy
- Information Security Objectives
- Statement of Applicability (SOA)
- Risk Assessment and Risk Treatment
- Asset Register
- Internal Audit report/evidence
- Management Review outputs
- Information required to be retained (Records)
- Etc.
Depending on the Audit Type as well as the organization’s processes and scope of the Information Security Management System, audits to the ISO 27001 standard, typically focus on the following areas:
- Top Management
- Information Technology
- Information Security
- Facilities/Building Security
- Document Control
- Operations
- HR and Training
- Server room or datacenter
An audit of the ISO 27001 standard can definitely be combined with other standards to become an Integrated Audit. Integrated Audits are easier to perform since the advent of the Common Framework and the High Level Structure that all ISO standards now follow.
The following documented information may be requested during any ISO 80079 audit, whether is an Internal Audit, Gap Analysis, or similar audit.
- Quality Manual
- Quality Policy
- Quality Objectives
- Explosive Supplier records
- Preventive Maintenance and Calibration records
- Internal Audit report/evidence
- Management Review inputs and outputs
- Competence and Training records
- Etc.
Typical audit of the ISO 80079 standard, focus on the following areas:
- Quality Assurance
- Document Control
- Contract Review/Sales
- Operations
- Engineering
- Purchasing/Logistics
- HR and Training
Mireaux Auditors can help conduct an integrated audit of ISO 9001 and ISO 80079, with minor modifications to the audit time.