Category Archives: ISO Certification
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Guidance for Implementation of Quality Management Systems for Certification to the ISO 9001:2015 Standard
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ISO-9001 & ISO-14001 Certification for Exporters of Recycled Materials to China
One of the largest exports from North America to China is recycled materials. Metals, plastics, paper, and other materials are in high demand in China, and an ample supply is generated in North America. It is a happy combination, but he process is carefully regulated by the Chinese Government by the AQSIQ, the General Administration of Quality, Supervision and Quarantine, who issues the licenses to import products. One of the requirements to obtaining an AQSIQ license is to have an accredited ISO-9001 certification for the quality management system of the company exporting the product to the Chinese buyers.
The accrediting organization for ISO certifying bodies in the US is an industry known as ANAB, a partnership organization of the American National Standards Institute (ANSI) and the American Society for Quality (ASQ), also known as the ANSI/ASQ National Accreditation Board. The ANAB derives its authority form the International Accreditation Forum, the only ISO licensee for accrediting certifying bodies. For the AQSIQ to accept your ISO-9001 Certification, it must have the logo of the Certifying Body and the ANAB.
Always insist on an ISO 9001 Certification by an Accredited Certification Body (CB)
ISO-9001:2008 is the latest version of the international Quality Management System standard. It is scalable from a one-person operation through an organization with thousands of employees across multiple locations. It is truly an all-encompassing Quality Management System that covers all phases of a business, not just a product quality or inspection system. It breaks down all business operations into processes, identifies how these processes interact, determines the criteria for effectiveness of the processes, and establishes a method to measure, monitor and improve each of these processes. The continual measurement, monitoring and improvement of the business processes is what makes the system so powerful. Companies implementing ISO-9001 find their operations, efficiencies, customer satisfaction continually improving resulting in increased profitability and improved relations with their customers, both existing and potential new customers.
Obtaining ISO-9001 certification is not a difficult task, but it must be embraced by the management of the company seeking certification. It is not something that can merely be purchased and administered. It requires effective implementation. It will be examined by the certifying body auditor and all aspects of the standard must be functioning in the organization being certified. The ISO standard touches on all aspects of the business, so all employees require training and engagement for the system to function.
The export of some materials to China also requires certification to ISO-14001. This is an environmental management system. ISO-14001 requires the identification and evaluation of the possible environmental effects of the business operations. Like ISO-9001, it is scalable, implemented throughout the business operations of a company, and contains some of the same principles of business effectiveness: objectives, monitoring, measuring and improvement, management review, and so on to achieve the environmental goals of the business.
For a company exporting recycled materials to China, the risks of not following sound quality and environmental management principles can be substantial. Facing the responsible disposal of a large shipment of products that does not meet the import standards, half a world away, can be devastating to the business responsible for supplying and getting the product there. The use of effective Quality Management and Environmental Management systems such as ISO-9001 and ISO-14001 goes a long way in mitigating those risks by providing a methodology to ensure customer requirements (as well as legal and regulatory requirements) are met verified prior to the product ever leaving the supplier.
What’s the importance of an accredited Certification Body?
“You can fool some of the people all of the time, and all of the people some of the time, but you cannot fool all of the people all of the time.” –Abraham Lincoln, (attributed)
Is your ISO Standards based Management System certified by an ‘accredited certification body’?
Acquiring your certification for your ISO management system through an accredited Certification Body is essential if you wish to be recognized as having a genuine Certification for your ISO Standards based system. However, certification is not a requirement of any of ISO’s management system standards. This section provides a basic understanding of what certification and related terms like accreditation, and registration mean.
Certification – the provision by an independent body of written assurance (a certificate) that the product, service or system in question meets specific requirements. Certification is very often referred to as ‘registration’ in North America.
‘Registration‘ often means that the certifying body (aka Registrar) records the certification in its client register. So, the organization’s management system has been both certified and registered.
Accreditation – the formal recognition by an independent body, generally known as an Accreditation Body (AB), that a Certification Body (CB) is capable of carrying out the certification audit process in accordance with the International Standard ISO 19011:2011.
ISO 19011:2011 provides guidance on auditing management systems, including the principles of auditing, managing an audit program and conducting management system audits, as well as guidance on the evaluation of competence of individuals involved in the audit process, including the person managing the audit program, auditors and audit teams.
ISO 19011:2011 is applicable to all organizations that need to conduct internal or external audits of management systems or manage an audit program.
Accreditation is not obligatory but it adds another level of confidence, credibility, and integrety, as ‘accredited’ means the certification body has been independently checked to make sure it operates according to International Standard. In the context of ISO 9001:2008 or ISO 14001:2004 and other ISO Standards, ‘certification‘ refers to the issuing of written assurance (the certificate) by an independent external body that it has audited a management system and verified that it conforms to the requirements specified in the standard.
Therefore, in the ISO 9001:2008 or ISO 14001:2004 context, the difference between the two terms is not significant and both are acceptable for general use. “Certification” is the term most widely used worldwide, although registration is often preferred in North America, and the two are used interchangeably.
On the contrary, using ‘accreditation’ as an interchangeable alternative for certification or registration is a mistake, because it means something different.
In the ISO Standards context, accreditation refers to the formal recognition by a specialized body – an accreditation body – that a certification body is competent to carry out a audit for certification in specified business sectors.
In simple terms, accreditation is like certification of the certification body. Certificates issued by accredited certification bodies are perceived on the market as having increased credibility.
The International Accreditation Forum (IAF) is one of the world associations for Conformity Assessment Accreditation Bodies and other bodies interested in conformity assessment in the fields of management systems, products, services, personnel and other similar program of conformity assessment. Its primary function is to develop a single worldwide program of conformity assessment which reduces risk for business and its customers by assuring them that accredited certificates may be relied upon. Accreditation assures users of the competence and impartiality of the body accredited.
What do AS/ISO auditors look for when conducting an audit for a certifying body?
It’s complex, but here’s a popular short answer in the form of “auditor questions”:
- Are the processes properly documented and operating within the requirements of the Standard?
- Are quality policies effectively communicated internally and externally to you suppliers and outsources?
- Do the records and objective evidence substantially demonstrate that the QMS is effective?
- Are the procedures for assessing process effectiveness validated?
- Are measuring and monitoring processes of your QMS indicate that Quality Objectives are being met?
- Are the procedures for Control of Documents, Control of Records, Control of Non-Conforming Products, Corrective Actions and Preventive Actions effective?
- Are the internal auditing and management review procedures effective and can you demonstrate continual improvement?
Access Business Communications, Inc.
International Management Systems
16835-236 Algonquin Street
Huntington Beach, CA 92649
Always insist on an ISO Certification issued by an ACCREDITED Registrar
Combining ISO-14001 (Environmental Management) and OHSAS-18001 (Health & Safety Management) Into a Single Unified System
Combining the ISO-14001 Environmental Management and OHSAS-18001 Health and Safety Management standards into a single, unified system, can offer substantial advantages over implementing these systems separately. Costs can be greatly reduced with a single, combined set of documentation, greatly reduced training costs, and a lower registration audit cost. This is the most practical and least time consuming path to registration.
ISO-14001 and OHSAS-18001 are the two most common and most requested ISO management systems outside of the ISO-9001 (or the more industry specific AS-9100, ISO/TS-16949, and ISO-13485) Quality Management System. More and more forward thinking companies are requesting that their suppliers have an effective Environmental Management system in-place. This is especially important when dealing with companies whose public image is important to them. Many European companies are flowing down their environmental management requirements to their sub-tier suppliers as well.
Always insist on an ISO Certification issued by an ACCREDITED Registrar
Once you are registered to the ISO type quality system, adding registration to the Environmental and Health and Safety standards is not difficult at all. You already have the understanding of how these systems work and how they are administered, improved and maintained. This means that implementing both can not only save you considerable money over implementing one at a time, but it will also improve your company’s bottom lime when the savings of managing these critical aspects of business starts to kick in. Implementing these two management systems greatly reduces your company’s exposure to lawsuits as well. Let’s examine each of these systems and discuss how effective implementation can save you money and control risks.
ISO-14001 is the International Environmental Management standard. This is the second most implemented ISO system. As of 2012, nearly a quarter of a million companies have become ISO certified. The ISO 14001 standard does not dictate environmental performance requirements. Instead, it serves as a framework to assist organizations in developing their own environmental management systems. ISO 14001 can be integrated with other management functions and assists companies in meeting their environmental and economic goals. ISO 14001, like ISO-9001 is very scalable, so it may be applied to any size or type of organization, product or service, in any sector of activity, so whether you have three or 5,000 employees, manufacture hazardous chemicals, or only produce intellectual property, you can certify your business to ISO-14001.
OHSAS-18001 is a virtual mirror of ISO-14001 with the exception that it focuses it’s management efforts on the company’s health and safety issues rather than its environmental issues. For this reason implementing both is not much more difficult than implementing only one. The majority of the effort in implementing these is training your employees how to effectively use them. ISO accreditation bureaus and registrars recognize this so they can offer a discounted registration audit when doing both systems simultaneously – as much as a 30% reduction.
In addition to improved operations efficiencies, implementing these standards can result in a big discount in insurance costs. Both liability insurance, because you have substantially less exposure to lawsuits, and worker’s compensation insurance, because you address, monitor and manage your company’s health and safety issues, can be reduced – sometimes paying back the cost of implementation is a single year, depending on your company’s size, exposure and other relevant issues.
Learning and implementing the ISO-14001 Environmental Management and OHSAS-18001 Health and Safety Management standards, while not difficult for an already qualified ISO-9001 Quality System manager, simply requires investing the time to receive training in these two standards and in how to combine them. Many procedures and methods can be combined. For instance, you only need one corrective action procedure, one management review meeting, and one set of documents that will cover the requirements of both standards. One way to ease this time consuming process is by using qualified and trained consultants. If you elect to go this route, be sure your consultants are not only trained on both the ISO-14001 and OHSAS-18001 standards, but also on how to combine them into a single combined system. ANAB accredited registrars are now offering Lead Auditor training for combined management systems.
Jeff Spira is a senior partner with ABCI Consultants.
Accredited Certification Delivers Real Added Value
In 2010/11, IAF carried out a global survey to capture market feedback on the value of certification. The survey aimed to gain intelligence on the drivers for seeking certification, the selection criteria when choosing a body to provide certification services, the appropriateness of the process, and the positive outcomes of certification.
Over 4,000 responses were received from businesses of all sizes operating across a diverse range of industries. While the majority of respondents were responsible for managing quality within their organization, over a quarter of respondents were either finance directors, marketing managers or other senior management personnel. This indicates that the value of ISO certification is recognized across the spectrum of business functions, and not just in the traditional quality management arena.
This is positive news for accreditation bodies that invest a significant amount of time and resources in raising awareness of the benefits of accredited ISO certification among businesses, government departments and regulators. The primary motivation for this is to enable organizations to make an informed choice on which ISO certification bodies they use. Using an accredited ISO certification body should assure the organization that it will get the business benefits and value it pays for. But was this recognized by those who responded to the IAF survey?
The real value of certification
Over 80% of all respondents reported that ISO certification had added value to their organization. As a more quantifiable measure, around half of all participants have seen an increase in sales as a direct result of the certification.
Internal business improvement was given by nearly half of all participants as the main driver for seeking certification, while approximately one third said it was a requirement of their customers. However, respondents overwhelmingly stated that ISO certification was important to their customers. Despite only 12% citing it as the main reason for gaining certification, over 80% confirmed that ISO certification had helped them meet national regulatory requirements.
Taken together, these figures indicate that ISO certification is something that organizations are choosing to seek, primarily to improve internal operations and to provide customer confidence, rather than something that is done begrudgingly merely to tick compliance boxes. It’s not just the larger companies that are realizing these benefits though, as nearly two thirds of respondents work in SMEs, half of which have less than 50 employees.
How important are ISO certification bodies?
Over 90% of those who took part in the survey confirmed that their ISO certification body was accredited by a recognized accreditation body, with nearly three quarters stating that accreditation was either essential or very important in their line of business. Only 3% reported that accreditation was not important. When asked about the importance of the ISO certification being covered by the IAF Multilateral Recognition Agreement (MLA), 35% stated that the acceptance of their ISO certification in overseas markets was very important.
The survey also revealed that the vast majority of organizations use ISO certification bodies that are based in their local economy, with less than one in 10 seeking ISO certification from an overseas organization. To help them through the process, 60% of respondents reported that they commissioned the services of an external consultant.
Is there value for money?
While the survey identified that achieving ISO certification could be fairly complex, businesses rated the competence of accredited ISO certification bodies highly, and confirmed that the time to navigate the process met with their expectations. Asked whether the ISO certification bodies provide value for money, 62% of respondents agreed.
Summary
The findings of the survey confirm that businesses are generating significant benefits and added value from accredited certification. Not only is it being used as a tool to deliver internal business improvement and to meet regulatory compliance, but businesses confirm that it has a positive effect on revenue. Given that the majority of businesses that responded to the survey (57%) employed less than 249 people, accredited ISO certification clearly benefits small to medium sized organizations, as well as large multinationals.
Businesses taking part also reported high levels of satisfaction with the ISO certification process in terms of the timeframe to achieve ISO certification and the competence of the assessment teams. Given these positive findings, businesses perceive accredited ISO certification as providing value for money.
Nearly all of the businesses that took part in the survey (91%) selected an accredited ISO certification body, providing an assurance that these organizations have the required competence and impartiality to do so as evidenced by fulfillment of international standards and requirements.
QMSCAPA™ stands for Quality Management System, Corrective Actions and Preventive Actions. QMSCAPA™ is a Microsoft Windows compatible computer application, which is designed to generate a CAPA log for a Quality Management System based upon the ISO Standards. 
ISO Awareness, Foundations & Internal Auditor Training