Sunday, June 25, 2017
Tags Posts tagged with "certification"

certification

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    Lean System

    Introduction to the Lean System

    As with anything in life, you will get out as much from your ISO 9001 management system as you put into it. If you treat it as a documentation requirement and burden on your business just to get certification then you are unlikely to see any real benefits; in fact, you may even stifle your own growth.

    The aim of any ISO 9001 QMS is to enhance your businesses product or service quality by standardizing and continually improving all of your business processes. This in turn will help you to increase productivity and drive out waste of all forms within your business.

    Why Use Lean System with ISO 9001?

    ISO 9001 outlines what is required for a certifiable QMS. However if you read ISO 9004 you will see that it suggests a huge amount more than 9001 requires as a minimum. Merely aiming for what the standard requires so that you achieve certification is not going to help you actually improve your business in a way that is going to help you grow it.

    A QMS should always consider the customer first, not the standard. It should also be put in place to continually improve the business and its output. Something that is also provided through implementing a Lean system.

    Lean Manufacturing has grown out of what is known as the Toyota Production System (TPS), and is why Toyota managed to dominate the world automotive market in such a short space of time. Lean is in its simplest form just another QMS; when you implement Lean you put in place the controls and systems to provide the customer exactly what they want, where they want it, when they want it, in the right quantity, without any waste or delays.

    Lean provides you with a host of tools such as 5S, which helps you to set up a highly visual, organized and efficient working space, through to continuous improvement techniques such as Kaizen. Lean fits perfectly within any ISO 9001 QMS and can only help you to further improve and grow your business using proven tools and techniques.

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      ISO Implementation Process

      Preparing for an ISO implementation process of any ISO standard can be overwhelming and frightening for many. How an organization prepares for implementation will depend on factors such as size and complexity of its processes, the current knowledge and culture related to the standard (quality, environmental, safety, etc), the maturity of any other existing systems related to the standard wishing to implement, and many others. Despite the differences there may be between organizations, there are a few tips that will facilitate the implementation process of any management system, these are:

      Know the standard.

      It is essential that some personnel knows the management system’s requirements. Everyone does not need to be an expert on the requirements of the specific standard that will be implemented, but key workers need to fully know and understand all of the requirements of the standard.

      Inform everyone what is going on.

      The implementation process is not a task of just a few chosen ones. Everyone needs to be involved in this process. Every worker needs to know what is being implemented, why is it being implemented, which are the benefits for the organization and for themselves, and how they will be involved in the process. When people are informed, they will be more open and willing to collaborate in the implementation.

      Analyze the organization’s current situation.

      Before starting to implement any ISO management system, an organization needs to know its level of compliance with the standard. This will allow the organization to understand beforehand its strengths and weaknesses regarding the ISO management system wishing to implement and estimate the time needed for implementation.

      Map your processes.

      Establish and record current processes in order to know the relationships between departments and how the processes flow within the organization. This will allow organizations to plan their implementation by processes and not just by areas and departments.

      Review existing procedures and work instructions.

      Many processes need written and documented information that will guarantee that activities are carried out in the correct manner. Organizations need to review which processes are documented and how many work instructions there are. It is not the same to develop a few documents and just review work instructions than to develop them from scratch. Organizations need to have an idea of how much time they will have to invest in developing and reviewing documents.

      Review current training programs.

      Evaluate existing training and awareness programs. Training and awareness are an important part in the implementation process and if an organization has not considered training its workers, it would be best to redefine these programs to make sure that a large percentage of workers are trained and informed about policies, procedures, regulations, etc that will be a part of their daily activities.

      These are some recommendations that will help organizations prepare for the implementation process of any ISO management system. The most important aspect to keep in mind is to make sure that the whole organization is working for the same objectives and pulling in the same direction.

       

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        ISO Certification

        This is a guest post from Michael Haile from ISO Quality Services Ltd, an independent organisation that specializes in the implementation, certification, training and continued auditing of ISO and BS EN Management Standards.


        Our lead assessors have countless years of experience in helping organisations to achieve ISO Certification. No matter the industry, they have worked tirelessly alongside our clients to aid the growth of their business. Whether it’s a charity, manufacturer or translation company, they have seen numerous successes.

        That being said, there is one issue that is actually very common in our industry and that is the perception of ISO Certification as a necessity rather than an aid. Some organisations, (whether they are aware of it or not) put the ISO Certification in one ‘box’ while putting their business in another.

        Many articles have been written which make a point of explaining the benefits and the importance of management buy-in with regards to certification. These are great and they are very important topics to highlight but sometimes people appreciate practical examples.

        The Myths of Non-Conformances

        One key example that our assessors highlight is that of non-conformances. A non-conformance is something that has happened which should not have happened. From experience the following are the most common misconceptions surrounding non-conformances:

        • Their recording is felt to be adding to their workload
        • Some employees feel like they are ‘telling tales’ on their colleagues
        • Or it is seen as a weakness

        The concern that the recording of non-conformances adds to current workloads is very common and we have a simple mantra which will hopefully ease this:

        “If a non-conformance takes longer to record than to rectify, it is not a non-conformance”

        We have in fact suggested to clients that they change their name to ‘Opportunities for Improvements’. Secondly, recording non-conformances and acting upon them enable organisations to have the ability to make significant improvements. After all, if everybody’s jobs can be made that little bit easier, why wouldn’t you?

        In some circumstances employees are reluctant to highlight non-conformances as they see them as a weakness that can give management a reason to criticize. This should not be the case and one way this can be remedied is by management taking the lead and demonstrating that they too are recording non-conformances.

        Don’t Forget Communication!

        One of the main reasons why there are issues with the non-conformance processes and procedures, or any change within the workplace for that matter, is communication.

        Internal communication in the form of departmental meetings for example is important to get ‘buy-in’ from all areas of the business. If everyone understands why change is happening, how it will impact positively upon their job and how they can help then this will help with employee buy-in.

        Taking the time to explain why change is needed and creating a sense of inclusion makes everyone feel appreciated.

        The Bottom Line

        The bottom line is that the ISO Standards provide a flexible framework that run parallel to an organisation instead of being a separate entity. Furthermore, when embraced and fully integrated, they are able to enhance business performance and make everyone’s job that little bit easier.


        This is a guest post from Michael Haile from ISO Quality Services Ltd, an independent organisation that specializes in the implementation, certification, training and continued auditing of ISO and BS EN Management Standards.

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          Getting Top Management Invested in Certification

          The commitment and involvement of top management is essential for the success of any management system. Top management must participate in the implementation process and must ensure the continuity and improvement of the system. Also, they are the ones that should guarantee the availability of resources necessary for the establishment and maintenance of the management system. However, in too many cases, top management’s involvement ends with the appointment of a Management Representative.

          There are reasons why top management doesn’t truly commit to a management system, and one of them is that they just don’t see the value of it. They don’t see why they need to be attending management reviews, looking at audit results, and spending money on trainings and “improvements” that don’t seem to improve anything.

          Because top management’s involvement is essential for the success of the management system, here are some ways to help them see the true value of any management system.

          Speak their language

          Management usually speak the language of money. The information presented to them should consist of a cost analysis. They want to know facts such as how the ISO management system will:

          • Help the organization use their resources more efficiently.
          • Promote improvements that reduce cost.
          • Create a work environment that will increase productivity.

          Present information that motivates them.

          Top management must participate in the implementation process and must ensure the continuity and improvement of the system.
          Top management must participate in the implementation process and must ensure the continuity and improvement of the system.

          Show them how the ISO management system is helping achieve the organization’s objectives, how targets are being improved, how customer satisfaction has increased (less complaints, increase in sales), or how the organization has received less complaints from other interested parties (regulatory bodies, community, etc). Show them what the system is doing for their business.

          Make Management Reviews important to them.

          Management doesn’t want to spend time on a meeting just to comply with an ISO requirement. During management reviews, present an overall picture of the organization’s performance; make sure that these meetings represent an opportunity to make important decisions regarding the improvement of processes and performance.

          Explain the importance of improvements.

          Among other things, top management is responsible for questioning anything that adds activities, time and requires money. When asking for resources for an improvement, show them what the nonconformity or nonvalue added activity is costing the organization, how will the improvement save them money, how will a process become more efficient and how it will help the organization achieve its goals.

          Make sure they understand their responsibilities.

          Top management needs to understand their role within the ISO management system. They need to know its requirements, the benefits it may bring if it is implemented correctly and what is most important, they need to understand that without their participation, any management system will fail to bring success to the organization.

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            Exploring the Pre-Assessment Audit

            A pre-assessment audit is one that is performed before a certification/registration audit takes place. This pre-assessment audit determines the degree of conformance of an organization’s management system(s) with the requirements of a standard (e.g. ISO 9001, ISO 14001, ISO 27001, etc.)

            After putting the time and effort to implement a management system and before diving into a certification audit, many organizations choose to contracting the services another organization or person to perform a pre-assessment audit. This is a full audit of a management system against the requirements of a specific standard that allows organizations to identify any nonconformities and implemented corrective actions before the certification audit.

            A pre-assessment audit is performed with the same independence and objectivity as a certification audit. The auditor(s) will conduct activities such as documentation review, process review, interview of process owners, etc, in order to gather the necessary information that evidence compliance.

            A pre-assessment audit is performed on-site and are a complete assessment of the management system against the requirements of the relevant standard. As any other audit, all nonconformities and observations found will be presented in an audit report that will be delivered at the end of the process; this report will serve as a baseline for the organization to improve its processes and implement the necessary corrective actions.

            Any organization that has implemented a management system and wishes to determine its readiness to undergo a certification audit can seek a pre-assessment audit. Some of the benefits of performing this audit are:

            • Helps organizations identify any non conformities and implement corrective actions.
            • Contributes in the optimal preparation for the certification audit.
            • An organization can focus its resources on weaknesses that might lead to nonconformities.
            • Depending on the outcome, organizations can decide to postpone a certification audit that has already been scheduled or, on the contrary, face the certification audit with a renewed confidence.
            • Helps organizations avoid unnecessary additional costs.

            This type of audit can be conducted by qualified consultants, registrars, or competent individuals with experience and knowledge regarding the relevant industry sector and standard. It is important to remember that, just as an organization carefully chooses  a certification body or any other service, it should also take the time to choose the correct organization or person to perform its pre-assessment audits.

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              Exploring the Pre-Assessment Audit

              The implementation and certification process of a management system based on ISO 9001, ISO 14001 or any other standard requires an enormous amount of effort by everyone in an organization. Therefore, after finally obtaining the desired ISO certificate the organization will surely want to tell the world about it.

              There are many ways an organization can advertise that their management system(s) comply with a specific ISO certification and that they have a certificate that proves it! Here are some ideas on how to do it:

              Within the organization:

              • It is important to let all the organization’s employees know that their effort paid off. They can be rewarded with items such as mugs, coolers, t-shirts with the organization’s logo and a message such as “ISO 9001:2008 certified quality management system”.
              • A breakfast or brunch can be organized in recognition of the ISO certification achievement.
              • Sending an e-mail to all employees announcing the achievement.
              • The certificate may be displayed in the organizations front lobby.
              • A flag or banner can be displayed on the organization’s main entrance to promote the certification.

              Outside the organization:

              • A press release can be distributed to the local media, industrial magazines and other newsletters to announce that the organization’s management system has been certified.
              • A letter or e-mail can be sent to customers and suppliers and even a reception can be organize to celebrate the achievement.
              • The achievement can be announced on the organization’s website, Facebook and Twitter account.
              • Messages announcing the certification can be added on the graphics of the organization’s vehicles.

              There are many other ways to advertise the organization’s certification of their management system. However, there are many mistakes organizations make when promoting their certification. An organization has to seek guidance from their Certification Body (CB) in order to avoid these mistakes. Here are some of the most common ones:

              • The International Organization for Standardization’s logo can not be used under any circumstance.
              • If it’s necessary, the advertisement should mention the scope of the certification (in the cases where one site or one process of the organization has been certified)
              • Phrases such as “ISO Certification” should be avoided; it’s essential to be specific about which standard has the organization’s management system been certified to (ISO 9001, ISO 14001, etc)
              • The organization’s certification logo can not be used in their products. These certifications certify management systems, not products nor services.

              Organizations should feel proud of achieving certification of their management system and with their CB’s guidance they should find the right and the best ways to promote it.

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                Organizations that have successfully implemented a management system may choose to seek certification by an independent third party audit from a registrar/certification body (CB). Certification can serve as a valuable tool to add credibility and to demonstrate to clients, customers and other stakeholders, that an organization’s management system meets the requirements of a given standard; thus, finding the right registrar is an important decision to be made.

                When choosing a registrar, organizations should consider the following:

                Accredited or non-accredited.

                Organizations should decide if they will contract an accredited registrar or a non-accredited one. Accreditation means that an independent, objective body (an accreditation body) recognizes that an organization is qualified to provide specific services.  Accreditation is not an obligation, and non-accreditation does not necessarily mean that an organization is not reputable; however, accreditation provides confirmation of competence by an independent body.

                If an organization is seeking certification as a regulatory or industry requirement, it is important to ensure if they are required to be certified by an accredited registrar; some clients and customers require their suppliers to do so. Organizations should ask the accreditation bodies in their countries for a lists of the registrar they have accredited.

                Relevant experience and sector expertise.

                There are many standards that an organization can be certified to (ISO 9001, ISO 14001, OHSAS 18001, ISO 22000, ISO 13485, AS9100, TS 16949, ISO/IEC 27001, ISO/IEC 50001, etc.) and when choosing a registrar, organizations should verify the registrar’s experience in the relevant standard.

                Also, it is important that the registrar has experience in the organization’s industry sector. Organizations need to ensure that the auditors know and understand the processes involved in their operations.

                The cost is important, but…

                Cost is an important factor for all organizations; however, not always the most inexpensive registrar is the most appropriate. It is possible that a certificate issued by a low-cost registrar, will not be recognized by clients, customers and other stakeholders. Therefore, even though the cost needs to be considered, it should not be the determining factor for the selection of the registrar.

                Meet them before choosing them

                Organizations should evaluate several registrar and schedule a meeting with them before making their final choice. This will allow them to “sense” if a good working relationship will be possible to establish. After the certification audit, the registrar auditors will visit the organization once or twice a year if they consider it necessary to maintain certification, so an active and reliable relationship will need to be developed between the two.

                Choosing a registrar should not be a decision taken lightly. A good selection process will ensure the credibility and value of the certificate issued, which will ultimately provide a valuable asset to the certified organization.

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                  Exploring ISO 9001 vs 9004
                  Exploring ISO 9001 vs 9004

                  Management systems such as ISO 9001, ISO 14001 and OHSAS 18001, require that internal audits are scheduled at planned intervals; they do not established a specific frequency nor do they establish that all processes need to have a yearly internal audit.

                  Organizations need to establish a frequency that is right for them. They decide if the audits will be performed monthly, quarterly, twice a year or once a year. However, there are some criteria that should be considered before defining a frequency that adjusts to an organization’s context and needs. These are:

                  Complexity of the processes.

                  • Crucial or high risk processes should be audited on a more frequent basis, perhaps quarterly or twice a year.
                  • Low risk processes can be audited just once a year or every other year.

                  Maturity of the processes.

                  • Well established processes that run efficiently can be audited once a year or every other year.
                  • New developed processes should be audited quarterly until they are stable.

                  Past experience.

                  • Processes that have a history of frequent deficiencies or non-conformities, can be audited quarterly or twice a year.
                  • Processes with troubles achieving targets and objectives can also be audited quarterly or twice a year.

                  There are other factors that can influence the frequency of auditing, such as:

                  • An organization’s budget for the execution of internal audits.
                  • Regulatory or customers’ requirements.

                  Another important fact is that there is no need to audit every process all at once, from past experiences, it is more suitable to spread out the internal audits throughout the year auditing different processes at different times; auditing many processes all at once can be exhausting and process deficiencies or areas for improvements may be overseen.

                  As mentioned above, most standards do not require that all process be audited every year; nonetheless, that is a common practice in many organizations. There are even some organizations, with mature and well-establish management systems, which schedule their audits over a three year time plan. Every organization needs to take a close look at each of their processes, their management systems and other applicable requirements in order to establish a rational schedule that fits their needs and that is right for them.

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                    Accreditation bodies allow organizations seeking accreditation can demonstrate to their customers that they have been successful at meeting the requirements of international accreditation standards.

                    An accredited registrar, also called an accredited certification body (CB), is an organization accredited by a recognized accrediting body for its competence to audit and issue certification confirming that an organization meets the requirements of a standard (e.g. ISO 9001 or ISO 14001). There are many benefits of using an accredited registrar when looking to obtain certification for your organization.

                    Accreditation means an independent, objective body recognizes that an organization is qualified to provide specific services. An accreditation body should assess a registrar’s facilities, procedures and staff against a set of criteria that define acceptable competence levels and capabilities.

                    There are many registrar companies that offer their services to audit and determine if an organization meets the requirements of a specific standard; however, not all registrars are accredited. An organization may decide to seek certification from any of these registrars, accredited and non-accredited. Nonetheless, choosing an accredited registrar can bring the following benefits to an organization:

                    • Organizations can be assured of the registrar’s ability, since the accreditation represents an independent assessment of the registrar’s credibility to perform management system registration.
                    • It provides assurance that the certification is based on conformance with internationally accepted practices and procedures, thus offering credibility to the certificate.
                    • Many clients and customers require suppliers’ management system is certified by an accredited registrar.
                    • Accredited registrars are prohibited to offer both consulting and registration services to one organization, in order to ensure that the value of the certificate will not be compromise due to conflict of interest; on the other hand, some non-accredited registrar do offer both services as one package in order to offer more competitive prices whilst jeopardizing the credibility of the certification.
                    • Accreditation assures organizations that a registrar meets specific requirements on an ongoing basis.
                    • Accredited registrars can assure that the auditors selected are properly qualified for the industry specialty, and that certification audits will be effective and objective.
                    • Accreditation provides an added safeguard against improper and fraudulent activities.
                    • In order to maintain accreditation, registrars are pressured to enforce internationally sanctioned registration standards and practices within its organization and among its auditors.
                    • Accreditation registrar are often stipulated and supported by local governments.

                    Organizations that choose an accredited registrar and develop an active relationship with it will ensure the value of its registration certificate, and they can guarantee their customers and clients that their management system has been certified by an unbiased, objective and professional audit.

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                      If your organization is ready to become ISO 9001 certified, there are a number of steps you can expect to go through on your path to certification. Once an organization has decided to obtain certification and has made a choice of the certification body (CB), the organization must:

                       Make a formal certification application to the CB.

                      • Fill out the application forms, which require a large amount of information about the organization and its operations. This will enable the CB to determine the scope of the certification activities and to appoint the team leader for the audit process.

                       The initial certification audit consists of a two-stage audit as described below:

                       The Stage 1 Audit determines if an organization is ready or not for a compliance audit.

                      • Organizations need to supply all relevant management and quality documentation to the CB.
                      • The CB determines if the organization is ready or not to undergo Stage 2 or compliance audit.
                      • If the organization is not ready, the CB will inform accordingly and stop the process.
                      • If the organization is ready, but a few nonconformities have to be rectified before the compliance audit can take place, the CB will provide the organization with a report.
                      • After nonconformities have been corrected, the organization must inform the CB, and if they concur with the actions taken, a compliance audit is arranged.

                       The Stage 2 Audit evaluates the implementation and effectiveness of the organization’s QMS.

                      • The team leader assembles a team of auditors and experts concomitant with the organization’s scope of activities, complexities and size of operations.
                      • A time for the audit is agreed and scheduled.
                      • Auditors will assess whether the contents of the documentation provided is consistent with the activities of the organization as well as the requirements of the standard.
                      • Overall findings and the list of non-conformities (if any) are presented.
                      • If the QMS complies with the requirements, the team will recommend to the certification committee of the CB that the organization should be certified.
                      • If there are non-conformities found, the team will agree with the organization a time schedule (typically 3 months) and the modalities for rectifying the non-conformities.
                      • The team may wish to witness the new procedures, or if the non-conformities are of a minor nature, the organization can send them evidence that these non-conformities have been fixed.
                      • The team will recommend to the certification committee of the CB that the organization should be certified.

                      Learn more about Stage 1 and 2 audits.

                      Certification

                      • Authorized persons or a committee which was not involved in the audit will review the audit report and the clearance report of the nonconformities and make a decision regarding certification.
                      • The decision will be followed by the issue of certification documents.

                       Surveillance Audits

                      • The CB will conduct a surveillance audit usually once a year.
                      • There are a few areas that will always be included in the surveillance audit, such as internal audits and management reviews as well as the non-conformity system.
                      • If any non-conformity is raised during the surveillance audits, the organization must correct them efficiently within an agreed time frame, otherwise certification may be lost.

                       Recertification Audit

                      • In the third year of certification, a re-certification audit will be conducted, similar to the original compliance audit.
                      • If this is negotiated successfully, the organization will be recertified for another three-year period, and the whole cycle repeats itself.