ISO 9001:2015

ISO 9001, AS9100 & Other Topics

By Kerri Williams 23 Mar, 2022
Due to the Russian Federation’s attack and invasion on Ukraine, certifications are not being supported for Russian Federation entities. Platinum is requesting that our clients doing business in or purchasing materials from the regions in crisis formally consider the risks of these business activities. Platinum Auditors will assess risk management systems to ensure that risks are analyzed and mitigated to reduce impact to product and service quality.
By Kerri Williams 01 Dec, 2021
As you may already know, the industry is anxiously awaiting the publication updated Aviation, Space and Defense (ASD) Standards. We anticipate that these will be released early in 2022. One of the main reasons for the changes being made to the standards is to better align with International Standardization Organization (ISO) accreditation and certification requirements as well as International Accreditation Forum (IAF) requirements. These specifications are currently used in ISO certifications and their incorporation improves consistency and simplicity for the ASD industry. The Standards being adjusted include: AS9101, AS9104/2, AS9104/3 as well as the Online Aerospace Supplier Information System (OASIS) tool. These changes will require adjustments from certification bodies on how audit days are calculated, as well as how audits are planned, recorded and reported. There will be a transition period for accreditation bodies and certification bodies, so changes will roll out slowly and methodically.
By Kerri Williams 01 Dec, 2021
As part of the upcoming relaunch of the Online Aerospace Supplier Information System (OASIS), the IAQG digital team and development partner Intact are offering free webinars for key user groups. Register to participate in one of these live webinars and receive all relevant information concerning the new OASIS platform and to participate in the live Q&A sections. All webinars will be recorded and made available after the live webinar dates. If you are unable to participate, you can still register to be informed about where to watch the recordings as soon as they are available. CLICK HERE TO REGISTER for the supplier/general user Webinar.
By Kerri Williams 08 Nov, 2021
Education is when you read the fine print; experience is what you get when you don't. – Pete Seeger Many times, in business, clients will provide a request for quotation (RFQ) with terms and conditions (Ts & Cs) and/or additional requirements including quality and product requirements. These requirements might be attached directly to the RFQ, referenced on the RFQ, or found on a website where they can be easily accessed and updated. Ts & Cs and requirements stipulate the expectations placed on you as a supplier by your customer. Although admittedly these contract documents are a bit of a snore, keep in mind they are legally and contractually binding to you. As a result, it is important that your management system has a robust process to ensure that you not only know about the Ts & Cs and any additional requirements, but also that you confirm your organization has the ability to satisfy these requirements prior to the acceptance of the order and before the release of your products and/or services to your customer. Nonconformances are on the Rise More and more as a certification body we are seeing issues with management systems that do not have a robust and effective process for the review of customer requirements resulting in an increase in certification nonconformities in this area. When management systems derail in the contract review process, nonconformances can be sprinkled throughout the entire management system resulting in incomplete risk analyses, incorrect supplier selection, incomplete flow-down of customer requirements to suppliers, data control issues, missed production operations, and poor customer communication. The list of issues it can cause goes on and on. It really can end up a Pandora's box. We are always looking for solid processes to ensure that you system consistently meets your customer’s requirements. Process Improvements If you have improved your requirements review process, but you have older long-term agreements that were reviewed the old way, repeating the review process on these older agreements and their stated requirements may give you valuable information that you could have missed during previous reviews. Improving the process and ensuring that all existing contracts are re-reviewed will not only protect your organization ultimately avoid future customer issues. Customers Expect Conformance For the Aviation, Space and Defense (ASD) industry, a new standard (AS9018) is being developed to help certification bodies like Platinum respond to major nonconformities identified by customers, including failures to flow-down and follow terms and conditions and quality/product requirements in contracts. We are already experiencing ASD customers using this approach and have addressed the ability to follow-up on customer complaints in our revised Certification Requirements document. So far, we’ve seen this used on…you guessed it…customer flow-down requirements. Walking through your management system with an eagle’s eye and truly understanding, evaluating, and adhering to your current and potential customer requirements can be the difference between a system that really works and one that doesn’t throughout all the management system processes in your organization. It is the difference between making your customers happy and giving you repeat business and not. Focus your next internal audit on this process keeping in mind the impact of this process on both your organization and the end customer will help you ensure that your system is truly working as intended and is meeting your customers’ expectations.
By Kerri Williams 29 Oct, 2021
We have just received notice that the Rocky Mountain Trade Adjustment Assistance Center (RMTAA) has several openings for Colorado manufacturing firms in all types of industries. They are looking for firms who have experienced declines in sales and employment over the past year. If that describes your organization, please read on for a program that may be just right for you! The RMTAA is an independent, non-profit organization funded by the U.S. Department of Commerce Economic Development Administration to manage trade adjustment assistance. They are one of eleven national non-profit organizations that provide these services to eligible firms. Platinum has worked with this organization for services related to certification for several of our clients. They have approved us in their system and have seen the success of the program. There are three phases to the program and once accepted, the RMTAA will typically work with you for 3-5 years. Phase 1 of the program begins with an application. The RMTAA prepares this application on your behalf. Phase 2, an analysis plan. The RMTAA works with your management team to develop a plan to identify projects that will most benefit from cost-sharing assistance. To assure your buy in – you are asked to contribute 25% of the plan development cost. Phase 3, implementation. Upon approval of the plan, you move forward with projects that with strengthen your business (which may include ISO and AS9100 preparation and certification) . According to the RMTAA, your cost depends upon the size of your organization the nature of the proposed projects and the availability of program funds. The program offers 50/50 cost sharing of projects to improve your organization’s competitive position, but is capped at $75,000 of government matching. Which means you can invest up to $75,000 in improvement programs. The costs and commitments are transparent and established up front. Again – this is time sensitive, but it is a resource available to Colorado firms and may be some thing worth exploring. For additional information, please reach out to Tania Bahr-Torline, she’s a Project Manager who can help you better understand the program and its offerings: 303-499-8222 x 3, tania.bahr-torline@colorado.edu.
By Kerri Williams 21 Jan, 2021
Quality standards trace their roots back to the Military. Decades ago, governments needed specifications to ensure that items procured from different vendors worked properly when brought together. Standards facilitate international trade by providing a common language with common expectations. They help companies identify precisely “how” they work, and they help organizations consistently implement the best way to run the business. The need for efficiency continues to influence the evolution of standards, because: “If you can measure something, then you can improve it.” The first national quality management system can be traced back to the BS 5750 Standard introduced in 1970 by the United Kingdom. This provided the predecessor to ISO, the International Organization for Standardization, which introduced the ISO 9000 series in 1987. Today in the United States, the Technical Advisory Group (TAG) to TC 176 is responsible developing and for maintaining standards for quality system management. ISO 9001 Certification: The 9001 standard can be applied to any service or any manufacturer. It is applicable to any- sized organization, ranging from the one-person shop, to an international company. In many cases, ISO certification enables small organizations to cast a bigger shadow, by securing Government contracts that require ISO certification as criteria for acceptance. Different standards apply to specific industries, such as:
By Kerri Williams 30 Apr, 2020
Everyone at Platinum Registration hopes this communication finds you well and doing the best that you can considering the unusual circumstances that we are all experiencing. Several weeks ago, we began assessing risks and planning for business continuity activities during the COVID-19 virus outbreak. It is our intention to protect our personnel and our clients from the spread of this illness without causing undue stress or unnecessary costs related to certification activities. We are rolling-out a more comprehensive plan to perform certification activities remotely, where possible. We are good at this. We have audited remotely and have validated processes that work. Communication We are developing audit plans based upon discussions with clients and other interested parties. If we haven't already, we will contact you to collect information about how you are operating under the circumstances so that we can analyze risk and our ability to use alternate audit methodologies. Our focus is currently assessments occurring in the next 90 days, but we will be looking 6 months into the future. We have also contacted each of our auditors to assess their individual situations to ensure that they are healthy and able to perform the planned assessments. So far, thankfully, we are all doing fine. Some of our auditors do have individual circumstances that need to be considered when planning for travel and auditing activities, which may require us to re-configure the auditor or team assigned. The good news is that our clients are operating! We have a strong and resilient American workforce who are managing to get on with business. We aren’t trying to be alarmist or cause disruption, but we are definitely trying to reduce risks, meet accreditation expectations for disaster planning and keep everybody operating as normal as we can. You have spent considerable effort implementing disciplined processes and your customers are certainly expecting you to maintain that discipline during this difficult time. This is your opportunity to promote that this makes you different from your competitors. This situation will not last for long and your management system will help you return back to normal operations quickly and efficiently. Travel At this time (and things seem to be changing rapidly), there are no federally mandated domestic travel restrictions in place, but the CDC does not recommend public transportation where social distancing cannot be achieved for individuals with compromised health conditions or who live with individuals with compromised health conditions. Additionally, we are keeping our eyes on local restrictions. Assessment Methods In an effort to reduce the potential transmission of COVID-19 while support our clients, Platinum and its assessment teams are evaluating the ability to perform remote audits using information technology. We are approved to use these techniques as long as the audit objectives can be achieved and the method is allowed by the accreditation bodies for the Standard to which we are auditing. We will need to understand your ability to support remote audit techniques if they may be applied. If it is determined by your organization and by Platinum that Platinum must perform on-site audits, we will approach each situation individually, based upon our risk analysis described above. General On-Site Protocol We ask that you understand that we will limit our interactions with your personnel. We ask that only minimal personnel attend opening and closing meetings. We will limit person-to-person contact by not shaking hands as we normally would. We will be washing our hands often and using hand sanitizer, when possible. Our auditors will not attend an on-site audit if they are symptomatic, if they have been exposed to the virus or if any of your staff are symptomatic or have been exposed. We also ask for private work spaces where work surfaces have been sanitized prior to our arrival. General Off-Site Protocol - Information Communication Technology (ICT) There are many great tools for on-line meetings that are free to and easy to use. To help you prepare, we have developed a Planning for Remote Audits document. You can find this on our website under Resources . Our auditors will contact you to test the connectivity prior to your assessment. We have done remote auditing for years – so this is not completely new to Platinum, but it is new for organizations where on-site auditing is preferred. All of our auditors are being trained to perform these assessments and as we learn how to improve connectivity in this new environment, we will modify our collective approach. Expect auditors to ask you to provide the names and titles of individuals that will be participating in the audit in advance. We would like to know who will be available for the assessment of each of the business processes on the audit plan. Being able to read your documents and records that have been selected by our audit team in advance will also speed up the process and prevent having auditors reading the procedures while tying up the internet. We understand that access may differ based upon your personal requirements and we will work within your security constraints. If you do not have all of your information in an electronic format, your auditor will help determine the records that they will want to review and the best approach to conduct the review. We may ask you to take us on a tour using video streaming so we can “see” things or collect records for us to review. We are going to have to play some of this by ear based upon connectivity. We just need to be patient and have perseverance. We aren’t too worried about the ability to do this. We know we can work though this together. Payments Please contact our office before sending payment: 303-639-9001. In the event that the office personnel at our building are not able to distribute mail, we may not be able to access it. We are asking that you pay via ACH bank to bank payments if possible. You will need our routing and account number and we will happily provide it to you via the phone. We really appreciate you working with us so that we can pay auditors as they deliver their services to you. If ACH payments are not possible, we can work together to find alternate methods. Consultants Many clients use the services of their consultants. Consultants may be a great resource to help prepare or be on-site during the assessment. Most are familiar with the software that works well for remote communications. We know that this is an unusual time, but the perseverance of the American workforce is evident and it is healthy for all of us to try to continue operations and do business as “normally” as possible. We are here to help and are wishing you, your colleagues and your family’s peace of mind and progress during this difficult time. Please, reach out if you have any questions or if you need help. Direct contact numbers Office: 303-639-9001 Melody Sands (9001): 720-280-7632 Hayley Brodish (AS9100): 303-515-9666 Kerri Williams, (14001, 13485 and other standards): 303-913-7281 Best regards, Kerri Williams, President Platinum Registration, Inc.
By Kerri Williams 25 Mar, 2020
Platinum may perform certification assessments off-site from client facilities when the entire facility works electronically, when personnel support the facility from remote locations and during emergency situations when it is unsafe or when travel and contact with personnel is prohibited by government agencies. We have defined processes for perform these audits using information and communication technologies (ICT). Clients who have not experienced and ICT audit may need some assistance. The following information has been developed to help you prepare and to answer any questions you may have: Remote audits are audits that are performed off-site using electronic tools. The assessments cover everything that would be confidently covered on-site. Certification bodies use these audits when a client operates electronically or when there is a need to temporarily audit remotely due to unusual circumstances. How do remote audits work? They are very similar to on-site audits. They are conducted over the same duration. They work when you share your screen with your audit team – so we simply watch as you display records and information to us. We can supplement the on-line screen share with off-line reviews of documented information sent via email or made available through sharing sites like drop box. What about Confidentiality and Security? We will perform your remote audits from private locations (or from a part of your facility, when possible) to keep your information as secure as possible. Through data viewing, we will not be having direct access to your systems. All documents and records are protected, controlled and destroyed when no longer needed. Tools to Consider Some communication tools include: Go to Meeting, WebEx, Zoom, Skype, Join.Me, Teams, and Google Hangouts. Scanning tools: Tiny scan or other phone apps Technical Issues We anticipate that there may be connectivity issues. Your auditors have been trained to help troubleshoot things that may come up. Please have attendees mute their phones and computers unless they are needed. If necessary we will reschedule or use alternate methods. What do I need to do? 1. Identify and Set-up Screen Sharing We will ask you what software you will use to connect to your Lead Auditor/Audit Team. If you do not use collaboration software, there are quite a few types of software available; many are free. Headphones will help with audio. 2. Plan for sharing paper records It may be necessary to supply images of hard copy records. Luckily, these can be captured using mobile phone applications such as tiny scanner which can be displayed on your computer emailed to your auditor. Your auditor will tell you what records are needed in advance of the audit. 3. Identify who will participate in the audit Please prepare a list of individuals that will participate in each part of the assessment (using the Assessment Plan/Schedule). Please include first name, last name and titles. Please send this to your auditor. It will not be necessary to have all personnel available during the audit, but they should join prior to their session. Leadership should be available during their session and during the opening and closing meetings. 4. Plan for site tours Where necessary, we will ask you to take us on a virtual tour of your facility. Mobile phones, tablets, webcams will work for this purpose.
By Kerri Williams 02 Feb, 2019
Your customers seek out quality, professionalism and excellence when choosing suppliers or service companies. As an ISO 9001 accredited business, this automatically puts you at the top of the list, inspiring confidence and trust in your customers Your customers are seeking you out because your management system – and therefore your way of doing business – has been deemed to be the best by the world’s foremost accreditation authorities. Why Customers Demand a Certified System It shows that your business strives to be consistent and accountable Reassures your customers that your products and services are of high quality–satisfies their product and service requirements Why Stakeholders Demand a Certified System A formalized system = increased efficiency = cost savings Increases productivity Increases quality and reduces rework costs Gives you the competitive advantage Opens up access to new markets, both domestically and globally Breaks down barriers to international trade, opening up new, global markets All of these benefits add up to increased customer satisfaction and confidence, repeat business and in many cases, customer referrals, which means more business for you. Join The Millions Over one million organizations worldwide are independently certified, making ISO 9001 one of the most widely used management tools in the world today. In addition, many major purchasers actually require their suppliers to hold ISO 9001 certification. Dig into the details To facilitate an understanding of accreditation, the following statements are from Joint Communique issued by the International Accreditation Forum and ISO: For the defined certification scope, an organization with a certified quality management system consistently provides products that meet customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction. Notes: Products also include services Customer requirements for the product may either be stated) for example ion a contract or an agreed specification) or generally implied (for example in the organization’s promotional material, or by common practice for that economic/industry sector). Requirements for the product may include requirements for delivery and post-delivery activities. What accredited certification to ISO 9001 means To achieve conforming products, the accredited certification process is expected to provide confidence that the organization has a quality management system that conforms to the applicable requirements of ISO 9001. In particular, it is to be expected that the organization: has established a quality management system that is suitable for its products and processes and appropriate for its certification scope analyzes and understands customer needs and expectations, as well as the relevant statutory and regulatory requirements ensures that product characteristics have been specified in order to meet customer and statutory/regulatory requirements has determined and is managing the processes needed to achieve the expected outcomes (conforming products and enhanced customer satisfaction) has ensured the availability of resources necessary to support the operation and monitoring of these processes monitors and controls the defined product characteristics aims to prevent nonconformities, and has systematic improvement processes in place to Correct any nonconformities that do occur (including product nonconformities that are detected after delivery) Analyze the cause of the nonconformities and take corrective action to avoid their recurrence Address customer complaints has implemented an effective internal audit and management review process is monitoring, measuring and continually improving the effectiveness of its quality management system What accredited certification to ISO 9001 does not mean 1. It is important to recognize that ISO 9001 defines the requirements of an organization’s quality management system, not for its products. Accredited certification to ISO 9001 should provide confidence in the organization’s ability to “consistently provide product that meets customer and applicable statutory and regulatory requirements”. It does not necessarily ensure that the organization will always achieve 100% product conformity, though this should of course be a permanent goal. 2. ISO 9001 accredited certification does not imply that the organization is providing a superior product, or that the product itself is certified as meeting the requirements of an ISO (or any other) standard or specification.
By Kerri G 20 Nov, 2017
If you are transitioning to ISO 9001:2015 you may find these correlation matrices published by the International Standard Organization helpful. Just click on the title to read the document. Correlation Matrices Between ISO 9001:2008 and ISO 9001:2015 (Published by ISO)
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