July 6th, 2020
Imagine you have a business making widgets and at the heart of your processes is a room full of highly trained employees who perform ten complicated functions to transform raw products into the best widgets in the world. They’re your top fabricators.
Then, suddenly a global pandemic occurs. The demand for your widgets is higher than ever and all of the top fabricators are incapacitated. Where would you turn? Panic is not an option.
While the 2020 Covid-19 pandemic may not have had a significant effect on your actual business, it underscored the importance of having in place both written documentation of procedures and a plan for continuity of operations.
If you had written procedures and a continuity of operations plan, then you might just need to sanitize the workspace, hire some healthy people capable of following directions, train them, and put them to work. Or, if hiring people were not an option, you might need to have identified in advance personnel who could be reassigned to the fabrication room.
While ISO 9001:2015 doesn’t explicitly require much documentation, written procedures are necessary to prove to auditors that your business can continue despite potential disruptive factors. And, of course, they’re necessary to keep your business running when actual disruptions occur.
A good place to start with documentation is the list that was required by the 2008 version of ISO 9001. The six mandatory procedures requiring documentation under ISO 9001:2008 were:
Control of documents Control of records Internal audits Control of non-conforming products Corrective action Preventive action
Processes, Procedures And Work Instructions Additional procedures vary from one organization to another. Procedures may be considered in the middle of a three-part hierarchy, even though sometimes these are blended into just two parts or a single item. Generally, a process is a strategy while a procedure is a uniform method for executing a specific aspect of the strategy. Work instructions provide guidance to an individual on their role in carrying out a procedure or part of a procedure.
In writing procedures, Cavendish Scott recommends that several factors be considered, though not all apply to every procedure. These include:
The purpose of the procedure and how it fits into the process of which it is a part. Who and what is involved in the procedure The qualifications and role of each person The machinery, equipment, and tools used and how they are used, along with detailed specifications What resources are used, how they are used, and how they are changed through the procedure What the product is Where the procedure is performed The standards required of the resources and final products A glossary of terms
Redundancy is an important aspect of continuity of operations, so it’s also helpful to have some backup for the procedures. These may include the following factors, which can be included in the procedures:
Forms Controls Organization Specific personnel
Procedures Exist Only If They’re Written You may be tempted to forego written procedures and rely only on backups, but Cavendish Scott recommends against that. Nothing is as reliable as having written procedures and not having a written procedure is the fastest way to lose certification. The firm takes the stand that if a procedure is not in writing it doesn’t exist.
Writing procedures is consistent with the approach to business processes promulgated by William Edwards Deming and followed by Cavendish Scott. It part not just of being good but being good all the time.
Cavendish Scott offers consulting, training and auditing to help organizations obtain and maintain certification in a full range of standards. Additional information is available at cavendishscott.com.
Cavendish Scott has been conducting ISO internal audits for 25 years. We have always followed a process approach having adopted it in principle right from the start. We teach thousands of auditors each year how to audit correctly. We are a certified training organization with the IRCA and are all qualified and practicing ISO Lead Auditors.
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May 12th, 2020
To have a successful audit, the right people within an organization need to receive appropriate training and be supported in making and maintaining the tweaks and improvements needed to maintain certification.
Choosing Employees To Take Training
The number and role of in-house auditors vary among organizations, but usually, their functions include the following at a minimum:
Planning and scheduling internal audits, whether these are conducted entirely in-house or using Cavendish Scott (or a similar firm) Serving as the point of communication for the registration auditor Ensuring audit findings are reported to top management and corrective actions are taken and enforced
Managers do well to consider several relevant factors in selecting employees for training as auditors.
Independence is important. It’s best to assign at least one person to work full-time as an in-house auditor. Otherwise, auditing may take a back seat to other duties. Changes that were made in the immediate aftermath of an audit may give way to older habits. In addition, employees who audit the areas of their primary jobs may blind to needed changes or reluctant to suggest them. If it’s necessary for auditors to split their time between auditing and other duties, it’s best if they do not audit their own areas. Auditing teams can be helpful, too, as they can assist with culture change related to quality improvement.
Consistency is helpful. Career-oriented auditors who want to stay in a position over time are the best candidates for training. It doesn’t help to train someone who will leave the organization or move out of the auditing role prematurely.
Personalities matter. The best auditors are usually good listeners who like people and processes. They’re confident enough to deliver sometimes unwelcome news to top management. They’re observant, patient and smile easily.
Trainers Speak From Experience
Cavendish Scott offers a range of auditing courses, including customized options tailored to suit specific standards and individual organizations. For example, Cavendish Scott taught a three-day remote ISO 9001:2015 internal auditor course to 19 enrollees involved in microelectronics at a federal lab. Common Requests include ISO 14001:2015, ISO 13485:2016, and AS9100D. Classes may be taught remotely, on-site, or at Cavendish Scott offices.
In all cases, trainers speak from experience. They strengthen their points with personal anecdotes from actual audits and engage trainees through interactive activities. Often client documents are used for exercises and a live internal audit is conducted on processes of the client’s choosing. This allows for specific questions to be asked and advice from the instructor to be given about scenarios described by the client.
From Classroom to Implementation
Putting the knowledge gained in training to work in an organization is essential to successful audits.
Whether they are in-house or from a firm like Cavendish Scott, internal auditors provide guidance and direction on changes that need to be made to keep an organization compliant with standards. Auditors must be independent and observant enough to see what needs to be done. They also need to have enough influence to see that management follows through on their guidance.
Cavendish Scott is an approved training partner of the International Register of Certified Auditors, or IRCA. While not all of the many courses available are individually IRCA-approved, Cavendish Scott follows the IRCA principles based on the company’s commitment to professional and effective training.
Look into options for selecting and training your in-house auditor(s). We offer training on a rolling basis, and can train your team remotely as well!
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March 9th, 2020
One of the most important decisions organizations face when planning their annual internal audits is whether to perform the function in-house or call in professionals. Without question, Cavendish Scott recommends professional, full-time auditors.
Pros Bring Depth of knowledge
All Cavendish Scott auditors take the 40-hour IRCA-accredited ISO 9001:2015 lead auditor class and pass the IRCA exam. But that’s only the beginning. The most experienced Cavendish Scott auditors spend significant amounts of time mentoring and training each new auditor.
Advantages Of A Pro Audit
Advantages of Cavendish Scott audits include the following.
Breadth of experience : Other responsibilities often leave in-house auditors with little time for audits. On the other hand, each Cavendish Scott auditor is involved in approximately 50 to 70 audits a year, working with organizations of various sizes and in a range of industry sectors. The exchange of knowledge and understanding that comes from working in teams further extends the breadth of experience they bring to audits.
Outside perspective : Whether it’s a process or a material object, something that’s been around for a while can be taken for granted. In a typical example of an internal audit performed by Cavendish Scott, there was a hodge-podge of uncontrolled documents on walls and machines. They were so much a usual part of the environment that personnel no longer noticed them. When the auditors arrived they were immediately drawn to the discordant display.
Inside neutrality: Internal auditors have a position within the hierarchy of their organizations. Especially when changes are in order, it’s difficult for personnel to audit leadership and management even though that’s part of a full-system audit. Cavendish Scott auditors are always willing to speak truth to power when reporting to organizational leadership.
Lack of disruption: Because an internal audit by Cavendish Scott requires minimal time from a client’s staff, disruption of usual operations is also minimal. Whenever possible, Cavendish Scott conducts simultaneous audits for organizations that are certified in multiple standards. When needed, several personnel are assigned to an audit, expediting its completion.
Ongoing support : Cavendish Scott auditors are full-time employees, not subcontractors. Because they work in teams, clients can always reach someone to help with their concerns, even if their primary consultant isn’t available. Besides being available for the duration of an audit, Cavendish Scott auditors are available for additional support as needed.
Sound Advice on Corrective Action: Cavendish Scott auditors provide coaching and teaching while auditing. They identify improvement opportunities and best practices and address issues and problems that go beyond minimum requirements. In one case an auditor noticed that the terms and conditions a client had issued contained a serious penalty for not meeting an on-time delivery. By pointing this out, the auditor saved the grateful owner from potentially thousands of dollars in penalties.
Readiness for other audits: In most sectors, certification is voluntary, but maintaining certification for any organization requires at least two kinds of audits. In addition to internal audits, external or registration audits are required for all and second-party audits are required for some standards. When followed, the advice offered by Cavendish Scott auditors positions clients well for good outcomes on other audits.
Pro Audits Mean Quality Management
Cavendish Scott has sometimes performed internal audits for a few years for clients who then decide to perform the function in-house. Then something happens. They don’t get the internal audits completed or they soft-pedal the audit, maybe because they don’t report findings or they don’t know what to look for. When the registrar comes in for their annual audit, major nonconformities are identified, jeopardizing certification and possibly leading to a panicked phone call to Cavendish Scott.
Cavendish Scott finds that a proactive plan that includes professional internal audits provides valuable protection for clients’ investment in ISO certification and is an essential element of a quality management system.
ISO 9001 is applicable for organizations of all sectors, sizes, and types. With the latest updates in 2015, it is now even more generalized for all enterprises; large and small. Get started today!
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October 1st, 2019
The International Organization for Standards (ISO) developed ISO 9001 to be an overarching standard focused on quality. Specifically, ISO 9001 gives us the standard that specifies requirements for a quality management system(QMS). It is the most popular standard in the series.
ISO 9001 can be applied to any organization, regardless of the industry or size. Organizations have found that using the ISO 9001 standard can drastically organize and improve processes and procedures.
Why ISO Standards Matter When an organization adopts an ISO standard it shows the government, other businesses, and customers that the organization cares about safety. In regards to ISO 9001 adoption of the standard shows all stakeholders the quality that an organization imbues into its management systems. It is important to have standards and principles to define a basis for quality management, and even more important to stay up to date with them. ISO 9001 is particularly important as it lays the groundwork for many of the other ISO standards that an organization may seek to adopt. By adopting ISO 9001 an organization is set on an easier path to adopt other standards that may fall inside their sector.
ISO 9001, Quality Management Principles
The Cavendish Scott team has years of experience and our team knows the importance of education on these new and updated course standards. Our instructors are experienced in the field and work in situations every day where ISO comes into play. Making them excellent resources for all ISO related questions, concerns, and solutions. It’s up to you to take the time & effort to make sure your team is participating in the ISO transition.
Customer satisfaction weighs heavily into a company’s (successful) business plan. Without our clients, let’s face it… All of us would be not be here.
Quality management is important because it focuses on how organizations can best meet the requirements and needs of its unique customers and audience. ISO 9001 is applicable for organizations of all sectors, sizes, and types. With the latest updates in 2015, it is now even more generalized for all enterprises; large and small.
ISO 9001 Benefits Spending time implementing ISO 9001 can benefit in the possible ways (if not all):
Increased Productivity
Your processes and procedures will be analyzed, improved, and understood. Everyone in your organization will be aligned with these processes too. Allowing more efficiency and ultimately resulting in lower internal costs.
Customer Satisfaction Focused
With customer satisfaction at the forefront of this course, your clients are getting the royal treatment. Focusing on customer requirements and procedures will help you better understand your market. Which will lead to quality leads that can be turned into satisfied customers.
Unified & Organized Team
Your team will operate and manage this quality management system for your organization. All processes will be clearly defined for all team members to review and fully understand. This will provide your team with confidence and clarity to perform their duties successfully. And your managers can manage the team successfully.
Get Compliant
Certification is not required but some sectors and clients such as governments or public bodies require ISO 9001 before doing business. So it’s important to stay compliant and meet necessary statutory and regulatory requirements. Even without certification, it is extremely respected for having completed this training.
Recent Updates ISO 9001:2008 recently updated to ISO 9001:2015. Now is the time to start familiarizing your team with the transition. Better late than never!
The new 2015 update changes ISO 9001 to focus on ISO’s Plan-Do-Check-Act cycle. This led to a change in a majority of the ISO 9001 clauses. The first three clauses in 2008 and 2015 are practically the same, it is the next seven in 2015 that are changed to fit within the PDCA cycle.
The latest update focuses on bringing standards into the 21st century. Before the standard focused heavily on documenting processes and now it is transitioned into focusing on “managing” processes. Any organization that wants to be seen as a company committed to quality should elect to adopt ISO 9001.
For more details visit the ISO website .
ISO 9001 with Cavendish Scott
Cavendish Scott offers training , consulting , internal auditing for ISO 9001. Our instructors are experienced with every facet of the standard from the ISO 9000 base all the way to the current ISO 9001:2015 update. Cavendish Scott can provide practical solutions and situational answers to all of your ISO needs.
We have been performing audits and training for 25 years.
Check out the advantages of a pro audit with Cavendish Scott.
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August 27th, 2018
September 15, 2018. About ten years after being introduced ISO 9001:2008 will be withdrawn. If you remember the 2008 changes – they were minimal. Indeed the standard has not changed since 2000. So after 18 years, the old standard will be withdrawn.
Often we hear criticism about how the standard changes too frequently but even if it was substantial changes every time that would still be only every 8 or 9 years. If your management system is not evolving faster than that you have more significant problems than a new standard. A change in the standard is an excuse to review things, push them, get everyone to improve.
Despite any prior warnings, it is reasonably sure that September will come and go without any fanfare and nothing notable. Anyone needing to beat the Sept 15 deadline should have already transitioned. There might be some last minute questions but no frenzy and nothing unusual.
However, what happens after September 15th?
The new standard has explicitly included many new requirements that encompass the strategic activities a company has. Strategy was probably always implied in ISO, but because it was not explicit, organizations minimized it, and certification auditors ignored it. Development of a clear direction for the organization is essential. It’s the basis of creating a culture and leading the organization where it needs to go and like everything else in the organization will form the basis of what quality is trying to achieve. ISO doesn’t demand complicated procedures, but it requires some discipline and definition, and this is a significant enhancement. The procedures should pull the whole organization together. If organizations have transitioned and done it well – the benefits are going to start coming.
The benefits are many. Organizations used to minimize the ISO control over their objectives and their change management activities. ISO has circumvented this too, insisting on meaningful and valuable goals with detail to ensure they will be reached. Similarly, it asks for the detail behind providing change is managed effectively. There is no downside to this, just more benefits.
Organizations who transitioned, who implemented these new requirements, controls, processes, need to reflect on them and reorganize them as necessary to ensure they maximize the value from them. If they cut corners, its time to review and optimize. It is fair to appreciate that some organizations did just that to transition. They thought they understood the requirement, the auditor explained it differently but passed them. Now there is time. Focus on the benefits and start to get the value from the system.
Some organizations decided not to transition. They typically did not get any value from ISO and did it because a customer demanded it. They complained about competitors without ISO getting contracts and did not promote their ISO. The costs of some significant changes with this transition were enough for them to put it off to save the effort and the money. The question here is “Will ISO 9001 go away”? If the standard is going to be dropped then these organizations will be on the leading edge. However, that is not likely. ISO still provides benefits for any customer. A customer can demand it without much effort and it “should” assure quality.
Moreover, customers also see these changes coming in, and they see them as hopeful to further the assurance of their supplier base (which fundamentally is all they are concerned about – as well as the cost of course). Agreed there are some circumstances where ISO doesn’t work for customers, but those organizations, those that claim ISO but let their customers down are usually dropped quite quickly by customers. So, if you did not transition, that may prove to be a mistake.
Some organizations did not transition on time but recognize or have been told by their customers that they need to get it back. If they are quick, then the transition will be an upgrade project to their previous system. If they leave it too long, then it will be like starting again.
It is hard to perceive a situation where ISO will go away. The basic principles behind ISO are hard to ignore and done right it will work well for both the customer and the organization. If organizations do it right, do it well then there are few contrary arguments, and there are serious benefits to be gained.
Cavendish Scott has been helping organizations obtain the benefits from ISO for over 30 years. We have always taken a process approach and applied the management system principles in a meaningful and valuable way for the organization. Practical solutions in an easy to maintain solution that reflects the way the organization works. If you have any questions about your current management system or transition or improvement of your system, then talk to Cavendish Scott .
We are prepared to assist your organization in transitioning from 2008 to 2015. It is not too late to get started. If you are on the fence about whether or not you should transition, reach out to us, we would love to talk.
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August 20th, 2018
The 2008 version of ISO 9001 will be officially withdrawn on September 15. The changes that came with the 2015 version were initially controversial, but have now calmed down and will soon be the new “standard.”
The controversy was created by the nay-sayers who took extreme opinions on risk in particular and how it will be applied to organizations. Another set of concerns arose over the lack of procedures , mistake proofing, knowledge and any topic that allowed nay-sayers a voice.
We have seen certification bodies take a more pragmatic view than this and generally they are very open to any evidence they see. It is clear they are or have been worried about their clients transitioning. Because of their worry, certification bodies have worked to make the transition as easy for them to stay customers as possible. In some respect, this dumbs down the standard, and because of this approach, it is possible that some ISO 2015 certified organizations did not fully understand and implement the changes. In turn, these organizations will not see the benefit that those changes will bring. We hope that this will change in time as follow up and surveillance auditors insist on better solutions.
The quality issue is much bigger and more complicated than succeeding in an audit that they shouldn’t have passed. Customers know, they know what ISO expects – they expect it too. They know, they were looking forward to a better ISO solution and are disappointed if they do not find it in their suppliers.
Certification organizations are not alone in taking the easy way out. We saw the major ISO training direction organizations IRCA and Exemplar Global, take different approaches to the new standard. One insisted on class-based skills training of 16 hours to understand how to audit the new standard. The other provided some online content and an exam – maybe 2-4 hours.
Welcoming the changes
The changes to the standard are excellent. Finally, documents are only needed if they are required. The flexibility of risks makes everything practical, and the inclusion of strategic processes for quality mean the whole organization is pulled together in a real success focused and forward-looking organization. It is always possible to look at things in the worst way; however, we at Cavendish Scott choose to see the new and changed requirements as a positive step forward. We work to get the best possible outcome in each change. The ISO 9001:2015 standard is an excellent standard that can help any organizations.
The impact of a new standard
However, good or bad the changes have had an impact. About a year ago different industry-leading organizations were reporting that as many as 40% of certified organizations were not transitioning. While it is likely that figure has moved some; it is probable a large number of organizations have chosen not to renew their certification.
Not renewing certification may be a big mistake. A robust QMS assures lower cost and designs greater confidence in performance. Customers need that and ISO provides them with this solution without having to know the details. There may now be a tremendous opportunity for all of the organizations that did transition to take business from those that dropped certification.
Time will tell, but the customer and their need for confidence are more important than ever. Newer, more dynamic, more flexible organizations need to demonstrate their reliability. Many organizations will find ISO is the way for them to do it. Customers will buy into that. They have historically. Established and inflexible organizations that suddenly do not have ISO might pay the price.
Cavendish Scott has been working with management systems for over 30 years. We take a practical solution that is success focused and optimized for the organization. We maximize value from the solutions we develop and guarantee certification. If you are a new and upcoming organization that wants ISO to demonstrate how good you are to the market or just for more information about how you can transition click here. Feel free to ask a question here or let us know about your project here .
Still swimming through all of the changes from 2008 to 2015? We offer IRCA Certified Transition Training courses. Click the button below to see when our next course is being offered and make plans to attend!
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July 30th, 2018
Around the world, there are many professional auditor registration organizations. In the UK it was the Institute of Quality (CQI) that formed the IRCA (International Register of Certified Auditors), and it was natural when the ASQ spun off RAB, since split to ANAB and RABQSA now Exemplar Global. In the USA Exemplar Global is the most recognized and essential quality auditor scheme. Exemplar Global as expanded to other auditor schemes and formed alliances for instance with QSA in Australia to become more diversified and more relevant.
Exemplar has set criteria to be able to recognize the professionalism of auditors. They define qualification requirements for direct auditor training, educational requirements, work experience and direct audit experience. Exemplar’s criteria align with the international thinking set out in ISO 19011 (auditing standard) and 17021 (certification body requirements) and also has a set of principles to quantify competence of auditors which is a challenging but essential task.
In support of the audit registration and recognition processes, Exemplar Global has defined training requirements in a broad sense for the training of management system auditors.
While IRCA does the same things, they have much less of a presence in the US and Exemplar Global’s training and auditor scheme while an equivalent with IRCA, it is sometimes better recognized.
Cavendish Scott has always designed their training solution to be recognized by both schemes, but now it has formal partner status with both IRCA and Exemplar Global. If you attend our ISO 9001 Lead Auditor class, you will receive two certificate – one for IRCA certification and one for Exemplar Global.
As an added benefit, you will be enrolled in a one-year free associate membership with Exemplar Global. Formal status to develop and enhance your career. Cavendish Scott training is designed to give you a full understanding of the subject matter. We approach training from a professional perspective with a focus on accelerated learning and training that is a mix of activities, exercises, discussion, and presentation. Our five day lead auditor class as no more than 15 powerpoint slides for the whole week.
To attend a Cavendish Scott ISO 9001 Lead Auditor training class click here .
Cavendish Scott hosts Lead Auditor Training Courses every other month. Click the button below to see when our next course is offered and make plans to attend.
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May 8th, 2018
Transition Time is Here
The time to transition to the new version of ISO 9001:2015 is upon us. Many have put off the transition for a host of reasons and we are now at a point where it is time to act. Differing opinions exist about how easy or how hard the changes will be, but there are many factors that come into determining that.
While it is possible to interpret the changes simply, or perhaps your auditor has always made your audit easy – implementing the letter of what is included in the standard or taking the simpler shortcut, you still have to consider that this year – you might get a tough auditor. Frankly, that’s a good thing. You are making an investment in quality, you should get a return. Nobody wants to fail their audit but it would be useful to know where there are opportunities. It would be useful to get pressure to be disciplined and organized, in a meaningful manner.
Irrespective of whether your Certification Auditor tells you how easy it is or your quality manager tells you it means a whole new solution, the goal of getting through the audit still exists. Transition problem number 1 is that any decent ISO resources are going to be already booked. If you have not reserved your help you may be too late.
As we progress internally, what is needed are quick and simple ideas to get the project on track and help navigate it to a successful solution.
Trick #1: Focus on Quality, not Requirements
The standard has changed significantly. The newer areas include the concept of allowing the organization to demonstrate conformance rather than dictating how it is done. This includes strategy, risk, and knowledge. There are also significant changes to Objectives, Change, Communication. As you can see, there are a lot of new requirements.
One of the more visible signs of the changes is the restructuring of the standard to adopt the annex SL approach. In some quarters a little controversial but probably overall a good idea for consistency going forward. A whole new standard to learn. Yes. You cannot argue the need to learn the new requirements if you want to get or remain certified.
One thing that has not changed; ISO is about QMS and QMS is about quality. This has not changed, not in the 31 years of its existence (since 1987). If you designed your ISO solution to be a QMS focused on quality then you probably have a good solution and your basic solution can stay. Yes, some new ideas (which because you focused on quality originally, you probably already addressed to some degree) and some changes to help focus and improve discipline perhaps) but the fundamentals are already there. Ensuring the focus is on quality and not directly on requirements will ensure your solution evolves through the transition in a meaningful way. It is a lot easier to get support and resources for something that makes sense.
Trick #2: Skip the Gap
Focus on outcomes. It is very common to insist on a gap analysis. Technically in most project management situations, this is an important step in determining where you are versus where you want to be. In this instance – less so. So much so that a gap analysis should not be required. You have a reasonable system. You have implemented ISO 9001:2008 and you meet those requirements well – your certification body has already confirmed. You audit your processes – thoroughly and effectively – and your certification body confirms it as well. Bottom line is you already know where you are. That is part of what having a QMS is about.
The next step is to determine where you want to be. You also already know that. You want ISO 9001:2015 certification. The gaps are defined by the differences between 2008 and 2015. But what does that mean specifically to you? Same answer. The Gaps are identified. Solutions are another matter. The purpose of a gap analysis is not to determine solutions.
The main function of transition is knowing where you want to be. Solutions require review, thought, and pondering. You need to put some time into determining what the best solution will be based on all the inputs. This might require analysis, brainstorming, consultation.
For instance, in 2008 we had preventive action. In 2015 we have to include a risk process. It’s a clear gap. There is nothing to explain what the solution should be. Your solution might have a weighted colored risk matrix with defined criteria and definitions for each characteristic. Or it might require a simple list. The solution needs to be appropriate and effective for you.
Don’t waste time quantifying gaps. Invest in a comprehensive, solutions-based, project plan.
Trick #3: Documents – You Need Them
ISO removed the need for many (any?) documents. So what? The standard changed in a really valuable way. It never made sense to require a procedure for internal audit but not for engineering. Why should ISO say what documents are needed in an organization?
By not insisting on any particular documents, the standard created a lot of confusion. With this change organization’s thought: “Now I don’t need any documents.” That is not what it says and it is definitely not what it means. First, the standard should not tell anyone how they demonstrate their system. By specifying mandatory documents and records it imposes tasks on organizations, to create and maintain the documents, this is something a standard has no business doing. Whether the documentation is good or not, it is not a standards place to say how. Further, by specifying, it implies that these are the only documents required and that if others were needed then they too would have been specified. Remember the ‘six mandatory procedures’? Not true and not what it says but that’s what happened. This alone led to terribly structured and impossible to operate solutions.
Now you may be saying: “But the new standard is worse or at least more confusing”. No. It clearly says that you have to be able to operate your system and demonstrate it. While it is possible to do this without documentation, getting this right is really difficult. The documentation describes how we define the process (and system) and without the documented description it is not possible to communicate it for clarity, training, reliability, or verify it or audit it. You can achieve this without documents but it is not easy. Bottom line: you need all the procedures, documents, and records. This has little to do with ISO and everything to do with operating a successful organization (and being able to demonstrate it).
Trick #4: Bring Quality into the Boardroom
Forever we have had our ISO programs led by dedicated professionals – the ISO Management Representative. In some quarters there has been noticeable confusion over the management representative. Often the ISO guy is not the representative. They do all the work but a VP covers the official role. This can be both good and bad. The 2015 standard removes the requirement for a management representative which many imply as getting rid of the role.
Let’s get one thing straight, there is no suggestion of getting rid of the role. The title is not discussed but it equally the standard does not say you cannot have one. This is up for the organization to decide. The important task here is making sure the responsibilities – all the responsibilities – for quality are properly determined and communicated. If you change this role or title or activity ensure the responsibilities are managed correctly. All too often the ISO guy is tasked with keeping or getting certification. But it is not the job of one quality guy.
Now, look at this point from a positive perspective. The management representative may lose a title but they still should oversee the system. Now the system includes the organizational purpose and strategic direction for quality formally included in ISO. They are obviously important to quality – essential in ensuring everything makes sense. It will not be possible to achieve certification if these elements are not part of the solution. This gives access to very high-level processes in the organization such as strategic and business planning. The management representative now has access to top management, and in a way has become a part of top management.
Trick #5: Identify the new ISO processes
ISO has introduced new, sensible, and important processes, however, we have found most if not all organizations already do these things. New requirements bring new processes and new controls. As discussed earlier, if it is important in an organization, then it is already being done, perhaps informally but still getting done. This is true of the big new areas brought into the ISO 9001:2015 standard. New to the standard…less so for the organization.
Business Planning, Strategy, and Purpose – the standard is very specific and requires us to start our quality systems with reference to organizational purpose and strategic direction. This helps appreciate that context is about understanding the environment and influences that affect quality so that planning can be completed…in context. Larger organizations already have a strategic or business planning process. Often quality is not explicitly included but can be achieved easily by adding a few simple controls to the process. In small organizations, it happens just the same. For instance, the owner goes to dinner once a year with their accountant and discusses how things went and what they want to happen next year or perhaps the owner has ideas for new products or new markets that should be pursued. At the moment this is informal, without structure, but it is being done and it just needs to add controls, some discipline, and organization. Let’s be clear about this, we are not doing this for ISO. We NEVER
Philosophy: Keep it Real
Never forget what we are doing here. The most important thing about ISO is that it is about QMS. What is QMS about? It is about being successful. To be successful you have to be effective, efficient, improving, and profitable – every good characteristic of an organization that you care to characterize it with. Whenever you are writing procedures, designing solutions, looking at controls, implementing ISO you need to proactively ensure you apply that principle always. Everything you do in ISO is good. If its not….stop it.
Cavendish Scott, Inc has been working with ISO for over 30 years. We are process and management system experts and craft solutions that don’t ask organizations to change to meet ISO, We see how ISO meets what you already do. Our focus is on solutions that are meaningful, help management deliberately achieve success and also happen to get them ISO certified. Guaranteed in writing. We have never had a failure. It is this experience that allows us to identify 5 tricks and 1 philosophy. If you have questions? Just ask! info@cavendishscott.com . Colin Gray has been consulting, training and auditing with Cavendish Scott for 30+ years. He has an MBA from the University of Middlesex, UK, and is a lead auditor for quality, environmental and information security.
If you think an ISO 9001:2015 transition is too expensive. If you are leaving your transition until the last minute to save the cost earlier. If your certification body is overly demanding. This transition workshop is for you. In two days we will have you ready for a quality transition.
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April 13th, 2018
Recently, Cavendish Scott presented at the International Conference on ISO 9000. The theme for the conference was “transition”. There were many presentations about interpretation and easy solutions. Overall, the conference provided a great forum for discussing transition.
The experts from the Aerospace industry provided fascinating feedback about transition. As of February 2018, there were less than 50% of AS9100 certified companies that had completed transition to the 2016 version of the standard. Obviously, some organizations have completed the audit stage but have not yet finished all their corrective actions or other paperwork, which could elevate the figure some. It is not clear how much, but it is not likely those who are actively working on their transitions will move the needle.
A speaker from the ANAB accreditation agency gave similar figures for the 9001 transitions. Less than 50% transitioned. Again, the numbers were a few months old and there are organizations who are in the process but not yet completed.
These figures are very interesting. They can mean several possibilities.
It could be that management has not recognized the importance of the transition and are assuming that 6 months to complete it is plenty of time. It could be management does not appreciate the timing, resources needed, and effort required. It could be that management have deliberately put it off as long as they can to minimize financial impact.
However, when you look at it you must acknowledge that this is a management problem. Did their quality function correctly inform them? It would not be the first time that management heard what they wanted. Whatever the reason, it is clear is that 50% of organizations are not going to be able to transition before September. There are not enough consultants, trainers or certification auditors available to help.
This means some organizations will drop certification and others will go into suspension. While other organizations will be working to re-establish certification after the deadline.
ISO is all about QMS and QMS is all about being deliberately successful and having reliable consistent quality. An organization’s quality does not change because of a lost certificate. If a company has a strong and optimal QMS (which is what ISO encourages) then the business, control, profitability, etc. should not be impacted. However, without a certificate, it may impact customer relations as well as current and potential contracts. There are major customer organizations including the government and government contracts that “require” certification. In that instance, suspension or losing a certificate can create serious problems for the organization.
What can a company do in this situation?
If you are in the Quality function you need to convince your management of the urgency. This is NOT a simple transition. This transition requires resources and effort. An organization that wants to transition needs to start NOW. Getting on the calendar with your certification body is essential. Phone them now. In fact, many organizations already have a transition date…. they just haven’t done anything and don’t know what to do.
Given the limited timing and lack of resources available, Cavendish Scott has put together a 2-day intensive workshop to help organizations complete their transition quickly and easily. All the necessary transition activities that can be completed in a workshop are going to be addressed.
Attendees will be walked through document changes. They will be given new tools. They will receive training and support.
At the end of two days they will be as close to transition as possible – acknowledging that some things will have to be completed on site.
In a time where outside help is going to be hard to find and expensive, this is a great opportunity for anyone who needs transition. For more information about this program click here.
Cavendish Scott has been helping organizations with ISO certification and management systems since 1985. We craft meaningful solutions that work for businesses and have never had a failure at ISO assessment. We give fixed price solutions and guarantee success. For more information about Cavendish Scott or to discuss your project with us contact us.
If your organization is transitioning to ISO 9001:2015 or if you are an auditor who needs to sharpen knowledge on the ISO 9001:2015 standard this training course is for you.
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February 22nd, 2018
Continuing education is a must to maintain your ISO certification. After all, the overarching point is continuous improvement, and that requires staying abreast of rule changes as well as learning new implementation and audit strategies. Unfortunately, not all ISO training is created equal.
Consider this cautionary tale A young woman attended an ISO workshop taught by one of our Cavendish Scott instructors. Over the next few years, she was sent to several other trainings, under the tutelage of a different organization. She described one instructor, in particular, as “horrible.” She formally complained about his rudeness and lack of preparation, but never even received a response.
Later, she attended another course taught by that same instructor, and had the same entirely negative experience. The venue was itself was run-down, the ceiling leaked, and the instructor’s comments directly contradicted her previous training.
Needless to say, she was upset and frustrated. This time, her formal complaint to the training organization was met with a retaliatory complaint to her boss that she had been “disruptive” in class. The response to her specific concern about conflicting information was that “you can’t expect a consistent answer because ISO is very widely interpreted.”
Enough, already! ISO is all about quality. The quality of your training directly determines the quality of your ability to follow up. To train your own colleagues. To audit accurately. And implement beneficial changes. So what does it take to ensure a superior training experience?
Clean, comfortable surroundings, of course. Beyond that, three critical factors:
Highly-skilled, professional trainers
Personalized attention
Hands-on, real-life problem solving exercises
Knowledgeable, experienced trainers not only know ISO inside and out, they take the time to offer insightful recommendations and ensure that attendees understand the nuances and ramifications of ISO guidelines. That’s what enables attendees to go home and make smart, competent decisions for their own company and situation.
At Cavendish Scott, every one of our ISO courses incorporates these three education principles. But there’s more. Each of our classes also includes an actual audit takeaway, to further learning relevance.
What do our attendees think? You guessed it – rave reviews:
“This has been the best, by far, lead auditor course I have taken.” “Instructor was amazing and very knowledgeable.” “The custom training provided to Managers and to our internal audit team is truly appreciated.” “There were a lot of activities to ensure you walk away knowledgeable and prepared to audit.” “This course gave me an entirely new perspective to audit from!” “We had several new auditors and she was attentive to their needs, working one-on-one with each to make sure they grasped the material.” “By the way, we had our surveillance audit yesterday and there were NO non-conformances found.” We’re pretty proud of reviews like these, just like we’re proud of the quality training we deliver. It’s our way of helping you make the most of your ISO certification. Isn’t that what you and what your customers expect?
Be sure that your ISO 9001:2015 certification goes smoothly. A Cavendish Scott expert consultant can help you get it right the first time.
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