“So…. You’re telling me we need to update to the latest ISO standard before September 2018 or risk losing our accreditation and most likely a good many of our customers? ”
“I only have 2 questions: How long and how much?”
As the deadline for ISO 9001:2015 rapidly approaches quality managers need to carve out time to make sure they are ready. Most are consumed with managing the daily aspects of the company’s QMS. Now they are being asked to take on the additional role of project manager. And this is not a simple revision change – there are major changes in the way a quality management system (QMS) is viewed as part of your organization’s strategic direction.
There are 2 costs involved. The first is the cost of the certification itself. To get this you need to call your registrar. While you’re at it, start addressing the 2nd question and ask when they are available to audit. You can expect there to be a rush as the deadline approaches and limited space available to fit you in. And most auditors will want to see that your system has been up and running for a few months at least. Booking time now will determine your project timetable.
By far the bigger cost is getting ready for it. How much this will cost? Well …… it really depends (probably not the answer the boss wants to hear). What it depends on, to a great amount, is your senior management’s commitment. One of the key changes to ISO is the requirement for Top Management to be more involved. Getting their backing will reduce costs and better still, reinforce the “quality culture” in your organization.
The next cost in getting ready is to determine where you are now and what gaps you need to fill to meet the new requirements. In order to adequately assess the work involved, determine next steps and prepare cost estimates with some degree of accuracy, a gap analysis is required. So what to do about this? Do we go it alone with our internal resources? Do we download a set of templates (like the free templates from Oxebridge)? Do we hire a consultant? Or how about a contractor to come in-house, write procedures, do internal audits? If you are looking for outside help, Quality Digest posted a few simple guidelines to help you choose the consultant best suited to your needs. A good ISO consultant will save you time and money. They have a wealth of experience and will save you from repeating mistakes others have made in the past.
You can also download this Toolkit that contains:
- An ISO Project Tracker,
- a matrix to show what elements need to be addressed in your QMS,
- a short list of required documents and
- a list of documents that are implied but may not be obvious (some of these may surprise you).
These are simple tools you can put to work today. Knowing what is needed, who is responsible for getting it done and what time frame it’s needed by will save you time and money.
Again it depends. As you are already certified to ISO 9001:2008, you have much of what is required in place:
- A senior management team committed to quality (they all need to be committed)
- A quality culture in the organization (some improvement here is always welcome)
- Documented systems and procedures (it would be nice to get some of those roguespreadsheets under control)
Many claim the whole process can be accomplished in a few months. If your goal is to put a patch in place to pass an audit, perhaps they are correct. But if you really want to make a difference in your business, take the time to do it right (it’s not the destination but the process of getting there that brings real structural change). With change comes learning and continual improvement. This takes time and trying to cut it short isn’t usually a good idea. That said, starting sooner will yield better results and less stress.
Generally, here are the major steps you’ll need to include in your project:
- Purchase and read the new standard.
- Use the Toolkit’s cross reference table to understand how the new ISO 9001:2015 requirements fit with your current ISO 9001:2008 QMS.
- Seek training or consulting assistance, if needed.
- Contact your Registrar for details about their transition plan and any additional costs.
One thing to keep in mind when setting up your schedule is to decide the best time for your company to transition. Typically, transition audits are done as part of a normally scheduled surveillance audit or recertification audit. By scheduling transition during a regular audit, there will likely be little, if any, additional audit costs. Be sure to ask your Registrar.
- Use management review and the Toolkit’s Project Tracker to coordinate transition internally.
- Conduct a gap analysis.
- Develop a detailed transition plan (using the Toolkit’s ISO Project Tracker).
- Make necessary updates to your QMS (use the Toolkit’s Document Guide).
- Provide training for your managers, internal auditors and employees (plan this with the Toolkit’s Project Tracker).
- Conduct a full internal audit based on ISO 9001:2015 requirements.
- Address non-conformances through corrective action.
- Complete the transition audit by your Registrar.
Use the Toolkit to get your list of required documents in hand, complete your gap analysis and get your project list ready to roll out. Call your auditor to schedule their time and work back from there to set up the rest of your timetable, tasks and due dates. If you have CIS – Continuous Improvement Software, take advantage of the Management Meeting feature to automatically track, schedule, notify and monitor all participants and manage your entire transition process. If you don’t have CIS, invest in a demo to see how this will simplify your entire transition project (and keep on adding value thereafter).
So, it is probably going to take longer than you think and cost more than you want (there’s a life lesson here). The key is to take the first step, start early, plan your upgrade project with top management commitment and avoid costly surprises along the way.
You may be looking for an easy-to-use, comprehensive tool that ties all this together, keeps all documents secure and updated and makes sure everyone is on track. Our company provides Continuous Improvement Software that integrates with your quality system, is fully customizable to your procedures and manages all timetables and communications. We are here to help.