If a company wants to obtain ‘ISO’ certification, it has to implement a quality management system. How do you go about doing that?
Developing and utilizing the QMS — as well as the subsequent audit — are going to take time and effort.
If you’re doing it purely for marketing’s sake, if you think you can knock out a QMS and pass a certification audit in a matter of months…you’re in for a load of grief. You’ll never get a solid quality management system under you AND you’ll never make deadlines, because they’re unrealistic.
If you build a QMS because you want to provide your customers with the best everything — if customers are the reason for everything you do, including the quality management system – you’ll take the time you need to get it right, you won’t set unrealistic goals and deadlines, and you won’t drive yourself crazy trying to figure out why you never meet expectations.
Keep in mind that a core problem with ISO 9000 implementation is communication. An effective quality implementation is really about effectively communicating with customers, suppliers, employees, and management to indentify, meet, or exceed requirements. Quality, sales, marketing, design, manufacturing, accounting, and management must all communicate using the same language.
It starts with collecting the customer’s requirements from the customer (i.e., voice of the customer), communicating customer requirements to design/development, and design/development communicating what they think the customer wants back to the customer for confirmation through verification and validation. Then design/development communicates specifications to purchasing, manufacturing engineering, and quality/testing to ensure it is made as designed.
Quality must communicate to management via internal audits, management reviews, and quality objectives that the system is capable of consistently reproducing the product or process. The company communicates its consistency to its stakeholders via its quality policy, ISO certification, and management commitment.
Management communicates its quality commitment by allocating budget for continuous improvement using corrective action and preventive action, training, and infrastructure expenditures. Waste is produced as a result of poor communication between one or more of the groups or departments within an organization. Total up the cost of all of your nonconformities, defects, and deviations from plan and you get the cost of poor communications.
When we talk about effective communication, we are talking about a real two-way exchange of information. Both the sender and receiver must be actively engaged and providing feedback for it to be effective. Implement an effective quality management communication system and the savings will be huge.
OK, so they’re not really easy steps…but the concept itself isn’t at all complicated. Each of the steps above is broken down into successively smaller pieces (things, activities, people, etc.) but if you start with the “big picture” and keep the big picture handy, you’ll do fine. Refer to it continually as you build. That’s where a lot of companies go wrong — they focus on just one partof the whole story as if that were the whole story.
The position of an ISO 9001 Management Representative is described in Clause 5.5.2 of the ISO 9001 2015 Procedures Management System (QMS) Requirements. It’s been brought up whether the ISO 9001 Management Representative really needed to have the title “manager.”
I think we can take the words of the standard itself – “appoint a member of the organization’s management” – to indicate that it does need to be someone with at least the title of manager. But we can also use our own common sense and organizational experience to understand the reasoning behind this ISO 9001 requirement, even though it is not explicitly stated.
First of all, the person responsible for managing the ISO QMS needs to have a fairly high level of authority in an organization. They need to be able to make decisions, apply resources, and implement changes in the organization related to the QMS without having to seek permission or feel that they are overstepping their authority. The QMS touches many disparate facets of an organization. Someone in a low position of authority will not be able to effectively implement and manage the QMS.
Secondly, the ISO 9001 Management Representative needs to be someone in a secure position in the organization who feels they can tell the truth to top management. That usually means someone at, or near, the top management level. Someone lower in the organization is usually not comfortable telling the truth to top management (for whatever reason, fear, intimidation, feeling out of place). An ISO QMS that does not have open communication to top management about its functionality and effectiveness will not truly benefit the organization.
Finally, if top management is not willing to use someone with real authority or power in an organization as its ISO 9001 Management Representative, what does that say about their commitment to the QMS? In my opinion, the ISO Management Representative needs to be a least a manager, and in larger, multi-tiered organizations it may need to be someone even higher in the organization.