Yes, you must include all personnel who affect the performance and effectiveness of the QMS. Exactly what the competency requirements are is up to you.
7.3 AWARENESS
Equivalent to clause 6.2 of ISO 9001:2008, with some minor additions.
This section of ISO 9001:2015 is a compilation of previous requirements, along with a couple of new requirements thrown in. The title “Awareness” is perfectly apt, as you’re simply making employees aware of certain things. They’re not expected to be experts on any of the topics. Awareness can be achieved through a meeting, email, newsletter, discussion, bulletin board, training, or whatever other method you deem appropriate. The proof of having done it is the employee’s understanding of the topic. Here are the topics you must ensure employees are aware of:
The quality policy. Employees should be aware of the quality policy’s existence and what it means to them. Some key words or concepts are all that’s necessary. Most quality policies discuss the organization at such an abstract level that it would be hard to say much more than a few key words. Employees could also demonstrate awareness by describing how their own tasks and activities help support the concepts included in the quality policy.
Quality objectives. The organization’s quality objectives have a sharper edge than the quality policy. They’re more specific and actionable. An awareness of the quality objectives will be harder to achieve simply because the topic is much tighter. An effective awareness campaign on objectives usually includes the following elements:
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Description of the objectives and what they indicate✓
Explanation of why the objective is important to the organization’s success✓
Illustration of how employees can contribute to objectives in their day-to- day activitiesDuring an audit, it’s common for personnel to be asked what objectives apply to their jobs and how they contribute to them. Make sure that everybody understands this in clear terms. It’s important from the standpoint of an audit, but much more important from the standpoint of effective operations.
How employees contribute to the QMS. The majority of employees contribute to the QMS by correctly applying its various components in their jobs. They access documents, utilize training, contribute to organizational knowledge, and monitor and measure processes and products. Simply make employees aware of the QMS tools and their correct use. The two biggest benefits of improved performance are customer loyalty and the long-term success of the organization. These are obvious, but it’s a message that can’t be sent too often.
What could happen if the QMS is not followed. This is a fun topic. You’re making employees aware of all the bad things that can happen if they don’t conform with the QMS (i.e., correctly use the tools of the QMS). Here are a few of the negative effects:
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Nonconforming product✓
Dissatisfied customers✓
Wasted resources✓
Higher costs✓
Loss of sales✓
Reduction of profit✓
Greater organization risk✓
Potential loss of employmentThe list goes on and on. Ideally, employees should be able to discuss the implications of not conforming with the QMS in their specific part of the operation. The whole point of this awareness is to drive home the significance of the QMS. It’s not an optional program. The QMS is literally how we run the company and stay in business.
7.3 FREQUENTLY ASKED QUESTIONS
Do we have to keep records of making employees aware of the quality
policy, quality objectives, and the like? We view the awareness activity as
being very similar to training.
No. Strictly speaking, ISO 9001:2015 doesn’t require records of awareness activities, though it does require records as evidence of competence. It all depends on how you view this activity and what sort of accountability you need.
7.4 COMMUNICATION
Equivalent to subclause 5.5.3 of ISO 9001:2008, with new planning requirements. There have been communication requirements in previous versions of ISO 9001, but they were weak compared to this. ISO 9001:2015 requires a fully proactive approach to communications. In essence, the organization is required to develop and implement a communication strategy. This doesn’t mean that you can’t communicate messages on the spur of the moment as information is needed. Of course, you can. It
simply means that the organization must at least have a communication strategy in place and use it as a starting point. ISO 9001:2015 lays out a five-point structure for a communication plan:
1. What are you trying to communicate? This is exactly what it sounds like. What message do you want to share? Examples might include monthly production numbers, orders to be shipped, status of regulatory permits, and employee anniversaries with the company. ISO 9001:2015 doesn’t require you to maintain documented information of these details, but I’ve never seen an effective “plan” that wasn’t documented in some manner.
2. When are you going to communicate? For the various topics identified by the organization, when will the communication take place? Answers might include “the third Thursday of every month” or “9:00 a.m. every Monday.” There are no right or wrong answers to frequency and timing of your communications. The plan is simply an attempt to establish some discipline and accountability around the process of communication.
3. Who are you communicating with? Every communication must have a target audience. The more targeted, the better. In these days of information overload, it’s important to tailor the message to the audience. Define exactly who the audience is for each type of communication and make sure the content of the message is appropriate.
4. How are you going to communicate? The choice of communication media is almost limitless. Sometimes the high-tech option is not the best option, however. Consider the sensitivity and importance of the message and the need for two-way dialogue.
5. Who is the communication coming from? In other words, who is responsible for making sure the message is heard? The more critical the message, the more likely the communicator will be a member of top management.
Here are some examples of how this sort of planning might look like for some different types of communications:
Daily production meeting
1. What: Orders in process and orders due to be shipped 2. When: Monday through Friday at 9:00 a.m.
3. Who to: Department managers, supervisors, and shift leads
4. How: Stand-up meeting beside the time clock, approximately 10 minutes in length
Employee news 1. What: Employee birthdays, work anniversaries, and family announcements 2. When: Monthly, on the third Thursday 3. Who to: All active employees at the Atlanta facility 4. How: Company newsletter emailed to each employee and posted on bulletin boards 5. Who from: Manager of human resources Corrective actions and complaints
1. What: Current status of all corrective actions and customer complaints, including new proposals for action
2. When: Friday afternoon at 1:00 p.m. 3. Who to: Improvement team members
4. How: In-person meeting in the North conference room (unless otherwise announced)
5. Who from: Quality assurance technician Regulatory overview
1. What: New regulations on the federal state and local level. Also current status of all permits and inspections. 2. When: Quarterly in January, April, July, and October. Exact date and time to be announced. 3. Who to: Environmental health and safety representatives, lab supervisors 4. How: Teleconference (audio and video) 5. Who to: Director of regulatory affairs
It would be impossible to identify all communications generated by the organization. Just cast a big net and try to capture the important ones. Documenting your communication plan in a matrix similar to the one shown in figure 5.2 would make a simple and user-friendly tool that everybody would understand. Is documentation required? No. ISO 9001:2015 makes no mention of retained or maintained documented information, but undocumented plans are very difficult to communication consistently.