Slide 63 of 262
This is meant to give you a basic idea of the intention / requirements. A detailed discussion is presented in Clause_Interp_and_Upgrading.doc.
5 MANAGEMENT RESPONSIBILITY
5.1 Management Commitment
Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by:...
But who IS ‘Top Management’? If it’s a small company and the owners do not participate on a regular basis you may want to omit them. In some smaller companies the owners really don't participate much but rather have 'handlers' (such as 'Director of Manufacturing' and 'Director of Quality'). Some companies have only 1 person watching the show (such as 'Manager of Operations'). I have had clients where the company owners were not even at the audit. Even though they 'actively' participated in the business. Their position was that they had designated who top management was and they were not part of it. This doesn't go over well with auditors in general but there's nothing they can actually do about it. Most often the organizational chart is what is used to define what positions ‘Top Management’ consists of.
> Do you think I should "Identify" for clarity sake who (by job title) is defined as TOP
> MANAGEMENT Under terms & definitions?
Depends on how often your organization chart changes and whether the positions are stable. It's a good idea, but don't get caught with something that will keep you 'on your toes'. In some companies management positions frequently change names and new ones come and old ones go. In other companies they are very stable.
a) Communicating to the company the importance of meeting customer as well as statutory and regulatory requirements,
Communicating the importance of these three compliance aspects are done in a number of ways. Company news letters, computer logon screens, from within appropriate company procedures. Some companies have TV monitors which are used for, among other things, 'indoctrination' in the importance of these. Some companies use posters (as is commonly seen in safety programs). Communication also typically takes place in an employees initial training.
Potential Audit Question: How is this done?
b) Establishing the quality policy,
Requirements for the quality policy are defined in clause 5.3 of ISO 9001:2000. The documented quality policy has to be controlled according to the requirements of clause 4.2.3. Some organizations may be revising their quality policy for the first time, in order to meet ISO 9001:2000 requirements, and will need to pay particular attention to clause 4.2.3 (c), (d) and (g).
* Requirements for the quality objectives are defined in clause 5.4.1 of ISO 9001:2000. These documented quality objectives are also subject to the document control requirements of clause 4.2.3.
c) Ensuring that quality objectives are established,
Note that here the operative word is objectives. The quality policy must contain objectives. These objectives must be measurable objectives (think data). Objectives implicitly imply that you have defined 1 or more measurables to enable you to determine whether objectives are being met or not. These will be looked at closely by your auditor. I suggest that 1 measurable is not going to be enough to satisfy an auditor.
d) Conducting management reviews, and
Management review is first mentioned here, but beware: There are places throughout the standard where the clause or paragraph specifically requires an input into management review meetings. Throughout ISO 9001 there are 'pointers' which indicate that a certain 'item' must be reviewed by or "…brought to the attention of upper management…"
The original 1987 intent of management review meetings was to ensure top management could not claim they did not know what was going on in their company. This has expanded to address issues such as control (e.g. as specified in 4.1 herein).
Management Reviews must be held a minimum of once a year. There is no requirement for 1 single, comprehensive meeting. Often different meetings cover different ‘requirements’. Management reviews are typically carried out by most companies. In fact, most companies hold management meetings quarterly, monthly or more frequently. However, often these management meetings are not 'recognized as such because of the terminology. You should note that in a number of instances this commentary will state something like "Evidence of this should be presented during Management Reviews".
The major required items which must be discussed once a year as a minimum are:
Internal Audit Status
Training Issues and Needs
M&TE & Calibration Issues and Status
Resources - Personnel
Resources - Equipment / Facilities
Supplier Quality Activities
Relevance and 'Continuing Suitability' of the Quality Policy
Quality Goals and Objectives
Customer Expectations and Satisfaction
These are typically discussed in terms of raw and statistical data. For example, in reporting on Internal Audits the Management Representative might talk about percentage of audits completed, percentage of open 'findings', and will include any specific problem areas.
Notes must be taken during Management review meetings where these issues are discussed. They need NOT be copious notes, but it is assured that your auditor will want to review at least two successive management review meeting minutes to ensure all required items are addressed. In addition, they will expect to see a carry forward and action on old business with the close out of an ‘action item’. My recommendation is to use a FORM (see Mgmt_Rev_Form.xls as an example) to ensure the auditor cannot cite you for not addressing a required item. Again, we are not looking at copious notes. But - we ARE looking for a little bit more than a checklist. A checklist without comments or some type of detail will typically be rejected. At least a sentence or two is required as 'evidence' that a discussion actually did take place.
I also suggest that either a single meeting be held which focuses on the ISO requirements or that a segment of a regularly held meeting be dedicated to the ISO aspect to avoid confusion. It is perfectly acceptable to deal with different issues in different meetings - the confusion will be when evidence is requested by the auditor and knowing what was addressed in each different meeting.
About Customer Expectations
What Are Customer Expectations?
Customer expectations are the customer defined attributes of your product or service you must meet or exceed to achieve customer satisfaction.
Are There Different Types of Customer Expectations?
There are two types of customer expectations, expressed and implied.
Expressed Customer Expectations are:
· Written, e.g., terms of a contract.
· Spoken, e.g., voice of the customer.
Implied Customer Expectations are:
· Too difficult for the customer to clearly communicate.
· Not written or spoken, but very basic to the product or service, e.g., the customer expects wheels on a car.
How Are Customer Expectations Identified?
Here are several methods to help identify your customer expectations.
· Market research
· Contractual agreements
· Focus groups
· Phone calls
· Satisfaction surveys
· Site visits
· Warranty records
· Informal discussions
· News media · competitive benchmarking
Do Customer Expectations Change Over Time?
Customer expectations change over time due to enhancements to products or services by competitors, technological innovations, or improved performance of your process.
It is important to periodically update your knowledge of customer expectations. The same methods used to identify your customer expectations can be used to update them.
e) Ensuring the availability of resources.
With regard to this issue, the auditor will look for evidence that management does consider both equipment and human resources as needs change. Typically this is evidenced in Management Review meetings.