Clause

Control of:

Meaning

The net effect is that there is no change in the actual requirements, except where noted below.

The ISO committee actually removed a number of potentially useful notes that had been included in the earlier drafts of the standard. Shame, really.

• determine the quality objectives and requirements for your products,
• ensure that you adequately plan all of the processes and sub-processes needed to provide your products/services,
• plan the required inspection/testing activities,
• identify what records must be kept, to prove that the product has been properly produced

A new note has been added to this Clause, for clarification purposes.

You must define how changes in requirements are recorded how the information is circulated around the relevant sections of your organisation.

Note: Even though you may not consider that you "design" anything, you may do! 

For example, within a Service-sector organisation, you will probably "design" the service that you supply on a Customer-by-Customer basis.

However, you should note that "design" only refers to the products or services that you supply to your customers. It does NOT include the design of software or equipment that you use in-house, for example.

Also identify all relevant responsibilities

Your inputs should include any relevant functional requirements, standards, legal requirements (e.g. mandatory safety requirements, packaging disposal/recycling requirements, CE marking requirements, etc). 

Where it is relevant, you should consider similar previous designs and learn from them.

A new note has been added to this Clause, for clarification purposes.

For example, your manufacturing department may require a Bill Of Materials, a "gold" sample, and a full set of engineering drawings, etc. Your design plans should state what is required, after you have discussed and agreed this with the recipient (whether an external Customer or an internal department).

A new note has been added to this Clause, for clarification purposes.

You must identify and record any problems and propose follow-up actions. Your plans should identify what these stages are and when they occur. 

You must keep records of these reviews.

Your plans should state how and when you plan to do this.

In some cases, validation may include reviews of Customer feedback after release of the product. This may lead to subsequent design changes, or changes in future products.  

Your plans should state how you plan to do this.

You must consider the effect that the changes may have on any sections of the design work already completed or under way.

This section is concerned with how you verify that the Vendor has supplied the correct items to you (in the 1994 version of the standard, this was usually conducted at "Receiving Inspection", or sometimes after the item was installed in another assembly ("In-process Inspection").

The second part of this section of the standard is relevant only if you intend to inspect goods at your Vendor's premises before the goods are released (whether to you or directly to your Customer) . 

In this case, you should specify when they will be checked ("within 10 days of notification by the Vendor", "following installation of sub-assembly 31", etc) and how they will be released ("not to be released until in receipt of our written release instruction", etc). This must be specified in the purchasing documents (this can be included on the purchase order that you send to the Vendor, or included in a "Terms & Conditions" document or "Contract of Supply", etc).

This section is concerned with the process of producing your goods or services. You should consider how you control these processes, including:

• information which specifies the characteristics of the product (so that inspections and functional tests can be properly conducted)

• provision of work instructions (or SOPs, Method Statements, etc). This can be by written instructions, drawings, photographs, samples, etc.

• provision of suitable equipment and appropriate maintenance of the equipment

• availability and use of suitable monitoring and measuring devices

• provision of procedures for release, delivery and (if applicable) post-delivery activities (e.g. installation, commissioning, servicing, etc).

This section is concerned with processes which produce items that cannot be tested directly.

Example: In specialist welding operations, where the the weld itself cannot be checked without destroying it. In this case, the way to ensure that the work has been properly conducted is to only use properly trained and qualified welders, with highly-specified materials and equipment. 

The resulting welds cannot be internally inspected, so all of the correct conditions must be ensured. 

Also, some of the welder's work may be selected for random tests. These are probably destroyed during the testing process, so a certain extra number are always produced, for testing purposes.

Other methods (e.g. for testing of crimped electrical connectors) might include destructive testing of first and last-off items or a sample destructive testing, etc.

In this case, you must:

• define how you review, approve and revalidate your production/service processes,
• define how you approve and revalidate equipment and personnel involved in these activities,
• use "specific methods and procedures" to control the processes.

You must also define:

• which methods or procedures must be followed when producing or servicing the product/service,
• what qualifications/experience are required for people involved in the processes
• what records must be kept

Where appropriate and to the extent necessary, you must ensure that materials and goods are identified, so as to prevent accidental mix-ups. Labelling is a typical method. Other methods include signs on the wall with a picture of the items. Metal rods can have coloured paint put the end. However, if the differences are immediately obvious, there may be no need to label goods. Do not overdo it!

Similarly, in some industries it may be necessary to be able to trace exactly which materials from which supplier were used in which goods. This may also extend to knowing which operators were involved. The aerospace industry is a good example of this sort of level of traceability. 

In the software industry, configuration management fulfils this requirement.

If you receive goods from your Customer which you then build into the items that you supply back to the Customer, then this clause of the standard applies to you. Also, if your activities involve items belonging to the Customer (e.g. if you service household electronic items, etc), you must take care of them, etc.

In that case, you must record the goods upon receipt, and check that they are suitable for use. If any problems are discovered, or it is damaged or lost whilst under your control, you must report this back to the Customer.

Customer data can be included under this heading (e.g. you provide an analytical service and you analyse the data, or you are an architect and you receive plans, property deeds, etc from the Customer. Also, if you receive confidential information from your Customer, etc). 

You must have procedures in place which ensure that all materials, subassemblies and finished goods, etc are stored and handled so as to prevent them from damage or deterioration.

However, this is not just limited to your stores or warehouse. It includes all areas where materials are handled, processed or moved. (The clause might have been more illuminating if had been entitled "Materials Handling"!)

Also included in this section are the steps that you take to ensure that goods are not damaged following your final inspection. If it is your responsibility to deliver goods to your Client (that is, they do not arrange for the collection of the goods), then you must also choose you method of carriage appropriately. (If you use a carrier/courier, then they should be included in your supplier selection methods.

Where measuring equipment is used to inspect or set up the goods that you manufacture, you must ensure that they are accurate enough for the purpose. You should have then regularly checked (calibrated). You must be able to prove that the equipment is calibrated, so keep records of it!

If you find that the equipment is faulty, you must consider the effect of that fault on the measurements taken using the equipment since the last time you knew it was OK. This may mean that you have to recall goods (e.g. if a braking system on a motor vehicle could have been adversely affected), or it may mean that no action is required (e.g. if the inaccuracy is not enough to cause any adverse consequences). Either way, you must formally consider the matter and record the consideration and the decision.