ISO 9001 Section 7
Product Realization

ISO 9001 Section 7 - Product Realization

7.1 Planning of Product Realization

We are to determine the process steps ahead of time. Determine the important steps, checks, records and objectives. This can be done in any manner the company chooses. Some companies use flowcharts, process maps, and/or process descriptions. Most people like the flowcharting or mapping methods because they can see the process interactions and linkages.

7.2 Customer-related Processes

7.2.1 Determination of requirements related to product

This clause is one of the most important in providing customer satisfaction. It requires you to have a complete understanding of the customer’s requirements. Including something the customer may have overlooked but you know is needed based on the customer’s use of the product.

7.2.2 Review of requirements related to product

Before we provide a quote or accept an order we must make certain we can do what the customer wants. This includes anything from a written description of the product or service to how soon they want to pay you for the product. Don’t forget shipping schedules, packaging and labeling!
If any of the requirements change we must make sure everyone involved is told of the change.

7.2.3 Customer Communication

Figure out the best way to communicate with the customer from the order to the delivery of the product. It could be by phone, fax, email, personal visit or any combination. We must keep the customer up-to-date. Listen to them about changes and their expectations.

7.3 Design and Development

There are seven sub-clauses in this section.

7.3.1 Design and development planning

The complete design process should be laid out in a documented plan. This can be accomplished through a written procedure. Or, sometimes a checklist showing all the steps in the design process works.

7.3.2 Design and development inputs

The design group must make sure that they have all the needed customer input. This can include specifications, material and production methods, packaging requirements. Basically anything that ensures the customer requirements are understood and met.

7.3.3 Design and development outputs

Simply stated: The design output must match the design input. All requirements are known and incorporated into the design. Or, negotiations with the customer have produced altered criteria that is included.

7.3.4 Design and development review

The reviews of the developing design are conducted according to the design plan from 7.3.1. The reviews are to include any departments that have an interest in the design at that stage.

Different departments can participate in the reviews at different stages of the design development.

7.3.5 Design and development verification

Design verification is usually analytical in nature. This may be alternate calculations for stacked tolerances, known limits of materials in the design, etc.

7.3.6 Design and development validation

Design validation is testing of designs and materials. Laboratory and bench testing, prototyping, field tests, etc.

7.3.7 Control of design and development changes

All changes to designs must be reviewed to ensure compatibility with customer requirements. All changes must be approved by an authorized person before the change is released to production. The organization must keep records of all design changes including when the change was implemented into the product.

7.4 Purchasing

7.4.1 Purchasing process

7.4.2 Purchasing information
7.4.3 Verification of purchased product

It is customary to buy some of the things you need for your product from other suppliers. This could be anything from completed assemblies to raw materials. It might be sub-contracting some of your work to a specialist, (i.e.); painting or plating or welding.

Let’s say we make computers and you buy the monitor from another company with your name on it. When the monitor breaks and your customer calls, do they call you or the maker of the monitor. You, of course. You can try and tell the customer it was the monitor maker, but they won’t care. They bought the computer from you. You are responsible in the customer’s eyes.

It is the responsibility of the company selling the product to make sure it meets the customer’s requirements, regardless of where the materials or parts came. Your company must evaluate the quality of their suppliers and approve the supplier for use. This means there has to be some criteria for that evaluation and suppliers are held to meeting those needs. If they don’t they will need to take action to fix the situation so it won’t happen again.

But, regardless of the fact the supplier is approved, your company is charged with making certain the goods you get meet all the requirements. The requirements need to be spelled out in the purchase documents sent to the supplier.
Also, if anyone from your company or your customer wants to inspect the goods at the supplier’s location, this is to be written in the purchase documents as well.

7.5 Production and Service Provisions

7.5.1 Control of production and service provisions

This may be the most important clause in the ISO 9001:2008 standard. The standard is based on this concept: If you control the input to your process and make sure it is good, the output has to be good. Why? Because the process consists of the input, that’s all there is. If it is good going in it will be good coming out. Therefore, this clause tells the company the things they need to do make sure the input is okay.

7.5.2 Validation of processes for production and service

This requirement is for processes where the output can’t or isn’t inspected or tested to see if it is okay. You have to make sure that everything in the process is controlled. Like how to do the work, what equipment and material must be use. It could even require the operator(s) be certified to run the operation. Once that’s all settled, it has to be checked on from time to time or what the standard calls ‘revalidation’.

7.5.3 Identification and traceability

The standard defines quality as conformance to requirements. Earlier we discussed the importance of clearly defining the customer’s requirements that are measurable. This clause reminds us it is necessary to always keep these requirements in mind.
As items move through the steps of processing, we need to know if they are ready for the next step. As obvious as this seems, at one time companies didn’t know what was what and where it was because it wasn’t always clearly identified.

The other condition in this clause is about traceability. This means we can look back and find where the materials came from, when it was made and who bought it.

7.5.4 Customer-owned property

The first thing you need to ask is “Do I have any customer owned property?” This can be anything the customer retains title to. It can be parts, materials, tooling, packaging and labels. Also include is intellectual property like blueprints, methods, formulas and recipes.

You are responsible for the care, custody and control of customer property and that means keeping it safe from damage and loss. It can also mean keeping it clean, properly identified and in useable condition.
If anything happens to it you must tell the customer and keep a record of the problem.

7.5.5 Preservation of product

You have to be careful in handling the materials and goods while being processed. You must use the appropriate containers and fillers so items won’t be chipped, broken or bent. Reducing the distance between operations inside the plant and fixing cracks and holes in the floor so the tow motors aren’t bouncing your stuff around like an eight-year old on a trampoline may be needed.

The final stage is seeing the goods are packaged correctly for the method of shipping; truck, air or sea. Sometimes a supplier doesn’t get to choose the shipping method or the carrier because the customer is paying the freight. Unfortunately, you are still responsible for seeing the goods arrive at your customer’s in good shape. We need to always keep in mind the customer pays for the product quality at their dock, not yours.

7.6 Control of monitoring and measuring devices

A lot people think this clause is about inspection gages and instruments. It’s not. It’s about data, good useable data. If we are to make a decision regarding the quality of something we must be able to rely on the data we use to make the decision. In order to feel comfortable about the data we have to be comfortable about the methods used to gather the data. This does include making sure the gages and instruments used in the data gathering method are stable and reliable. 

Additional Information Resources

ISO 9001 Section 4: Quality Management

ISO 9001 Section 5: Management Responsibility 

ISO 9001 Section 6: Resource Management

ISO 9001 Section 8: Measurement, Analysis and Improvement

What are Quality Management Systems?

What is ISO 9000?

What is ISO 9001?

What is ISO 9004?

What is ISO 19011?

ISO 9000-2008 Changes

Online ISO 9000/9001 Overview Course

Auditor Training: Online

Auditor Training Courseware