How to design QMS for ISO 9001 certification

How to Design QMS For ISO 9001 Certification

ISO 9001 is the internationally recognized standard for the quality management of businesses. It applies to the processes that create and control the products and services an organization supplies, and prescribes systematic control of activities to ensure that the needs and expectations of customers are met.

What is a Quality Management System? It is a management system pure and simple.

It is not quality’s management system; it is a management system that, if done right, produces quality products. A Quality Management Systems is built for ISO registration, to satisfy customer requirements, or to produce better products.

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10 Step Design For Quality Management System 1. Define and Map your processes The process of creating process maps will force you to define your processes and the sequence and interaction of those processes.

Process maps are important for understanding that is responsible for what. They define your core business process and communicate the flow of your business. When mapping your processes: ďƒ˜ Follow an order through the system. ďƒ˜ Building an ISO Quality Management System with Process Map Identify support processes for IT, HR, and Accounting.

ďƒ˜ Determine how quality interacts with each process either for inspection, review, or to roll-up metrics in support of Quality Objectives

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2. Define your quality policy Your Quality Policy states the mission of your organization as it relates to quality. It is your quality mission. When building your quality management system and writing your quality policy, think about your commitment to customer focus:  Quality – What do you need to do consistently to satisfy your customer?  Customer Satisfaction requirements?

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 Continuous Improvement – What do you need to do better to satisfy your customer more than now?

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3. Define your quality objective These are the objectives of the quality management system. They must be communicated and each employee must understand their impact on quality. ISO requires that your quality objectives are:

 Derived from your quality policy  Measureable

 Deployed through the organization

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4. Define your Defects for Each process Defects are nonconformance’s that occur either as a product defect or a process defect. Each time a defect occurs it needs to be counted in some way. When defining your defects:  Determine transaction volume  Determine defects (product and process based)  Define how defects are recorded  Define how defects are charted and communicated

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5. Develop your Document and Records ISO 9001 Standard requires a Quality Manual, seven procedures, and records. There are many more optional documents and records that can be used but they are not required. Start with the minimum ISO document set and add more as needed.

Create required documents for your business model Create necessary policies, procedures and forms

Create Records for each process

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6. Define your quality process Your quality processes include: Internal audit process

Corrective and preventive action process Management review, communication, and commitment process

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7. Determiner your training needs

Everyone needs to demonstrate competence in their job.

Training is only the beginning and can occur on the job, from a class, or through other means. Either way: ďƒ˜Internal auditor competence is critical ďƒ˜Corrective Action training is highly recommended

ďƒ˜Failure Modes Effects Analysis training is strongly suggested to find preventive actions

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8. Use your Quality management system Yes you have to use the system for it to be any good at producing quality products. Using the QMS means:  Collecting nonconformance data continuously  Reviewing nonconformance data for corrective action, continuously Procedures Review Change Management

 Reviewing for Preventive action, frequently  Performing internal audits and management reviews periodically

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9. Measure and monitor your performance If you are using the quality management system, then you are collecting data. But what good is data you collect but do not understand? You need to: ďƒ˜Track your Quality Objectives performance ďƒ˜Define new performance benchmarks ďƒ˜Discover improvement opportunities in identifying trends, patters, or correlations

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data

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10. Take action that improves your performance If you have data and identified trends, then it is time to act. Action is what the QMS is all about. We are not tracking data for the auditor, for ISO, or for the quality manager. The whole goal is to deliver improvement and this happens by:

ďƒ˜ Prioritizing your improvement opportunities ďƒ˜ Choosing opportunities that make a difference

ďƒ˜ Reinforcing your commitment to quality to achieve better results

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