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ISO 9001:2008 Requirements for a Quality Management System QMS

Updated on January 21, 2015
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I am a trainer and consultant in lean manufacturing, Six Sigma, quality management, and business management.

ISO 9001 Quality Management System Requirements

What are the ISO 9001:2008 requirements for a quality management system (QMS)?

ISO 9001 is a written standard that specifies the requirements for a quality management system to help an organization to demonstrate it’s ability to consistently provide products and services that meet customer, regulatory, and statutory requirements. In addition to this it seeks to put in place systems to measure and improve customer satisfaction and to drive continuous improvement of all processes.

ISO 9001 does not specify requirements for specific products, it refers to the structure and functions of the company’s management systems and processes with regard to ensuring that products and services meet quality requirements.

The processes put in place to meet the requirements of ISO should then be auditable so that a third party can then assess your conformance to the standard (or otherwise).

ISO 9001 Quality Management System

ISO 9001 Quality Management System
ISO 9001 Quality Management System | Source

What is a Quality Management System QMS

A quality management system is the management system that is put in place to ensure that the organization’s systems are controlled and can ensure the delivery of product and services that meet customer, statutory, and regulatory requirements.

A process is any activity, or set of activities that transforms an input into an output, so your manufacturing production line is a process, taking raw materials and converting them into widgets. Your ordering department is a process, converting customer requests into instructions to manufacture for your production line. All of the processes within your business need to be controlled, either through using skilled experienced staff, clear documentation or electronic systems or through documented procedures. This forms your ISO 9001 quality management system, a system that needs to be continuously improved so that you can stay ahead of your competition.

ISO 9001 QMS Requirements

ISO 9001 is based around eight quality principles, those principles are structured around the Deming cycle or Shewhart cycle – PDCA. The standard itself is broken down into a number of sections;

The first three sections explain the scope, references and terms and definitions, the following sections then define the requirements of the actual quality management system, a brief summary of each is below;

Quality Management System ISO 9001

ISO 9001 Quality Management System
ISO 9001 Quality Management System | Source

ISO 9001:2008 Requirements Section 4. Quality Management System

This section of the standard explains the requirements for specific documentation to control the quality management system. This is to ensure that the company puts in place a system that is both auditable and that records are kept by which conformance can be verified It also provides a basis for continuous improvement. The main sections are with regard to the creation and maintenance of a “quality manual” and your procedures, as well as how documents and records will be controlled.

ISO 9001 Management Responsibility

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Management Responsibility ISO 9001ISO Management ResponsibilityISO 9001:2008 Requirements Management Responsibility
Management Responsibility ISO 9001
Management Responsibility ISO 9001 | Source
ISO Management Responsibility
ISO Management Responsibility | Source
ISO 9001:2008 Requirements Management Responsibility
ISO 9001:2008 Requirements Management Responsibility | Source

ISO 9001:2008 Requirements Section 5. Management responsibility

This section requires top management’s commitment to the quality management system, it forms the top level PDCA loop for the whole organization;

Top management must define policy, objectives and plans to achieve customer satisfaction, (Plan). Then they must assign responsibility and authority to those who have to execute the plan, (Do).

All of this should then be communicated and reviewed through the Management Review attended by top management and monitored by the “management representative”, (Check).

The plan should be reviewed as part of the output of the Management Review meeting and communicated to all (Act).

ISO 9001 Resource Management

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Resource Management ISO9001:2008ISO 9001:2008 Resource Management
Resource Management ISO9001:2008
Resource Management ISO9001:2008 | Source
ISO 9001:2008 Resource Management
ISO 9001:2008 Resource Management | Source

ISO 9001:2008 Requirements Section 6. Resource management

As part of the planning for the quality management system the top management shall also ensure that the required resources are in place to ensure the smooth running of the system, this includes physical infrastructure, environment and trained competent people.

ISO 9001 Product Realisation

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ISO 9001:2008 Product Realization PlanningCustomer Related Processes ISO 9001 RequirementsISO 9001 Customer related processesISO 9001 Design and DevelopmentDesign and DevelopmentISO 9001:2008 Requirements for PurchasingISO 9001 Control of Production and Service ProvisionISO 9001:2008 requirements for  Identification and TraceabilityISO 9001 Requirements Customer PropertyISO 9001 Preservation of Product
ISO 9001:2008 Product Realization Planning
ISO 9001:2008 Product Realization Planning | Source
Customer Related Processes ISO 9001 Requirements
Customer Related Processes ISO 9001 Requirements | Source
ISO 9001 Customer related processes
ISO 9001 Customer related processes | Source
ISO 9001 Design and Development
ISO 9001 Design and Development | Source
Design and Development
Design and Development | Source
ISO 9001:2008 Requirements for Purchasing
ISO 9001:2008 Requirements for Purchasing | Source
ISO 9001 Control of Production and Service Provision
ISO 9001 Control of Production and Service Provision | Source
ISO 9001:2008 requirements for  Identification and Traceability
ISO 9001:2008 requirements for Identification and Traceability | Source
ISO 9001 Requirements Customer Property
ISO 9001 Requirements Customer Property | Source
ISO 9001 Preservation of Product
ISO 9001 Preservation of Product | Source

ISO 9001:2008 Requirements Section 7. Product realisation

The largest section, covering the planning, product development, purchasing and production. This is the part of the business with the main interactions with the customer, the customer specifying their requirements, then you planning and delivering their requirements.

ISO 9001 Measurement, analysis and Improvement

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ISO 9001:2008 Requirements Monitoring and MeasurementISO 9001:2008 Control of Nonconforming productISO 9001 Requirements Analysis of DataISO 9001 ImprovementISO 9001:2008 Requirements for Corrective and Preventive Action
ISO 9001:2008 Requirements Monitoring and Measurement
ISO 9001:2008 Requirements Monitoring and Measurement | Source
ISO 9001:2008 Control of Nonconforming product
ISO 9001:2008 Control of Nonconforming product | Source
ISO 9001 Requirements Analysis of Data
ISO 9001 Requirements Analysis of Data | Source
ISO 9001 Improvement
ISO 9001 Improvement | Source
ISO 9001:2008 Requirements for Corrective and Preventive Action
ISO 9001:2008 Requirements for Corrective and Preventive Action | Source

ISO 9001:2008 Requirements Section 8. Measurement, analysis and improvement

This section is not just about providing gauges and equipment to check production output and controlling defective product, it is also about putting in place ways to monitor your attainment of your objectives, measuring customer satisfaction, and auditing your management systems. It also requires that you take preventative action before errors occur as well as corrective action when things go wrong. On top of all of this you are required to continuously improve all of these systems and processes.

ISO 9001 Documentation requirements

ISO 9001:2008 Documentation Requirements

The actual requirements for specific documents within ISO 9001 are actually very small, although many companies go far too far and create bureaucratic systems filled with reams of paperwork and requirements that end up slowing the processes, not what ISO 9001 is meant to do at all! ISO 9001 only requires that written procedures are put in place where there would be an adverse effect to quality if they were not there, if the process is clear, the people are trained and experienced, then there is no need for comprehensive written procedures.

Most companies structure their system in a typical “pyramid” formation, the company’s quality policy, objectives and manual being the peak; this being the aims of the company. The next level are the procedures, what the company will do, when it will be done and who by. The next tier are the work instructions or standard operating instructions which explain how to do it. The final tier being forms and records required.

Pyramid Structure of QMS Documentation

QMS Documentation Pyramid
QMS Documentation Pyramid

ISO 9001 QMS generic requirements

Bizmanualz(tm) ISO 9001 QMS Policies, Procedures & Forms
Bizmanualz(tm) ISO 9001 QMS Policies, Procedures & Forms

Pre-Defined QMS that you can adapt to reflect your own company.

 

Off the shelf QMS for ISO 9001

Because of the nature of ISO 9001 it is possible to purchase generic documentation systems that you then modify to meet the requirements and specifics of your company. These documentation packs are simple to use and can quickly form a basis for a system to grow around.

If you use a consultant, most of the time they will use systems like these, either purchased or self developed, to save them time in developing your system. Whilst these may not be ideal they are a very good and simple beginning point that everyone can understand. Trying to develop everything entirely from scratch can be a very daunting and time consuming task.

ISO 9001 Video

Support for QMS Requirements

The following are some useful links that will help you gain additional information regarding the ISO 9000 standards;

International Organization for Standardization; The ISO home page will have information regarding updates and developments for the ISO 9001 standard.

Lloyds Register Quality Assurance Lloyds Register Quality Assurance is the oldest of the quality management certification bodies, they offer training and certification audits for ISO 9001.

British Standards Institute; The British Standards Institute is also a certification body that offers training and certification services.

The American Standards Organization; (ANSI) American Standards Organization can help ensure that your quality management system meets the requirements of ISO 9001.

International Register of Certified Auditors (IRCA); The International Register of Certified Auditors keeps records of all approved auditors.

UKAS; United Kingdom Accreditation Service accredits all of the certification bodies, if you are going to be audited by a certification body to see if your management system meets the requirements of ISO 9001 check that they are registered with UKAS.

Chartered Quality Institute (CQI); The Chartered Quality Institute has many resources that you could access with regard to quality as well as membership services for quality professionals.

American Society for Quality (ASQ); The American society for quality has similar services to the CQI in the UK.

The above links can help you find more information as to ISO 9001:2008 requirements for a quality management system (QMS).

Continuous Improvement ISO 9001

Comments

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    • LeanMan profile imageAUTHOR

      Tony 

      7 years ago from At the Gemba

      Thank you for your comment ISO 9000, good luck with your business implementing ISO 9001 and other standards.

    • profile image

      ISO 9000 

      7 years ago

      I read your post . it was amazing.Your thought process is wonderful.

      The way you tell about things is awesome. They are inspiring and helpful.Thanks for sharing your information and stories.

      ISO 9000

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