2014年9月19日金曜日

ISO 9001 2008 Translated into Plain English

ISO 9001 2008 Translated into Plain English:

ISO 9001 2008 Translated into Plain English
This web page presents an overview of ISO 9001. It doesn't provide detail. 
It starts with section 4 because the ISO 9001 QMS requirements start there.
We've also translated the new ISO 9004 2009 standard into plain English.
4.
GENERAL
REQUIREMENTS
4.1 DEVELOP YOUR QUALITY MANAGEMENT SYSTEM (QMS)
  • Establish your organization's process-based QMS.
  • Document your organization's process-based QMS.
  • Implement your organization's process-based QMS.
  • Maintain your organization's process-based QMS.
  • Improve your organization's process-based QMS.

4.2. DOCUMENT YOUR QUALITY MANAGEMENT SYSTEM (QMS)
4.2.1 MANAGE QUALITY MANAGEMENT SYSTEM DOCUMENTS
  • Develop documents for your organization's QMS.
  • Make sure that your organization's QMS documents respect and reflect what you do and how you do it.
4.2.2 PREPARE QUALITY MANAGEMENT SYSTEM MANUAL
  • Establish a quality manual for your organization.
  • Maintain your organization's quality manual.
4.2.3 CONTROL QUALITY MANAGEMENT SYSTEM DOCUMENTS
  • Control your organization's QMS documents.
  • Control documents that are used as QMS records.
4.2.4 ESTABLISH QUALITY MANAGEMENT SYSTEM RECORDS
  • Establish your organization's QMS records.
  • Establish a procedure to control your QMS records.
 
5.
MANAGEMENT
REQUIREMENTS
5.1 SHOW YOUR COMMITMENT TO QUALITY
  • Support the development of your organization's QMS.
  • Support the implementation of your organization's QMS.
  • Support efforts to continually improve the effectiveness of your organization's QMS.

5.2 FOCUS ON YOUR CUSTOMERS
  • Enhance customer satisfaction by ensuring that customer requirements are being identified.
  • Enhance customer satisfaction by ensuring that customer requirements are being met.

5.3 SUPPORT YOUR QUALITY POLICY
  • Ensure that your policy serves its purpose.
  • Ensure that your quality policy makes it clear that requirements must be met.
  • Ensure that your quality policy makes a commitment to continually improve the effectiveness of your QMS.
  • Ensure that your quality policy supports your organization's quality objectives.
  • Ensure that your quality policy is communicated and discussed throughout your organization.
  • Ensure that your quality policy is periodically reviewed to make sure that it is still suitable.

5.4 CARRY OUT YOUR QMS PLANNING
5.4.1 ESTABLISH QUALITY OBJECTIVES
  • Support the establishment of quality objectives.
  • Establish quality objectives for your organization.
  • Make sure that your quality objectives are effective.
5.4.2 PLAN QUALITY MANAGEMENT SYSTEM (QMS)
  • Plan the establishment of your QMS.
  • Plan the documentation of your QMS.
  • Plan the implementation of your QMS.
  • Plan the maintenance of your QMS.
  • Plan the continual improvement of your QMS.

5.5 ALLOCATE QMS RESPONSIBILITY AND AUTHORITY
5.5.1 DEFINE RESPONSIBILITIES AND AUTHORITIES
  • Ensure that your organization's QMS responsibilities and authorities are defined.
  • Ensure that QMS responsibilities and authorities are communicated throughout your organization.
5.5.2 CREATE MANAGEMENT REPRESENTATIVE ROLE
  • Appoint a member of your organization's management to oversee your QMS.
  • Give your management representative authority over and responsibility for your organization's QMS.
5.5.3 SUPPORT INTERNAL COMMUNICATION
  • Ensure that appropriate communication processes are established within your organization.
  • Ensure that internal communication actually occurs.

5.6 PERFORM QMS MANAGEMENT REVIEWS
5.6.1 REVIEW QUALITY MANAGEMENT SYSTEM (QMS)
  • Carry out management reviews of your organization's QMS at planned intervals.
  • Evaluate improvement opportunities.
  • Assess the need to make changes.
  • Maintain a record of your management reviews.
5.6.2 EXAMINE MANAGEMENT REVIEW INPUTS
  • Examine information about your QMS (inputs).
5.6.3 GENERATE MANAGEMENT REVIEW OUTPUTS
  • Generate management review decisions and actions to improve your organization.
  • Generate management review decisions and actions to change your general quality orientation.
  • Generate management review decisions and actions to address resource needs.
 
6.
RESOURCE
REQUIREMENTS
6.1 PROVIDE REQUIRED QMS RESOURCES
  • Identify the resources that your QMS needs.
  • Provide the resources that your QMS needs.

6.2 PROVIDE COMPETENT QMS PERSONNEL
6.2.1 ENSURE THE COMPETENCE OF WORKERS
  • Ensure the competence of anyone within your QMS who could directly or indirectly affect your ability to meet product requirements.
6.2.2 MEET COMPETENCE REQUIREMENTS
  • Identify the competence requirements of personnel within your QMS who perform work that could directly or indirectly affect your organization's ability to meet product requirements.
  • Provide training, or take other suitable steps, to meet your organization's QMS competence requirements.
  • Evaluate the effectiveness of your organization's QMS training and awareness activities.
  • Maintain suitable records which show that personnel within your QMS are competent.

6.3 PROVIDE NECESSARY INFRASTRUCTURE
  • Identify the infrastructure that your organization needs in order to ensure that product requirements are met.
  • Provide the infrastructure that your organization needs in order to ensure that product requirements are met.
  • Maintain the infrastructure that your organization needs in order to ensure that product requirements are met.

6.4 PROVIDE SUITABLE WORK ENVIRONMENT
  • Identify the work environment that your organization needs in order to ensure that product requirements are met.
  • Manage the work environment that your organization needs in order to ensure that product requirements are met.
 
7.
REALIZATION
REQUIREMENTS
7.1 CONTROL PRODUCT REALIZATION PLANNING
  • Establish a product realization planning process.
  • Use your product realization planning process to plan the realization of your organization's products.
  • Prepare planning outputs that are suitable and consistent with your organization's methods.
  • Develop the processes that you will need to use in order to realize products.

7.2 CONTROL CUSTOMER-RELATED PROCESSES
7.2.1 IDENTIFY YOUR UNIQUE PRODUCT REQUIREMENTS
  • Identify the unique requirements that your customers want you to comply with.
  • Identify the requirements that are dictated by your product's intended use or purpose.
  • Identify the requirements that are imposed on your products by external agencies.
  • Identify any additional requirements that are important to your organization and must be met.
7.2.2 REVIEW CUSTOMERS' PRODUCT REQUIREMENTS
  • Review your customers' product requirements.
  • Maintain a record of your product requirement reviews.
  • Control changes in customers' product requirements.
7.2.3 COMMUNICATE WITH YOUR CUSTOMERS
  • Establish customer communication arrangements.
  • Implement customer communication arrangements.

7.3 CONTROL PRODUCT DESIGN AND DEVELOPMENT
7.3.1 PLAN PRODUCT DESIGN AND DEVELOPMENT
  • Plan the design and development of your products.
  • Control the design and development of your products.
  • Update your planning outputs whenever product design and development progress makes this necessary.
7.3.2 IDENTIFY DESIGN AND DEVELOPMENT INPUTS
  • Define product design and development inputs.
  • Maintain a record of design and development inputs.
  • Review your product design and development inputs.
7.3.3 GENERATE DESIGN AND DEVELOPMENT OUTPUTS
  • Produce product design and development outputs.
  • Approve product design and development outputs before they are formally released.
  • Verify that product design and development outputs meet design and development input requirements.
7.3.4 CARRY OUT DESIGN AND DEVELOPMENT REVIEWS
  • Perform systematic design and development reviewsthroughout the design and development process.
  • Maintain a record of design and development reviews.
7.3.5 PERFORM DESIGN AND DEVELOPMENT VERIFICATIONS
7.3.6 CONDUCT DESIGN AND DEVELOPMENT VALIDATIONS
7.3.7 MANAGE DESIGN AND DEVELOPMENT CHANGES
  • Identify changes in design and development.
  • Record changes in design and development.
  • Review changes in design and development.
  • Verify changes in design and development.
  • Validate changes in design and development.
  • Approve changes in design and development before you implement these changes.

7.4 CONTROL PURCHASING AND PURCHASED PRODUCTS
7.4.1 ESTABLISH CONTROL OF YOUR PURCHASING PROCESS
  • Establish criteria that you can use to control suppliers.
  • Evaluate your suppliers' ability to supply products that meet your organization's requirements.
  • Select suppliers that are capable of supplying products that meet your organization's specified requirements.
  • Make sure that purchased products meet specified purchase requirements.
7.4.2 SPECIFY YOUR PURCHASING REQUIREMENTS
  • Describe your purchasing requirements.
  • Ensure that purchasing requirements are adequately specified before you discuss them with suppliers.
7.4.3 VERIFY YOUR PURCHASED PRODUCTS
  • Establish product verification or inspection methods in order to ensure that purchased products meet purchase requirements.
  • Implement product verification or inspection methods in order to ensure that purchased products meet purchase requirements.

7.5 CONTROL PRODUCTION AND SERVICE PROVISION
7.5.1 ESTABLISH CONTROL OF PRODUCTION AND SERVICE
  • Carry out production under controlled conditions.
  • Carry out service provision under controlled conditions.
7.5.2 VALIDATE PRODUCTION AND SERVICE PROVISION
  • Validate production and service provision processes whenever process outputs cannot be measured, monitored, or verified until after the product is in use or the servicehas been delivered (such a process is often referred to as a special process).
  • Establish arrangements to control special processes.
7.5.3 IDENTIFY AND TRACK YOUR PRODUCTS
  • Establish the unique identity of your products.
  • Identify the monitoring and measurement status of your organization's products.
7.5.4 PROTECT PROPERTY SUPPLIED BY CUSTOMERS
  • Identify property supplied to you by customers.
  • Verify property supplied to you by customers.
  • Protect property supplied to you by customers.
  • Safeguard property supplied to you by customers.
7.5.5 PRESERVE YOUR PRODUCTS AND COMPONENTS
  • Make sure that your products and components continue to conform to requirements while they are being processed internally.
  • Make sure that your products and components continue to conform to requirements while they are being delivered to the intended destination.

7.6 CONTROL MONITORING AND MEASURING EQUIPMENT
  • Identify your organization's monitoring and measuring needs and requirements.
  • Select equipment that can meet your organization's monitoring and measuring needs and requirements.
  • Establish monitoring and measuring processes.
  • Calibrate your monitoring and measuring equipment whenever necessary to ensure that results are valid.
  • Protect your monitoring and measuring equipment.
  • Confirm that monitoring and measuring software is capable of doing the job you want it to do.
  • Evaluate the validity of previous measurements whenever you discover that your measuring or monitoring equipment is out-of-calibration.
 
8.
REMEDIAL
REQUIREMENTS
8.1 ESTABLISH MONITORING AND MEASUREMENT PROCESSES
  • Identify the monitoring, measurement, and analyticalprocesses that you need to have in order to be able to demonstrate conformity and make improvements.
  • Plan how monitoring, measurement, and analytical processes will be used to demonstrate conformity and make improvements.
  • Implement your organization's monitoring, measurement, and analytical processes.

8.2 CARRY OUT MONITORING AND MEASUREMENT ACTIVITIES
8.2.1 MONITOR AND MEASURE CUSTOMER SATISFACTION
  • Establish methods that you can use to monitor and measure customer satisfaction (perceptions).
  • Monitor and measure customer satisfaction.
8.2.2 PLAN AND PERFORM REGULAR INTERNAL AUDITS
  • Establish an internal audit procedure.
  • Carry out internal audits of your QMS.
  • Take action to address audit results.
8.2.3 MONITOR AND MEASURE YOUR QMS PROCESSES
8.2.4 MONITOR AND MEASURE PRODUCT CHARACTERISTICS
  • Monitor your organization's product characteristics.
  • Measure your organization's product characteristics.

8.3 IDENTIFY AND CONTROL NONCONFORMING PRODUCTS
  • Establish a nonconforming products procedure.
  • Document your nonconforming products procedure.
  • Implement your nonconforming products procedure.
  • Maintain your nonconforming products procedure.

8.4 COLLECT AND ANALYZE QUALITY MANAGEMENT DATA
  • Figure out what kind of data you need to collect about your organization's QMS.
  • Collect data about your organization's QMS.
  • Provide information by analyzing your QMS data.

8.5 MAKE IMPROVEMENTS AND TAKE REMEDIAL ACTIONS
8.5.1 IMPROVE THE EFFECTIVENESS OF YOUR QMS
8.5.2 CORRECT NONCONFORMITIES TO PREVENT RECURRENCE
  • Establish a corrective action procedure.
  • Document your corrective action procedure.
  • Implement your corrective action procedure.
  • Maintain your corrective action procedure.
8.5.3 PREVENT THE OCCURRENCE OF NONCONFORMITIES
  • Establish a preventive action procedure.
  • Document your preventive action procedure.
  • Implement your preventive action procedure.
  • Maintain your preventive action procedure.
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