2014年9月19日金曜日

ISO 9001 requirements in a nutshell

ISO 9001 requirements in a nutshell:

A simple overview of the ISO 9001 Standard

An overview of the requirements of ISO 9001 (2008v ersion) in plain English. 
4 Overall Requirements for the System
4.1   Set up your quality management system: develop, use and improve it.
4.2   Document your system to say how it should work.
   4.2.1  Write documents including a quality policy, objectives, manual, procedures and records; decide what procedures you need for your system; must include those listed below
   4.2.2  Have a quality manual
   4.2.3  Control your documents to make sure they are accurate and suitable, including a procedure 
   4.2.4  Manage your records (which show your system works as you say it does) suitably, including a procedure.
5 Requirements for Management
5.1  Demonstrate your commitment to the quality management system by
      - communicating to personnel how important quality is
      - setting a quality policy and objectives for your system.
      - providing adequate resources (people, plant, equipment, IT etc).
      - ensuring there is adequate planning
      - reviewing how the system performs.
     
5.2  Focus on customers
       Identify their requirements and aim to enhance their satisfaction.

5.3 Write a quality policy. Use it.
      Commit to meeting requirements of the quality system and ISO 9001, including continual improvement.
      Make sure you communicate this policy and that it's understood.

5.4 Plan for quality
  5.4.1  Set objectives (aims/goals) that you can measure.
  5.4.2  Have suitable plans to achieve these objectives

5.5    Define and communicate 'who does what'
  5.5.1  Identify who has what responsibility and authority
  5.5.2  Give a senior manager responsibility for the quality system overall
  5.5.3  Have effective methods of internal communication.

5.6   Review your quality management system (management review) at regular intervals
 5.6.1  Review the system and performance. 
 5.6.2  Include consideration of: customer feedback, performance, nonconformity, audits, actions raised, changes and any need to improve
 5.6.3  Keep records of outcomes from your reviews; include decisions and actions.
6 Resource Requirements
6.1 Decide what resources are need for the system, and to enhance customer satisfaction. Provide them.
6.2  Make sure people are competent:
 6.2.1  Include this for anyone whose work affects whether your services/products meet requirements
 6.2.2  Decide what competencies are needed; provide and maintain them
6.3  Infrastructure: Decide what you need (to meet requirements).Provide it and maintain it.
6.4  Work environment: provide what you need so that your services/products meet requiremnts. 
7 Requirements for Products or Services

7.1 Plan
Plan and develop the processes needed for your products/services.

7.2  Have effective 'customer-related' processes:
7.2.1  Know what requirements apply to your products/services
7.2.2  Make sure you can meet them (or don't take the order)
7.2.3  Have effective ways to communicate with your customers.

7.3  Have effective processes for designing & developing products/services
7.3.1  Plan design/development.
7.3.2  Define what inputs are needed to design/create/develop
7.3.3  Do the 'design' /plan in some form that enables you to verify the output (see 7.3.5)
7.3.4  Review the design/plan at suitable stages
7.3.5  Make sure the result meets the agreed & defined requirements (verification)
7.3.6  Validate design (where practicable).
7.3.7 If changes happen during design, manage them.

7.4 Control what you buy, outsource or subcontract (goods, materials or services) if it affects your services or products
7.4.1 Make sure what you buy meets the requirements you specified; assess and monitor your suppliers/supply chain.
7.4.2 Describe what you plan to purchase.
7.4.3 Make sure it meets requirements.

7.5 Manage your operations
7.5.1  Have effective ways to control what you do (providing products/ services)
7.5.2  Validate production/service provision (if required).
7.5.3  Identify and track services/products (when appropriate)
7.5.4  Take care of any property supplied by your customers, including IP and confidential information
7.5.5 Care for products/components during storage/delivery, etc.to make sure they stay in good condition
7.6 Control measuring and monitoring equipment
When measuring, make sure your results are valid.  Identify what equipment and processes you need for this. Choose suitable equipment or instruments.  Make sure the results are and stay accurate.
8 Requirements for Analysis and Improvement
8.1 Have processes suitable to ensure your services/products meet all relevant requirements (customer, yours, contractual, legal, etc). include improvement.

8.2 Monitor and measure processes and services/products (as necessary) to check you got the results you wanted:
8.2.1 Monitor customer perception of satisfaction.
8.2.2 Plan and implement a suitable program of internal system audits, including a procedure
8.2.3 Have suitable methods to monitor / measure your processes. 
8.2.4 Monitor and measure products/services at suitable stages.  Release the final only when all requirements are met.
8.3 Control nonconformity (services/products not meeting requirements) in suitable ways, including a written procedure.

8.4 Collect and analyse information
Decide what information is needed to tell you how your system is working and for improvement.
Collect, analyse and use it.

8.5 Continually improve.
8.5.1 Improve your system.
8.5.2 Have a systematic approach to fix nonconformity and stop it recurring, including a procedure.
8.5.3 Have a systematic approach to prevent potential nonconformity or failures happening, including a procedure.

Note: the numbers correspond to the clause numbers in the Standard. They start at #4 since the requirements themselves are in sections 4 to 8 of the Standard.

Disclaimer:  This is a simplified summary only.  No representation or warranty is made for the accuracy or the completeness of the contents. We specifically disclaim any implied warranties or fitness for any particular purpose and will not be liable for any loss of profit or any other commercial damage as a result of your acting or relying upon any of this information.
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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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