ISO 9001 Translated into Plain English

ISO 9001 is for Organizations that Design,
Produce, Install, and Service Products

ISO 9001 is a Quality Assurance Model
made up of Quality System Requirements

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Orion Registrar, Inc.	National Quality Assurance, USA

This section summarizes ISO 9001. It highlights the main points.
It does not present detail. If you need a detailed and complete interpretation
of the ISO 9001 standard, please consider purchasing our hardcopy version.

ISO 9001 is a quality assurance model made up of 20 sets of quality system requirements.
This model applies to organizations that design, develop, produce, install, and service
products. ISO expects organizations to apply this model, and to meet these requirements,
by developing a quality system.

ISO 9001 4.1 - Management responsibilities

• Define a quality policy. Your policy should describe your organization's attitude towards quality.

• Define the organizational structure that you will need in order to manage your quality system.

  • Define quality system responsibilities, give quality system personnel the authority to carry out these responsibilities, and ensure that the interactions between these personnel are clearly specified. Also, make sure that all of this is well documented.

  • Identify and provide the resources that people will need to manage, perform, and verify quality system work.

  • Appoint a senior executive to manage your quality system and give him or her the necessary authority.

• Define a procedure that your senior managers can use to review the effectiveness of your quality system.

ISO 9001 4.2 - Quality system requirements

• Develop a quality system and a manual that describes it.

• Develop and implement quality system procedures that are consistent with your quality policy.

• Develop quality plans which show how you intend to fulfill quality system requirements. You are expected to develop quality plans for products, processes, projects, and customer contracts.

ISO 9001 4.3 - Contract review requirements

• Develop and document procedures to coordinate the review of sales orders and customer contracts. Make sure you include the customer in the process of review.

• Your contract review procedures should ensure that all contractual requirements are acceptable before you agree to provide products or services to your customers.

• Develop procedures which specify how customer contracts are amended, and which ensure that changes in contracts are communicated throughout the organization.

• Develop a record keeping system that you can use to document the review of customer orders and contracts.

ISO 9001 4.4 - Product design requirements

• Develop and document procedures to control the product design and development process. These procedures must ensure that all requirements are being met.

• Develop product design and development planning procedures.

• Identify the groups that should be routinely involved in the product design and development process, and ensure that their design input is properly documented, circulated, and reviewed.

• Develop procedures to ensure that all design input requirements are identified, documented, and reviewed; and that all design flaws, ambiguities, contradictions, and deficiencies are resolved.

• Develop procedures to control design outputs.

• Develop procedures which specify how product design reviews should be planned and performed.

• Develop procedures which specify how design outputs, at every stage of the product design and development process, should be verified.

• Develop procedures which validate the assumption that your newly designed products will meet customer needs.

• Develop procedures to ensure that all product design modifications are documented, reviewed, and formally authorized before the resulting documents are circulated and the changes are implemented.

ISO 9001 4.5 - Document and data control

• Develop procedures to control quality system documents and data.

• Develop procedures to review, approve, and manage all of your quality system documents and data.

• Develop procedures to control changes to documents and data.

ISO 9001 4.6 - Purchasing requirements

• Develop procedures to ensure that purchased products meet all requirements. These procedures should control the selection of subcontractors, the use of purchasing data, and the verification of purchased products.

• Develop procedures to select, evaluate, monitor, and control your subcontractors (your suppliers). Make sure that quality records are kept which chronicle the performance of all your subcontractors. Your records should identify the acceptable subcontractors and the products and services they provide.

• Develop procedures to ensure that your purchase order documents precisely describe what you want to buy.

• Develop procedures that allow you or your customers to verify the acceptability of products you have purchased.

ISO 9001 4.7 - Customer-supplied products

• Develop procedures to control products supplied to you by customers. These procedures should ensure that you:

  • Examine the product when you receive it to confirm that the right items were shipped without loss or damage.

  • Prevent product loss, misuse, damage, or deterioration through proper storage and security.

  • Record, and report to the customer, any product loss, misuse, damage, or deterioration.

  • Clarify who is responsible for the maintenance and control of the product while it is in your possession.

ISO 9001 4.8 - Product identification and tracing

• Develop and document procedures to identify and track products from start to finish. When appropriate, these procedures should ensure that you:

  • Identify and document products every step of the way from the purchase of supplies and materials through all stages of handling, storage, production, delivery, installation, and servicing.

  • Trace products or product batches by means of unique identifiers and suitable record keeping

ISO 9001 4.9 - Process control requirements

• Develop and document procedures to plan, monitor, and control your production, installation, and servicing processes.

• Design a record keeping system that monitors and controls process personnel and equipment. Make sure that all important process qualities are monitored and recorded.

ISO 9001 4.10 - Product inspection and testing

• Develop procedures to inspect, test, and verify that incoming, in-process, and final products meet all specified requirements. Also ensure that appropriate product inspection and testing records are developed, and that your procedures ensure that these records are properly maintained.

• Develop procedures which ensure that incoming products are not used until you have verified that they meet all specified requirements.

• Develop procedures which ensure that work-in-process meets all requirements before work is allowed to continue.

• Develop procedures which ensure that final products meet all requirements before they are made available for sale.

• Develop a record keeping system that your staff can use to document all product testing and inspection activities.

ISO 9001 4.11 - Control of inspection equipment

• Develop procedures to control, calibrate, and maintain inspection, measuring, and test equipment used to demonstrate that your products conform to specified requirements (the term equipment includes both hardware and software).

• Develop procedures to ensure that your measurement equipment is appropriate, effective, and secure.

• Develop procedures to calibrate all of your quality oriented inspection, measuring, and test equipment.

ISO 9001 4.12 - Inspection and test status of products

• Develop procedures to control the test status of your products. These procedures should ensure that:

  • Each and every product is identified as having passed or failed the required tests and inspections.

  • The test status of each product is documented and respected throughout the production, installation, and servicing process.

  • Only products that have passed all tests and inspections are subsequently used or sold to customers (unless an official exception is made under section 4.13 below).

ISO 9001 4.13 - Control of nonconforming products

• Develop procedures to prevent the inappropriate use of nonconforming products. Also make sure that everyone is notified when your products do not conform to specified requirements.

• Develop procedures to control how your nonconforming products are reviewed, reworked, regraded, re-tested, recorded, and discussed.

ISO 9001 4.14 - Corrective and preventive action

• Develop procedures to correct or prevent nonconformities.

• Develop procedures to ensure that nonconformities are identified and corrected without delay.

• Develop procedures to ensure that potential nonconformities are routinely detected and prevented.

ISO 9001 4.15 - Handling, storage, and delivery

• Develop and document procedures to handle, store, package, preserve, and deliver your products.

• Develop product handling methods and procedures that prevent product damage or deterioration.

• Designate secure areas to store and protect your products.

• Develop procedures which specify how your products will be placed into storage and removed from storage.

• Develop procedures which specify how your products will be protected from damage or deterioration during storage.

• Develop procedures which specify how your products will be monitored and evaluated to detect damage or deterioration while in storage.

• Develop packing, packaging, and marking methods and procedures to protect and control the quality of products and packaging materials.

• Develop methods and procedures to protect and preserve product quality prior to delivery and while the product is still under your control.

• Develop procedures to protect your products after final testing and inspection, and during product delivery.

ISO 9001 4.16 - Control of quality records

• Identify and define the quality information that should be collected.

• Develop a quality record keeping system, and develop procedures to maintain and control it. Develop procedures to:

  • Collect and record quality information (create records).

  • File, index, store, and maintain quality records.

  • Remove, archive, and destroy old quality records.

  • Protect quality records from unauthorized access.

  • Prevent records from being altered without approval.

  • Safeguard records from damage or deterioration.

ISO 9001 4.17 - Internal quality audit requirements

• Develop internal quality audit procedures which:

  • Determine whether quality activities and results comply with written quality plans, procedures, and programs.

  • Evaluate the performance of your quality system.

  • Verify the effectiveness of your corrective actions.

• These procedures should also ensure that:

  • Audit activities are properly planned.

  • Auditors are independent of the people being audited.

  • Audit results, corrective actions, and corrective action results and consequences are properly recorded.

  • Audit conclusions are discussed with the people whose activities and results are being audited, and deficiencies are corrected.

  • Audit reports are fed back into the quality system review process.

ISO 9001 4.18 - Training requirements

• Develop quality training procedures. These procedures must ensure that:

  • Quality system training needs are identified.

  • Quality training is provided to those who need it.

  • People are able to perform quality system jobs.

  • People have the qualifications they need to do the work.

  • Accurate and appropriate training records are kept.

  • Everyone understands how your quality system works.

ISO 9001 4.19 - Servicing requirements

• Develop and document quality service procedures. Your procedures should specify how:

  • Products should be serviced.

  • Product service activities are reported.

  • The quality of product service is verified.

ISO 9001 4.20 - Statistical techniques

• Select the statistical techniques that you will need in order to establish, control, and verify your process capabilities and product characteristics.

• Develop procedures to explain how your techniques should be applied.

• Develop procedures to monitor and control how techniques are used.

• Make sure that all statistical procedures are documented.

• Make sure that proper statistical records are kept.

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