ISO 9000-2 Guidelines Translated into Plain English

Guidelines for Applying ISO 9001, ISO 9002, and ISO 9003 Standards

Management Centre Europe

This section summarizes ISO 9000-2. It highlights the main points.
It does not present detail. If you need a detailed and complete interpretation
of the ISO 9000-2 standard, please consider purchasing our hardcopy version.

ISO prepared 9000-2 to help you implement ISO 9001, ISO 9002, and ISO 9003. Because of the close link between this section and ISO 9001, ISO 9002, and ISO 9003, we suggest you study these three sections before you examine ISO 9000-2. But you do not need to do so in order to understand ISO 9000-2.

Also, please note that ISO 9000-2, ISO 9001, ISO 9002, and ISO 9003 use the same numbering system. This is designed to make cross-referencing easier. However, this similarity breaks down at the more detailed level.

• ISO 9000-2 4.1 Management responsibility
  • Your senior managers must demonstrate their continuous commitment to your quality policy and your quality system.
    This commitment must be both active and visible.
  • Make sure all management and staff members understand
    how their jobs affect quality.
  • Encourage everyone in your organization to feel responsible
    for the quality of your products and services.
  • Appoint people to monitor your quality system and to report their observations directly to senior management.
  • Provide the resources that people need to verify quality work.
  • Quality system reviews should be carried out by senior managers.
  • Changes to the quality system must be implemented without delay.

• ISO 9000-2 4.2 Quality system
  • Your quality manual could be several manuals. You could have one quality system manual that is supported by several more detailed procedure manuals. All of these define your quality system.
  • Quality plans can also have several levels, from general to specific. Like procedures, quality plans explain how quality requirements will be met. But, unlike procedures, plans are usually tied to a time frame and often involve contractual obligations.

• ISO 9000-2 4.3 Contract review
  • Make sure you understand what customers need.
  • Make sure that everyone who must review contracts in fact does so.
  • Make sure that all contract review concerns and questions are answered before the contract is finalized.

• ISO 9000-2 4.4. Design control
  • Design control is very important because many quality requirements can be satisfied through good design.
  • Make sure you develop plans to evaluate, test, and measure the safety, dependability, and performance of your products.
  • Your design teams should know what kinds of information should be shared, who should get this information, how it should be transmitted, and what records should be kept.
  • Use a "design description document" to record design agreements and solutions. And develop procedures to update and distribute this design description document.
  • Use at least two different methods to verify your design outputs.
  • Your design reviewers should be competent.
  • Your designs should deal with safety and environmental issues.
  • Your designs should meet functional and operational requirements.
  • Make sure you can actually implement your design.
  • Verify the accuracy of design calculations done by computer.
  • Verify the validity of all your design assumptions.
  • Test your products in realistic settings.
  • When designs must be changed, after the design phase is finished, make sure that previous design verification results are still valid.
  • When designs have been changed, make sure your design verification procedures are still valid.

• ISO 9000-2 4.5 Document control
  • Control documents by maintaining a central registry that specifies exactly which documents should be controlled, their revision status, what kinds of approvals they need, and how they should be distributed and stored.
  • Control documents and data in areas such as purchasing, design, and inspection. In general, all documents and data related to the quality system, and the work that is carried out within the system, should be controlled.
  • Develop procedures that specify exactly which documents should be controlled, who should control them, as well as how, when, and where this control should occur.
  • Develop procedures to control changes in documents and data.

• ISO 9000-2 4.6 Purchasing
  • Make sure that you have a good working relationship with your subcontractors (suppliers), and make sure that the lines of communication and feedback are always open.
  • Maintain records that show how each subcontractor is selected. Make sure that these records show that each subcontractor meets your quality and contract requirements.
  • Review the performance of your subcontractors on a regular basis.
  • Make sure that you specify who is responsible for reviewing and approving purchasing documents and data, including purchase orders and contracts.

• ISO 9000-2 4.7 Customer-supplied product
  • Clarify who is responsible for telling the customer that products supplied to you by him are unsuitable.
  • You (the supplier) should ensure that all products and services provided by your customers are suitable.

• ISO 9000-2 4.8 Product identification and traceability
  • Mark or tag products, product batches, or product containers.
  • You may need to use special identifiers to indicate:
    • Who worked on the product.
    • What raw materials were used.
    • What tools and equipment were used.
    • What process methods were applied.
  • Inspection and stock records should use product identifiers.

• ISO 9000-2 4.9 Process control
  • All products (and services) are created by means of processes.
  • Process control is necessary to avoid product nonconformities.
  • Control the process characteristics that influence product quality.
  • Monitor and control the materials that enter your processes.
  • Monitor and control the materials that are inside your processes.
  • Develop procedures to ensure that process:
    • Software and hardware works properly.
    • Materials are suitable and properly stored.

• ISO 9000-2 4.10 Inspection and testing
  • Develop procedures that explain how your staff should verify that incoming shipments meet all contractual requirements.
  • Develop procedures that explain how your staff should handle incoming shipments that do not conform to requirements.
  • When incoming shipments are subject to future recall, try not to release them for use until you have inspected them.
  • Develop procedures to control what happens to incoming products that are released without inspection and later found not to conform.
  • Clarify who has authority to release incoming products subject to recall and describe the conditions under which release is allowed.
  • In-process inspection should be carried out in order to detect nonconformities as early as possible.

• ISO 9000-2 4.11 Inspection, measuring, and test equipment
  • Your measurement process should ensure that:
    • Appropriate measurements are done.
    • Suitable measuring equipment is used.
    • Effective measuring procedures are applied.
  • Measurement instruments can be either tangible (e.g. equipment)
    or intangible (e.g. questionnaires).

• ISO 9000-2 4.12 Inspection and test status
  • The inspection and test status of your products should be clearly indicated by means of tags, marks, numbers, physical location, or any other suitable means.
  • Your inspection and test procedure should identify and segregate products that:
    • Have not been inspected.
    • Have been inspected and
      • Have either been accepted, or
      • Have been rejected, or
      • Have been placed on hold.

• ISO 9000-2 4.13 Control of nonconforming products
  • Develop procedures to prevent the inappropriate use of nonconforming products. These procedures should cover both your own products and the products supplied to you by your subcontractors (suppliers).
  • Make sure that you identify exactly where each nonconforming product came from, when and how it was produced, and what caused the problem.

• ISO 9000-2 4.14 Corrective action
  • Product nonconformities can be caused by:
    • Tool and equipment faults and malfunctions.
    • Material and supply defects and deficiencies.
    • Systemic weaknesses and shortcomings.
    • Process failures and deficiencies.
    • Process control defects and breakdowns.
    • Procedural gaps and weaknesses.
    • Human ignorance and negligence.
  • Product nonconformities can be discovered by:
    • Examining inspection, testing, and nonconformity documents.
    • Observing work activities and processes.
    • Conducting quality audits and reviews.
    • Reviewing customer ideas and complaints.
    • Analyzing regulatory input and observations.
    • Studying staff suggestions and feedback.

• ISO 9000-2 4.15 Handling, storing, packaging, and delivery
  • Procedures for handling, storing, packaging, and delivery should cover both in-process materials and finished products.
  • Tools and equipment, used to handle products, should be appropriate and well maintained.
  • Storage methods should ensure that products are secure and protected from damaging environmental conditions.
  • Packaging methods must ensure that products are identified and protected against damage, deterioration, or contamination.
  • Delivery methods must ensure that that products are protected from loss, damage, deterioration, or contamination.

• ISO 9000-2 4.16 Quality records
  • Develop a record keeping system that can prove that your products meet requirements and your quality system is implemented.
  • Your records can be either paper based or electronic as long as they document the performance of your quality system.
  • When you determine how long old quality system records should be kept, consider contractual and regulatory requirements as well as the life expectancy of your products.

• ISO 9000-2 4.17 Internal quality audits
  • Periodic internal quality audits should be done to:
    • Determine whether you have documented all quality elements.
    • Determine whether you have implemented all quality elements.
    • Evaluate how effective your quality system is.
    • Improve your quality system.
    • Prepare for external quality audits.
  • Special internal audits may also be done after major systemic or procedural changes have been made or after significant problems have been solved. This type of audit is done to verify that the changes were effective and that the problems really were solved.

• ISO 9000-2 4.18 Training
  • Make sure that your training records keep track of the training provided and the results that were achieved.
  • Training and awareness activities should be carried out in order to:
    • Show people how to carry out tasks.
    • Show people how to apply procedures.
    • Motivate people to support quality.

• ISO 9000-2 4.19 Servicing
  • If your products require after-sale service or post-installation support, you should clarify how service responsibilities will be shared between you, your distributors, and your customers.
  • Make sure that:
    • Customers and distributors know how to service products.
    • Service delivery people receive technical support.
    • Service delivery people receive training.
    • You develop product service delivery plans.
    • Your service and test equipment is effective.
    • You have an adequate supply of spare parts.
    • You set up an information feedback system.

• ISO 9000-2 4.20 Statistical techniques
  • Use statistical methods to help you:
    • Decide what data to collect.
    • Make the best use of your data.
    • Control processes.
    • Avoid nonconformities.
    • Measure quality characteristics.
    • Design products and services.
    • Define product and process limits.
    • Identify problems and analyze causes.

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