ISO 9001:2000 Requirement

4.0 Quality management system
4.1 General Requirements
The Quality Management System (QMS) is the collection of processes, documents, resources, and monitoring systems that direct the work of an organization regarding product and service quality. The organization needs to establish, document, carry out, and maintain this system to meet the requirements of ISO 9001:2000.
4.2 Documentation requirements
4.2.1 General
The organization needs to document – either electronically or on paper – the quality policy, quality objectives, and quality manual. Written procedure, plans, and operations need to describe how product and service quality is attained. Certain records, providing evidence of activities that were carried out (i.e. purchase orders, sales contracts, inspection records, design review notes, etc.), have to be retained
The quantity, detail, and form of the documentation can differ from one organization to another depending on size, type of activities, or complexity of processes.
4.2.2 Quality manual
The quality manual describes the extent of the QMS and may exclude certain sections of the Standard that don't pertain to the organization. All of the quality procedures are either included in the quality manual or are referenced by it. The interaction between processes making up the QMS is also described.
4.2.3 Control of documents
All of the documents in your QMS must be legible, identified, reviewed, authorized, up-to-date, issued, distributed, and periodically updated. Obsolete documents have to be identified and protected from unintended use. Documents that come from outside the organization also have to be identified and controlled.
4.2.4 Control of records
Certain records need to be kept to demonstrate how the QMS is operating. These records must be legible, and easy to identify and retrieve. A written procedure must describe how they are identified, stored, protected, retrievable, and define their retention and disposal times.
5 Management responsibility
5.1 Management commitment
The Standard recognizes that an effective quality program requires the involvement and commitment of the organization’s top management. Therefore, the Standard assigns top management the following responsibilities:
Overseeing the creation of the Quality Management System (QMS),
Communicating the importance of meeting requirements, including customer, legal, and regulatory requirements,
Establishing the quality policy and the quality objectives,
Communicating with parties responsible for product and service quality,
Providing adequate resources for the operation of the QMS
Reviewing the operation of the QMS.
5.2 Customer focus
Top management must ensure that customer requirements are understood and met with the goal of improving customer satisfaction.
5.3 Quality policy
The quality policy identifies the main goals of the QMS. The quality policy must be:
Appropriate to the organization’s purpose,
Include a commitment to meet customer, legal and regulatory requirements,
Create a background for establishing quality objectives,
Communicated throughout the organization,
Reviewed for ongoing suitability to the needs of the organization and its customers
5.4 Planning
5.4.1 Quality objectives
Establish measurable quality objectives that support the quality policy and communicate them throughout the organization.
5.4.2 QMS planning
Plan the QMS so that the quality objectives are met and so the system continues to work as it is changed to incorporate improvements.
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
Effective work depends on a clear understanding of each persons responsibility and authority. Therefore responsibility and authority must be defined and communicated.
5.5.2 Management representative
Top management must appoint a manager to have ongoing operational responsibility for the QMS. This person is referred to as the Management Representative. The duties of the Management Representative include:
Ensuring that processes needed for the QMS are established, implemented, and maintained,
Reporting on the performance of the QMS and any improvements needed,
Promoting awareness of customer requirements throughout the organization
5.5.3 Internal communication
Top management needs to set up an effective system of communication to ensure effective operation of the QMS.
5.6 Management review
5.6.1 General
Top management is required to regularly review certain aspects of the QMS to make sure that the goals are being achieved and to look for ways to improve the QMS. The review must cover suitability, adequacy, and effectiveness of the QMS. The review also includes assessing opportunities for improvement and needed changes to the QMS, quality policy, and quality objectives. Records of these review must be kept.
5.6.2 Review input
These meetings must address the following areas:
Internal audit results,
Customer feedback,
How well processes have been working,
How well products have been meeting requirements,
Status of previously identified problems,
Items identified for follow-up in previous management reviews,
Planned process or product changes that could affect quality,
Recommendations for improvement generated through the operation of the QMS
5.6.3 Review output
These reviews result in decisions and actions related to:
improving the QMS, and
improving the product,
the need for additional resources, including human resources.
6 Resource management
6.1 Provision of resources
Provide the people, equipment, tools, and materials need to:
build and maintain the QMS,
continually improve the effectiveness of the QMS, and to
meet customer requirements
6.2 Human resources
6.2.1 General
People performing work affecting product and service quality must be competent to carry out that work. This competency is attained through a combination of education, training, skills, and experience.
6.2.2 Competence, awareness and training
The organization must:
Identify the talents, skills, knowledge, and capabilities each person needs to carry out their assigned responsibilities,
train or otherwise assist people to meet these identified competencies,
assess the competency of each person to carry out their responsibilities,
make sure each person understand how their work contributes to the quality of products and services and to meeting quality objectives.
keep records of each person's education, training, skills, and experience
6.3 Infrastructure
The infrastructure for a QMS includes the building, workspace, equipment, and the supporting services involved in creating the organization’s products or services. The organization will needs to determine, provide and maintain the infrastructure needed to achieve the planned results.
6.4 Work environment
The work environment of the organization must not interfere with the ability of employees to perform effectively in order to meet quality requirements
7 Product Realization Requirements
7.1 Planning of product realization
Product realization is the term used to describe the work that the organization goes through to develop, manufacture, and deliver the finished goods or services. An effective Quality Management System (QMS) includes a comprehensive approach to getting from the product concept to the finished product. This approach, sometimes called a quality plan, includes the following:
product requirements and quality objectives,
creation of the processes, documents, and resources needed for product realization,
required verification, monitoring, inspection, and test activities,
the records to be kept.
7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
The Standard requires the organization to determine product requirements. These requirements can come from the customer, may be mandated by laws or regulations, and include generally accepted standards within your industry or market. Requirements are established by standard contracts or oral agreements that the sales department uses in discussions with customers, and other sources.
7.2.2 Review of requirements related to the product
After gathering preliminary product requirements, these requirements need to be reviewed to be sure that the customer understands them and that the organization is meeting these requirements. This review must ensure:
The requirements are known and understood,
Any changes from the original contract or discussions is understood,
The organization has the ability to meet the requirements
Records are kept of this review.
Routine orders for items described in a catalog of products are considered reviewed when the relevant product information is reviewed.
7.2.3 Customer communication
Put in place effective customer communications channels, to allow dialogue regarding:
product information,
questions about contracts, order handling, changes, and
receiving customer feedback, including complaints.
7.3.1 Design and development planning
To effectively plan the design and development process, the organization must:
Clearly define the stages involved in the design and development process.
Identify how the review and verification of the design will take place.
Describe clear responsibility and authority for the people doing this work.
See that design information flows effectively among the various groups having a role in designing, selling, managing, manufacturing, and servicing the products.
Keep design and development plans up to date.
7.3.2 Design and development inputs
Determine the product requirements, including:
what it does and how well it must perform,
legal and regulatory requirements,
pertinent information from similar designs,
other pertinent requirements.
7.3.3 Design and development outputs
The output of design and development must include sufficient information to verify that design output meets design input requirements. In addition, it must:
include the information need to purchase component materials, manufacture the product, and service the product.
specify how to determine if the product has acceptable performance,
highlight safety and usage considerations.
7.3.4 Design and development review
Review the design and development work products to:
determine if the design meets the design input requirements,
identify and problems with the design,
propose solutions to identified design problems,
Include representatives from each function concerned with the design and development stage being reviewed. Keep records of the reviews.
7.3.5 Design and development verification
Verify, according to your plan, that the design output meets design input requirements. Record the results of these verification activities.
7.3.6 Design and development validation
Validate the operation of the resulting product under actual operating conditions. If the product has multiple uses, validate operation for each intended use. The methods for validation defined in the design output should be followed. Whenever possible, the validation of a product or service should be performed prior to delivery to the customer. Record the results of these validation activities.
7.3.7 Control of design and development changes
Identify, document, review, and approve all design changes before carrying them out. Evaluate the impact of the changes on the present design of the product. Keep records of the review.
7.4 Purchasing
7.4.1 Purchasing process
The organization needs to ensure that purchased products and services meet purchasing requirements. The purchasing group must establish criteria for how they evaluate and choose suppliers. These criteria must be based on the suppliers’ ability to provide products and services that meet order specifications, especially product and service quality requirements. The extent of the controls depend on the importance of the purchased goods in the finished product. Finally, records must be kept showing how purchased products and services were evaluated.
7.4.2 Purchasing information
Clearly describe on purchase orders the product or service being ordered. Consider including the following specifications:
how products, procedures, processes, and equipment are approved for purchase,
required competencies for contracted personnel,
requirements for the supplier's quality management system.
Review and approve purchasing requirements before sending them out.
7.4.3 Verification of purchased product
Carry out a plan for verifying that purchased services and materials are adequate, i.e. meet purchase specifications.
7.5 Production and service provision
7.5.1 Control of production and service provision
Plan production, installation, and service processes and provide an environment where work can proceed in an orderly fashion. These controlled conditions may include:
information regarding product specifications,
written instructions for carrying out the work,
suitable equipment,
adequate tools for monitoring and measuring process and product characteristics,
activities for monitoring and measuring process and product characteristics,
criteria for product release,
delivery and post delivery servicing activities.
7.5.2 Validation of processes for production and service provision
Process validation demonstrates that operation of the processes achieves the planned results. When it is not possible to verify the finished good or service through monitoring or measurement the QMS must require validation. Validation is particularly important where deficiencies are not identified until the product is in use, or the service is delivered. When validation is required, the QMS must define the criteria for the following:
review and approval of the process,
approval of the equipment used,
competency of the people who operate the process,
specific methods and procedures used,
records to be kept,
ongoing assessment of the process validation
7.5.3 Identification and traceability
Where appropriate, establish procedures to identify a product and determine what specifications pertain to it as it moves through manufacturing, delivery, and installation. Record the inspection and measurement status of the product. Individual products or batches of products must have unique serial identification recorded if assuring product product quality requires this.
7.5.4 Customer property
Special care must be taken when a customer provides their property for use or incorporation into the product. Identify, verify, and protect customer property provided and maintain records of lost, damaged or unsuitable customer property. This may include intellectual property.
7.5.5 Preservation of product
The standard requires the organization to preserve the product, including identification, handling, storage, packaging, protection, and delivery of parts and products throughout all processes.
7.6 Control of monitoring and measuring devices
Any measurement worth taking is worth taking correctly. The standard requires the organization to identify the inspection, test and measurements taken, their required accuracy, and the equipment used to make the measurements. Procedures must describe how measurements are carried out.
Measuring equipment must be carefully cared for, including:
timely calibration to national standards,
identification with a calibration label,
preventing adjustments that would invalidate the calibration,
preserving the equipment accuracy during handling, storage and use.
Measurements taken with equipment later found to be inaccurate must be assessed and corrected.
8 Measurement, analysis and improvement requirements
8.1 General
Plan and carry out the inspection, test, measurement, analysis, and improvement activities needed to:
assure product meets product requirements,
assure the QMS works as planned,
improve the operation and results from the QMS.
8.2.1 Customer satisfaction
Monitor the end customers' opinion of your product and service. Determine how to gather and use this information.
8.2.2 Internal audit
Internal audits are verification activities performed by trained auditors within the organization. Their purpose is to determine how well the plans making up the QMS are being followed. The Standard requires internal audits be carried out regularly in each area covered by the QMS. Audits address conformity with the QMS, the requirements of ISO 9001:2000, and the effectiveness of the implementation.
Audit plans address:
Audit criteria, and extent,
Frequency, and methods used,
Responsibility for conducting the audit
Auditors are trained, objective, and never audit their own work.
Identified problems are quickly resolved by the manager responsible for area being audited.
Audit results are reported and recorded, follow up actions are verified.
8.2.3 Monitoring and measurement of processes
Monitor and measure the performance of the processes that make up the QMS. Compare these actual results to the planned results. Take corrective action to make sure the product or service meets requirements.
8.2.4 Monitoring and measurement of product
During the production process, monitor and measure the product to assess if requirements are met. Keep records showing:
The product meets acceptance criteria.
The name of the person who authorized release of the product.
The product has proceeded through all of the planned process steps, including all planned verifications.
8.3 Control of nonconforming product
Nonconforming product is any product or service that does not meet requirements. Have documented procedures to identify nonconforming products and to make sure they are not used by accident. Define who is responsible for deciding what to do with a bad product. One of the following three actions must be taken:
fix the product as if the problem never happened,
ask the customer to accept it, perhaps on new terms,
discard it or clearly mark it as unsuitable for its original use.
Keep records of nonconformities.
Re-inspect any corrected products according to the procedures for new products.
Mitigate potential losses, perhaps by recall, from any product that has been found to be defective after its release to the customer.
8.4 Analysis of data
The standard requires the organization to collect information on the functioning of the QMS. This information is then analyzed to evaluate the effectiveness and efficiency of your system and to identify opportunities for continual improvement of the QMS. Information collected and analyzed relates to:
customer satisfaction,
meeting product requirements,
process characteristics and trends,
product characteristics and trends,
supplier performance.
8.5 Improvement
8.5.1 Continual improvement
Make use of the quality policy, quality objectives, audit results, data analysis, corrective and preventive actions and management review to improve the QMS.
8.5.2 Corrective action
When problems occur, fix the underlying process responsible for the defect. The thoroughness of each solution depends on how costly or unsafe the actual or possible problems are.
Create written procedures for:
satisfying customer complaints
investigating and solving reported product and process problems,
identifying the underlying cause of these nonconformities,
understanding how to eliminate the cause of nonconformities,
making sure corrective actions are carried out,
keeping a record of corrective actions,
following up on corrective actions.
8.5.3 Preventive action
The same actions described above for corrective actions must be considered for problems that have yet to occur. This is called preventive action. Effective preventive action involves identifying the potential problem, examining the root cause, putting a plan in place to prevent occurrence of the problem, evaluating the effectiveness of the plan, recording actions taken, and reviewing the preventive actions taken. A written procedure is required to describe the preventive action process.