Business Process Management

The Process Approach

• A process is a series of activities that add value to input, producing output for customers.
• Customers can be internal or external to the organization.

Measuring a Process

• Qualified people are essential for a process.
• Efficient processes have no waste.
• Effective processes achieve desired results.
• Right equipment and materials are necessary for a process.
• Proven methods ensure quality output.

Documentation Requirements

• Quality documentation consists of 3-4 levels, including policies, procedures, and manuals.
• The documentation pyramid has four levels: Quality Manual, Operational Procedures, Instruction to Operations, and Formats and Records.
• Documentation requirements include control of documents, control of records, QMS manual, external document register, document control register, and work procedures register.

Quality Manual

• The Quality Manual provides evidence of specific controls implemented to ensure product/service quality.
• It benefits customers, suppliers, employees, and ISO.
• It addresses all quality system elements.

Control of Documents

• Documents are approved prior to issue.
• Changes and current revision status of documents are identified.
• Relevant versions of documents are available at the point of use.
• Documents remain legible and readily identifiable.

Structure of ISO 9001:2008

• The standard consists of 8 clauses, including scope, normative references, terms and definitions, QMS requirements, management responsibility, resource management, product realization, and measurement, analysis, and improvement.
• There are 3 general/informative clauses and 5 major clauses.
• 6 mandatory documented procedures are required: control of documents, control of records, internal audit, control of non-conforming product/service, corrective action, and preventive action.

ISO 9001 Requirements

• The standard requires a quality management system (QMS).
• It does not establish requirements for product.
• It uses two approaches: the QMS approach and the process approach.

Clause 4: QMS Approach

• Determine the needs and expectations of customers.
• Establish the quality policy and quality objectives.
• Determine the processes and responsibilities necessary to attain quality objectives.
• Determine and provide resources necessary to attain quality objectives.
• Establish methods to measure the effectiveness and efficiency of each process.
• Apply these measures to determine effectiveness and efficiency of each process.

Control of Records

• Records provide evidence of implementation/conformity to the requirements specified in the process.
• Records should not be tampered with.
• Records should be legible, bear unique identification, and have proper storage locations, protection, and accessibility.
• A disposable mechanism is required.

Clause 5: Management Responsibility

• Management review includes results of the audit, customer feedback, process performance, and product conformity.
• Customer complaints and feedback are considered.
• The organization chart and individual responsibility authorities are established.
• Quality policy and objectives are set.

Management Review

• Results of the audit are reviewed.
• Customer feedback is considered.
• Process performance and product conformity are reviewed.
• Status of preventive and corrective action is reviewed.
• Follow-up actions from previous management reviews are reviewed.
• Changes that could affect QMS are reviewed.
• Recommendations for improvement are made.

Review Output

• Management decisions are based on the review.
• QMS improvement requirements are identified.
• Customer requirements are identified.
• Resource requirements are identified.
• Product/process requirements are identified.