QMS UNIT 4

ISO

• stands for International Organization for Standardization.

• Founded in 1946, a non-governmental organization based in Geneva, Switzerland.

• Facilitates international consensus in formulating International Standards (voluntary in nature).

ISO 9000

• Internationally recognized model for Quality Management System (QMS).

• First published in 1987, revised in 1994, 2000, 2008, and 2015.

• Based on generally accepted practices and common sense.

• Applies to manufacturing, process industries, software developers, and service companies.

• Establishes a foundation to build a total quality management system.

• Recognized by over 170+ countries.

Background to the Standards

• ISO rules require periodic review of all standards to reflect best practices and lessons learned. Outcome: confirmed, revised, or withdrawn.

• In 1997, Technical Committee TC176 (responsible for ISO 9000 series) conducted a global survey of users/customers.

• In 1997, TC176 also issued "Quality Management Principles and Guidelines on their application", which served as key design input for revisions.

ISO 9000 Family of Standards (2015 Family)

1. ISO 9000:2015: Quality Management Systems - Fundamentals and vocabulary.

2. ISO 9001:2015: Quality Management Systems - Requirements.

3. ISO 9004: Quality Management Systems - Guidelines for Performance Improvements.

4. ISO 19011 (IS/ISO 19011:2002): Guidelines for Quality And / Or Environmental Management System Auditing (applicable to both QMS and EMS audits).

ISO 9000 Requirement

1. Quality requirements must be clearly defined and communicated.

2. Personnel contributing to standards must have adequate training and documented procedures to follow.

3. Processes producing products/services must be defined and controlled.

4. Objectives / Targets must be established at functional levels.

5. QMS must be monitored by an internal audit system.

6. Corrective action / Preventive action programs must be in place for improvement.

7. Top Management must be actively involved to assure system effectiveness.

8. Records and objective evidence must be maintained to demonstrate compliance.

SEVEN (7) QUALITY MANAGEMENT PRINCIPLES

1. Customer Focus

2. Leadership

3. Engagement of People

4. Process Approach

5. Improvement

6. Evidence-based Decision Making

7. Relationship Management

Customer Focus

Organizations depend on customers; must understand current/future needs and meet/exceed expectations.

Leadership

Leaders establish unity of purpose, direction, and an environment for people to achieve objectives.

Engagement of People

Full involvement and realization of potential at all levels maximize organizational benefit.

Process Approach

Desired results are achieved more efficiently when related resources and activities are managed as a process.

Improvement

Permanent objective to enhance performance and move the organization forward.

Evidence-based Decision Making

Decisions are based on the analysis and evaluation of data and information.

Relationship Management

Sustains success by managing relationships with interested parties (partnerships with common goals).

HIGH-LEVEL STRUCTURE (HLS) – 10 CLAUSES

1. Scope

2. Normative references

3. Terms and definitions

4. Context of the organization

5. Leadership

6. Planning

7. Support

8. Operation

9. Performance evaluation

10. Improvement

CLAUSE 4: CONTEXT OF THE ORGANIZATION

4.1 Understanding the Organization and its Context

4.2 Understanding Needs and Expectations of Interested Parties

4.3 Determining the Scope of the QMS

4.4 QMS and its Processes

4.1 Understanding the Organization and its Context

The organization shall determine external and internal issues relevant to its purpose and strategic direction affecting QMS results.

• External Context: Key drivers, trends, legal, regulatory, statutory, financial, technological, political, economic, natural, and competitive environments (local, national, regional, or international).

• Internal Context: Governance, structure, roles/responsibilities, policies, objectives, resource availability, organizational culture, contractual relationships, information flow, and decision-making processes.

4.2 Understanding Needs and Expectations of Interested Parties

Determine relevant interested parties (customers, shareholders, regulators, suppliers, distributors, competitors, end-users, community) and their requirements. Monitor and review this information.

• Intention: Anticipate current/future needs; identify opportunities for improvement and innovation.

4.3 Determining the Scope of the QMS

Define boundaries and applicability of QMS based on internal/external issues (4.1), interested parties (4.2), products/services, main processes, and sites.

• Exclusions: Justification must be provided when a requirement cannot be applied. Scope must be maintained as documented information.

4.4 QMS and its Processes

Establish, implement, maintain, and continually improve the QMS.

• Determine required inputs and expected outputs.

• Determine sequence and interaction of processes.

• Apply monitoring, measurement, and performance indicators (KPIs).

• Assign responsibilities and authorities.

• Address risks and opportunities.

• Retain documented information to have confidence processes run as planned.

CLAUSE 5: LEADERSHIP

5.1 Leadership and Commitment

5.2 Policy

5.3 Organizational Roles, Responsibilities, and Authorities

5.1 Leadership and Commitment

• 5.1.1 Top management must take accountability for QMS effectiveness; ensure quality policy and objectives align with strategic direction; integrate QMS into business processes; promote process approach and risk-based thinking; ensure resources are available.

• 5.1.2 Customer Focus: Ensure customer and statutory/regulatory requirements are met; address risks/opportunities affecting product conformity; maintain focus on enhancing customer satisfaction.

5.2 Policy

• Establishing: Appropriate to context; provides framework for objectives; includes commitment to satisfy applicable requirements and continual improvement.

• Communicating: Must be documented, communicated, understood, applied internally, and available to relevant interested parties.

5.3 Organizational Roles, Responsibilities, and Authorities

Top management must assign and communicate responsibilities for: conforming QMS to ISO 9001; reporting performance & improvement opportunities; promoting customer focus.

CLAUSE 6: PLANNING

6.1 Actions to Address Risks and Opportunities

6.2 Quality Objectives and Planning to Achieve Them

6.3 Planning of Changes

6.1 Actions to Address Risks and Opportunities

• Consider 4.1 (issues) and 4.2 (requirements) to plan actions for risks/opportunities.

• Options: Risk avoidance, mitigation, elimination, or acceptance.

• Hierarchy of Control: Eliminate -> Substitute -> Engineering Controls -> Administrative Controls -> Acceptance.

6.2 Quality Objectives and Planning to Achieve Them

• 6.2.1 Requirements: Objectives must be consistent with Quality Policy, measurable, monitorable, communicated, updated, and documented.

• 6.2.2 Action Planning: Must specify WHAT will be done, WHAT resources are needed, WHO is responsible, WHEN it will be completed, and HOW results will be evaluated.

6.3 Planning of Changes

Changes to QMS must be carried out in a planned manner.

• Consider: potential consequences, QMS integrity, resource availability, and responsibility allocation/reallocation. (Utilize a Change Management Form)

CLAUSE 7: SUPPORT

7.1 Resources

7.2 Competence

7.3 Awareness

7.4 Communication

7.5 Documented Information

7.1 Resources

• 7.1.1 General: Determine and provide internal/external resources for QMS.

• 7.1.2 People: Provide necessary personnel.

• 7.1.3 Infrastructure: Buildings, utilities, equipment, software, transport, IT.

• 7.1.4 Environment for Operation: Social, psychological, and physical factors.

• 7.1.5 Monitoring & Measuring Resources: Provide fit-for-purpose equipment; retain calibration evidence.

  • 7.1.5.2 Traceability: Calibrate against national/international standards; tag equipment status; safeguard against unauthorized adjustments.

• 7.1.6 Organizational Knowledge: Maintain internal knowledge (experience, lessons learned) and external knowledge (standards, academia, training).

7.2 Competence

Determine necessary competence; ensure personnel are competent based on education, training, or experience; take actions to acquire competence (Training Need Analysis); retain evidence (Competency Matrix, training records).

7.3 Awareness

Ensure personnel are aware of the Quality Policy, Quality Objectives, their contribution to QMS effectiveness, and implications of non-conformity.

7.4 Communication

Determine internal/external communication: What, When, With whom, How, and Who communicates.

7.5 Documented Information

• 7.5.1 General: Includes scope, policy, objectives, procedures, records, calibration reports.

• 7.5.2 Creating/Updating: Proper title, date, author, rev number, reference number, format, and approvals.

• 7.5.3 Control: Ensure availability, protection, distribution, access, retrieval, storage, version control, retention, and disposition. Control external documents.

Document

is a "work in progress" , it is editable.

Record

are permanent; they cannot be recreated or edited.

Procedure

Detailed documentation describing WHO does WHAT and WHEN (shows sequence or order).

Work Instruction

Very detailed documentation on HOW to perform or accomplish a specific job, task, or assignment.

Form

Fillable documents used to create records.

MANUAL NOMENCLATURE

This number coding system applies to all types of manuals related to the Quality Management System of the university (e.g., Operations Manual, Faculty Manual, Student Manual).

DOCUMENT NOMENCLATURE

Consists of the following:

• Acronym

• 3-letter acronym of the Office/College Name from the where the Manual was originated.

• 2-letter acronym of the Office/College Name from the where the Manual was originated.

• 2-digit representing the sections under each chapter number of the manual.

QMS RELATED DOCUMENT NOMENCLATURE

This coding structure applies to procedures, work instructions, guidelines, and forms used within the system.

Consists of the following:

• Acronym

• 3-letter acronym of the Office/College Name from the where the Manual was originated.

• 2-letter representing the document type

  • SP - System Procedure

  • WI - Work Instructions

  • GL - Guidelines

  • SF - System Form

• 2-digit representing the series number (SN) of the document per document type authored by an originating office or college.

CLAUSE 8: OPERATION

8.1 Operational Planning and Control

8.2 Requirements for Products and Services

8.3 Design and Development of Products and Services

8.4 Control of Externally Provided Processes, Products, and Services

8.5 Product and Service Provision

8.6 Release of Products and Services

8.7 Control of Nonconforming Outputs

8.1 Operational Planning and Control

Plan, implement, and control operational processes: set product criteria, acceptance criteria, resource needs, risk controls, and outsourced process controls.

8.2 Requirements for Products and Services

• 8.2.1 Customer Communication: Information, handling inquiries/orders/changes, feedback/complaints, customer property, contingency actions.

• 8.2.2 Determining Requirements: Defined statutory/regulatory requirements and internal standards.

• 8.2.3 Review of Requirements: Review prior to delivery commitment (customer specs, unstated needs, regulatory rules, contract differences). Confirm unwritten requirements before acceptance. Retain review records.

• 8.2.4 Changes to Requirements: Amend documentation and notify personnel.

8.3 Design and Development of Products and Services

• 8.3.1 General: Establish and maintain design/development process.

• 8.3.2 Planning: Consider stages, reviews, verification, validation, roles, resources, controls.

• 8.3.3 Inputs: Performance, regulatory requirements, previous designs, standards.

• 8.3.4 Controls: Evaluate results, verify, validate, and correct deviations.

• 8.3.5 Outputs: Meet input criteria, adequate for subsequent processing, specify essential characteristics.

• 8.3.6 Changes: Identify, review, authorize, and control design changes.

8.4 Control of Externally Provided Processes, Products, and Services

• 8.4.1 General: Ensure external supplies/outsourced processes conform. Apply criteria for evaluation, selection, monitoring, and re-evaluation.

• 8.4.2 Type & Extent of Control: Keep external processes within QMS control; assess potential impact.

• 8.4.3 Provider Information: Communicate requirements for processes, product approval, competence, and performance monitoring.

8.5 Product and Service Provision

• 8.5.1 Control of Provision: Controlled conditions: SOP availability, measuring tools, monitoring stages, competent staff, validation, human error prevention, release/post-delivery protocols.

• 8.5.2 Identification & Traceability: Identify output status; maintain unique identification when traceability is required (trace forward to clients and backward to suppliers).

• 8.5.3 Property Belonging to Customers/External Providers: Exercise care, safeguard, verify, and report any lost/damaged property (materials, components, tools, IP, personal data).

• 8.5.4 Preservation: Preserve outputs (handling, packaging, contamination control, storage, transport).

• 8.5.5 Post-delivery Activities: Meet warranty, maintenance (AMC), statutory, and feedback obligations.

• 8.5.6 Control of Changes: Review, document, and control production/service changes.

8.6 Release of Products and Services

• Implement planned arrangements to verify requirements are met. 

• Products/services shall not be released until planned arrangements are complete. 

• Retain records (conformity evidence + authorizing person).

8.7 Control of Nonconforming Outputs

Identify and control nonconforming outputs: correction, segregation, containment, return, client notification, or concession authorization. Retain description of nonconformity, actions taken, concessions, and authorization

CLAUSE 9: PERFORMANCE EVALUATION

9.1 Monitoring, Measurement, Analysis, and Evaluation

9.2 Internal Audit

9.3 Management Review

9.1 Monitoring, Measurement, Analysis, and Evaluation

• 9.1.1 General: Determine what to measure, methods, frequency, and evaluation criteria.

• 9.1.2 Customer Satisfaction: Track customer perceptions (surveys, feedback, market share, compliments).

• 9.1.3 Analysis & Evaluation: Evaluate conformity, customer satisfaction degree, QMS effectiveness, external provider performance, and improvement needs.

9.2 Internal Audit

• Conduct internal audits at planned intervals.

• Maintain audit plans, programs, checklists, and impartial auditors.

• Report results to management, perform root cause analysis, apply corrective actions, and retain records.

9.3 Management Review

• 9.3.1 General: Top management reviews QMS suitability, adequacy, effectiveness, and strategic alignment at planned intervals.

• 9.3.2 Inputs: Previous review actions, internal/external context changes, quality objective status, non-conformities/CARs, audit results, external provider performance, resource adequacy, risk action effectiveness.

• 9.3.3 Outputs: Improvement opportunities, QMS revision needs, resource allocations.

CLAUSE 10: IMPROVEMENT

10.1 General

10.2 Nonconformity and Corrective Action

10.3 Continual Improvement

10.1 General

Determine improvement opportunities. Implement actions via: Reactive methods (corrective action), Incremental steps (continual improvement), Step changes (breakthrough), Creative methods (innovation), or Re-organization.

10.2 Nonconformity and Corrective Action

React to nonconformities: contain, correct, evaluate root cause to prevent recurrence (Preventive Action concept integrated), and document results.

10.3 Continual Improvement

Continually improve suitability, adequacy, and effectiveness of the QMS using analysis, evaluation, and management review outputs.