You must have heard about the term Quality Management System or QMS! The Quality Management System is also known as QMS is a baseline requirement to implement processes and requirements as per ISO 9001 or IATF 16949 or ISO 17025.
What is Quality Management System (QMS)?
A QMS covers all key essential elements, activities, processes, sub-process, work-instruction, forms, records of the product manufacturing process or service processes to meet customer requirements, statutory and regulatory requirements.
Why is QMS / Quality Management System essential?
In any organization, the key essential thing is to deliver a consistent quality product or services. This only is possible with QMS. Without QMS it is highly impossible to keep every employee, supplier on a common goal and process.
A QMS is an organizational framework with a prime focus on achieving customer satisfaction and meeting regulatory and statutory requirements by delivering a quality product or services or both consistent with the help of organization structure, procedures, processes, management responsibilities.
Why QMS is essential?
- To form a goal quality assurance and control process and adhere to it.
- It helps to keep everyone in the organization, suppliers, stakeholders to work on a common quality goal and objective.
- A standardized way of working across the organization, it’s group-wide, plant-wide, and legal entity-wide.
- To form better co-ordination between each department, each cross-functional team.
- To deliver quality products and services consistently.
- To meet customer requirements and statutory and regulatory requirements.
QMS comprises the following key elements,
A QMS is an organization’s framework deployed group-wide, plant-wide, legal entity-wide, operation-wide deployed and followed to achieve product and service quality.
- Definition & Scope
- Management Responsibilities
- Organization Structure
- Roles and Responsibilities
- Quality Objective and Quality Policy
- Document and Record control
- Continual Improvement
- Corrective Action & Preventive Action
- Customer Satisfaction & Focus
- Handling customer complaints
- Internal Audit
- Control of externally provided product or service
- Design and Development
- Production and Service control
- Handling non-conforming products or services
Quality System Pyramid
Hierarchy in the QMS system is being followed in various industries. Each QMS level or hierarchy level defines the intent of QMS. In the majority of industrial sectors, four levels of quality system pyramid are used.
Let’s review QMS levels one by one.
Level 1 – Quality Manual:
A Quality manual acts as a manual to define, deploy and operate the overall quality management system in the organization. A Quality manual covers each sub-process requirement and interaction of processes within the organization. A Quality manual can be drafted based on industry standards like ISO 9001 or ISO 13485 (for a medical device) or IATF 16949 (for the automotive industry).
Quality Policy and Objective: Quality Policy is the overall organization’s strategic decision and expectation about product or service quality. Quality Policy and objective are part of the Quality manual.
Level 2 Standard operating procedures:
Standard Operating procedures are also known as SOP or procedures. SOP / Quality procedure covers,
- In scope / Out of Scope
- Roles and Responsibilities
- What is to be achieved.
- Interaction with other procedures / SOP.
- Fulfilling requirements as per level 1
In simple words, SOP/procedure defines WHO, WHEN, WHERE!
Level 3 Work Instruction:
A work instruction covers the ‘How part’. A work instruction is a detailed step-by-step method that is used to achieve the desired outcome.
Level 4 Forms & Records:
The last level of the Quality Pyramid is forms and records. This level indicates i.e. requirements laid out in Quality Manual, Quality procedures, and work instructions are followed. Quality records serve as compliance to Quality Management System.
Level 4 records serve as objective evidence are subject to review during the internal and external audit. Level 4 Records prove whether an organization is following level 1 to 3 requirements or not.
Following image represents different levels of the Quality management system documentation. Level 1 to 4 is most commonly used in the majority of business sectors.
Following a high-level table helps to understand types of documents, procedures, and records at each quality pyramid level.
|Level||List of Applicable Documents||List of Applicable Records|
|Quality Manual||1. A latest released quality manual|
2. Quality Policy
3. Quality Objective
4. Risk Management
|1. SWOT Analysis|
2. Management Review meeting evidence (attendance & action item list)
3. Continual Improvement
4. List of stakeholders and their input, output and roles and responsibilities.
|Standard Operating Procedure||1. Procedure of product design and development.|
2. Procedure of process design and development
3. Tools and instrument procedure & Calibration process
4. Procedure to handle externally provided services and products
|Work Instruction||1. Work instruction of product verification and validation.|
2. Work instruction of process verification and validation.
3. Tool calibration process work instruction as per ISO 17025 standard
4. Supplier audit work instruction, PPAP work instruction.
|1. Product verification & validation record|
(APQP outcome), FMEA, Control Plan
2. Process validation, statistical process control record.
3. Calibration records
4. Supplier audit, product PPAP, supplier performance review.
We hope this blog post helped to understand about Quality Management System and its importance in the organization.