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ISO 9001

ISO 9001 Quality Management System

ISO 9001

ISO 9001 is a Quality Management System standard focusing the customer satisfaction, process/product conformity and overall perspective of the organization to consistently perform and continually improve based on the framework provided by the standard. Currently, the available standard is ISO 9001:2015 i.e. Quality Management System.

 

What are the requirements of QMS (ISO 9001) – QMS is the set of policies, procedures, processes that are required for planning and execution of product/services. The structured way of delivering quality products/services is supported by documented information.

 

Requirements of the ISO 9001 standard 

Refer to the standard it is split into 10 clauses. Clauses are nothing but minimum requirements stated by this standard through which the goal of the effective quality management system can be achieved.

 

ISO 9001 Clause 1 – Scope 

It specifies the requirement when an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements and aims to enhance customer satisfaction through effective application

 

 

ISO 9001 Clause 2 – Normative references –

It refers to fundamentals and vocabulary applied to this standard

ISO 9001 Clause 3 – Terms and definitions –

It refers to the terms and definitions for ISO 9001:2015

 

 

ISO 9001 Clause 4 – Context of the organizations

This is subdivided into 4 clauses stating – Understanding the organization and its context (ref. 4.1 – determination of internal and external issues considering issues arising from the legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional, or local).

 

Understanding the needs and expectations of interested parties (ref.4.2 – determining the needs and expectations of interested parties relevant to the quality management system (Interested parties are – Customer, Supplier, Worker, Visitors, Stakeholders, bankers, Statutory and regulatory bodies, neighbor, etc.) )

 

 

Determining the scope of the quality management system (Ref. 4.3 – It is the activities of the organization considering internal and external issues, requirements of relevant interested parties and product/services of the organization)

 

 

Quality Management System and its processes (Ref. 4.4.1 – here to determine the process inputs and desired outputs of mentioned processes and their interaction, determining the resources needed to ensure their availability, assigning the responsibilities and authorities for the processes and determining criteria and methods to ensure the effective operation and control for the processes

 

 

To the extent necessary, the organization (Ref. 4.4.2 – to maintain and retain the documents/records to support the operation and have process conformity)

 

 

Document requirement of this clause –

Clause No. Document reference / Name
4.1 Risk Register
4.2 Quality Manual describing Needs and expectations of interested parties / Contractual agreements / Statutory and regulatory requirements as described by the legal authority
4.3 Quality Manual describing the scope of the organization and its applicability relevant to the quality management system
4.4 Process flow charts and its interaction, detailed process inputs and its expected output, Organization chart

 

 

ISO 9001 Clause 5 – Leadership

This is sub-divided in three sub-clauses –

Leadership and commitment (Ref.5.1 – stating General (5.1.1) requirements for leadership and customer focus (5.1.2).

 

The general clause states the demonstration of leadership taking the accountability for the effectiveness of the quality management system, It is the appointment of the Team leader ensuring the establishment of quality policy and objectives, resources needed and supporting other relevant management roles/functions

 

Customer focus – states fulfilling applicable statutory and regulatory requirements, risks, and opportunities that affect the performance/conformity and focusing customer requirements to be fulfilled at its desired level and maintaining customer satisfaction.

 

 

Policy – it is further sub-divided to 2 sub-clauses Establishing the quality policy (Ref. 5.2.1 – which states the organization has to implement and maintain the quality policy that is appropriate to the purposes and context of the organization and supports its strategic directions, provides the framework for setting quality objectives, includes a commitment to continually improve and satisfy the applicable requirements).

 

 

Communicating the quality policy (Ref. 5.2.2 – which states policy to be available within the organization, for interested parties, and to be understood and applied within the organization).

 

Organizational Roles, responsibilities, and authorities (Ref. 5.3 – it states relevant roles are assigned, communicated and understood within the organization in addition organization to assign the responsibilities and authorities to ensure standard compliance, processes are delivering the desired outputs, reporting the performance of the management system, promoting customer focus)

 

 

Document requirement of this clause –

Clause No. Document reference / Name
5.1.1 Documents describing allotment of Team Leader and his/her responsibilities for the effectiveness of the quality management system
5.1.2 Legal Register / Customer Survey form / Risk Register
5.2 Documented statement of quality policy that is available within the organization and to interested parties
5.3 Job Description / Work Portfolio / Job Charter Register

 

 

ISO 9001 Clause 6 – Planning

QMS planning further subdivided into 3 clauses/sections

Action to address risk and opportunities (Ref. 6.1 – Which states to determine the risks and opportunities considering internal and external issues as identified by the organization to assure its results, enhance desirable effects & improvement (6.1.1) and to plan the action to address the risks and opportunities (6.1.2)

 

 

Quality objectives and planning to achieve them – its states to establish quality objectives those are (6.2.1) – measurable, consistent with the quality policy, accounts applicable requirements, relevant to the conformity of the product/services, be measurable, communicated and updated as appropriate and (6.2.2) – organization shall determine what to be done, what are the resources, who is responsible, when to be completed and how to evaluate

 

 

Planning of changes (Ref. 6.3 – which states to consider the purpose of changes and its potential consequences, resource availability and allocation of responsibilities and authorities

 

 

Document requirement of this clause

Clause No. Document reference / Name
6.1 Risk Register that imposes internal and external issues of the organization, needs, and expectations of interested parties, its relevant action plan to minimize or control its.
6.2 The document describing Quality objectives, and its action plan on how to achieve / monitor
6.3 Change request form

 

 

ISO 9001 Clause 7 – Support

Resources (Ref. 7.1 this clause / section further subdivided in 6 sub-clauses / sections)

 

 

General (7.1.1 – it refers to the establishment of internal resources considering external providers / outsourced activities)

 

People (7.1.2 – it refers to the provision of peoples/workers/personnel/employees for the effective implementation of the management system).

 

 

Infrastructure (7.1.3 – provision and maintenance of necessary infrastructure for the operation of its processes to achieve conformity of products/services. The infrastructure that includes building and related utilities, equipment with hardware/software, transportation resources, and IT technologies)

 

 

Environment for the operation of processes (7.1.4 – it states organization to determine, provide, and maintain the environment/surroundings those are necessary for the operations of its described processes to achieve product/service conformity. Environment/surroundings that is a combination of human and physical factors e.g. non-discriminatory, calm, non-confrontational, stress-reducing, burnout prevention, emotionally protective, temperature, heat, humidity, light, airflow, hygiene, noise, etc.)

 

 

Monitoring and measuring resources (7.1.5 – this is further sub-divided in 2 clauses)

 

 

General (7.1.5.1 – it states the provision of appropriate monitoring and measuring equipment/resources to verify the product/service conformity)

 

Measurement Traceability (7.1.5.2 – it states calibration and its traceability, identification, and safety of the instruments/equipment/resources for the product/service conformity)

 

 

Organizational Knowledge (7.1.6 – an organization to determine, gain, upgrade its knowledge to improve further. Knowledge-based on internal/external sources).

 

 

Competence (7.2 – it refers the ability of the personnel/employee/worker to perform the work relevant to his/her capacity, education, training or experience and his/her knowledge improvement plan / necessary actions along with documented evidence

 

 

Awareness (7.3 – which states persons within the organization are aware of the quality policy, its relevant objectives, their contribution towards the effectiveness of the management system

 

 

Communication (7.4 – it is the communication procedure to be performed internally and externally indicating on what – when – with whom – how to and who communicate)

 

 

Documented Information (7.5 – this section is further divided in 3 sub-clauses)

 

 

General (7.5.1 – it refers to documented information requirements relevant to the standard and other documents as determined by the organization)

 

Creating and updating (7.5.2 – it is about when creating and updating the document it has appropriate – identification and description (Title, date, author/reference no.), Format and review and approval

 

Control of documented information (7.5.3 – it is subdivided in 2 clauses)

Documented information (7.5.3.1 – it is about the availability of the information suitable for use when needed, its protection from loss of confidentiality, improper use or loss of integrity)

 

Control of documented information (7.5.4.2 – it is about documented information and its distribution, access, retrieval, use, storage criteria, control of changes, retention and disposition to be addressed by the organization

 

 

Document requirement of this clause

Clause No. Document reference / Name
7.1.1 Infrastructure list, Plant Layout, Machine List, Utilities
7.1.3 Maintenance Plan / Preventive and Breakdown Maintenance Register.
7.1.4 Cleaning / Sanitation plan or record
7.1.5.1 List of Monitoring and Measuring instruments/equipment/resources

Calibration Plan

7.1.5.6 Calibration certificate along with its master traceability/ Certificate of analysis/safeguard conditions
7.1.6 Literature / Theses / Customer complaints and its Corrective action record / Customer Feedbacks / Work instructions
7.2 Bio data / CV, Training plan / records
7.3 Training plan / Training records / Training need identification / Training evaluation
7.4 Communication procedure
7.5.1 Quality Manual / Procedures / Master list of documents and records
7.5.2 Forms and formats / Master list of documents and records / Revision record
7.5.3 Source of Master list of documents and records
7.5.4 Source of Master list of documents and records

 

 

ISO 9001 Clause 8 – Operation

Operational planning and control (8.1 – it is about to plan and control the processes to meet the desired product/services results

 

 

The requirement for product and services (8.2 – this is further sub-divided in 4 clauses/sections)

 

 

Customer communication (8.2.1 – it is about communication procedure related to the customer that includes product/service information provided to the client, handling inquiries, contracts or orders along with changes, obtaining customer feedback, handling customer property and handling specific requirements for contingency actions

 

 

Determining the requirements for products and services (8.2.2 – it is about customer purchase orders / contractual agreements / Memorandum of association / Work Agreement, etc., that describes customer requirements along with applicable statutory and regulatory requirements and the requirements those not stated by the customer but considered as necessary by the organization

 

 

Review of the requirements for products and services (8.2.3 – it is a review of customer requirements including requirements specified by the customer, applicable statutory and regulatory requirements, requirements differing from those previously expressed, requirements those not stated by the customer but considered as necessary by the organization, requirements specified by the organization and its customer approval/confirmation before acceptance).

 

 

Changes to requirements for products and services (8.2.4 – it is about the procedure for changes in customer requirements)

 

 

Design and Development of products and services (8.3 – it is sub-divided in 6 clauses/sections)

 

General (8.3.1 – it states about the D&D process to ensure the subsequent provision of products and services)

 

Design and development planning (8.3.2 – it is planning of product/services considering nature of the product/services, its duration and complexity of the d&d activities, required process stages including design reviews, verification and validation activities, responsible authorities, its interface and subsequent provision of product and services)

 

Design and development inputs (8.3.3 – While designing, organization have to consider functional and performance requirements of the product/services)

 

Design and development controls (8.3.4 – it is about ensuring D&D results to be achieved are defined, D&D reviews, verification, validation, and action against identified issues, and relevant documentation on control).

 

Design and Development output (8.3.5 – it is the result of the proposed design that meet input requirements)

 

Design and Development changes (8.3.6 – it is about changes made during the design and development of products and services).

 

Control of externally provided processes, products, and services (8.4 – it is subdivided into 3 clauses/sections)

 

General (8.4.1 – it is about supplier evaluation, selection, monitoring of supplier performance, their validation / re-validation and retention of documented information for the same)

 

Type and extent of control (8.4.2 – it is about control on externally purchased product/services and controls applied, verification or other activities to ensure the product conformity)

 

Information for external providers (8.4.3 – it is supplier purchase order/work agreement/memorandum of the association on product/service approval, approval on methods, processes, and equipment).

 

Production and service provision (8.5 – it is sub-divided in 6 clauses/sections)

 

Control of production and service provision (8.5.1 – it is ensuring the availability of work instructions, product characteristics, process validation, resource availability, and actions to prevent human error).

 

Identification and Traceability (8.5.2 – it is about the identification of the status of output throughout production and service provision)

 

Property belonging to customer or external provider (8.5.3 – it is about exercise care with belongings to customers and external providers while under organization control).

 

Preservation (8.5.4 – it is about the extent of care taken for a product during the production and service provision.

 

Post-delivery activities (8.5.5 – It is the activities that are associated with the products and services while determining the post-delivery activities organization to consider applicable statutory and regulatory requirements, potential undesired consequences, customer feedback.)

 

Control of changes (8.5.6 – it is about changes in product/service to ensure conformity requirements and retention of records of review of changes, the authority to change, and any necessary actions on review).

 

Release of products and services (8.6 – it is stage inspection of product/services to verify the product conformity)

 

Control of nonconforming outputs (8.7 – it is further divided into 2 sub-clauses) –

 

Nonconforming output (8.7.1 – it is dealing with rejection / Nonconforming product/services)

 

Documented information (8.7.2 – it is documented information on nonconforming output/rejection and its Corrective action record)

 

Document requirement of this clause –

Clause No. Document reference / Name
8.1 Cleaning/sanitation plan, preventive / breakdown maintenance plan, Manpower plan, production plan, quality control plan, inspection plan, outsourced process plan, storage plan, dispatch plan, acceptance plan
8.2.1 Communication procedure, customer feedback register, customer property list, the contingency action plan for handling specific requirements, Enquiry register, customer complaint register, and respective Corrective action record
8.2.2 customer purchase orders / contractual agreements / Memorandum of association / Work Agreement / Product catalogue
8.2.3 Review records of customer requirements i.e. customer purchase orders / contractual agreements / Memorandum of association / Work Agreement
8.2.4 Amendment records of customer purchase orders / contractual agreements / Memorandum of association / Work Agreement
8.3.1 Design & Development procedure
8.3.2 Design & Development Planning
8.3.3 Design & Development Inputs
8.3.4 Design & Development reviews, Design & Development verification, Design & Development validation and Corrective action record on identified issues
8.3.5 Design & Development output
8.3.6 Design & Development changes
8.4.1 Supplier list, supplier evaluation, supplier selection, supplier performance, Supplier validation / re-validation
8.4.2 Inward inspection report, Certificate of analysis, Material Test certificate, Lab Test Certificate
8.4.3 Supplier purchase order, Indent, requisition form
8.5.1 Work instruction, Machine List, Equipment list, process validation records, Daily production/service plan, Job Card
8.5.2 Production / Service record / Job Card, Inspection record
8.5.3 Customer property list/record of maintenance and or Corrective/preventive action on customer assets
8.5.4 Production / Service record / Job Card, Inspection record
8.5.5 Warranty / Guaranty record, Field call report, Service report
8.5.6 Production change record/plan
8.6 An in-process inspection report, first piece inspection report, final inspection report, Lab test report, certificate of analysis, Pre-dispatch inspection report, etc.
8.7 Rejection Record and its Corrective action record

 

 

ISO 9001 Clause 9 –

Performance evaluation (9 – this is sub-divided in 3 subsections / clauses) –

 

 

General (9.1.1 – it is about determining the criteria for what to be monitored and measured, methods of monitoring, measurement, when it is to be performed and evaluated)

 

Customer Satisfaction (9.1.2 – it states monitoring customer’s perception to which their needs and expectations have been met/fulfilled).

 

Analysis and evaluation (9.1.3 – it is about the evaluation of data and information arising from monitoring and measurement of – Product/service conformity, customer satisfaction, QMS performance, supplier evaluation, and need for improvement).

 

Internal audit (9.2 – it is subdivided in 2 clauses / sections) –

Conducting Internal audit (9.2.1 – it is conducting an internal audit at planned intervals to verify the QMS compliance and organizations owned requirements).

 

Internal audit (9.2.2 – it is about audit programme, procedure, frequency, methods, and audit reporting with the consideration of the importance of the processes concerned, changes that affecting the organization and results of the previous audit).

 

Management Review (9.3 – this is referred in 2 subsections/clauses)

 

General (9.3.1 – it is a review of the management system at planned intervals, about review procedure to ensure its continuing suitability, adequacy, effectiveness, and alignment with the strategic directions of the organization).

 

 

Management Review Inputs (9.3.2 – it is the consideration of previous MRS actions, changes to external/internal issues, the performance of customer satisfaction/feedback, process performance, identified product NC’s and its Corrective action record, results of monitoring and measurement, audit results, supplier performance, resource adequacy, opportunities for improvement).

 

 

Management review output (9.3.3 – it is review output considering management review inputs and includes decision and action related to opportunities for improvement, need for changes, and resource needs).

 

 

Document requirement of this clause –

Clause No. Document reference / Name
9.1.1 Procedure for performance evaluation
9.1.2 Customer satisfaction / Survey form, Customer Feedback
9.1.3 Data Analysis
9.2.1 Procedure for internal audit
9.2.2 Internal audit plan, Internal audit schedule, internal auditor list, Internal auditor competence and evaluation, internal audit summary record, Corrective action record of Internal audit NC’s
9.3.1 The management review procedure, MRM Circular
9.3.2 MRM record

 

 

ISO 9001 Clause 10

Improvement – (10 – this is further divided into 2 sub-clauses / sections) –

 

 

General (10.1 – it is the determination of opportunities for improvement and implement any necessary actions to meet customer requirement

 

 

Nonconformity and corrective action (10.2.1 & 10.2.2 – it is corrective action on identified non-conformity arising from customer complaints).

 

 

Continual improvement (10.3 – it is an improvement plan on data analysis and MRM output).

 

 

 

Document requirement of this clause –

Clause No. Document reference / Name
10.1 Business plan
10.2.1 / 10.2.2 Corrective action records on customer complaint
10.3 Improvement plan on data analysis and MRM output