ISO 9001 Certification

ISO 9001 Certification

About ISO 9001 – Quality Management System

ISO 9001 :2015 is Quality Management System standard – It is a strategic decision for a company to adopt for implementation and ISO 9001 Certification, that can help it improve its overall performance and provide a solid foundation for long-term development initiatives for the organization.

The requirements for a Quality Management System (ISO 9001:2015) specified in this Standard are in addition to those for products and services.

The process approach is used in this Standard, which includes the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking.

Process Approach – The process approach allows an organization to plan its processes and how they interact with one another process within the organization.

PDCA Cycle – The PDCA cycle allows an organization to ensure that its processes are adequately resourced and managed, and that opportunities for improvement are identified and pursued.

Risk- Based Thinking –  The Risk-based thinking enables an organization to identify the factors that may cause its processes and quality management system to deviate from the expected results, to implement preventive controls to mitigate negative effects, and to capitalize on opportunities as they arise.

 

In an increasingly dynamic and complex environment, organizations face a challenge in meeting requirements while also anticipating future needs and expectations. To achieve this goal, the organization may find that, in addition to correction and continuous improvement, other forms of improvement, such as breakthrough change, innovation, and re-organization, are required.

Quality-Management-System-Standard-Certification

Understanding ISO 9001 Certification

It is a Quality Management System Standard Certification.  This QMS Standard was revised in the year 2015 and the latest QMS Stands is ISO 9001:2015, This new revised ISO 9001 Standard has adopted the PDCA, Risk Based Thinking and Process Approach in the requirement. The organization seeking ISO 9001 Certification must  implement the QMS Standard to  get the optimum benefits of  QMS Certification  by adopting the PDCA, Risk Based thinking and Process Approach methods. 

ISO 9001 certification will help the organization to enhance the process performance and customer Satisfaction There are some of the key factors that every organization with ISO 9001 Certification must follow:

  • ISO CERTIFICATION MUST BE RENEWED EVERY 3 YEARS.
  • AN ORGANIZATION MUST FOLLOW THE WAY OF DOING BUSINESS THAT PROMOTES QUALITY.

 

Important Aspects Covered in ISO 9001:2015

  • RISK BASED THINKING
  • PROCESS APPROACH
  • CONTINUAL IMPROVEMENTS
  • QUALITY MANAGEMENT PRINCIPLES
  • INTERNAL AND EXTERNAL ISSUES
  • NEEDS AND EXPECTATIONS OF INTERESTED PARTY
  • ORGANIZATIONAL KNOWLEDGE
  • RISK ANALYSIS

 

ISO 9001:2015 has added a few new requirements in addition to the requirements said in ISO 9001:2008.

 

This standard has adopted the methodology of a process approach and Risk base thinking throughout the requirements.

Risk-Based Thinking

The concept of risk-based thinking specifies requirements for the organization to understand its context and determine risks as a basis for planning. The key objective of the QMS requirements is to act as a preventive tool. The risk-based thinking has enabled some reduction in prescriptive requirements and their replacement by performance-based requirements.

The requirements of ISO 9001 Certification and ISO 9001:2015 requirements are given below

This standard has 10 clauses, from Clause #1 to Clause # 10, but the requirements for QMS is provided in clause # 4 to 10, where the organization is required to implement the requirements and demonstrate the compliance for third-party certification.

 

The requirements for ISO 9001:2015 are as under

 

Context of The Organization

Understanding the organization and its context – The organization shall determine the internal and external issues within the context of the organization and monitor and review the identified issues.

Understanding the needs and expectations of interested parties– where the organization shall determine the needs and expectations of the interested parties. The Interested party many are Customer, Regulatory Body, an employee of the organization, supplier, stakeholders etc.

Determining the scope of the quality management system– Where the organization is required to determine the scope of the organization within the context and its applicability Considering the internal and external issues, needs, and expectations of interested parties and product /services of the organization.

Quality management system and its processes– Where the Organization shall determine the Inputs and outputs of the process, sequence the process, establish the criteria /Methods for the effective operation of processes. Determine the resource needed and role responsibility. Monitor and evaluate the process and take necessary action for continual improvements. Same time address the Risk and opportunity.

 

Leadership

Top management shall demonstrate leadership and commitment with respect to the quality Management system.

Customer focus – Where the organization’s top Management shall demonstrate the leadership and commitments towards customer Focus by enhancing customer satisfaction, meeting the compliance to applicable regulatory requirements, and addressing the Risk & opportunity.

Establishing the Quality Policy – The Top management of the organization shall establish, implement, and maintain the quality policy of the organization which shall be appropriate to the context of the organization. Where top management has the commitments to satisfy applicable requirements and continual improvement of the quality management system.

Organizational roles, responsibilities, and authorities – The Top Management of the organization shall ensure that the responsibilities and author
 

Planning

Actions to address risks and opportunities – Considering the Internal and External Issues the organization shall determine the Risk and Opportunity. Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.

Quality objectives and planning to achieve them– to demonstrate the compliance to Quality policy the organization established the Quality objective, which shall be measurable and shall be communicated within the organization.

 

Support

The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system For implication and effective operation the organization required Human Resource, Infrastructure, and Environment for the operation of processes, Monitoring and measuring resources, Organizational knowledge, Competence of Human resource, Awareness, and Communication

Documented information – The organization shall maintain the documented information required for QMS and retain the documents to demonstrate compliance.

 

The organization shall create and update the documents – as required and control the documents.

 

Operation

Operational planning and control – where the organization shall plan the resources and processes to meet the requirements for the provision of products and services. Requirements for products and services – The organization shall determine the requirements for products and services to be offered to the customer. Including the review of product/service requirements along with communication with the customer.

Design and development of products and services – which includes the requirements of Design and development planning, design and development inputs, Design and development controls, Design and development outputs, and Design and development changes.

Control of externally provided processes, products, and services – which includes the requirements of Type and extent of control on supplier and Information for external providers.

Production and service provision – Control of production and service provision – where the requirements are that the organization shall implement production and service provision under controlled conditions.

Identification and traceability – where the organization is required to identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision.

Property belonging to customers or external providers – As per the requirements the organization shall identify, verify, protect, and safeguard customers’ or external providers’ property provided for use. Preservation – as per the requirements the organization shall preserve the outputs during production and service provision. Which can include – identification, handling, contamination control, packaging, storage, transportation and protection

Release of products and services – where the organization shall ensure that at each stage of production or service activities – the product or service is meeting requirements of the customer. The most commonly used activities or known as In-process Inspection / Final inspection as appropriate. Which ensures that the product or service is meeting the customer requirements.

Control of nonconforming outputs – As per requirements, the organization shall make a system in the organization for ensuring that the Non- Confirming product is controlled within the organization, which are produced during manufacturing or created during the service activities. As when a non- confirm product is identified – it shall be kept in the identified place to ensure that it cannot be mixed with the correct product.

When a nonconforming product is identified the responsible person of the organization does the re-inspection and takes the decision of Disposal of product or accepts the same with deviation.
 

Performance Evaluation

Monitoring, measurement, analysis, and evaluation – As per the requirements the organization has to determine – which is to be monitored and measured. The method of Monitoring and measurements, Frequency of Monitoring, and Measurements. Plan for analysis and evaluation of the result of monitoring and measurements.

Customer satisfaction – As per the requirements the organization shall do the analysis of customer satisfaction to ensure that the degree to which their needs and expectations have been fulfilled

Internal audit – As per requirements, the organization shall conduct the internal audit at the planned intervals to ensure that the Quality Management system of the organization is effectively implemented and maintained.

Management review – The organization shall conduct the Management review meeting at Planned internal to ensure its continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organization.

Where organization shall discuss the points of MRM – which includes the followings (but not limited)

  • STATUS OF ACTIONS FROM PREVIOUS MANAGEMENT REVIEWS
  • CHANGES IN EXTERNAL AND INTERNAL ISSUES
  • CUSTOMER SATISFACTION AND FEEDBACK FROM RELEVANT INTERESTED PARTIES
  • PROCESS PERFORMANCE AND CONFORMITY OF PRODUCTS AND SERVICES
  • NON-CONFORMITIES AND CORRECTIVE ACTIONS
  • AUDIT RESULTS
  • EFFECTIVENESS OF ACTIONS TAKEN TO ADDRESS RISKS AND OPPORTUNITIES
  • OPPORTUNITIES FOR IMPROVEMENT.

 

Improvement

As per the requirements – The organization shall determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction.

Nonconformity and corrective action – when there is non-conformity identified the organization shall take necessary corrective action.

Continual improvement – The organization shall consider the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that shall be addressed as part of continual improvement.

 

 

ISO 9001 Certification Process 

  • APPLY TO ISO 9001 CERTIFICATION BODY
  • APPLICATION REVIEW
  • STAGE-1 AUDIT
  • STAGE-2 AUDIT
  • CERTIFICATION DECISION
  • AWARD OF ISO 9001 CERTIFICATION

 

An organization may select the  ISO Certification Body in Delhi, ISO Certification Body near to their Location – Select the ISO Certification Body – who have valid accreditation from Accreditation Body and Accreditation Body has IAF MLA membership.

 

ISO 9001 implementation

The shall implementation ISO 9001 in the organization by self or with the Help of ISO Certification Consultants – who can help the organization for Development of Documentation and Implementation of ISO 9001 in the organization.

9001 Certification Benefits

Benefits of  Implementing QMS and ISO 9001 Certification 

  • EFFECTIVE USE OF RESOURCES IN AN ORGANIZATION
  • BETTER PROCESSING OF THE ORGANIZATION
  • IMPROVEMENT IN THE PERFORMANCE OF THE ORGANIZATION.
  • CUSTOMER SATISFACTORY LEVEL INCREASES
  • IMPROVES DECISION MAKING OF AN ORGANIZATION

 

Requirements of ISO 9001:2015

The ISO 9001:2015 provides a set of requirements that will guide you in applying the Quality Management System in any organization in any industry. ISO 9001:2015 also requires demonstrating the ability, quality, consistency, and aim to enhance customer satisfaction. The requirement details of ISO 9001:2015 are given below: –

Structure of ISO 9001:2015

The structure of ISO 9001:2015 is divided into 10 sections in which “1, 2, 3” include Introduction, Scope, Normative reference, Terms, etc. The requirement of ISO 9001:2015 for implementation of Quality Management System is given Section 4 to Section -10

It includes the requirements of the determination of Internal and External issues, Understanding the needs and Expectations of Interested Party, Determining the scope of the quality management system and Quality management system, and its processes.  Where in the Quality management system and its processes – the requirements are to Identification of processes, sequencing of processes, the interaction of processes, the criteria and methods (including monitoring, measurements, and related performance indicators), responsibilities, and authorities for these processes and address the risks and opportunities.

It includes the requirements of – Leadership and commitment, Customer focus, Establishing the quality policy, Communicating the quality policy, Organizational roles, responsibilities, and authorities.

It includes the requirements of – Actions to address risks and opportunities, Quality objectives, and planning to achieve them and Planning of changes.

It includes the requirements of – Resources, People, Infrastructure, Environment for the operation of processes, Monitoring and measuring resources Organizational knowledge, Competence, Awareness, Communication and Documented information.

It includes the requirements of – Operational planning and control, Requirements for products and services, Design and development of products and services, Control of externally provided processes, products and services, Production and service provision, Release of products and services and Control of nonconforming outputs.

It includes the requirements of – Monitoring, measurement, analysis and evaluation, Customer satisfaction, Analysis and evaluation, Internal Audit and Management review.

It includes the requirements of – Nonconformity and corrective action & Continual improvement

Therefore, in order to manage the quality of the management of an organization, the quality of the products/services and improve quality or performance in every aspect of the organization for ISO 9001 Certification is necessary. It can’t only show the QMS standard of the organization but also shows the better processing of the organization which increases Customer satisfaction level.

So any organization looking for ISO 9001 Certification  must implement the QMS requirements in the organization prior to  get ISO 9001 Certification.

Requirements of the ISO 9001 standard 

Referring 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 that 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 subdivided 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 affect 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
iso certification

ISO 9001 Certification Services Provider in India

As per ISO Expert View – If you are looking for ISO 9001 Certification Services provider in India. Please note that – Any organization like OSS Certification, who has the accreditation for Management System Certification – where ISO 9001:2015 is under the scope of the accreditation, may provide ISO 9001 Certification to the organization. 

So, there are many ISO Certification Bodies in India who are ISO 9001 Certification Services providers in India. The ISO 9001 Certificate issued by any Accredited Certification Body are equally same, but only it has to be Look for the Accreditation of ISO Certification and How the ISO 9001 Certification authentication & Traceability are demonstrated by Certification Body. 

So while selecting the ISO Certification Body of ISO 9001 Certification, the organization must ensure – how the authentication & Traceability of ISO 9001 Certification are maintained by Certification Body. So that any time any one can verify the authentication & Traceability of the ISO 9001 Certified organization.

 

How to get ISO 9001 Certified Organization?

As per ISO Experts view, the best practices to get an ISO 9001 Certified organization is to implement the ISO 9001:2015 requirements in the organization, with proper understanding and gap analysis. Understand the Internal and External issues of the organization – which are affecting the overall performance of the organization and address them by proper Risk Analysis.  Develop and implement the proper documentation requirements of ISO 9001 Certification, which may be (but not Limited)- Quality Policy, Quality objective, SOP for each key process, process Monitoring record, Overall performance monitoring record, Provide the proper training to employee – who needs.   once proper documentation & Implementation is completed. Do the proper Internal Audit and Management Review meeting.  Once the organization found that there is satisfactory implementation and performance monitoring is done, apply to the ISO Certification Body and Get ISO 9001 Certified organization.