ISO 9001:2015 Quality Manual

A quality manual is a document that states the company’s intentions for operating the processes within the quality management system. It can include policies for all areas of the business that affect your ability to make high-quality products and meet your customers’ and ISO’s requirements. These policies define how your department managers will implement procedures within the boundaries specified in the quality manual. The use of Quality Manual are as follows:

  1. To communicate management’s expectations to employees
  2. To demonstrate the company’s plan to conform to the requirements of ISO 9001:2015
  3. To demonstrate the fulfilment of Clause 5.3, that organizational roles, responsibilities and authorities are assigned, communicated and understood
  4. To provide a starting point for auditors:
    1. Internal
    2. Customer
    3. ISO Certification Body

To develop a quality manual, you might consider these steps:

  1. List policies to be written (note any ISO requirements that do not apply).
  2. Draft policies based on applicable ISO requirements.
  3. List operating procedures or refer to them as appropriate.
  4. Determine the format and structure of the manual and make the first draft.
  5. Circulate the draft manual for input from all departments and address inadequacies identified.
  6. Attain a formal approval and release.

The contents of your quality manual are completely up to you. But, remember that everything you say you do, you must show evidence that you really do it! So be careful what you include and make sure the policies reflect actual practices. Here are some common topics included in quality manuals.

  • the scope of QMS
  • Quality policy
  • Explanation of the company’s documentation structure
  • Organizational chart
  • Policy statements for each applicable ISO requirement
  • Reference to operating procedures

1) The scope of the Quality Management System. This is in place to identify the limit of the system and is based on the scope agreed with the registrar to be placed on the ISO9001 certificate. This is the explanation of what your company does, be it “Design and Manufacture of the bevel Gear,” “Machining Services for Customers in the oil and service Industry,” or “Providing Fast Food for People in Kuwait city.” The second part of the scope requirement is to identify any exclusions from the standard. In many cases, the Quality Manual will identify none, but the most common exclusion is the requirement of the ISO 9001 standard for “Design & Development” for companies such as a machining shop, which works exclusively from customer drawings and does not design any products itself.

2) The documented procedures established for the Quality Management System (or references): ‘Documentation’ means anything written down or captured in some form such as written procedures, policies, checklists, forms, or graphics, drawings, flowcharts, diagrams, IT systems. This is called ‘documented information’ in the current version (2015) of ISO 9001. Confusingly, they have also decided to use the same term for what was formerly called ‘records’ – those things that showed what had been done, such as registers, logs, competed for forms, reports, meeting minutes and so on. ‘Documented information’ in 9001 terms means both the ‘written stuff’ that describe your quality system and say how it should operate (eg, flowcharts, procedures, policies, checklists) and the ‘written stuff’ that shows what was done. A system must be documented to achieve ISO 9001 certification because having certain documented information is required by the Standard.  All the documents t needs to control how things are done, whether procedures, flowcharts, checklists, forms, IT systems or any other media or format that work in your business. But note that no mandatory procedures are prescribed. Nor a quality manual. What can confuse people is that actually, you can choose what your documents look like, what format and structure you use, and what to put in them. Provided you meet these requirements. You can use one or many formats, from checklists and flowcharts to intranets, wikis or workflow embedded into IT systems. You can use any media, hardcopy or soft, including intranet, online, internet or wiki. One often used way to do that was with a thing called a ‘quality manual’. And you can still do that if you choose. And it can be in hard copy (paper) or softcopy: online documents like web pages, help files or IT systems. And you can write your document in various ways, from easy and user-friendly to bureaucratic, verbose and very hard to follow. And such a manual may be the only document you have for your system, or it may be one of a number of documents. Or something in between.

3) A description of the interaction of processes. This is most simply done with a flowchart that identifies all the processes in the organization with arrows showing how they connect. While an in-depth flowchart may help you to better understand the interactions between processes in your organization, a simple top-level flowchart is all that is needed for most people to understand the basics.

Example of Quality Manual

1.0 Company Profile

Include your company profile

1.1 The mission of the Firm

Our mission is to enhance mobility through innovation, leadership and public service. Innovation by providing unparalleled value combined with flexibility and risk-taking ability, leadership by delivering exceptional performance in every domain and corporate responsibility through service to society.

1.2 The vision of the Firm

To strive relentlessly with an aim to achieve excellence in all businesses that we venture into, with the objective of becoming an organization that all its employees and associates are proud of.

2.0 Organization Scope

 Design, Development of Land, Construction Sales of Residential and Commercial Complexes 

2.1 Exclusions:

NIL

2.1 Quality Policy

XXX is committed to delivering quality construction work with promised amenities, in time possession, which meets and exceeds the needs & expectation of our customers. We promise our valued customer’s commitment to excellence in each activity by each employee in the organization by adopting innovative and best in class engineering and management practices with continual improvement in business and quality management system as a part of our efforts for enhancement in customer satisfaction while assuring 100% quality and quantity.

2.2 Key Objectives

  • Timely completion of projects
  • Increase Customer satisfaction
  • Reduce Customer Complaint

3.0 Glossary & Abbreviations

Sr.No. Abbreviation Description Sr. No. Abbreviation Description
1 SPAD Shah Promoters and Developers 18 ASL Approved supplier list
2 QSM Quality System Manual 19 PDIR Pre Despatch Inspection Report
3 DI Documented Information 20 MME Measuring & Monitoring Equipments
4 CFT Cross-Functional Team 21 ISO International Organizational for Standardization
5 CH Chart 22 MKT Marketing
6 CP Control Plan 23 QA Quality Assurance
7 FG Finished Goods 24 PUR Purchase
8 QF Quality Format 25 STR Stores
9 SYS System 26 PRD Production
10 IA Internal  Audit 27 HR Human Resource
11 List List 28 MNT Maintenance
12 NC Non Conformance 29 DD Design and Development
13 CA Corrective action 30 LOI Letter of Indent
14 OK Organizational Knowledge 31 MI Measurement traceability
15 NCP Non-Conforming Product 32 PI Performance evaluation
16 NCR Non Conformance Report 33 MRM Management review meeting
17 EP External provider 34 IP Interested Parties

4.0 Context of Organization

4.1 Understanding the organization and its context:

Shah Promoters and Developers determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system through PEST and SWOT. The external and internal issues identified through PEST and SWOT are continuously being monitored and reviewed by CEO.

PEST

Political Factors (P)

  1. Political direction on Smart Cities
  2. Allocation for Infrastructure
  3. Skill enhancement in Automation Sector
  4. Monetary policies
Economic Factors (E)

  1. The growth of banks in rural areas
  2. Funding for smart cities
  3. Increase in car park density
  4. High GDP growth
Social Factors (S)

  1. Increased literacy
  2. Technological awareness
  3. Banking on banks
  4. Increased per capita income
Technology Factors (T)

  1. Advancement in chip design
  2. Automation tools growth
  3. High technology at low cost
  4. Digital technology growth

SWOT

Strength (S)

  1. Strong technology backup
  2. Young and motivated team
  3. Nil borrowing
  4. Quick decision making
  5. Strong customer focus
Weakness (W)

  1. Very small team
  2. Lack of experience
  3. Weak marketing
  4. High inventory
  5. Limited customer base
Opportunity (O)

    1. Lean organization leads to
      1. Flexibility in products
      2. Quick response to customer needs
    2. Low level of competition
    3. High growth potential
Threat (T)

  1. High technology imports
  2. Skill development velocity
  3. Increased competition
  4. Technology leakage
  5. Attrition

4.2- Understanding the needs and expectations of interested parties

xxx has determined the interested parties who are relevant to the xxx Quality management system and the requirement of the interested parties in order to prevent the potential effect on the organization’s ability to consistently provide products and services which meet the customer and applicable statutory and regulatory requirements.

Interested parties Requirements Monitoring & Review mechanism
External providers
  1. Specification communication
  2. Payment as agreed
  3. On time Supply of Input material (if any)
  4. Technology  support
  1. Defined in the Documented information of External providers control
  2. Review in Management review meetings
Customer
  1. Quality of product & Service
  2. Delivery of product on  time
  3. Response to complaint
  4. Proper Communication channel
  1. Defined in the documented information of Marketing & Sales process
  2. Review in Management review meetings
Statutory & Regulatory Body Complying with the statutory and regulatory requirements as defined from time to time.
  1. Defined in the documented information of Leadership
  2. Review in Management review meetings
Bankers / Financiers Updating of changes in the organization whenever it happened Review in Management review meetings
Employees Management Support, Payments on time Accounting Control of management

4.3 Determining the scope of the quality management system

The organization had determined the scope of the Quality management system by considering external and internal issues, the requirement of relevant interested parties and Product & Service of the organization.

The scope of Quality Management System is

Design, Development of Land, Construction Sales of Residential and Commercial Complexes 

Exclusions:

NIL

4.4 Quality management system and its processes

4.4.1: xxx has determined the processes needed for the quality management system and their application throughout the organization in Process map & Interactions of processes.

xxx has determined the inputs required and the outputs expected from each process in individual process map addressed in the documented information of each process.

xxx has determined the sequence and interaction of the processes in Process map & Interactions of processes.

xxx has determined and applied the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes in the documented information of each process.

xxx has determined the resources needed for these processes and ensure their availability in the documented information of Support process.

xxx has assigned the responsibilities and authorities for each process

xxx has addressed the risks and opportunities

xxx has been evaluating these processes and implementing any changes needed to ensure that these processes achieve their intended results and improve the processes and the quality management system

Improve the processes and the quality management system

4.4.2- xxx is also maintaining documented information to support the operation of its processes and retaining documented information to have confidence that the processes are being carried out as planned.

5.0 Leadership

5.1 Leadership and commitment

 Xxx Management has demonstrated leadership and commitment with respect to the quality management system through

  1. Taking accountability for the effectiveness of the quality management system by periodical review of quality management system through management review meeting, Quality objectives review and providing necessary resources.
  2. Management has established the quality policy and quality objectives for the quality management system and is compatible with the context and strategic direction of the organization.
  3. Management has determined the organizational processes and integrated with the quality management system requirement through process map & Interaction this can be demonstrated.
  4. The established procedure for promoting the use of the process approach and risk-based thinking.
  5. Ensuring that the resources needed for the quality management system are available, this is being periodically reviewed through management review meeting.
  6. Communicating the importance of effective quality management and of conforming to the quality management system requirements
  7. Ensuring that the quality management system achieves its intended results
  8. Engaging, directing and supporting persons to contribute to the effectiveness of the quality management system by providing training, conducting awareness programs and
  9. Promoting improvement by introducing the suggestion scheme, Kaizens and conducting meetings.
  10. Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

5.1.2 Customer focus

Xxx management has demonstrated leadership and commitment with respect to customer focus by ensuring that:

  1. Customer and applicable statutory and regulatory requirements are determined, understood and consistently met.
  2. The risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed

 c) The focus on enhancing customer satisfaction is maintained and procedure for customer satisfaction is addressed

5.2 QUALITY POLICY

XXX is committed to delivering quality construction work with promised amenities, in time possession, which meets and exceeds the needs & expectation of our customers. We promise our valued customer’s commitment to excellence in each activity by each employee in the organization by adopting innovative and best in class engineering and management practices with continual improvement in business and quality management system as a part of our efforts for enhancement in customer satisfaction while assuring 100% quality and quantity. We are also committed to serving society as a whole by generating through clean development mechanism (CDM) project.

 5.2.1 Establishing the quality policy

 Xxx management has established, implemented and maintained a quality policy that:

  1. is appropriate to the purpose and context of the organization and supports its strategic direction.
  2. Provides a framework for setting quality objectives
  3. Includes a commitment to satisfy applicable requirements
  4. Includes a commitment to continual improvement of the quality management system

5.2.2 Communicating the quality policy

The quality policy is

  1.  Available and be maintained as documented information
  2. Communicated, understood and applied within the organization through display, Training and periodical review.
  3. Available to relevant interested parties, as appropriate.

5.3 Organizational roles, responsibilities and authorities

Xxx management has ensured that the responsibilities and authorities for relevant roles are assigned communicated and understood within the organization. While assigning roles, responsibility and authority, top management has considered and ensured that

  1. The quality management system conforms to the requirements of this International Standard
  2. The processes are delivering their intended outputs
  3. Reporting on the performance of the quality management system and on opportunities for improvement, in particular, to top management
  4. The promotion of customer focus throughout the organization
  5. The integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

Roles, responsibility and authorities assigned are available in process & as per Organization chart wise

Directors

Responsibility

  • Overall Responsibility for formulating and communicating Quality Policy & Quality objectives.
  • Formulation of Strategy for continuous up gradation of Business and Quality System.
  • Ensure periodic assessment of the performance of Quality System.
  • Approval of Quality System Manual.
  • Budget Approval for the organization.
  • Overall Responsibility for Business Development & all financial issues.
  • Provision of resources as required.
  • Strategic decisions on developments and technical setups.
  • To provide the leadership for efficient implementations of the system.

Authorities:

  • Approval of customers orders, P.O. and Cheque.
  • Sanctioning leaves of all Staff.
  • Approval of funds for Training needs.
  • All the authorities of downline personnel.
  • Chairing Management review meetings.

Project Planning

Responsibilities:

  • Overall coordination between client, project managers and office department.
  • Follow up for Schedules.
  • The entire responsibility of Quality.
  • Monitoring Client Satisfaction.
  • Coordination with the consultants.
  • Disciplinary actions against the staff.
  • Prime responsibility for the safety at the site
  • Provision of a suitable working environment
  • Ensure the quality system is established, implemented and maintained.

Authorities:

  • Appointment of the staff, engineers and tech staff.
  • Sanctioning the Leaves to Staff.
  • All the authorities of downline personnel.

Project Managers

Responsibilities:

  • Responsibilities for the entire Project work, i.e. Quality, Quantity and Time.
  • Coordination with consultants and contractors.
  • Coordination with Consultants for drawings.
  • Coordination with the Site engineers.
  • Coordination with the client for the ongoing changes in drawings and projects.
  • Monitoring site engineers work on a daily basis.
  • Reporting to the GM Projects on the above issues
  • Responsibilities for safety at the site. (Good working environment).

Authorities:

  • Make or force a required decision at all levels to achieve project objectives.
  • Initiate actions on the Contractors and consultants for Quality, Quantity and Timeframe issues related to project work.
  • To stop and initiate corrective actions on non–confirming products/services.

Site Supervisor

Responsibilities:

  • Coordinating with all staff for the Quality related issues of Construction.
  • Daily Labour Handling for Civil Work.
  • Monitoring of Work progress and daily reporting.
  • Preparation of work progress report / Quality Documentation.
  • Control of non – conformities on site
  • Safety at site / Construction work.
  • Coordination with the Site Contractor for the daily work requirements.
  • Coordination with external agencies for calibration of instruments and material testing.

Authorities:

  • Initiate actions on the staff for non-fulfillments of the documentation related quality
  • To stop and initiate corrective actions on non–conforming products.

 Site engineer

 Responsibilities:

  •  Monitoring of site and labour contractors.
  • Monitoring of work progress and daily reporting
  • Preparation of work progress report.
  • Control of non – conformities on site.
  • Ensuring instruments are properly used and are with the status of calibration.
  • Track Project progress & produce regular weekly status reports.
  • Coordinate with all labour contractors to achieve continuous progress at the site as per schedule.
  • Follow up with the Project manager for pending decisions/drawings/building specifications.
  • Communicate management decisions and information to Site subordinate staff.
  • Ensuring the worker’s safety at site and usage of safety equipment.
  • Implementation and follow up and regular monitoring of implemented ISO 9001 system at the site.
  • Coordination with the Quality Person for Quality related issues.
  • Coordinating Material Accountability at site

Authorities:

  • Initiating the corrective and preventive actions as needed on contractors and consultants.
  • Decision making on during any emergencies at the site.

In-charge Marketing:

 Managing & motivating the sales force towards the achievement of target.

  • Preparation of Sales plan.
  • Annual sales forecast.
  • Monthly sales forecast.
  • Implementation of sales plan.

Authorities:

  • Approval of documents as per the Master list of Quality System Document.
  • Authorized to decide corrective & preventive action.
  • Authorized to obtain concessional acceptance for non – conforming product from the customer.

InCharge – ADMIN + ACCOUNT

Responsibilities: 

  • Responsible for tendering activity.
  • Customer order review.
  • Handling and coordinating customers
  • Identification of resources, as applicable.
  • Document & Data control system pertaining to his department.
  • Maintain all documents related to the quality system.
  • Coordinator for Management reviews.
  • Promoting awareness of customer requirements throughout the Organization.
  • Compliance & effectiveness of the training system.
  • Suitable working environment (cleanliness, ventilation, lighting, safety etc.).
  • Record maintaining for Sales Register, Rent Register, Sale Files, Stationery and Office equipment.
  • Archiving and record keeping of old files.
  • Payroll Monthly: Salary –To release monthly salary of the employees as per policy finalized.
  • Leave – To keep the record of leave as per policy finalized.
  • Annual Allowance – To release annual allowances as per policy finalized.
  • Employee Record – To update employee details as per organization Policy and QMS.
  • To prepare an appointment letter, confirmation letter, experience letter & all employee-related matter as per policy finalized with the help of the Managing Director.

Authorities:

  • Approval of customer orders.
  • Approval of documents as per the master list of Quality System Document.
  • Authorized to decide corrective & preventive action.

 In charge Purchase:

Responsibilities:

  • Overall in charge of purchase activities.
  • Identification of resources, as applicable.
  • Purchasing system – Evaluation, selection, purchasing, monitoring.
  • Document & Data control system pertaining to his department.
  • Corrective / Preventive action system (subcontractor non-conformances, in particular.)
  • Control of records

Authorities:

  • Authorized to review & approve purchasing documents.
  • Authorized to select & discontinue sub-contractor

6.0 Planning

6.1 Actions to address risks and opportunities

6.1.1

Xxx is addressed the issues, requirements the risks and opportunities

  1. give assurance that the quality management system can achieve its intended result(s)
  2. Enhance desirable effects
  3. Prevent, or reduce undesired effects
  4. achieve improvement

6.1.2

  1. actions to address these risks and opportunities
  2. How to
    1. integrate and implement the actions into its quality management system processes
    2. Evaluate the effectiveness of these actions
Interested parties Requirements Risks and Opportunities Effectiveness of actions
External providers Communication, Payment Terms, On Time Supply, Technology  Support, Communication Gap,  Payment  & Delivery terms not in written, Output Failure Communication like  Emails, Phone, Payment  & delivery terms mention in PO, Documented information is provided for Technical  support
Customer Product Quality, Delivery & service of  on  time,  Response to the complaint, Proper Communication channel Business Loss, Reputation Down for Organization Defined in the documented information of Marketing & Sales process & Review in Management review meetings
Statutory & Regulatory Body Organization & product related Statutory & regulatory requirements are kept The customer is not acceptable material or loss of business Defined in documented information & Review in Management review meetings
Bankers/financiers All product & organization related documents are kept The organization is facing the problems (funds related) All product & organization related documents are kept
Employees On time Payments Work is not properly operated On time payments issue to employees
Marketing Competitive rates, More amenities, Prime Location, Organization facing problems in sales, Reputation in market Market analysis, Competent marketing team.
Purchase Competitive rates, Good Quality material, Timely Delivery, The organization facing Finance problems, Customer dissatisfied, Delay in project completion &  Reputation in market Market analysis, Competent   Purchase team

6.2.2 Quality objectives and planning to achieve them

 6.2.1  Xxx establish quality objectives at relevant functions, levels and processes needed for the quality management system.

The quality objectives shall

  1. Be consistent with the quality policy
  2. Be measurable
  3. Take into account applicable requirements
  4. Be relevant to the conformity of products and services and to the enhancement of customer satisfaction
  5. Be monitored
  6. Be Communicated
  7. Be updated as appropriate

6.2.2 Xxx achieve its quality objectives,

  1. What will be done?
  2. What resources will be required?
  3. Who will be responsible?
  4. When it will be completed
  5. How the results will be evaluated

Our Quality Objectives are as below:

  • Timely completion of projects
  • Energy Generation Per Year
  • Increase Customer satisfaction
  • Reduce Customer Complaint

6.3 Planning of changes

Xxx determines the need for changes to the quality management system, the changes are carried out in a planned manner

  1. the purpose of the changes and their potential consequences
  2. the integrity of the quality management system
  3. the availability of resources
  4. the allocation or reallocation of responsibilities and authorities

Xxx has determined the processes needed for the quality management system and their application throughout the organization in Process map & Interactions of processes

7   Support

7.1 Resources

7.1.1 General

Xxx is determined and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system. Xxx is consider

  1. the capabilities of, and constraints on, existing internal resources
  2. what needs to be obtained from external providers

HR  determine and provide the resources needed to implement and maintain the quality management system and continually improve its effectiveness and to enhance customer satisfaction by meeting customer requirement. The resources will be in the form of

  • Human resources including qualified personnel for verification activities.
  • Manufacturing machines, Test Equipment’s & infrastructure.
  • Provide raw material & other inputs for the realization of the product.
  • Providing funds.

The Required resources are identified in the event of new Process Development / Business plan review, Mfg Process Flow, also based on the Organization performance review in MRM and monthly business reviews.

7.1.2 People

Xxx determine and provide the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes. HR along with respective process IN CHARGE ensures that personnel performing work affecting product quality is competent and training to give on the basic operation and control of its processes.

7.1.3 Infrastructure

Xxx is determined, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services. Infrastructure can include

  1. buildings and associated utilities
  2. equipment, including hardware and software
  3. transportation resources
  4. information and communication technology

At Xxx management determine, provide and maintain the infrastructure needed to achieve conformity to product requirements & in identifying the required resources the PARTNER play a key role based on their day to day  interactions with respective IN CHARGE’s and employees

7.1.4 Environment for the operation of processes

Xxx is determined, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services. A suitable environment can be a combination of human and physical factors

  1. Social (e.g. non-discriminatory, calm, non-confrontational)
  2. Psychological (e.g. stress-reducing, burnout prevention, emotionally protective)
  3. Physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise).

Project in coordination with respective IN CHARGE determines and manages the work environment needed to achieve conformity to product requirement and reviewed ongoing basis.

7.1.5 Monitoring and measuring resources

7.1.5.1 General

Xxx is determined and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. The organization shall ensure that the resources provided

  1. are suitable for the specific type of monitoring and measurement activities being undertaken
  2. are maintained to ensure their continuing fitness for their purpose

Xxx is retained appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources

7.1.5.2 Measurement traceability

Xxx is measurement traceability is maintained requirement if applicable for the instruments or is considered by them to be an essential part of providing confidence in the validity of measurement results,

  1. calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information
  2. identified in order to determine their status
  3. safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results

Xxx is determined the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary.

Control of Monitoring & Measuring Equipments.

Measurement & Monitoring system is well equipped and the system has complete control over the monitoring and Measuring Equipment. The measurement methods used are evaluated to ensure that they are appropriate and reliable. To ensure that the measuring equipment operates effectively and give reliable results, we have taken the following steps:

  • Equipments are maintained properly and are calibrated & adjusted as and when needed. Necessary safeguards are in place to take care of adjustments that could lead to invalid results.
  • Calibrations are carried out as per national standards (by NABL accredited laboratories only). Where no such standard exists, the basis used for calibration or verification is recorded. The calibration records include the last date of calibration, calibrating agency (for the external agency), calibration result, and frequency of calibration as per the process and/or instrument requirement and the next calibration date. The required accuracy is identified and compared to the measurement that meets expectations.
  • Identification of appropriate equipment is accomplished by tagging, labelling, numbering or by including it in a calibration/maintenance database.
  • Proper control is maintained to ensure that no faulty equipment is used, the reliability of the equipment is ensured through routine maintenance and re-calibration.
  • Equipments are used, handled and stored under conditions that protect the accuracy and prevent. Unauthorized adjustment. Work environmental controls are all in place for equipment.
  • Instrument history cards are maintained for all measuring & Test Instruments.

Laboratory Requirements

 Internal Laboratory

The internal laboratory is available as on date the various test is carried out as per customer requirement, standard specification and internal laboratory test procedure are available & record is kept.

External Laboratory

  • External / Commercial/independent laboratory facilities used by IM will be accredited laboratory facilities to NABL or NPL or as accepted by the Customer.
  • Evidence of acceptance by national accreditation or customer shall be kept.

7.1.6 Organizational knowledge

Xxx is determined the knowledge necessary for the operation of its processes and to achieve conformity of products and services. This knowledge shall be maintained and be made available to the extent necessary. When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates. Organizational knowledge is specific to the organization; it is generally gained by experience. It is information that is used and shared to achieve the organization’s objectives.

Organizational knowledge can be based on:

  1. Internal sources (e.g. intellectual property; knowledge gained from experience; lessons learned from failures and successful projects; capturing and sharing undocumented knowledge and experience; the results of improvements in processes, products and services);
  2. External sources ( e.g. standards; academia; conferences; gathering knowledge from customers or external providers).

7.2 Competence

Xxx is

  1. Determine the necessary competence of person(s) doing work under its control that affects the Performance and effectiveness of the quality management system
  2. Ensure that these persons are competent on the basis of appropriate education, training, or Experience
  3. Where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken

Retain appropriate documented information as evidence of competence for all  employees

7.3 Awareness

Xxx is ensured that persons doing work under the organization’s control are aware of

  1. The quality policy
  2. Relevant quality objectives
  3. Their contribution to the effectiveness of the quality management system, including the benefits of improved performance
  4. The implications of not conforming to the quality management system requirements

7.4 Communication

Xxx is determined the internal and external communications relevant to the quality management system, including

  1. On what it will communicate
  2. When to communicate
  3. With whom to communicate
  4. How to communicate
  5. Who Communicates
INTERNAL COMMUNICATION
What When with whom How Who
Quality policy Permanent All Employees  / Interested parties Display / Letter / Training Management
Importance of effective QMS As per the Training plan / during Orientation training All Employees Training / Display Management
Responsibilities and Authority During recruitment / Promotion / Department change Employee Procedure / Oral / Training Management
Quality objectives While defining / Once in 3 months All employees Procedure / Oral / Training Management
Customer complaint / Feedback At the time of receipt Head of the department / Respective process owner Meeting Director
External COMMUNICATION
What When with whom How Who
Information to external providers Placing purchase order / Quotation collection Supplier (External provider) Purchase order / Letter / Email / Oral  Purchase I/C
Product information Enquiry stage Customer Email / Website / Catalogue / Letter Director
Enquiry, order, amendments Enquiry review / Order review Customer Electronic media / Letter/ oral Director
Customer feedback Once in a year / After service Customer Forwarding customer feedback form Director
The action is taken for customer complaints Once the action is taken Customer Electronic media / Letter/ oral Director
Information to external providers As agreed with the customer Customer Delivery challan / Letter / Email Stores I/C

7.5 Documented information

7.5.1 General

7.5.2 Creating and updating

XXX creating and updating documented information, the XXX is ensured appropriate

  1. a) Identification and description
  2. b) Format (e.g. language, software version, graphics) and media (e.g. paper, electronic)
  3. c) Review and approval for suitability and adequacy 

XXX’s quality management system is included

Quality Management System documentation is established with the following approach. A four-level- documented structure is followed for the operation of Quality Management System.

L-1 QUALITY MANUAL (Standard Requirement)
L-2 PROCEDURES
L-3 PROCESS FLOW CHART, WI, QUALITY PLANS, CHECKSHEETS, MANUFACTURING PROCESS FLOW CHARTS
L-3 DOCUMENTED INFORMATION
  • Level 1: Quality Manual (standard Requirement) Defines the approach and responsibility, which includes a documented statement of quality policy & objectives etc.
  • Level 2: Procedures
    Defines what, where, when, who & why of an activity being done as stated in ISO- 9001:2015 standard. The documented procedure activity process flowchart defines the effective planning, operation and control of processes.
  • Level 3: WI, Quality Plans, Check sheet etc
    Defines how exactly an activity is to be done ensuring the effective planning, operation and control of processes.
  • Level 4: Documented Information
    Provides the evidence, which has to be established for all the activities, stated above which In turn Documented Information.  A master list of Quality Record is maintained by respective Departments/ section heads as per the requirement of ISO 9001:2015.

Control of Quality System Manual.

  • Partner is approved the Quality Manual, procedure, WI & documented Information and its amendments.
  • Management Representative / Quality In charge is responsible for the preparation, review, issue & control of the manual and its amendments.
  • In case any person ceases to be the holder of manual copy for any reason, his copy number of manual will be allocated to any new holder with the note in amendment list to this effect.
  • MASTER COPY will be stamped “MASTER” on the front side of all pages in “BLUE”
  • A photocopy will be taken for all MASTER & will be “CONTROLLED” stamped in RED MR/Quality in charge maintains the master copy having original signatures.

 Document changes.

MR/Quality in charge perceives the need for the amendment to this manual based on adequacy audit report, mistake/corrections during review by any holder, system change and amendment to reference ISO standard or any change in the organization affecting system described in this manual. Amendments to this manual are recorded in the Amendment list (After Amendment).

The holders of Quality System Manual refer to amendment list before referring to respective amended sections to clearly understand details/purpose of amendment. A list indicating the latest revision status of each page of this manual, whenever a page of any chapter is amended, the page and the chapter bear the latest Rev. No. The latest revision no. is indicated in the amendment sheet, and on the cover page of the Quality Manual. The revised version of the document pages is sent only to the holders as along with the updated amendment list and revision status page.

Controlled copyholders of this manual should ensure that the obsolete pages are removed & destroyed and revised pages are inserted in the Manual at appropriate places. Management Representative / Quality In charge maintains one copy of the obsolete version of revised pages at the time of each amendment for reference purpose and having the OBSOLETE stamp in RED colour. When the Rev. No. Of Amendment sheet reaches 09, or in case an amendment to ISO standard is released, the entire manual will be reissued and bear next serial number of issue no. No details of amendments to earlier issue and recorded in amendment list for the new issue.

Numbering Logic Of Quality System Manual :

The numbering logic of this quality system manual will be as described here:

  1. The numbering logic will be -QM-XX.
  2. indicates xxx.
  3. QM indicates Quality System Manual of ISO 9001:2015.

7.5.3 Control of documented information

7.5.3.1 Documented information required by the quality management system and by this International Standard shall be controlled to ensure

  1. It is available and suitable for use, where and when it is needed.
  2. It is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity)

 7.5.3.2 For the control of documented information, xxx  is address the following activities, as applicable

  1. Distribution, access, retrieval and use
  2. Storage and preservation, including preservation of legibility
  3. Control of changes (e.g. version control)
  4. Retention and disposition

Documented information of external origin determined by the organization to be necessary for the Planning and operation of the quality management system is identified as appropriate and is controlled. Documented information retained as evidence of conformity shall be protected from unintended alterations.

8 Operation

8.1 Operational planning and control

Xxx will plan, implement and control the processes needed to meet the requirements for the provision of products and services, and to implement the actions in & maintained risks and opportunities related to planning maintained in operational planning control. The bar chart for planning are

  1. Determining the requirements for the products and services
  2. Establishing criteria for
    1. The processes
    2. The acceptance of products and services
  3. Determining the resources needed to achieve conformity to the product and service requirements
  4. Implementing control of the processes in accordance with the criteria
  5. Determining, maintaining and retaining documented information to the extent necessary
    1. To have confidence that the processes have been carried out as planned
    2. To demonstrate the conformity of products and services to their requirements

Xxx is control planned changes and reviews the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary. Xxx is ensuring that outsourced processes are controlled.

 8.2 Requirements for products and services

 8.2.1 Customer communication

Communication with customers is include

  1. Providing information relating to products and services
  2. Handling enquiries, contracts or orders, including changes
  3. Obtaining customer feedback relating to products and services, including customer complaints
  4. Handling or controlling customer property
  5. Establishing specific requirements for contingency actions, when relevant

Customers are communicated regarding the product information through the letter, verbal and/ or through phone, Fax, e-mail. If any amendments in enquiries, purchase orders it will be communicated through Phone, letter & Email. The customer complaints are registered in customer complaint register and the corrective action taken is communicated.

8.2.2 Determining the requirements for products and services

When determining the requirements for the products and services to be offered to customers, the Xxx is ensuring that

  1. The requirements for the products and services are defined, including
    1. Any applicable statutory and regulatory requirements
    2. Those considered necessary by the organization
  2. The organization can meet the claims for the products and services it offers

At present, the marketing activities are looked after by Marketing in charge and both of them are actively involved in the determination of customer requirements and for each enquiry, he determines the

  • Requirements related to the product in contract review form with respect to requirements specified by the customer, including the requirements for delivery and post-delivery activities.
  • Requirements not stated by the customer but necessary for specific or intended use (where Known)
  • Statutory and Regulatory requirements related to the product
  • Any additional requirements determined by the organization.

8.2.3 Review of the requirements for products and services

8.2.3.1 Xxx is ensuring that it has the ability to meet the requirements for products and services to be offered to customers. Xxx is conducting a review before committing to supply products and services to a customer, to include

  1. Requirements specified by the customer, including the requirements for delivery and post-delivery activities.
  2. Requirements not stated by the customer, but necessary for the specified or intended use, when known.
  3. Requirements specified by the organization.
  4. Statutory and regulatory requirements applicable to the products and services.
  5. Contract/order requirements differing from those previously expressed

Xxx is ensuring that contract or order requirements differing from those previously defined are resolved. The customer’s requirements are confirmed by Xxx is before acceptance, when the customer does not provide a documented statement of their requirements

8.2.3.2 Xxx is retain documented information, as applicable

  1. On the results of the review
  2. On any new requirements for the products and services
  • IN CHARGE MKT shall review the requirement related to the product. This review takes place as and when a new P.O or verbal order is placed/confirmed by the customer for a new part no. and prior to the commitment taken to supply the products.
  • The review ensures that
    1. the product requirements are defined
    2. Contract/order requirements differing from those previously expressed in the proposal or quote are resolved.
    3. Our organization has the ability to meet the defined requirements

8.2.4 Changes to requirements for products and services

Xxx is ensured that relevant documented information is amended, and those relevant persons are made aware of the changed requirements when the requirements for products and services are changed

8.3 Design and development of products and services

 8.3.1 General

Xxx is establishing, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services.

8.3.2 Design and development planning

Xxx is considering In determining the stages and controls for design and development, including

  1. Nature, duration and complexity of the design and development activities
  2. The required process stages, including application design and development reviews
  3. The required design and development verification and validation activities
  4. The responsibilities and authorities involved in the design and development process
  5. The internal and external resource needs for the design and development of products and services
  6. The need to control interfaces between persons involved in the design and development process
  7. The need for involvement of customers and users in the design and development process
  8. The requirements for the subsequent provision of products and services
  9. The level of control expected for the design and development process by customers and other relevant interested parties.
  10. The documented information needed to demonstrate that design and development requirements have been met.

8.3.3 Design and development inputs

Xxx determines the requirements essential for the specific types of products and services to be designed and developed. Xxx is consider

  1. Functional and performance requirements
  2. Information derived from previous similar design and development activities
  3. Statutory and regulatory requirements
  4. Standards or codes of practice that the organization has committed to implement
  5. Potential consequences of failure due to the nature of the products and services

Inputs shall be adequate for design and development purposes, complete and unambiguous. Conflicting design and development inputs is resolved. Xxx is retain documented information on design and development inputs.

8.3.4 Design and development controls

Xxx is applying controls to the design and development process to ensure that

  1. The results to be achieved are defined
  2. Reviews are conducted to evaluate the ability of the results of design and development to meet requirements,
  3. Verification activities are conducted to ensure that the design and development outputs meet the input requirements.
  4. Validation activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use,
  5. Any necessary actions are taken on problems determined during the reviews, or verification and validation activities.
  6. Documented information of these activities is retained

8.3.5 Design and development outputs

Xxx ensure that design and development outputs

  1. meet the input requirements
  2. are adequate for the subsequent processes for the provision of products and services
  3. include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria
  4. specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision

Xxx is retain documented information on design and development outputs

8.3.6 Design and development changes

Xxx is identifying, review and control changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements. Xxx is retain documented information on

  1. Design and development changes
  2. The results of reviews
  3. The authorization of the changes
  4. The actions are taken to prevent adverse impacts

8.4 Control of externally provided processes, products and services (Purchase)

8.4.1 General

Xxx is ensuring that externally provided processes, products and services conform to requirements, Xxx determines the controls to be applied to externally provided processes, products and services when

  1.  Products and services from external providers are intended for incorporation into the organization’s own products and services
  2. Products and services are provided directly to the customer(s) by external providers on behalf of the organization.
  3. A process, or part of a process, is provided by an external provider as a result of a decision by the organization

Xxx determines and apply criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements. The organization shall retain documented information of these activities and any necessary actions arising from the evaluations.

IN CHARGE Purchase ensures that the purchased products are procured from Approved sources only and which conforms to specified purchase requirement. This is done as per business process flow for PROCUREMENT. The type and control to be exercised on the supplier, based on the effect of the purchased product on the process/final product, is defined in the approved Supplier list. IN CHARGE Purchase evaluates and select supplier based on their ability to supply product in accordance with the requirements of the organization. Criteria for selection, evaluation and re-evaluation are described and depicted in the Business Process Flowchart.

  1. Selection, Evaluation and approval of suppliers
  2. Periodical evaluation of Supplier
  3. Approved Supplier List will be maintained by the IN CHARGE Purchase and also the records of their periodical performance.

8.4.2 Type and extent of control

Xxx ensures that externally provided processes, products and services do not adversely affect the organization’s ability to consistently deliver conforming products and services to its customers

Xxx is

  1. Ensure that externally provided processes remain within the control of its quality management system
  2. Define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output
  3. Take into consideration
    1. The potential impact of the externally provided processes, products and services on the organization’s ability to consistently meet customer and applicable statutory and regulatory requirements
    2. The effectiveness of the controls applied by the external provider
  4. Determine the verification, or other activities, necessary to ensure that the externally provided processes, products and services meet requirements

8.4.3 Information for external providers

Xxx ensures the adequacy of requirements prior to their communication to the external provider. Xxx is communicating to external providers its requirements for

    1. The processes, products and services to be provided
    2. The approval of
      1. Products and services
      2. Methods, processes and equipment
      3. The release of products and services
  1. Competence, including any required qualification of persons
  2. The external providers’ interactions with the organization
  3. Control and monitoring of the external providers’ performance to be applied by the organization
  4. Verification or validation activities that the organization, or its customer, intends to perform at the external providers’ premises

The Purchase order describes the product to be purchased including

  1. Requirement of Material Test Certificate / Dimensional report / PPAP such as Control Plan / Process Flow Chart / Process Sheets / Process Capability studies etc.
  2. Requirements for qualification of personnel
  3. QMS requirements.

PO will be reviewed for adequacy of the specified requirement prior to release by IN CHARGE Purchase & M.R. The Purchase order released to the supplier indicates the intended verification arrangements and method of product release, whenever KWS or its customer intends to perform such verification at external providers end.

Incoming Product Quality

The control / Inspection plan for incoming be based on the control exercised on the external providers

  1. Inspection and/or testing on sampling method. The sampling size should be decided based on past performance of the supplier.
  2. Inspection at Sub-contractor’s premises with/without system audit.
  3. Quality assurance certificate or the test report from the supplier.
  4. Part evaluation by accredited laboratories.
  5. Receipt and evaluation of statistical data.
  6. Any of above method or Combination of any two or more from above.

Supplier Monitoring

External providers performance monitoring through the following indicators, & will be carried out by IN CHARGE PUR as described in Procedure for Purchase.

Delivered Product Quality.

  • Delivery Performance.
  • Customer disruptions including field Returns.
  • Customer notification Related to quality Or delivery Issues
  • Premium freight.

Xxx promotes monitoring of the performance of manufacturing processes of the external providers’ as part of supplier development.

8.5 Production and service provision

8.5.1 Control of production and service provision

Xxx is implemented production and service provision under controlled conditions. Controlled conditions include, as applicable

  1. The availability of documented information that defines
    1. The characteristics of the products to be produced, the services to be provided, or the activities to be performed
    2. The results to be achieved
  2. The availability and use of suitable monitoring and measuring resources
  3. The implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services have been met
  4. The use of suitable infrastructure and environment for the operation of processes
  5. The appointment of competent persons, including any required qualification
  6. The validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement;
  7. The implementation of actions to prevent human error
  8. The implementation of release, delivery and post-delivery activities

Production In Charge shall plan the production as per and respective Section In charge carry out the process under the controlled condition as defined in  Process Flow in respective process procedures. Controlled conditions shall include:-

  1. Production plans for all processes which describes the characteristics of the product and process flow chart for the sequence of operations
  2. Work Instructions made available at all workstations.
  3. Use of appropriate equipment for a particular process/operation
  4. Use of calibrated monitoring and measuring devices
  5. In process inspection/verification
  6. Verification of acceptance criteria

Production  Plan

The production plan for all stages of production, including receipt of the material sample, pilot & regular production shall be used. These Production plans at each stage may be amendments of production plans of the earlier stage. As described above, Marketing shall be involved in the preparation of production plans where required by customer production Plans will be submitted to the customer for approval. The production plan shall

  • list the controls used for the manufacturing processes
  • Include methods for monitoring of control exercised over special characteristics defined by both the customer and the organization.
  • Include the customer required information if any
  • Initiate the specified reaction plan when the process becomes unstable or not statistically capable production plans shall be reviewed and updated, as appropriate:
  • The product is changed.
  • The manufacturing processes are changed.
  • The processes become unstable.
  • The processes become non-capable.
  • Inspection frequency and method changes
  • Change in supply sources
  • Corrective actions based on process NC,s & customer concerns
  • Drawing changes / ECNs.

Production plans are developed for all the process involved in the manufacturing by the Cross-functional team. These are identified during the advanced product planning process. Wherever approvable. The production plans are live documents and are reviewed and updated when the change to the original product or process occurs.

 Work Instructions

Respective IN CHARGE prepares Work Instructions for all operations/process activities and for all employees having responsibilities under them. These instructions are made accessible for use at the work station& are prepared based on trial run result and old documents of the similar product at the time of job induction into production and will be reviewed for applicable changes in event of production Plan change(s).

Preventive Maintenance

IN CHARGE MNT maintains a list of all machines/equipment used in production and designated key process equipment in the list. A plan for preventive maintenance for this key equipment shall be developed & implemented to ensure continuous process capability. This plan shall be based on the available data from manufacturer’s recommendations, previous break down and preventive history, the extent of usage, and rate of wear and tear etc., based on these details appropriate predictive techniques are used. IN CHARGE MNT ensures that required spare-parts for replacement along with other resources for maintenance as per preventive maintenance schedule are available in time. Appropriate records of maintenance shall be maintained by IN CHARGE MNT. A system that describes the planned & predictive maintenance method is detailed in Procedure respectively.

Validation of processes for production and Service Provision

All processes are validated before the start of the production through set up approval and First Five Piece Inspection. The above processes are controlled and continually monitored through documented work instructions, process qualifications, set up approval and worker qualification, as applicable to ensure that the specified requirements are met.

Appropriate records are maintained by All IN CHARGE to demonstrate the control of these processes and equipment. Records of personnel qualifications and re-qualifications are maintained by All IN CHARGE. Stipulate workmanship standards to the greatest practicable extent, where appropriate, by means of written standards, representative samples or display boards.

Ensure Handling, Storing and transporting within the production shop are carried to protect all materials/products.  The details of process controls are described in respective department procedures.

8.5.2 Identification and traceability

Xxx is used suitable means to identify outputs when it is necessary to ensure the conformity of products and services. Xxx has identified the status of outputs with respect to monitoring and measurement requirements throughout production and service provision. Xxx is controlling the unique identification of the outputs when traceability is a requirement and shall retain the documented information necessary to enable traceability.  All material are identified including inspection and test status inappropriate manner (paint, punch mark, labels, stickers and tagging etc.) from receipts at stores through various stages of production. The final product is kept on trolleys & transferred to Finished Goods area before delivery to the customer as detailed in work procedures for storage, packing & dispatch procedure. Traceability is provided, if required by customer or decided for some products by KWS to identify finished products by providing punch mark/tag/batch code. For such products, proper records are maintained also the main packages are traceable through Barcode system.

8.5.3 Property belonging to customers or external providers

Xxx is exercise care with property belonging to customers or external providers while it is under the organization’s control or being used by the organization

Xxx identify, verify, protect and safeguard customers’ or external providers’ property provided for use or incorporation into the products and services

When the property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer or external provider and retain documented information on what has occurred

  • Any arrangement of Customer Supplied raw materials, components, tooling, returnable packaging, measuring instruments etc., are identified during the contract review by CFT/ IN CHARGE MKT and communicated to the people concerned.
  • All such products are uniquely identified after proper verification and properly stored and maintained. Any such product that is lost damaged or is otherwise unsuitable for use shall be recorded and reported to the Customer by customer representative & IN CHARGE Marketing.

It shall be the responsibility of QA personnel to verify the quality of such product even if it has been supplied by the Customer

8.5.4 Preservation

Xxx preserve the outputs during production and service provision, to the extent necessary to ensure conformity to requirements. Preservation includes identification, handling, contamination control, packaging, storage, transmission or transportation, and protection. At all stages of production, appropriate material/product handling, storage, packing of products, preservation and delivery of products established viz.. The material in storage – are preserved by packing in Gunny bags. In process – material is stored in Bins and Air Bubble bags. Finished goods – All parts are surface coated & packed in BINS with Plastic coverage.

Storage and Inventory

A suitable inventory control system is established to optimize inventory turns, assure stock rotation & minimize inventory levels. Stores Section shall monitor stock levels and inform purchase section in time & FIFO is emphasized.

 Handling and Storage of Incoming Material

At present manual method are provided for movement of brought out items and raw material respectively. In charge, Stores shall ensure safe handling of materials/items received in stores.

Secured storage space with proper environmental conditions to protect the products stored shall be provided for all items in stores. Shelf life items are identified and periodic inspection of all stored items is conducted once in three months for fitness for use.

Store In-charge has the defined responsibility to receive issue & dispatch materials from secured storages i.e., Stores & Finished Goods Stock point.

All material in stock is periodically assessed to verify continued fitness for use. The proper material accounting shall be maintained in the stock ledger, with the consideration for keeping stored items in usable conditions.

 In process Products

Handling of In-process material is done using Trollies and BINS. At all times the individual operator ensures safe handling of the material to prevent damage. Storage on the shop floor, for in-process products, if required suitable packaging material will be used to protect the products from any kind of damages, deterioration due to environmental conditions.

Finished Products

Finished products are handled carefully with the use of hydraulic Trollies and packed  by using BINS and Polythene bags, so as to protect them from any kind of damage and kept in Finished goods area in duly cleaned condition. All finished products stored will be under control of assembly in charge.

 Packaging

The packaging of products carried out according to packaging instructions/drawings wherever applicable, i.e., contractually agreed or if product nature calls for packing. Type of packaging material & its quality is ensured as per customer requirements if mentioned in the purchase order. Material/packages used for packing of products are verified before packing to ensure its conformance to specified requirements as per Purchase Order/ Customer Requirement. Packing method employed will be adequate to protect the products fully till they reach their destination if contractually specified.

8.5.5 Post-delivery activities

Xxx is meet requirements for post-delivery activities associated with the products and services

Xxx  considers In determining the extent of post-delivery activities that are required,

  1. statutory and regulatory requirements
  2. the potential undesired consequences associated with its products and services
  3. nature, use and intended lifetime of its products and services
  4. customer requirements
  5. customer feedback

Delivery

The product quality is protected after final inspection & testing and wherever contractually specified extended from delivery to destination. The deliveries of products are done as per contract terms/delivery schedules for the customer.

8.5.6 Control of changes

Xxx is review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements. Xxx is retain documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review.

8.6 Release of products and services

Xxx implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been met. The release of products and services to the customer shall not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer.

Xxx is retain documented information on the release of products and services. The documented information includes

  1. Evidence of conformity with the acceptance criteria
  2. Traceability to the person(s) authorizing the release

To ensure that the products manufactured meet the quality requirements of customer fully, a systematic approach for inspection and testing at all stage viz. incoming, in the process and final are demonstrated. At each stage, the activity is performed according to documented procedures.

Receiving Inspection & Testing

Inspection / Verification of incoming material is carried out according to the respective Incoming Inspection Standards & Control plans. This is the responsibility of IN CHARGE QA. The control plan for incoming shall use one of the following methods –

  • Inspection and/or testing on sampling method.
  • Inspection at suppliers premises with/without system audit.
  • Quality assurance certificate or the test report from the supplier.

The incoming materials used in production shall not be used or processed without acceptance by Receipt inspection. Store Personnel are responsible for receipt, identification, records and storage of all Incoming materials, the detailed procedure for incoming material inspection is described.

In-process Inspection & Testing

All in-process inspection carried out according to the applicable control plans by QA during in process based on sample inspection and as per the documented procedures for the required tests. The details of in-process inspection are described in respective process owner’s procedure   Inspection and Tests Records

Records of inspection/tests at all stages mentioned above are prepared in specific forms & maintained. The format number(s) of records as mentioned in respective procedures/work instructions /control plans. IN CHARGE QA & IN CHARGE PRD will be the approving authority at each stage for disposition of non-conforming materials/products. The system of handling of non-conforming materials/products is described in  

8.7 Control of nonconforming outputs

Procedures are established for identifying non-conforming product at Stores and stages of production/inspection as well as at the final inspection stage. The non-conforming materials are identified by the production operator/ QA Personnel at these stages and suitably identified. Responsibility and authority are assigned for segregation, review and disposition of non-conforming product. Documented information of segregation, review and suitable disposition of non-conforming materials are maintained by QA Personnel. Who is authorized to review the non-conforming product?

The decisions of review as per application for disposition may be

  • The action which has to be taken to eliminate the non-conforming situation.
  • Use as it is under concessions (deviation) / with partial rework or without rework after approval from defined Authorization.
  • Rework to meet specifications.
  • Reject / scrap.
  • Return to the supplier.
  • Regard for alternative applications.
  • Reworked / Repaired product re-verified to demonstrate conformity to the requirement in accordance with the documented control plan. Details for the handling of nonconforming outputs are described in Procedure

9 Performance evaluations

9.1 Monitoring, measurement, analysis and evaluation

9.1.1 General

Xxx is evaluating the performance and the effectiveness of the quality management system. Xxx is retaining appropriate documented information as evidence of the results.

Purpose:  To establish measurement, analysis and improvement plan for all the process / Function defined in the Quality Management System.

Objective: To establish quality management measurement process and monitor as per planned results for achievement also establish processes to identify non-Conformity situation and subsequently corrective & preventive actions to be taken. IN CHARGE QA in consultation with all respective production process heads plan and implement the monitoring, measurement, analysis and improvement processes needed.

  1. What needs to be monitored and measured
  2. The methods for monitoring, measurement, analysis and evaluation needed to ensure valid results
  3. When the monitoring and measuring shall be performed
  4. When the results from monitoring and measurement are analysed and evaluated

9.1.2 Customer satisfaction

Xxx is to monitor customers’ perceptions of the degree to which their needs and expectations have been fulfilled. Xxx is determined the methods for obtaining, monitoring and reviewing this information. The MKT In Charge has primary responsibility for Customer Satisfaction as one of the measurements of the Quality Management System and as to whether the organization has met customer requirements. Customer satisfaction shall include the collection of authentic data, frequency and validity of the analysis. The trend and major elements affecting customer satisfaction and key indicators of customer dissatisfaction will be monitored supported by objective evidence. Wherever data available, the level of customer satisfaction will be compared with those of our competitors & relevant action plan will be evolved. A customer satisfaction analysis survey will be conducted ONCE IN A 12 MONTHS Review of customer satisfaction will be taken by top management during Management Review Meeting as described in Procedure.

9.1.3 Analysis and evaluation

Xxx is analyzed and evaluate appropriate data and information arising from monitoring and measurement. The results of the analysis are used to evaluate

  1. Conformity of products and services
  2. The degree of customer satisfaction;
  3. The performance and effectiveness of the quality management system;
  4. If planning has been implemented effectively;
  5. The effectiveness of actions taken to address risks and opportunities;
  6. The performance of external providers;
  7.  The need for improvements to the quality management system

9.2 Internal audit

Procedures are established for a system of planned and documented internal quality audits to verify that the Quality Management System conforms to the planned arrangements as per           ISO 9001:2015 requirements and effectively implemented and maintained.

The MR is responsible for:

  • Planning and organizing audits at works depending on the importance and the extent of the activity concerned and the results of the previous audits. The internal quality system audits as per schedule are to be carried out at least once in SIX Months period and at least 02 times during a year.
  • MR also ensures that the trained auditors are involved in quality system audit to ensure the objectivity of the auditing processes and are not directly responsible for the area under audit. The results of the audit are documented in the specified format to record non-conformances in product/process and work practices and brought to the notice of person responsible for the area audited, who in turn shall take appropriate corrective actions within the agreed time limit and ensure removal of deficiencies observed. Follow up the effectiveness of the corrective action taken.
  • The effectiveness of identified corrective action against any such internal audit findings is verified by the MR prior to subsequent management review meeting and recorded.
  • MR is responsible for ensuring that non-conformances observed during IA are closed by appropriate corrective action implementation in a defined period.MR identifies and marks the corrective actions needing confirmation for their effective implementation and also arrange for the verification in subsequent audits or follow up audits will be planned.
  • MR maintains appropriate records of implementation & effectiveness in the form of internal audit reports. The details of the audit team, schedule, preparation of non-conformances reports,
  • The follow up on the corrective actions is detailed in the procedure for corrective action
  • The nonconformance identified during third-party audits or by external agencies are handled in the same manner. The non-conformances of IA remaining open due to a delay in the implementation of corrective action along with major non-conformances recorded will be reviewed during management review meetings.

9.3 Management review

9.3.1 General

Top management of Xxx is reviewing the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization. Management review will be conducted and chaired by MD  once in SIX Months to ensure continuing suitability & effectiveness in satisfying the requirements of   ISO 9001:2015 and the stated quality policy and objectives.

The Management Review will include all elements of the entire quality system as detailed in procedure and schedule for the Management Review. Records of Management Review Meetings shall be maintained by MR. The Director during review shall assess opportunities for improvement and the need for changes in the Quality Management System, including the Quality Policy and Quality Objectives.

 9.3.2 Management review inputs

The management review is planned and carried out taking into consideration

    1. The status of actions from previous management reviews
    2. Changes in external and internal issues that are relevant to the quality management system;
    3. Information on the performance and effectiveness of the quality management system, including trends in:
      • customer satisfaction and feedback from relevant interested parties;
      • the extent to which quality objectives have been met;
      • process performance and conformity of products and services;
      • nonconformities and corrective actions;
      • monitoring and measurement results;
      • audit results;
      • the performance of external providers
    4. The adequacy of resources;
    5. The effectiveness of actions taken to address risks and opportunities;
    6. Opportunities for improvement

9.3.3 Management review outputs

The outputs of the management review shall include decisions and actions related to:

  1. Opportunities for improvement;
  2. Any need for changes to the quality management system;
  3. Resource needs.

The Xxx is retain documented information as evidence of the results of management reviews

10 Improvement

10.1 General

Xxx determines and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction. These include

  1. Improving products and services to meet requirements as well as to address future needs and expectations.
  2. Correcting, preventing or reducing undesired effects;
  3. Improving the performance and effectiveness of the quality management system.

Improvement is included correction, corrective action, continual improvement, breakthrough change,  innovation and re-organization.

10.2 Nonconformity and corrective action

10.2.1 When nonconformity occurs, including any arising from complaints, Xxx is

  • All nonconformities relating to product, process and quality system are investigated & the results are recorded. While investigating the causes of non-conformances & deciding corrective actions, the team identifies other products/situations where same or similar nonconformance can occur.
  • Corrective actions for nonconforming products and processes, detected in the organization are recorded; analyzed, reviewed and necessary actions are taken. This will be the responsibility of IN CHARGE QA & PRD (respective production process In-charge) the corrective action and preventive measures are implemented and their effectiveness is monitored.

The details are as described in the procedure. Corrective actions are taken on customer complaints; by analyzing the causes of the complaints and taking suitable action to prevent their reoccurrence. The effectiveness of the identified corrective action is monitored through customer feedback and also the customers are kept aware of the corrective actions initiated, with each identified corrective action.

10.3 Continual improvement

Xxx continually improved the suitability, adequacy and effectiveness of the quality management system. Xxx considers 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 the continual improvement

Process Sequence & Interaction

…………………………………………………. End of Example ……………………. 

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