How to implementing ISO 9001: 2015 Standards?

Quality Management System Requirements

Mandatory Documents For Implementation of  ISO 9001:2015

• The scope of the QMS (clause 4.3) 
• Quality policy (clause 5.2) 
• Quality objectives (clause 6.2) 
• Criteria for evaluation and selection of suppliers (clause 8.4.1) 

For the requirements with the sign (*) are mandatory only in cases when the relevant clause is not excluded or is part of the Organization's/company's business practices.

Record Mandatory For Implementation of  ISO 9001:2015

1. Recording monitoring and measurement equipment calibration * (clause 7.1.5.1) 
2. The recording of the training, skills, experience and qualifications (clause 7.2) 
3. Record review product/service requirements (clause 8.2.3.2) 
4. The recording of the results of the review of the design and development * (clause 8.3.2) 
5. Recording of input to the design and development * (clause 8.3.3) 
6. Recording control design and development * (clause 8.3.4) 
7. Recording the results of design and development * (clause 8.3.5) 
8. Recording of changes in the design and development * (clause 8.3.6) 
9. The characteristics of the product to be manufactured and the services to be provided (clause 8.5.1) 
10. The recording of the customer's property (clause 8.5.3) 
11. The recording of a change in production/service provision (clause 8.5.6) 
12. Recording compliance with product/service acceptance criteria (clause 8.6) 
13. Record output/outcome that is not appropriate (clause 8.7.2) 
14. Monitoring and measurement results (clause 9.1.1) 
15. Internal audit programs (clause 9.2) 
16. The results of the internal audit (clause 9.2) 
17. The result of the management review (clause 9.3) 
18. The results of the corrective action (clause 10.1) 

Non-Mandatory Documents For Implementation of  ISO 9001:2015

There are non-mandatory document that can be used for the implementation of  ISO 9001:2015. Here are the documents of non-compulsory to be the most commonly used:

1. The procedure for determining the organizational context and the parties concerned (article 4.1 and 4.2) 
2. Procedures to deal with risks and opportunities (clause 6.1) 
3. Procedure for competence, training and awareness of QMS (clause 7.1.2, 7.2 and 7.3) 
4. The procedure for maintenance of the equipment and measuring instruments (clause 7.1.5) 
5. Procedures for the control of documents (clause 7.5) 
6. Sales procedure (clause 8.2) 
7. Procedures for design and development (clause 8.3) 
8. Procedures for the production and provision of services (clause 8.5) 
9. Warehousing procedures (clause 8.5.4) 
10. Procedures for the management of discrepancies and corrective action (clause 8.7 and 10.2) 
11. Procedures for monitoring customer satisfaction (clause 9.1.2) 
12. Procedures for internal audit (clause 9.2) 
13. The procedure for review of management (clause 9.3) 

This requirement is not absolute as above but the management determines according to the policy direction of each organization.

Thank you & may be useful

IATF 16949:2016 Requirements Clause 7

7. Support

7. Support

7.1 Resources

7.1.1 General

• The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system.
• The organization shall consider:

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

7.1.2 People

The organization shall determine and provide the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes.

7.1.3 Infrastructure

The organization shall determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services. Note: Infrastructure can include:

a. buildings and associated utilities;

b. equipment, including hardware and software;

c. transportation resources;

d. information and communication technology.

7.1.3.1 Plant, facility, and equipment planning

The organization shall use a multidisciplinary approach including risk identification and risk mitigation methods for developing and improving plant, facility, and equipment plans. ln designing plant layouts, the organization shall:

• optimize material flow, material handling, and value-added use of floor space including control of nonconforming product, and
• facilitate synchronous material flow, as applicable.

Methods shall be developed and implemented to evaluate manufacturing feasibility for new product or new operations. Manufacturing feasibility assessments shall include capacity planning. These methods shall also be applicable for evaluating proposed changes to existing operations.

The organization shall maintain process effectiveness, including periodic re-evaluation relative to risk, to incorporate any changes made during process approval, control plan maintenance and verification on job set-ups. Assessments of manufacturing feasibility and evaluation of capacity planning shall be inputs to management reviews.

7.1 .4 Environment for the operation of processes

The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services.

Note: A suitable environment can be a combination of human and physical factors, such as:

• social (e.g. non-discriminatory, calm, non-confrontational);
• psychological (e.g. stress-reducing, burnout prevention, emotionally protective);
• physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise).

These factors can differ substantially depending on the products and services provided.

7.1.4.1 Environment for the operation of processes — supplemental

The organization shall maintain its premises in a state of order, cleanliness, and repair that is consistent with the product and manufacturing process needs.

7.1.5 Monitoring and measuring resources

7.1.5.1 General

The organization shall determine 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:

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

The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources.

7.1.5.1.1 Measurement system analysis

• Statistical studies shall be conducted to analyze the variation present in the results of each type of inspection, measurement, and test equipment system identified in the control plan.
• The analytical methods and acceptance criteria used shall conform to those in reference manuals on measurement systems analysis.
• Other analytical methods and acceptance criteria may be used if approved by the customer.
• Records of customer acceptance of alternative methods shall be retained along with results from alternative measurement systems analysis 

Note:  Prioritization of MSA studies should focus on critical or special product or process characteristics.

7.1.5.2 Measurement traceability

When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be:

• 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;
• identified in order to determine their status;
• safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results.

The organization shall determine if 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.

7.1.5.2.1 Calibration/verification records

• The organization shall have a documented process for managing calibration/verification records. Records of the calibration/verification activity for all gauges and measuring and test equipment (including employee-owned equipment relevant for measuring, customer-owned equipment, or on-site supplier-owned equipment) needed to provide evidence of conformity to internal requirements, legislative and regulatory requirements, and customer-defined requirements shall be retained.
• The organization shall ensure that calibration/verification activities and records shall include the following details:

1. revisions following engineering changes that impact measurement systems;
2. any out-of-specification readings as received for calibration/verification;
3. an assessment of the risk of the intended use of the product caused by the out-of-specification    condition;
4. when a piece of inspection measurement and test equipment is found to be out of calibration or defective during its planned verification or calibration or during its use, documented information on the validity of previous measurement results obtained with this piece of inspection measurement and test equipment shall be retained, including the associated standard's last calibration date and the next due date on the calibration report;
5. notification to the customer if suspect product or material has been shipped;
6. statements of conformity to specification after calibration/verification;
7. verification that the software version used for product and process control is as specified;
8. records of the calibration and maintenance activities for all gauging (including employee-owned equipment, customer-owned equipment, or on-site supplier-owned equipment);
9. production-related software verification used for product and process control (including software installed on employee-owned equipment, customer-owned equipment, or on-site supplier-owned equipment).

7.1.5.3 Laboratory requirements

7.1.5.3.1 Internal laboratory

An organization's internal laboratory facility shall have a defined scope that includes its capability to perform the required inspection, test, or calibration services. This laboratory scope shall be included in the quality management system documentation. The laboratory shall specify and implement, as a minimum, requirements for:

a. adequacy of the laboratory technical procedures;

b. competency of the laboratory personnel;

c. testing of the product;

d. capability to perform these services correctly, traceable to the relevant process standard (such as ASTM, EN, etc.); when no national or international standard(s) is available, the organization shall define and implement a methodology to verify measurement system capability;

e. customer requirements, if any;

f. review of the related records.

Note: Third-party accreditation to ISO/IEC 17025 (or equivalent) may be used to demonstrate the organization's in-house laboratory conformity to this requirement.

7.1.5.3.2 External laboratory

• External/commercial/independent laboratory facilities used for inspection, test, or calibration services by the organization shall have a defined laboratory scope that includes the capability to perform the required inspection, test, or calibration, and either:
• The laboratory shall be accredited to ISO/IEC 17025 or national equivalent and include the relevant inspection, test, or calibration service in the scope of the accreditation (certificate); the certificate of calibration or test report shall include the mark of a national accreditation body; or there shall be evidence that the external laboratory is acceptable to the customer.
• Note Such evidence may be demonstrated by customer assessment, for example, or by customer-approved second-party assessment that the laboratory meets the intent of ISO/IEC 17025 or national equivalent. The second-party assessment may be performed by the organization assessing the laboratory using a customer-approved method of assessment.
• Calibration services may be performed by the equipment manufacturer when a qualified laboratory is not available for a given piece of equipment. In such cases, the organization shall ensure that the requirements listed in Section 7.1.5.3.1 have been met.
• Use of calibration services, other than by qualified (or customer accepted) laboratories, may be subject to government regulatory confirmation, if required.

7.1.6 Organizational knowledge

The organization shall determine 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.

NOTE 1: Organizational knowledge is knowledge specific to the organization; it is generally gained by experience. It is information that is used and shared to achieve the organization’s objectives.

NOTE 2:  Organizational knowledge can be based on:

• 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);
• external sources (e.g. standards; academia; conferences; gathering knowledge from customers or external providers).

7.2 Competence

The organization shall:

• determine the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the quality management system;
• ensure that these persons are competent on the basis of appropriate education, training, or experience;
• 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.

7.2.1 Competence — supplemental

The organization shall establish and maintain a documented process(es) for identifying training needs including awareness (see Section 7.3.1) and achieving competence of all personnel performing activities affecting conformity to product and process requirements. Personnel performing specific assigned tasks shall be qualified, as required, with particular attention to the satisfaction of customer requirements.

7.2.2 Competence — on-the-job training

The organization shall provide on-the-job training (which shall include customer requirements training) for personnel in any new or modified responsibilities affecting conformity to quality requirements, internal requirements, regulatory or legislative requirements; this shall include contract or agency personnel.

The level of detail required for on-the-job training shall be commensurate with the level of education the personnel possess and the complexity of the task(s) they are required to perform for their daily work. Persons whose work can affect quality shall be informed about the consequences of nonconformity to customer requirements.

7.2.3 Internal auditor competency

• The organization shall have a documented process(es) to verify that internal auditors are competent, taking into account any customer-specific requirements. For additional guidance on auditor competencies, refer to ISO 19011. The organization shall maintain a list of qualified internal auditors.
• Quality management system auditors, manufacturing process auditors, and product auditors shall all be able to demonstrate the following minimum competencies:

a. understanding of the automotive process approach for auditing, including risk-based thinking;

b. understanding of applicable customer-specific requirements;

c. understanding of applicable ISO 9001 and IATF 16949 requirements related to the scope of the audit;

d. understanding of applicable core tool requirements related to the scope of the audit;

e. understMaintenance of and improvement in internal auditor competence shall be demonstrated through: executing a minimum number of audits per year, as defined by the organization; and

g. maintaining knowledge of relevant requirements based on internal changes (e.g., process technology, product technology) and external changes (e.g., ISO 9001, IATF 16949, core tools, and customer specific requirements).anding how to plan, conduct, report, and close out audit findings.

7.2.4 Second-party auditor competency

The organization shall demonstrate the competence of the auditors undertaking the second-party audits. Second-party auditors shall meet customer specific requirements for auditor qualification and demonstrate the minimum following core competencies, including understanding of:

a. the automotive process approach to auditing, including risk based thinking;

b. applicable customer and organization specific requirements;

c. applicable ISO 9001 and IATF 16949 requirements related to the scope of the audit;

d. applicable manufacturing process(es) to be audited, including PFMEA and control plan;

e. applicable core tool requirements related to the scope of the audit;

f. how to plan, conduct, prepare audit reports, and close out audit findings.

7.3 Awareness

The organization shall ensure that persons doing work under the organization’s control are aware of:

a) the quality policy;

b) relevant quality objectives;

c) their contribution to the effectiveness of the quality management system, including the benefits of improved performance;

d) the implications of not conforming with the quality management system requirements.

7.3.1 Awareness — supplemental

The organization shall maintain documented information that demonstrates that all employees are aware of their impact on product quality and the importance of their activities in achieving, maintaining, and improving quality, including customer requirements and the risks involved for the customer with non-conforming product

7.3.2 Employee motivation and empowerment

The organization shall maintain a documented process(es) to motivate employees to achieve quality objectives, to make continual improvements, and to create an environment that promotes innovation. The process shall include the promotion of quality and technological awareness throughout the whole organization.

7.4 Communication

The organization shall determine the internal and external communications relevant to the quality management system, including:

a. on what it will communicate;

b. when to communicate;

c. with whom to communicate;

d. how to communicate;

e. who communicates.

7.5 Documented information

7.5.1 General

The organization’s quality management system shall include:

a. documented information required by this International Standard;

b. documented information determined by the organization as being necessary for the effectiveness of the quality management system.

Note: The extent of documented information for a quality management system can differ from one organization to another due to: the size of organization and its type of activities, processes, products and services;

7.5.1.1 Quality management system documentation

The organization's quality management system shall be documented and include a quality manual, which can be a series of documents (electronic or hard copy).

The format and structure of the quality manual is at the discretion of the organization and will depend on the organization's size, culture, and complexity. If a series of documents is used, then a list shall be retained of the documents that comprise the quality manual for the organization.

The quality manual shall include, at a minimum, the following:

• the scope of the quality management system, including details of and justification for any exclusions;
• documented processes established for the quality management system, or reference to them;
• the organization's processes and their sequence and interactions (inputs and outputs), including type and extent of control of any outsourced processes;
• a document (i.e., matrix) indicating where within the organization's quality management system their customer-specific requirements are addressed.

Note: A matrix of how the requirements of this Automotive QMS standard are addressed by the organization's processes may be used to assist with linkages of the organization's processes and this Automotive QMS.

7.5.2 Creating and updating

• When creating and updating documented information, the organization shall ensure appropriate:
• Identification and description (e.g. a title, date, author, or reference number); format (e.g. language, software version, graphics) and media (e.g. paper, electronic);
• Review and approval for suitability and adequacy.

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:

• it is available and suitable for use, where and when it is needed;
• 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, the organization shall address the following activities, as applicable:

• distribution, access, retrieval and use;
• storage and preservation, including preservation of legibility;
• control of changes (e.g. version control);
• 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 shall be identified as appropriate, and be controlled.

Documented information retained as evidence of conformity shall be protected from unintended alterations.

Note:  Access can imply a decision regarding the permission to view the documented information only, or the permission and authority to view and change the documented information.

7.5.3.2.1 Record retention

The organization shall define, document, and implement a record retention policy. The control of records shall satisfy statutory, regulatory, organizational, and customer requirements. 

Production part approvals, tooling records (including maintenance and ownership), product and process design records, purchase orders (if applicable), or contracts and amendments shall be retained for the length of time that the product is active for production and service requirements, plus one calendar year, unless otherwise specified by the customer or regulatory agency.

Note: Production part approval documented information may include approved product, applicable test equipment records, or approved test data.

7.5.3.2.2 Engineering specifications

• The organization shall have a documented process describing the review, distribution, and implementation of all customer engineering standards/specifications and related revisions based on customer schedules, as required.
• When an engineering standard/specification change results in a product design change, refer to the requirements in ISO 9001, Section 8.3.6. When an engineering standard/specification change results in a product realization process change, refer to the requirements in Section 8.5.6.1. The organization shall retain a record of the date on which each change is implemented in production. Implementation shall include updated documents.
• Review should be completed within 10 working days of receipt of notification of engineering standards/ specifications changes.

Note: A change in these standards/specifications may require an updated record of customer production part approval when these specifications are referenced on the design record or if they affect documents of the production part approval process, such as control plan, risk analysis (such as FMEAs), etc.

IATF 16949:2016 Requirements Clause 6

6. Planning

Planning

6.1 Actions to address risks and opportunities

6.1.1

When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to:

a) give assurance that the quality management system can achieve its intended result(s);

b) enhance desirable effects;

c) prevent, or reduce, undesired effects;

d) achieve improvement.

6.1.2 The organization shall plan:

a. actions to address these risks and opportunities;

b. how to:

1. integrate and implement the actions into its quality management system processes (see 4.4);
2. valuate the effectiveness of these actions.

Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.

6.1.2.1 Risk analysis

The organization shall include in its risk analysis, at a minimum, lessons learned from product recalls, product audits, field returns and repairs, complaints, scrap, and rework.

The organization shall retain documented information as evidence of the results of risk analysis.

6.1.2.2 Preventive action

The organization shall determine and implement action(s) to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the severity of the potential issues.

The organization shall establish a process to lessen the impact of negative effects of risk including the following:

• determining potential nonconformities and their causes;
• evaluating the need for action to prevent occurrence of nonconformities:
• determining and implementing action needed;
• documented information of action taken;
• reviewing the effectiveness of the preventive action taken; utilizing
• lessons learned to prevent recurrence in similar processes 

6.1.2.3 Contingency plans

The organization shall:

• identify and evaluate internal and external risks to all manufacturing processes and infrastructure equipment essential to maintain production output and to ensure that customer requirements are met;
• define contingency plans according to risk and impact to the customer;
• prepare contingency plans for continuity of supply in the event of any of the following: key equipment failures; interruption from externally provided products, processes, and services; recurring natural disasters; fire; utility interruptions; labor shortages; or infrastructure disruptions:
• include, as a supplement to the contingency plans, a notification process to the customer and other interested parties for the extent and duration of any situation impacting customer operations;
• periodically test the contingency plans for effectiveness (e.g., simulations, as appropriate);
• conduct contingency plan reviews (at a minimum annually) using a multidisciplinary team including top management, and update as required;
• document the contingency plans and retain documented information describing any revision(s), including the person(s) who authorized the change(s).

The contingency plans shall include provisions to validate that the manufactured product continues to meet customer specifications after the re-start of production following an emergency in which production was stopped and if the regular shutdown processes were not followed.

6.2 Quality objectives and planning to achieve them

6.2.1

The organization shall establish quality objectives at relevant functions, levels and processes needed for the quality management system.

The quality objectives shall:

• be consistent with the quality policy;
• be measurable;
• take into account applicable requirements;
• be relevant to conformity of products and services and to enhancement of customer satisfaction;
• be monitored;
• be communicated;
• be updated as appropriate.

The organization shall maintain documented information on the quality objectives.

6.2.2

When planning how to achieve its quality objectives, the organization shall determine:

• what will be done;
• what resources will be required;
• who will be responsible;
• when it will be completed;
• how the results will be evaluated.

6.2.2.1 Quality objectives and planning to achieve them - supplemental

Top management shall ensure that quality objectives to meet customer requirements are defined, established, and maintained for relevant functions, processes, and levels throughout the organization.

The results of the organization's review regarding interested parties and their relevant requirements shall be considered when the organization establishes its annual (at a minimum) quality objectives and related performance targets (internal and external).

6.3 Planning of changes

• When the organization determines the need for changes to the quality management system, the changes shall be carried out in a planned manner (see 4.4).
• The organization shall consider:

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.

IATF 16949:2016 QMS REQUIREMENTS (Clause 4.1 to 4.3)

4. Context of the organization

IATF 16949 Picture

4.1 Understanding the organization and its context

• The organization shall 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.
• The organization shall monitor and review information about these external and internal issues.

4.2 Understanding the needs and expectations of interested parties

• Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:

a) the interested parties that are relevant to the quality management system;

b) the requirements of these interested parties that are relevant to the quality management system.

• The organization shall monitor and review information about these interested parties and their relevant requirements.

4.3 Determining the scope of the quality management system

The organization shall determine the boundaries and applicability of the quality management system to establish its scope. When determining this scope, the organization shall consider:

a. the external and internal issues referred to in 4.1;

b. the requirements of relevant interested parties referred to in 4.2;

c. the products and services of the organization.

The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system. The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system. Conformity to this International Standard may only be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction. 

4.3.1 Determining the scope of the quality management system — supplemental

Supporting functions, whether on-site or remote (such as design centres, corporate headquarters, and distribution centres), shall be included in the scope of the Quality Management System (QMS).

The only permitted exclusion for this Automotive QMS Standard relates to the product design and development requirements within ISO 9001, Section 8.3. The exclusion shall be justified and maintained as documented information (see ISO 9001, Section 7.5).

Permitted exclusions do not include manufacturing process design.

4.3.2 Customer-specific requirements

Customer-specific requirements shall be evaluated and included in the scope of the organization's quality management system.

4.4 Quality management system and its processes (Klic to Next)

IATF 16949:2016 QMS REQUIREMENTS (Clause 4.4. to 4.4.2 )

4.4 Quality management system and its processes

4.4.1 The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall:

• determine the inputs required and the outputs expected from these processes;
• determine the sequence and interaction of these processes;
• determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes;
• determine the resources needed for these processes and ensure their availability;
• assign the responsibilities and authorities for these processes;
• address the risks and opportunities as determined in accordance with the requirements of 6.1;
• evaluate these processes and implement any changes needed to ensure that these processes achieve
• improve the processes and the quality management system.

Automotive Picture

4.4.1.1 Conformance of products and processes

The organization shall ensure conformance of all products and processes, including service parts and

those that are outsourced, to all applicable customer, statutory, and regulatory requirements (see Section 8.4.2.2).

4.4.1.2 Product safety

The organization shall have documented processes for the management of product-safety related products and manufacturing processes, which shall include but not be limited to the following, where applicable:

a. identification by the organization of statutory and regulatory product-safety requirements;

b. customer notification of requirements in item a);

c. special approvals for design FMEA;

d. identification of product safety-related characteristics;

e. identification and controls of safety-related characteristics of product and at the point of manufacture;

f. special approval of control plans and process FMEAs;

g. reaction plans (see Section 9.1.1.1);

4.4.2 To the extent necessary, the organization shall:

• maintain documented information to support the operation of its processes;
• retain documented information to have confidence that the processes are being carried out as planned.

5.1 Leadership and commitment (clik to Next)

Understanding of Warehouse Management System and Inventory Control

I. Definitions

•    Warehousing : A place, location, rooms used for storing materials / goods big, small, expensive, cheap, long, short, hard, soft, sensitive, non-sensitive, hazardous, non-hazardous, etc.
• Management System : A work activity which is done on a regular, clear, systematic and  effective which is used as a source of information that can be accountable.
• Inventory : A material / useful items and placed at the location, the rooms were given a clear identity that can be used as information and communications from one place to another (eg part number, part type, etc.)
• Control : Working system that can monitor with clear and transparent material / goods stored at a location starting from arrival, entry, moving, out or delivery.

That is set at a work place (Warehouse) is done on a regular basis starting from receiving, transferring, spending, delivery (Control) an the material / goods have a clear indication (Inventory) which can be monitored in a systematic, effective and accountable to the each relevant area/function (Management system).

II. Warehouse Basic Concepts

Warehouse is the storage of raw materials, semi-finished goods (semi-product), finished goods that is useful to meet the needs of production and marketing in accordance with the needs of consumers.

After World War II, many experts tried to improve warehouse management by: 

• forecasting and production schedule 
• improving the process of production 
• distribution system improvement

III. Warehouse Functions/Activties;

1. Receiving  Function of Material/Part/Product                                                                       record and unloading ➡ store into warehouse                                                                               
2. Transferring Function                                                                                                                After material / parts received, it will be treated at least three stages, namely; (1) move into the barn and placed in the specified location ➨ (2) sent to the designated location ➡ transport from the warehouse to the consumer. 
3. Identification/Selection Function                                                                                        Classify to raw material, work in-progress part, and final product based on type and each category
4. Delivery Function in this delivery process usually company works together with forwarder company.
5. Storage Function                                                                                                                              - temporary store; the storage by certain period of time                                                                  - permanent store; the storage quantity is over then common needs in certain period of time. 
6. Protection Function ; to protect material/part or product against to consumer needs or demand
7. Segregation Function ; To segregate the hazardous material from goods or contaminated material. 
8. Value added Services Function ; As value added services for company against to customer and internal process. 
9. Inventory Function; To inventories part/material, product and/or others

Domino Effect

The Seven Quality Management Principles

1. Customer Focus

Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and should strive to exceed customer expectations.

2. Leadership

Leaders establish unity of purpose, direction and the internal environment of the organization. They create the environment in which people can become fully involved in achieving the organization’s objectives.

3. Engagement of People

People at all levels are the essence of an organization and their full involvement enables their abilities to be used to the organization’s maximum benefit.

4. Process Approach

A desired result is achieved more efficiently when related resources and activities are managed as a process.

5. Improvement

Successful organizations have an ongoing focus on improvement. Improvement is essential for an organization to maintain current levels of performance, to react to changes in its internal and external conditions and to create new opportunities.

6. Evidences Based Decision Making

Effective decisions should be based on logical analysis of available data and information and intuition based on past experience.

7. Relationship Management

For sustained success, organizations manage their relationships with interested parties, such as suppliers. Interested parties influence the performance of an organization. Sustained success is more likely to be achieved when an organization manages relationships with its interested parties to optimize their impact on its performance. Relationship management with its supplier and partner network is often of particular importance.