Risk and opportunities

New aspects in ISO 9001:2015 which does not specifically required in ISO 9001:2008 Risks and Opportunities Clause 4.4.1 (f) of ISO 9001:2015: address the risks and opportunities as determined Clause 5.1.2 of ISO 9001:2015: Top management to demonstrate leadership to ensure focusing on customer through determining the risk and opportunity Clause 6.1.1 & 6.1.2 of ISO 9001:2015: Action to address risk and opportunities Clause 9.1.3 (e )  of ISO 9001:2015: Analysis and evaluation of effectiveness of action addressing risks and opportunities...

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Transition Period

Certification Transfer process for ISO 9001:2008 certified company According to ISO Recommendation for process steps. Company to determine suitable date (current certificate will only valid until Sep 2018) Readiness review Liaise with certification body Transfer audit (re-certification) based from IAF table New full certificate with 3 years validity We able to assist you for step 2, 3 and 4. Contact us now at HERE or email us at admin@o...

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Feedback Form

Please do feel free to contact us via online form below. Then, let's begin our partnership for your QMS implementation Name: Company Name: Company address Email Address: no. tel Status of QMS implementation ISO 9001 certified In progress of upgrading to 2015 version Uncertified but implementing ISO9001 Not certify but has intention to develop QMS Interested on; Package 1 Package...

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Package

If you have an enquiry, please do feel free to fill up the Feedback Form or email to us at admin@osh-isis.com  ...

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Interactive Quality Manual

New version of ISO 9001 has released by focusing on the effectiveness of operation with simplifying the fulfilment of requirement as now to be understood easily and more practical in application. Therefore, it brought into the great idea for generating the QMS documentation which to be more user-friendly, simple and straight-forward. This is a new concept of documentation where the integration of all aspects required by the standard has been formatted in one platform for better accessibility. As noted, new released standard does...

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Main Changes of ISO 9001:2015

The transition of ISO 9001:2008 to ISO 9001:2015 is mainly to emphasize on the following subjects;   High level structure and core text from „annex SL“ The new format of ISO 9001 standard is providing identical structure, text and common terms to be applied to the system user. It consist 10 elements of the requirement to simplify and to be easily understood by the system implementer (see details of ISO 9001:2015 Standard Requirement) There is also explanatory item to clarify the new structure, terminology and concepts of this ISO...

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ISO 9001:2015 Standard (clause-by-clause)

NOTE: This chapter provides an index of standard requirement for the reader to acknowledge on each of clause of ISO 9001:2015. The input of the content is just extracted from the header or sub-header of the element addressed by the standard. The user is just only need to click on the respective clause and the requirement of the standard will appear by opening with new window. Anyway, the full sets of requirement can be referred through this LINK.   4. context of the organization 4.1 Understanding the organization and its context 4.2...

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Internal Audit Procedure

GENERAL REQUIREMENT This procedure provides guideline to extent information explained in clause Internal Audit of the Quality Manual. The requirement is also enable to provide conformity to clause 9.2.2 (Internal Audit) of ISO 9001:2015 Standard Requirement. COMMON DEFINITION USED The definitions addressed are mainly refer to IS0 9000:2015 RESPONSIBILITY AND AUTHORITY SELECTION OF AUDITORS QMR shall nominate an Internal Auditor; Selected auditor should be complied with one of the following criteria a)...

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Corrective Action Procedure

GENERAL REQUIREMENT This procedure provides guideline to extent information explained in clause 10.2 Nonconformity and corrective action of the Quality Manual. The requirement requirement is also enable to provide conformity to clause 10.2 Nonconformity and corrective action of ISO 9001:2015 Standard Requirement. COMMON DEFINITION USED The definitions addressed are mainly refer to IS0 9000:2015 RESPONSIBILITY AND AUTHORITY IDENTIFICATION OF NON-CONFORMITY OCCURRENCE 1 Identification of non-conformity can be defined...

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Control of Nonconforming Output Procedure

GENERAL REQUIREMENT This procedure provides guideline to extent information explained in clause 8.7 Control of Nonconforming output of the Quality Manual. The requirement is also enable to provide conformity to clause 8.7.1 and 8.7.2 of Control of nonconforming outputs of ISO 9001:2015 Standard Requirement. COMMON DEFINITION USED The definitions addressed are mainly refer to IS0 9000:2015 Complaint Correction Quality Defect Concession Supplier Release Corrective action Conformity Verification Requirement Nonconformity RESPONSIBILITY...

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Documented Information Control Procedure

GENERAL REQUIREMENT This procedure provides guideline to extent information explained in clause 7.5 Documented Information of the Quality Manual. The requirement requirement is also enable to provide conformity to clause 7.5 Documented Information of ISO 9001:2015 Standard Requirement. (Clause 7.5.1, 7.5.2 and 7.5.3) Type of Documented information applied in Company is as follows; a) Information type 1: Instruction or guideline document such as manual, procedure, work instruction, flow chart and others. b) Information type 2: Blank...

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Verification

Verification Verification is a process. It uses objective evidence to confirm that specified requirements have been met. Whenever specified requirements have been met, a verified status is achieved. There are many ways to verify that requirements have been met. For example you could inspect something, you could do tests, you could carry out alternative calculations, or you could examine documents before you issue them....

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Validation

Validation Validation is a process. It uses objective evidence to confirm that the requirements which define an intended use or application have been met. Whenever all requirements have been met, a validated status is established. Validation can be carried out under realistic use conditions or within a simulated use environment. There are several ways to confirm that the requirements which define an intended use or application have been met. For example you could do tests, you could carry out alternative calculations, or you could...

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Traceability

Traceability Traceability is the ability to identify and trace the history, distribution, location, and application of products, parts, materials, and services. A traceability system records and follows the trail as products, parts, materials, and services come from suppliers and are processed and ultimately distributed as final products and services...

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Top management

Top management The term top management normally refers to the people at the top of an organization. It refers to the people who provide resources and delegate authority and who coordinate, direct, and control organizations. However, if the scope of a management system covers only part of an organization, then the term top management refers, instead, to the people who direct and control that part of the organization...

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System

System A system is defined as a set of interrelated or interacting elements. A management system is one type of system. It is a set of interrelated or interacting elements that organizations use to formulate policies and objectives and to establish the processes that are needed to ensure that policies are followed and objectives are achieved....

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Supplier

Supplier A supplier is a person or an organization that provides products or services. Suppliers can be either internal or external to an organization. Internal suppliers provide products or services to people within their own organization while external suppliers provide products or services to other organizations. Examples of suppliers include organizations and people who produce, distribute, or market products, provide services, or publish information. While ISO still includes a definition for this term, the new ISO 9001 2015 ...

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Strategy

Strategy A strategy is a plan for achieving an objectiv...

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Statutory requirement

Statutory requirement A statutory requirement is defined by a legislative body and is obligatory. &nbs...

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Service

Service A service is an intangible output and is the result of a process that includes at least one activity that is carried out at the interface between the supplier (provider) and the customer. Service provision can take many forms. Service can be provided to support an organization’s own products (e.g. warranty service or the serving of meals). Conversely, it can be provided for a product supplied by a customer (e.g. a repair service or a delivery service). It can also involve the provision of an intangible thing to a customer...

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Risk-based thinking

Risk-based thinking Risk-based thinking refers to a coordinated set of activities and methods that organizations use to manage and control the many risks that affect its ability to achieve objectives. Risk-based thinking replaces what the old standard used to call preventive action. While risk-based thinking is now an essential part of the new standard, it does not actually expect you to implement a formal risk management process nor does it expect you to document your organization’s risk-based approach...

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Risk

Risk According to ISO 9000, risk is the “effect of uncertainty on an expected result” and an effect is a positive or negative deviation from what is expected. The following two paragraphs will explain what this means. This definition recognizes that all of us operate in an uncertain world. Whenever we try to achieve something, there’s always the chance that things will not go according to plan. Sometimes we get positive results and sometimes we get negative results and occasionally we get both. Because of this, we need to reduce uncertainty...

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Review

Review A review is an activity. Its purpose is to figure out how well the thing being reviewed is capable of achieving established objectives. Reviews ask the following question: is the subject (or object) of the review a suitable, adequate, effective, and efficient way of achieving established objectives? There are many kinds of reviews. Some of these include management reviews, design and development reviews, customer requirement reviews, nonconformity reviews, and peer reviews....

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Requirement

Requirement A requirement is a need, expectation, or obligation. It can be stated or implied by an organization, its customers, or other interested parties. A specified requirement is one that has been stated (in a document for example), whereas an implied requirement is a need, expectation, or obligation that is common practice or customary. There are many types of requirements. Some of these include customer requirements, quality requirements, quality management requirements, management requirements, product requirements, service...

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Release

Release To release means to grant permission to proceed to the next stage of a process. The term release is also used to refer to a version of software or documented information...

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Regulatory requirement

Regulatory requirement A regulatory requirement is an obligation that is specified by an authority which gets its mandate from a legislative body...

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Quality policy

Quality policy A quality policy should express top management's commitment to the quality management system (QMS) and should allow managers to set quality objectives. It should be based on ISO’s quality management principles and should be compatible with your organization’s other policies and be consistent with its vision and mission. ISO's quality management principles ask you to focus on customers and interested parties, to provide leadership, to engage and involve people, to use a process approach, to encourage improvement, to...

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Quality objective

Quality objective A quality objective is a quality result that you intend to achieve. Quality objectives are based on or derived from an organization’s quality policy and must be consistent with it. They are usually formulated at all relevant levels within the organization and for all relevant functions. The adjective quality applies to objects and refers to the degree to which a set of inherent characteristics fulfills a set of requirements; and an object is any entity that is either conceivable or perceivable. Therefore, a quality...

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Quality management system

Quality management system A quality management system (QMS) is a set of interrelated or interacting elements that organizations use to formulate quality policies and quality objectives and to establish the processes that are needed to ensure that policies are followed and objectives are achieved. These elements include structures, programs, practices, procedures, plans, rules, roles, responsibilities, relationships, contracts, agreements, documents, records, methods, tools, techniques, technologies, and resources. ...

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Quality management

Quality management Quality management includes all the activities that organizations use to direct, control, and coordinate quality. These activities include formulating a quality policy and setting quality objectives. They also include quality planning, quality control, quality assurance, and quality improvement. ...

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Quality

Quality The adjective quality applies to objects and refers to the degree to which a set of inherent characteristics fulfills a set of requirements. An object is any entity that is either conceivable or perceivable and an inherent characteristic is a feature that exists in an object. The quality of an object can be determined by comparing a set of inherent characteristics against a set of requirements. If those characteristics meet all requirements, high or excellent quality is achieved but if those characteristics do not meet...

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Provider

Provider A provider is a person or an organization that supplies or provides products or services. Providers can be either internal or external to the organization. Internal providers supply products or services to people within their own organization while external providers supply products or services to other organizations...

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Product

Product A product is a tangible or intangible output that is the result of a process that does not include activities that are performed at the interface between the supplier (provider) and the customer. Products can be tangible or intangible. According to a note to this definition, there are three generic product categories: hardware, processed materials, and software. Many products combine several of these categories. For example, an automobile (a product) combines hardware (e.g. tires), software (e.g. engine control algorithms),...

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Process-based quality management system

Process-based quality management system A process-based quality management system uses a process approach to manage and control how its quality policy is implemented and how its quality objectives are achieved. A process-based QMS is a network of interrelated and interconnected processes. Each process uses resources to transform inputs into outputs. Since the output of one process becomes the input of another process, processes interact and are interrelated by means of such input-output relationships. These process interactions...

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Process approach

Process approach The process approach is a management strategy. When managers use a process approach, it means that they manage and control the processes that make up their organization, the interaction between these processes, and the inputs and outputs that tie these processes together...

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Process

Process A process is a set of activities that are interrelated or that interact with one another. Processes use resources to transform inputs into outputs. Processes are interconnected because the output from one process often becomes the input for another process. While processes usually transform inputs into outputs, this is not always the case. Sometimes inputs become outputs without transformation. Organizational processes should be planned and carried out under controlled conditions. An effective process is one that...

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Policy

Policy A policy is a general commitment, direction, or intention and is formally stated by top management. A quality policy statement should express top management's commitment to the implementation and improvement of its quality management system and should allow managers to set quality objectives...

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Performance indicator

Performance indicator A performance indicator (metric) is a characteristic that is used to measure customer satisfaction and how well outputs are realized....

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Performance

Performance According to ISO, the term performance refers to a measurable result. It refers to the measurable results that activities, processes, products, services, systems and organizations are able to achieve. Whenever they perform well it means that acceptable results are being achieved and whenever they perform poorly, unacceptable results are achieved...

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Outsource

Outsource When an organization makes an arrangement with an outside organization to perform part of a function or process, it is referred to as outsourcing. To outsource means to ask an external organization to perform part of a function or process normally done inhouse. While an outsourced organization is beyond the scope of your QMS, the outsourced process or function itself falls within your scope...

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Output

Output An output is the result of a process. Outputs can be either tangible or intangible. The output from one process is often the input for another process. ISO 9001 lists four generic output categories: services, software, hardware, and processed materials. Outputs often combine several of these categories. For example, an automobile (an output) combines hardware (e.g. tires), software (e.g. engine control algorithms), and processed materials (e.g. lubricants)...

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Organization

Organization An organization can be a single person or a group that achieves its objectives by using its own functions, responsibilities, authorities, and relationships. It can be a company, corporation, enterprise, firm, partnership, charity, association, or institution and can be either incorporated or unincorporated and be either privately or publicly owned. It can also be an operating unit that is part of a larger entity...

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Objective evidence

Objective evidence Objective evidence is data that shows or proves that something exists or is true. Objective evidence can be collected by performing observations, measurements, tests, or using other suitable methods....

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Objective audit evidence

Objective audit evidence Objective audit evidence is information that is verifiable and generally consists of records and other statements of fact that are relevant to the audit criteria being used...

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Objective

Objective An objective is a result you intend to achieve. Objectives can be strategic, tactical, or operational and can apply to an organization as a whole or to a system, process, project, product, or service. Objectives may also be referred to as targets, aims, goals, or intended outcomes. Quality objectives are generally based on or derived from an organization’s quality policy and must be consistent with it....

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Object

Object An object is any entity that is either conceivable or perceivable. Objects can be real or imaginary and could be material or immaterial. Examples include products, services, systems, organizations, people, practices, procedures, processes, plans, ideas, documents, records, methods, tools, machines, technologies, techniques, and resources...

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Nonconformity

Nonconformity Nonconformity is a nonfulfillment or failure to meet a requirement. A requirement is a need, expectation, or obligation. It can be stated or implied by an organization or interested parties...

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Monitoring

Monitoring To monitor means to determine the status of an activity, process, or system at different stages or at different times. In order to determine status, you need to supervise and to continually check and critically observe the activity, process, or system that is being monitore...

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Measuring equipment

Measuring equipment Measuring equipment includes all the things needed to carry out a measurement process. Accordingly, measuring equipment includes instruments and apparatuses as well as all the associated software, standards, and reference material...

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Measurement

Measurement Measurement is a process that is used to determine a value. In most cases this value will be a quantity...

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Management system

Management system A management system is a set of interrelated or interacting elements that organizations use to formulate policies and objectives and to establish the processes that are needed to ensure that policies are followed and objectives are achieved. These elements include structures, programs, procedures, practices, plans, rules, roles, responsibilities, relationships, contracts, agreements, documents, records, methods, tools, techniques, technologies, and resources. There are many types of management systems. Some of...

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Management

Management The term management refers to all the activities that are used to coordinate, direct, and control organizations. These activities include developing policies, setting objectives, and establishing processes to achieve these objectives. In this context, the term management does not refer to people. It refers to what managers do...

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Knowledge

Knowledge Knowledge is a collection of information and a justified belief that this information is true with a high level of certainty...

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Involvement

Involvement Involvement occurs when people share objectives and are actively engaged in and contribute to their achievement...

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Interested party

Interested party An interested party is anyone who can affect, be affected by, or believe that they are affected by a decision or activity. An interested party is a person, group, or organization that has an interest or a stake in a decision or activity....

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Innovation

Innovation Innovation is a process that results in a new or substantially changed object. An object is any entity that is either conceivable or perceivable. Objects can be real or imaginary and could be material or immaterial. Examples include products, services, systems, organizations, people, practices, procedures, processes, plans, ideas, documents, records, methods, machines, tools, technologies, techniques, and resources...

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Infrastructure

Infrastructure The term infrastructure refers to the entire system of facilities, equipment, and support services that organizations need in order to function. According to ISO 9001, section 7.1.3, the term infrastructure can include buildings, equipment, utilities, and technologies (both hardware and software)....

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Information system

Information system In the context of this ISO 9001 standard, an information system is a network of communication channels used within an organization....

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Information

Information Information is “meaningful data”. While it's not entirely clear what the word “meaningful” is supposed to mean in this context, dictionaries tend to say that something is meaningful if it is significant, relevant, material, valid, or important...

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Improvement

Improvement Improvement is a set of activities that organizations carry out in order to enhance performance (get better results). Improvement can be achieved by means of a single activity or by means of a recurring set of activities...

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Function

Function A function is a role that is performed by a unit of an organization...

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Feedback

Feedback The term feedback is used to refer to a comment or an opinion expressed about a product or service or an interest expressed in a product or a service. It may also be used to refer to the customer complaints-handling process itself. ...

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Effectiveness

Effectiveness Effectiveness refers to the degree to which a planned effect is achieved. Planned activities are effective if these activities are actually carried out and planned results are effective if these results are actually achieved....

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Documented information

Documented information The term documented information refers to information that must be controlled and maintained and its supporting medium. Documented information can be in any format and on any medium and can come from any source. Documented information includes information about the management system and related processes. It also includes all the information that organizations need to operate and all the information that they use to document the results that they achieve (aka records). ...

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Determination

Determination To determine means to find or to identify the value of a characteristic...

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Design and development

Design and development Design and development is a process (or a set of processes) that uses resources to transform general input requirements for an object into specific output requirements. An object is any entity that is either conceivable or perceivable. Objects can be real or imaginary and could be material or immaterial. Examples include products, services, systems, organizations, people, practices, procedures, processes, plans, ideas, documents, records, methods, tools, machines, technologies, techniques, and resources. ...

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Defect

Defect A defect is a type of nonconformity. It occurs when a product or service fails to meet specified or intended use requirement...

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Data

Data The term data is defined as any facts about an object...

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Customer satisfaction

Customer satisfaction Customer satisfaction is a perception. It's also a question of degree. It can vary from high satisfaction to low satisfaction. If customers believe that you've met their requirements, they experience high satisfaction. If they believe that you've not met their requirements, they experience low satisfaction. Since satisfaction is a perception, customers may not be satisfied even though you’ve met all contractual requirements. Just because you haven’t received any complaints doesn’t mean that customers are satisfied. There...

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Customer

Customer A customer is anyone who receives products or services (outputs) from a supplier. Customers can be either people or organizations and can be either external or internal to the supplier organization. Examples of customers include clients, consumers, users, guests, patients, purchasers, and beneficiaries...

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