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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