What is ISO 9001:2015?

ISO 9001:2015 is an international standard dedicated to Quality Management Systems (QMS). It outlines a framework for improving quality and a vocabulary of understanding for any organization looking to provide products and services that consistently meet the requirements and expectations of customers and other relevant interested parties in the most efficient manner possible.i The QMS is the aggregate of all the processes, resources, assets, and cultural values that support the goal of customer satisfaction and organizational efficiency. First published in 1987, the latest iteration (ISO 9001:2015) replaces ISO 9001:2008.

ISO 9001:2015 doesn’t dictate what an organization’s objectives should be or how to achieve them. In other words, it doesn't tell anyone how to run their business. It's a flexible standard that allows each organization to define for itself what its objectives and adherence to the standard ought to be. ISO 9001:2015 defines the guiding principles that can be used to create efficiencies by aligning and streamlining processes throughout the organization, in an effort to bring down costs, create new opportunities, meet regulatory requirements, and help organizations expand into new markets in which clients demand ISO 9001 certification (the last of which is increasingly crucial for businesses working in or with the public sector or serving as suppliers in automotive or private OEM (Original Equipment Manufacturer) scenarios).

ISO does not perform certifications to ISO 9001:2015. Instead, organizations engage an independent certification body to audit their QMS implementation against the ISO requirements. Organizations of any size can certify to this standard, including smaller ones with no dedicated Quality resources.

SOURCE LINK 

ISO 9001: 2015 - DBS, IAS

REFERENCE CODE - E000 - ED00

CONTACT @Whtasapp @Gmail

GMP

REFERENCE CODE - RD00 - E000

CONTACT @Whtasapp @Gmail

ISO APPLICATION FORM

	APPLICATION QUESTIONNAIRE FOR MANAGEMENT SYSTEM CERTIFICATION

                                                                                                                    

 

 

*Name of Company
*Postal Address
Number of Sites Linked & Address(if certification required):
*Phone	*Fax
*Email:	*Website
*Contact Person Name:	*Position:	*Mobile No
*Legal Status of Company: Pvt. Ltd./Public Ltd./Proprietorship/Partnership
*Statutory & Regulatory Requirements: (Related to the Nature Work & Management System Certification)
*Service Tax/Excise/TIN:
*Outsourced Process: (which effects the conformity of the product/service)

         

CERTIFICATIONS REQUESTED   Quality Management System ISO 9001:2015                             Is the category “design and development” included in the activities to be certified?              Yes  No   Is there any process that affects product conformity outsourced?                                            Yes  No              Exclusions if any?            Any legal obligation?

Occupational Health & Safety System OHSAS 18001:2007  How many sites is your company managing at the same time?          Hazard’s Identified?        Please detail any critical occupational health & safety risks identified?

Environmental Management System ISO 14001:2015                                                   How many sites is your company managing at the same time?          A Register of Significant Environment aspect?                          Yes  No               An Environmental Management Manual?                                    Yes  No            An Internal Environmental Audit Programme?                            Yes  No            Has the Internal Environmental Audit Programme been implemented?            Yes  No

 

Food Safety Management System                                                            ISO 22000:2005                                             HACCP implementation or Study conducted ?:  Yes  No  How many sites is your company managing at the same time?               How many process lines?                   Any prior audits?                          Yes  No If yes then Specify the result

Any other standards: ISO13485/HACCP/27001/TS16949/CE/GMP/HALAAL/SA8000/Product Certification etc :     Yes  No   CERTIFICATION PROGRAMME REQUESTED  Initial certification  Recertification                                                   Combination audit  Transfer Cum Surveillance      In the case of several certification programmes, would you like the audits to be                         Combined or carried out separately?         If the answer is yes, please specify which combination :

 

EMPLOYEES (For multi-site, indicate all sites to be covered under certification)          Site Detail                                                   Staff                                 Workers (Permanent/ Temporary)                                                                                                                                                              Total No. of Employee   :   No. of Shifts  :   Scope:   Please define key processes at your facility?

 

ADDITIONAL INFORMATION Ø  Have You A Specific Programme/Timescale For Achieving Registration?              Have you called on the services of a consultant?                     Yes /  No Ø  If yes, please specify which one :   Name of Business Associates:- Ø  Is any way Business Associate involved other than marketing?

Declaration: The information provide above is true to the best of our knowledge and Belief.     (Authorized signatory Name, Seal & Signature)                           Position                          Date

 

FOR CERTIFICATION USE ONLY:-   REVIEWED BY:   DATE:   Can the application be further processed?

 

STAGE -­‐1 AUDIT REPORT

STAGE -­‐1 AUDIT REPORT

 

Date of Audit
Name of the Organization
Address
Site Specific Conditions (Ifany)
Auditduration Manday(s):
No. ofEmployees
No. OfShift
Contact Personwith mailid
Telephone/Fax
Scope
Technical Area/NACE Code
Non Applicabilityof clause	Clause Detailed justification for NonApplicability
AuditTeam	Team Leader: Auditor: Technical Expert: Observer/Trainee:
AuditObjective	To evaluate the client's documented system, location & site-specific conditions and gather other details through discussions with theclient's personnel to determine the organization’s readiness for the Stage 2 Audit for Certification.
Changes since last assessment/Application	Scope: No. ofEmployees: No. ofShift: Anyother:
Brief aboutthe organization

 

 

 

 

 

Signature of Authorized Person 

 

 

AUDIT CHECKLIST

 

REQUIREMENTS	COMMENTS	Status C/NC/O
Is the client has determined the internal and external issues for understanding of organization and its context?
Is the client has determined the need and expectation of the interested parties?
Is the Client Management system is based on Risk based thinking and analyzing the risk at each process after considering the Internal, external issues and need and expectation of Interestedparties?
Is scope of QMS is documented and having Boundaries?
Are processes for QMS identified and their sequence & interactiondefined?
Any Statutory and/or regulatory requirements applicable to the product identified and compliedwith?
Is there a documented statement of Quality Policy?
Is Quality objectives identified, documented and  are measurable andmonitored?
Are Internal audits conducted as planned and effective?   Date of Last Internal Audit andfrequency?
Are Management reviews conducted as planned andeffective?

 

 

 

 

Signature of Authorized Person

 

Date of Last MRM andfrequency?
Are customers complaints recorded? Is there evidence of resolving thesame?
Is there any outsourced process effecting in the conformity of theproduct?

 

 

 

Signature of Authorized Person

AuditSummary

 

 

 

COMMENTS	TICK (√ Asapplicable)
Client’s management system documentation adequate for Stage 2auditing
Client understand the requirements of the relevant standards adequately for the stage 2 audit to beconducted
Auditing is based on sampling process of availableinformation
Level  of implementation substantiate that the client is ready for stage2
The  audit is not combined, joint orintegrated
The effectiveness of corrective actions taken regarding previously identified nonconformities  and observations has verified and foundsatisfactory
The capability of the management system to meet applicable requirements and expected outcomes are effective andcomplying
The internal audit and management review process are effective and complying with therequirements.	.
The  Objective of the audit isachieved

 

 

 

Signature of Authorized Person

 

Observations
NonConformities		Minor
		Major
Recommendation (√ Asapplicable)			Recommend proceeding with Stage2
			Recommend not proceeding to stage 2 until audit evidence has been submitted showing that the concerns raised by          the auditor (s)have been rectified. A date for stage 2 will then be agreed
			Recommend not proceeding without a further stage 1 Audit due to the severity of the concerns raised by the auditteam

 

 

 

 

 

Sign Off :Date
	Client Acceptance for Report
Name of Team Leader Signature:	Name: Sign Designation: