ISO 9001 Certification

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What IS ISO 9001 Certification?

ISO 9001 Certification is a Quality Management System Certification – Where the organization adopts to implement the ISO 9001 Standard in the organization, with objective to further enhancement of customer Satisfaction along with its applicable regulatory & other requirements compliances by consistently supply of products / services which meets the customer requirements.

ISO 9001 Certification is a process of management System certification activities performed by accredited ISO Certification Body, which includes the Auditing of implement ISO 9001 Standard to verify organizational QMS effectiveness, review of Audit report, Certification Decision and award of ISO 9001 Certification to the organization.

Benefits of Getting ISO 9001 Certification In India:

An ISO 9001 Standard is most widely used by the organization across the industry sectors for implementation and Certification – as it has the several benefits for ISO 9001 certified, the few most prominent benefits of ISO 9001 certification in India are:

Enhancement of overall Performance of the organization by effectively apply the process approach, Risk-Based Thinking, PDCA Model and Quality Management Principles.
Enhance the Productivity of the organization
Enhance the Customer Satisfaction by consistent supply of products / services meeting the customer requirements
Provide the Opportunity to address the Expectations of interested party.
Provide the Effective Monitoring and Measurement of the processes.
Reduces the Potential Internal and Customer rejections
Provide the opportunity for new business opportunity
Certification of ISO 9001 Certification is accepted worldwide across the industry
Enhancement of Credibility of the organization
Provide the opportunity to compete the market competitions

Benefits of Getting ISO 9001 Certification

Important Aspects Covered in ISO 9001

Important aspects Covered in ISO 9001 standard are adopting Risk-Based Thinking, Process approach, Continual Improvement P-D-C-A model and understanding the needs & expectations of Interested Party. This 9001 is compatible with any other Management System Standards - such as ISO 14001, ISO 45001, ISO 27001, ISO 22000 etc & many more ISO Standards. In this ISO 9001:2015, the preventive actions wording removed by providing the requirements of Risk -Based Thinking – while planning the activities, the organization identify the Internal and External issues along with expectations of interested party they do proper Risk analysis, so the consistency of process is maintained, which helps the organization to maintain the Business continuity in any impact. Adopting the Process approach help the organization to maintain the consistency of product / process and Continual Improvements (PDCA) models help the continually improvement of overall QMS of the organization.

ISO 9001:2015 Requirements:

ISO 9001:2015 Requirements As per the ISO 9001 Standards, the ISO 9001:2015 requirements given in the clause # 4 to Clause # 10, for the Implementation in the organization and Certification. The summarized ISO 9001 requirements are as followings:

Identification of Internal and External Issues affective QMS and its monitoring & review.
Identification of Needs and expectations of Interested Party (i.e Customer, Regulatory Body, etc) and its monitoring & review.
Identification of applicability of QMS (i.e Exclusion of Clauses of ISO 9001 – if any).
Establishing the QMS and Its Processes.
Establishing the Leadership and Its commitments towards QMS.
Demonstration of Commitments towards Customer Focus.
Establishing the Quality Policy and Objectives.
Establishing the Role, Responsibility and Authorities of all the personal in the organization.
Risk Analysis of -Internal & External Issues along with Need and Expectations of Interested Party
Ensuring the necessary resources availability- such as – People, Infrastructure, work environments, Monitoring & measurements equipment (if any)
Maintain the organizational Knowledge for reference
Provide the Training to the person working in the organization as per Training needs requirement and evaluate the competency
Development of necessary Documents and Records required by QMS – such as – Quality Policy, Objective, SOP, WI, etc and maintain them by proper Controls of Documents & record with identification, traceability & retrieval
Identification of Customer Requirements and timely review of customer Requirements
Customer Communication
Planning of Resources
Design and development of Products and services (If applicable)
Control of externally provided processes, products and services
Control of production and service provision
Identification and traceability
Property belonging to customers or external providers
Preservation
Post-delivery activities
Release of products and services
Control of nonconforming outputs
Monitoring the Customer satisfaction
Monitoring the conformity of products and services , effectiveness of actions taken to address risks and opportunities , performance of external providers , etc
Internal audit
Management review
Nonconformity and corrective action
Continual improvement

ISO 9001 Certification Cost

ISO 9001 Certification Cost – The Certification Body derived ISO 9001 Certification cost – by taking the reference of IAF -MD 5 and CAB procedures, to evaluate how many man-days is needed to perform the ISO 9001 Certification Audit and other associated administrative cost. The Audit – Man-day is calculated taking reference of Number of Employee, activities of the organization, Key process /Function, Products / services of the organization, Site /Location of the organization, etc. so on. So, ISO 9001 Certification cost is depending of various factors, which is not fixed. The Certification Body charged the certificate Fee per Man-day Rate, i.e Time Involve to complete entire ISO 9001 Certification activities of the organization, till award of ISO 9001 certification.

ISO 9001 Certification Process In India:

The ISO 9001 Certification process are categorized in two Steps

Step-1 - First the company wanted iso 9001 registration must search for trusted ISO 9001:2015 provider, implement the ISO 9001 Standard in the organization effectively, develop the Policy, Procedures as per ISO 9001 requirements, completed at least one Complete Internal Audit and Management Review meeting a professional ISO 9001 consultants. After Completion of QMS implementation, Internal Audit and Management Review meeting – Apply to ISO Certification Body

Step-2 – At Certification Body Level - After receipt of Application from organization for ISO 9001 Certification, the Following activities are performed by Certification body prior to awards of ISO 9001 Certification

Receipt of Application for ISO 9001 Certification from the organization (Looking for ISO Certification)
Acceptance of Cost involving for ISO 9001 Certification by applicant organization (offered by Certification Body)
Application Review and Audit Team selection
Onsite Audit by ISO Auditors, Audit Report Preparation and submission to Certification Body for Review
Certification Decision
Award of ISO 9001 Certification
Annual surveillance Audit

These are the key ISO 9001 Certification process are involved in the entire Certification process, till the applicant organization becomes ISO 9001 Certified.

Frequently Asked Questions About ISO 9001 Certification:

1. What is ISO 9001 Standards and what are its responsibilities?

ISO 9001 Standard is a Quality Management System Standard, most widely adopted ISO Standard in the world by the Industry/ Business across the sectors. This QMS Standard are adopted by the organization as business practices to over all enhance the performance of the organization and its customer Satisfaction. Its responsibility is -when the organization adopt this Standard for implementation, must maintain the consistency of implementation of requirement and continually improve the overall QMS performance of the organization by ensure the compliance of QMS through-out the process/ activities of the organization.

2. What is the use of ISO 9001: 2015?

The use of ISO 9001:2015 -Quality Management System is to overall enhance the performance of the organization and improve the productivity of the organization.

3. What is the meaning of applicability as per iso 9001:2015?

As per ISO 9001:2015, requirements said in Clause # 4.3 applicability of the quality management system- where applicability of QMS is required to establish the Scope of the organization. So, the organization has to identify the Exclusions of clauses of ISO 9001:2015 (considering the all aspects of the organization including Internal, external issues and need & Expectations of Interested party) – which are not applicable to organization – considering the nature of activities of the organization. also provide the Justification of Exclusion of Clauses.

4. How to apply for ISO 9001 certifications?

To apply for ISO 9001 service, first of all implement the requirements of ISO 9001 Standard in the organization, maintain the necessary Policy, Procedures, Records and other relevant ISO 9001 Documents. After that you can visit to ISO 9001:2015 provider website and apply online for ISO 9001 Certification services, by providing the necessary information to Certification Body – such as – Name of organization, Contact Person Name, Contact Number, activities of the organization, Number of Employee, etc.

5. Why 9001 Certification is needed in India?

As India is a developing country, there is huge market competitions and same time the demand of products and services are also very high. So, to meets the market competition and demand of customer, the business in India need the ISO 9001 Certification in India. As ISO 9001 Certification provides the requirements to the organization for enhancement of customer Satisfaction by consistent supply of products and services that meets the customer requirements.

6. What is the basic ISO 9001:2015 QMS requirements?

The basic ISO 9001:2015 QMS requirements are – Risk Based Thinking, Adopt Process Approach, Continual Improvement (apply PDCA model) , apply Quality Management Principle (QMS principles ) , enhance customer satisfaction and maintaining the compliance of applicable regulatory & other requirements.

7. Can ISO truly help in quality management?

ISO 9001 is a Quality Management System – it helps the organization a Lot – when the organization implement the applicable requirements of ISO 9001 Quality Management System effectively in the organization, also consistently maintain the compliance, time conduct of Internal Audit & Management Review meeting, monitor the customer Requirement compliance, Customer Satisfaction, Proper Response to client if any issues and Focused on Continual Improvement. This QMS ISO certification truly help the organization for enhancement of overall performance of the organization, Productivity, customer Satisfaction and new business opportunity.

8. How often should we do management review for ISO 9001?

As per ISO 9001 standard requirement of Clause # 9.3, the organization shall do the management review at planned interval. So, there is no time limit frequency to do the management review. So, the organization can perform the Management review at any frequency, but please note it should be at least once in a Year (as Minimum). So, after defining the Management review meeting frequency, the same shall be updated in Management Review Procure or Quality Manual.

9. ISO 9001:2015 VS SIX Sigma- Whis one Is Better?

ISO 9001:2015 is a Quality Management System Standard – where the requirements of this standard are for monitoring of the overall organizational performance- considering the entire aspects of the organization. Where Six-Sigma statistical Tools which is apply to organization to improve the process performance, reduce the process variations, reduce the internal rejections of the products, etc . So, ISO 9001:2015 or Six-Sigma both have their own specific purpose and requirements. Both are equally better depending on the necessity of the organization.

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