ISO 9001:2015 QUALITY MANAGEMENT SYSTEM
ISO 9001 is one of the most renowned standards instituted by over 800,000 organizations in 162 countries.
What is ISO 9001?
ISO 9001 certification was designed for large production facilities, but it has recently been upgraded to suit companies of all sizes across various industries. In addition, the ISO keeps updating the standard for continuous improvement in an organization’s procedures. This standard sets out the requirements for a quality management system. It helps businesses and organizations to be more efficient and improve customer satisfaction. The latest version of this standard is ISO 9001: 2015.
An Integrated management system (IMS) all of an organization system’s design and process into one complete framework, enabling an organization to work as a single unit with unified objectives.
IMS= QMS + EMS + SMS + EnMS +FSMS+ISMS etc.
The purpose of the standard is to assist companies in meeting statutory and regulatory requirements relating to their product quality while achieving excellence in their customer service and Delivery. The standard can be used throughout an organization to improve performance or within a particular site, plant or department. It also helps streamline departmental procedures, increasing overall interdepartmental workflow efficiency.
What is Quality Management System?
Each organization has several interested parties with different needs and expectations from the organization—for example Customers, employees, vendors, regulatory bodies, suppliers, investors, etc.
A Quality Management System (QMS) is a structured and formalized system that consists of documented policies, processes, responsibilities, and procedures necessary for an organization to provide products and services and operate in a way that meets the needs and expectations of these interested parties.
The goal of a Quality Management System
The ultimate goal of a QMS is to maintain consistency in operations, management, products, and services. The proper implementation of a QMS gives assurance to interested parties and increases their trust in the company. When an organization assures consistency and reliability, it can improve its reputation, attract customers, maintain good employees and achieve better partnerships.
The key standard that can assist a company in this effort is ISO 9001, being internationally the most recognizable standard for establishing best practices in terms of quality management.
Here’s a Video Tutorial About ISO 9001
What are the ISO 9001 Principles?
The primary focus of quality management is to meet customer requirements and exceed customer expectations. The seven quality management principles are:
1. Customer Focus
- Meet and exceed customer expectations.
- Provide Purpose, direction, and engagement.
3. Engagement of People
- Recognition, empowerment, and enhancement of skills and knowledge.
4. Process Approach
- Understand the process to optimize Performance.
- To Maintain Current Performance and create new opportunities.
6. Evidence-Based Decision Making
- Facts, Evidence, and data analysis for decision-making.
7. Relationship Management
- Manage Relationships with interested parties to optimize Performance.
Why do we need ISO 9001 Certification?
- To Be effective in whatsoever we do, we need a system of doing things to be consistently. Just like artisans, managers need a good management tool to get the job done.
- There are too many activities in any organization. East to lose track of things and focus. Easy to get distributed. Managers need an excellent system to keep things in order.
- Systemizing activity is a natural phenomenon. We do it all the time privately, Publically, or commercially.
- And Most Importantly Government gives recognition to it.
What are the Clauses of ISO 9001:2015?
It needs to demonstrate its ability to consistently provide a product that meets customer and applicable stationery and regulatory requirements and aims to enhance customer satisfaction through the practical application of the system.
2. Normative Reference
- Certification Fundamentals and Vocabulary.
3. Terms and Reference
- This document applies the terms and definitions in ISO 9001: 2015.
4. Context of the Organization
This new clause provides critical insight into the organization’s quality management system.
- Understanding the organization and expectations of interested parties.
- Understanding the organization and its context.
- Determining the scope of the quality management system.
- Quality management system and its process.
The Things required by the top Management
- Leadership & Commitment.
- Organizational Roles, Responsibilities, and Authorities.
- Top Management now has greater involvement in QMS.
5.1 Leadership & Commitment
Top Management must ensure that
- Customer and regulatory requirements are met.
- Risks and opportunities are determined and addressed.
- Focused on enhancing customer satisfaction.
- It must be documented and must be available internally.
5.3 Organizational Roles, Responsibilities, and Authorities
- Ensures responsibilities and authorities for relevant roles are assigned, communicated, and understood.
- No formal requirements for a specific management representative.
- Actions to address risks and opportunities.
- Quality Objectives and planning to achieve them.
- Planning of Changes.
6.1 Action to Address risk and Opportunities
- When Planning, one must consider External / Internal issues and interested parties.
- Determine risks to ensure QMS achieves results, enhances the desired effect, and achieves Improvement.
6.2 Quality Objectives and Planning to achieve them
Objectives should be
- Consistent with the quality policy.
- Relevant to the conformity of products and services and enhancement of customer satisfaction.
- Monitored, Communicated, and updated as appropriate.
6.3 Planning of Changes
- When change is needed, it needs to be carried out in a planned and systematic manner.
- Must ensure the integrity of QMS.
The support required to meet the organization’s goals
- Documented Information
The Resources of this clause are as follows
- Environment for the operation of the process
- Monitoring and Machinery resources
- Organization Knowledge
- Determine the necessary competence of a process.
- Persons are aware of quality, policy, objectives, etc.
- Internal and external communication relevant to QMS.
The heart of the management system. It covers many of the product realization requirements contained in clause 7 of the 2008 revision
- Operational Planning & Control.
- Requirements for products and services.
- Design and development of products and services.
- Production and service provision.
- Release of products and services.
- Control of nonconforming outputs.
9. Performance Evaluation
Determining what is to be monitored, measured, analyzed, and evaluated will enable the organization to determine if the management system is suitable, adequate, and effective.
- Monitoring, measurement, analysis, and evaluation.
- Internal Audit.
- Management Review.
9.1 Must Determine what needs to be monitored
- The monitoring, measurement, analysis, and evaluation methods are applicable to ensure valid results.
9.2 Internal Audit
- Evidence of internal audits and results must be documented.
9.3 Management Review
- Evidence of management review and results must be documented.
Continual Improvement remains a core of the QMS.
- QMS must Continually Improve.
- Non-Conformities must be identified and reacted to.
- Corrective action must be considered.
- Action must be taken to meet customer requirements and enhance customer satisfaction.
10.2 Non-Conformities and Corrective Action
- Root Cause analysis must be considered based on its significance.
- The effectiveness of corrective action must be reviewed.
- Change QMS if required.
- Evidence of action taken from non-conformities must be documented.
What Are the Benefits of ISO 9001 to My Business?
ISO 9001 Certification allows you to observe and deliver quality in your products or services consistently. It is a powerful business improvement tool that helps you put in place processes that will continually improve and satisfy your customers.
Some of the main benefits of ISO 9001 certification include:
- Attract more business.
- Compete in tenders with a competitive edge.
- Customer satisfaction.
- Cost-cutting through improved resource management.
- Reduce Waste and Improve Efficiency.
- Increased productivity leads to more profit.
- Better control of internal systems & processes.
- Improved customer retention and acquisition.
- Consistent achievement of operational goals.
- Added brand value through the globally recognized standard.
What Are The Benefits of ISO 9001 To My Customers?
ISO 9001 Certification is the most well-known and authentic globally recognized standard, giving more confidence to customers in your organization’s commitment to quality management. Many of your customers would prefer working only with ISO 9001:2015 Certified Companies. It assures them that your management systems are up to the mark.
They will know from experience that working with certified companies provides many advantages, including:
- Quality products and services guaranteed.
- Reliability in production and Delivery.
- Consistent communication and reporting.
- Minimized risk.
- Annual assessments maintain standards.
How to Get ISO 9001 Certification in Pakistan?
ISO 9001 Certification in Pakistan is the hallmark of quality and standardization. Organizations in Pakistan that want to maintain their ability to meet customer demands with quality products and services must adhere to the Quality Management System. This standard is their most preferred choice. As an international standard for Quality Management Systems (QMS), It has brought International quality control to local businesses. Small to large organizations in various sectors rely on improving operations, cutting costs, and delivering customer satisfaction.
In Pakistan, the First ISO 9000 certification was awarded in 1994. AGE was the first company that achieved this milestone, followed by Caltex and Philips Pakistan (Shahab & Tian, 2006). Initially, it started very slow; however, competing in the international market developed a positive trend toward its standard. According to ISO Survey 2014 (conducted in Pakistan), a total of “26476” ISO 9000 certifications were awarded from 1994 to 2014, including 2512 certifications in 2014 alone.
TUV Austria Bureau of Inspection & Certification provides the best in class ISO 9001:2015 Certification and Lead Auditor Courses in Pakistan. We take pride in delivering excellent services across various industries in Pakistan & Bangladesh.
What is ISO 9001 Certification Cost?
In today’s competitive environment, organizations that want to reduce costs without compromising quality are looking at 9001:2015 certification as a value-for-money solution. It is impossible to calculate the cost without a detailed risk assessment. Price also depends on many factors:
- Size of Organization.
- Structure of Operations.
- Maturity and Complexity of Existing Systems.
For more information and a free inquiry, Contact Us.
Why Choose TUV Austria BIC? For Implementing Certifications Requirements?
Some of the leading international accreditation bodies have awarded TUV Austria Bureau of Inspection & Certification with the accreditation to offer certification to a vast range of industry sectors. Therefore, the TUV Austria Bureau of Inspection & Certification is the preferred brand across multiple industry sectors for certification services.
Local Regulatory authorities like The Pakistan National Accreditation Council (PNAC) and The Pakistan Engineering Council (PEC) also recognize the TUV Austria Bureau of Inspection & Certification as a leading certification and inspection body in Pakistan. TUV Austria Bureau of Inspection & Certification has earned global respect instead of its approach and service quality through its highly trained and experienced Consultants.
In addition, to this certification audit, we also offer a range of complementary ISO Certification services:
- ISO 14001 – Environmental Management System
- ISO 45001 – Occupational Health & Safety Management System
- ISO 50001 – Energy Management System
- ISO 27001 – Information Security Management System
- ISO 20000 – IT Service Management System
- ISO 22000 – Food Safety Management System
- FSSC 22000 – Food Safety System Certification
- HACCP – Food Safety Management System
- ISO 21001 – Educational Organizations Management System
- ISO 29990 – Learning Services Management System
- ISO 20121 – Sustainability Event Management System
- ISO 22301 – Business Continuity Management System
- ISO 37001 – Anti-Bribery Management System
- ISO 28000 – Supply Chain Security Management System
- ISO 13485 – Quality Management Systems for Medical Devices
- ISO 39001 – Road Traffic Safety Management System
- ISO 31000 – Risk Management – Guidelines
- ISO 22716 – Good Manufacturing Practices for Cosmetics
- ISO 3834 – Quality Requirements for Fusion Welding of Metallic Materials
- Halal Certification
- “Covid-Shield” Certification
- GlobalG.A.P. Certification
- IFS Certification Services
What is the ISO 9001 Standard?
ISO 9001:2015 is a standard that sets out the requirements for a quality management system. It helps businesses and organizations be more efficient and improves customer satisfaction.
What are the ISO 9000 series of standards?
The ISO 9000 family of quality management system standards is designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or service.
What is the Difference between ISO 9001 and 9000?
ISO 9000 is a document that gives guidelines on the quality management system, put together through input from a wide spectrum of organizations and experts in the public and private sectors. So an organization cannot get certification for ISO 9000. Read more
How long does it take to achieve ISO 9001 Certification?
On Average, this certification takes between 9 to 12 months to implement.
Isn’t it the Preserve of Big Business?
No organization can use the standard, regardless of size or type. So while small companies may not have staff dedicated to quality, they can still enjoy the benefits of implementing the standard.
Will it help me Increase my Profits?
ISO 9001 can help bring financial benefits in several ways:
- Using ISO 9001 can increase productivity and effectiveness, thus lowering the costs of an organization.
- Using ISO 9001 can improve customer experience, results in repeat business, increased sales, and additional income for your business.
- Certified in ISO 9001 can enhance your reputation and attract new customers to your organization.
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