ISO 9001: 2015 QUALITY MANAGEMENT SYSTEM
It is one of the most renowned standards instituted by over 800,000 organizations in 162 countries.
ISO 9001 Certification
ISO is the International Organization for Standardization. ISO is based in Switzerland, and over 170 nations participated with approximately 20000 standards. Over 350,000 in this world are registered with ISO 9001. Its Quality Management System (QMS) is internationally recognized as the world’s leading quality management standard. It is a range of measures designed to help organizations ensure they meet the needs of their customers and other stakeholders.
Originally its certification was designed for large production facilities, but it has been upgraded to suit companies of all sizes across varied industries in recent times. In addition, the ISO keeps updating the standard for continuous improvement in an organization’s procedures.ISO 9001 is a standard that 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 900: 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.
Journey of ISO 9001
- 9001: 1987 Quality Assurance
- 9001: 1994 Preventive Action
- 9001: 2000 Process Approach and PDCA
- 9001: 2008 Minor Revision
- 9001:2015 Risk and Opportunities
7 Quality Management Principle of ISO 9001: 2015
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
Relationship with other management systems Standard
The ISO 9001: 2015 enables an organization to use the process approval, PDCA cycle and risk-based thinking to align its quality management system with other management system standards.
Why do we need ISO 9001?
- To Be effective in whatsoever we do, we need a system of doing things to be consistent. 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.
Why ISO 9001: 2008 change to ISO 9001: 2015
- The pace of change is necessary
- The standard must reflect the needs of all interested parties
- Standards undergo formal review every 5 or 6 years to meet the demand of increasingly complex organizational environments.
What has changed in ISO 9001:2015
ISO 9001: 2008 was based on eight quality management principles, whereas the revised revision refers to just seven
- The principle of “a systematic approach to management” has been dripped
- The best principle is called “Relationship Management” instead of “Mutually Beneficial Supplier Relationship.”
What Else has changed
- Increased emphasis on achieving value for the organization and its customers
- Increased focus on understanding and control risk to the organization.
- Reduced emphasis on documentation
- A new standard ISO format has been developed for use across all management system standards
- More focus on continued Improvement
- Enhanced leadership involvement
ISO 9001:2015 Clauses
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
- ISO 9001- Fundamentals and Vocabulary
3. Terms and Reference
- For this document, the terms and the definitions are given in ISO 9001: 2015 apply.
4. Context of the Organization
This is a new clause and 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
- Must be documented and must be available internally
5.3 Organizational Roles, Responsibilities and Authorities
- Ensures responsibilities and authorities for relevant roles 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 must consider External / Internal issues and interested parties
- Determine risks to ensure QMS achieve results, enhance the desired effect and achieve 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
- Must determine what, how, who, when etc.
6.3 Planning of Changes
- When change be 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 organizations goals
- Documented Information
The Resources of this clause is 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 and 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 product 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 methods for monitoring, measurement, analysis and evaluation as 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?
Its Quality Management System (QMS) 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 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 leading 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?
The certification standard is the most well-known and authentic globally recognized standard, giving more confidence to customers in your organizations’ 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.
Why Is it Preferred Over Other Standards Of Quality Management Systems?
It is a flexible standard that all industries and developments can adopt. It can be coordinated at numerous layers to ensure quality and Delivery. Its flexibility gives it a distinctive edge over other quality management system standards.
How to Get ISO 9001 Certification in Pakistan?
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 (QSMs), It has brought International quality control to local businesses. Small to large organizations in various sectors rely on improving their 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 towards 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. Read More
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 a myriad of industries in Pakistan & Bangladesh.
ISO 9001:2015 Certification Cost In Pakistan
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 not possible to come up with the cost without a detailed risk assessment. Price also depends on many factors like:
- Size of Organization.
- Structure of Operations.
- Maturity and Complexity of Existing Systems.
Generally, this certification cost in Pakistan is not much compared to the improved productivity and brand equity benefits it offers to organizations. For more information and a free enquiry, contact us.
Why Choose TUV Austria Bureau of Inspection & Certification 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 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. Our professional auditors work with clients to ensure that the requirements are maintained and continuously improved to be up to customers’ expectations and the law.
In addition, to this certification audit we also offer a range of complimentary services:
- ISO Certifications
- ISO 20000:2018 IT Service Management System
- ISO 5001:2018 Energy Management System (EnMS)
- ISO 28000:2007 Supply Chain Security Management System
- ISO 22000:2018 Food Safety Management System
- ISO 29990:2010 Learning Services Management System
- ISO 31000:2018 Risk Management – Guidelines
- ISO 21001:2018 Educational Organizations Management System
- Process improvement solutions
What is 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 improve customer satisfaction.
What are the ISO 9000 series of standards?
The ISO 9000 family of quality management system standards are 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 both 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 Certification?
On average, this certification takes between 9 to 12 months to implement.
Is it very complicated?
No. ISO 9001 can seem complicated at first, but the concepts behind the standard are elementary. However, the seven quality management principles are an excellent place to start and will help define your quality management system.
Isn’t it the preserve of big business?
No. The standard can be used by any organization, 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 efficiency, thus lowering the costs of an organization.
- Using ISO 9001 can improve customer experience, resulting in repeat business, increased sales, and additional income for your business.
- Getting certified to ISO 9001 can enhance your reputation, attracting new customers to your organization.
Would you mind sending an Enquiry so we can assist you in getting certified?Send Enquiry