ISO 9001 Certification
Introduction to ISO 9001 Certification
ISO 9001 is the international standard for the quality management system (QMS). This certification showcases the organization’s commitment to providing products or services that meet customer and regulatory requirements and shows continuous improvement. In some industries, ISO 9001 certification is mandatory. To become ISO 9001 standard certified, the organization must adhere to the requirements set forth in the standard.
What is ISO 9001:2015 quality management system?
ISO 9001:2015 replaced ISO 9001:2008. The latest iteration acts as guiding principles that are used to create efficiency within an organization by aligning and streamlining processes. The seven quality management principles of ISO 9001:2015 are
- Customer focus
- Leadership
- Engagement of people
- Process approach
- Improvement
- Evidence-based decision making
- Relationship management
Objectives of ISO 9001 Certification
The ISO 9001 standard allows businesses to organize processes, improve process efficiency, and continually improve products and services. Having an ISO 9001:2015 certification means that an organization :
Maintains documentation- Follows the guidelines of the regulated ISO 9001 standard
- Meets statutory and regulatory requirements
- Fulfills its own requirements
What are the benefits of being ISO 9001 certified?
Having ISO 9001 certification is globally recognized and assures the stakeholders that the management systems are consistently assessed and approved. The certificate also offers other benefits such as:
Globally recognized standard- Suitable for both small and large organizations
- Better internal management
- Minimizes wastage
- Improves efficiency, productivity, and profit
- Enhanced customer retention and acquisition
- Helps achieve consistent outcomes
- Compatible with other ISO standards
Best Practices For ISO 9001 Certification
To ensure a successful implementation of ISO 9001, follow these five focus points diligently —
A well-implemented ISO 9001 process will have to be driven from the top, with the senior management completely committed to achieving compliance with ISO 9001 requirements
Co-create and collaborate with the on-ground team to keep up morale and motivation as lack of clear understanding of the processes as well as the need for and impact of change can lead to a failure of ISO implementation
Proper knowledge regarding ISO compliance and implementation is an essential factor for its implementation to bear results
Plan a strategy that has realistic timelines, allocate resources, assess risks and opportunities assessment, conduct periodic audits, and track progress
ISO implementation requires an allocation of budget for consultants, training, quality resources to pay auditors and pay for the certification
How do I get ISO 9001 certified?
Step 1: Set the Goals for the Business
Identify the results of past quality efforts using a gap analysis with regard to ISO requirements, and delineate the right approach suited to the company’s culture and requirements- Step 2: Document Management
ISO 9001:2015 standard focuses on documentation as it helps maintain business continuity, operations, efficiency, and profitability. The documentation should detail workflows and processes - Step 3: Collaborative Mindset for Implementation
A successful implementation process includes communicating the new requirements to the employees to help them understand the new way of working - Step 4: Automation of Internal Audit, Document Management, CAPA, etc.
On completing the implementation of ISO 9001 processes, evaluate the conformance to ISO 9001 internally. Trained employees or a subcontractor can do the audit, which is not a one-time affair but should be conducted periodically - Step 5: Getting Certified
Upon completion of the documentation process, the organization must have a third-party ISO 9001 audit to achieve the certification within two months of the implementation process. - Step 6: Recertifying
ISO certification is not a one-time process and organizations must get recertified every three years to remain certified.
Requirements For ISO 9001 Certification
Typically, the ISO 9001 standard is adopted by a company either because customers mandate it as part of the contract, governments require the certification to allow trading, or when a business wants to improve its products and customer satisfaction. Simply put, ISO certification assures customers and other vendors that the company can be trusted as the certification is focused on quality.
The ISO 9001 requirements for certification are mandated by ISO in ten clauses. These clauses follow a Plan-Do-Check-Act cycle as mentioned below.
Plan
Clause 1 – Document the scope detailing the various aspects of the business such as product, regulatory requirements, remote locations, activities
Clause 2 – Prepare a list of normative references, including concepts, principles, and definitions that should be understood and applied as defined in ISO 9000
Clause 3 – Identify the various terms and definitions defined in the ISO 9001:2015 standard that will help the organization during the implementation process
Clause 4 – Determine the context of the organization focusing on both internal and external issues that will have an impact on the strategic objective, purpose, and direction of the organization.
Clause 5 – Outline the commitment requirements from the leadership and top management on various issues such as customer focus, quality policy, defined QMS related responsibilities, and authorities
Clause 6 – Align the quality policy with risks, opportunities, and quality objectives
Do
Clause 7 – Create a support system that includes people, infrastructure, knowledge base, communication, and documented information to operate the QMS
Clause 8 – Focus on operational planning and contro, to help uncover customer requirements, review design, delivery, and post-delivery support.
Check
Clause 9 – Prepare a performance evaluation that helps assess data related to customer satisfaction, internal audits, process performance evaluation, analysis, and management review.
Act
Clause 10 – Address nonconformity and process improvement requirements through corrective actions and continual improvement actions.
Steps to get ISO 9001 Certification With ComplianceQuest
Using ISO 9001:2015 helps ensure that customers receive consistent, high-quality products and services, which in turn brings many business benefits. ComplianceQuest – A 100% modern cloud Enterprise Quality & Safety Management System (QHSE) – goes above and beyond the requirements for ISO 9001:2015 while automating your entire ISO 9001 Quality Management System requirements. The QMS solution from ComplianceQuest is mapped to the ISO requirements for enabling businesses to become compliant and thereby make the quality management system efficient and effective. ComplianceQuest’s main goals when embarking on ISO certification are:
- Providing a secure, homogeneous, and repeatable internal process execution
- Creating a platform for consistency during expansion and growth
- Improving client delivery services and customer satisfaction
CQ significantly reduces the effort involved in maintaining your ISO 9001:2015 Quality System by making the required processes automated while maintaining full traceability. In addition, it provides a complete view of your organization’s data concerning the performance and effectiveness of your quality and compliance management system. Some of the features include:
- Change Management for organization, collaboration and governance for efficient changes
- Complaints Management to create loyalty by address customer complaints smartly
- Document Management for relevant information to be within reach always
- Equipment Management for keeping the tools of the trade in top condition
- Nonconformance Management across departments and locations
Steps to get ISO 9001 Certification With ComplianceQuest
Using ISO 9001:2015 helps ensure that customers receive consistent, high-quality products and services, which in turn brings many business benefits. ComplianceQuest – A 100% modern cloud Enterprise Quality & Safety Management System (QHSE) – goes above and beyond the requirements for ISO 9001:2015 while automating your entire ISO 9001 Quality Management System requirements. The QMS solution from ComplianceQuest is mapped to the ISO requirements for enabling businesses to become compliant and thereby make the quality management system efficient and effective. ComplianceQuest’s main goals when embarking on ISO certification are:
- Providing a secure, homogeneous, and repeatable internal process execution
- Creating a platform for consistency during expansion and growth
- Improving client delivery services and customer satisfaction
CQ significantly reduces the effort involved in maintaining your ISO 9001:2015 Quality System by making the required processes automated while maintaining full traceability. In addition, it provides a complete view of your organization’s data concerning the performance and effectiveness of your quality and compliance management system. Some of the features include:
- Audit Management
- CAPA for Continuing Improvement
- Change Management for organization, collaboration and governance for efficient changes
- Complaints Management to create loyalty by address customer complaints smartly
- Document Management for relevant information to be within reach always
- Equipment Management for keeping the tools of the trade in top condition
- Inspection Management
- Nonconformance Management across departments and locations
- Risk Management
- Supplier Management
- Training
Frequently Asked Questions
What is the need for ISO 9001?
- ISO 9001 promotes process-based QMS by integrating interrelated processes at the enterprise level, thus ensuring greater effectiveness and better-integrated processes to minimize waste and reduce costs.
- A well-implemented ISO 9001 helps businesses make informed decisions as its framework for quality management focuses on facts and data
- Being process-oriented with quality as the motivating force, a business can deliver a better quality of products in a timely manner, earning customer loyalty and repeat business.
- By implementing ISO 9001 first, businesses can deploy and manage other standards such as ISO 14001 (environmental management), ISO 20000 (IT service management), ISO 13485 (medical devices), or ISO/TS 16949 (automotive industry) easily.
- ISO promotes productivity and employee performance as better documentation and predictive analytics enable timely response to challenges and improve employee engagement.
Why should organizations automate the ISO 9001 process with Quality Management Software?
- Lack of control on the quality of inputs, manufacturing, or even distribution
- Inability to enforce processes and procedures on third-party vendors
- Lack of visibility into the processes followed by the vendors except through a few inspections
- Inability to meet customer expectations in terms of quality of products and services
- Inability Increasingly stringent regulatory bodies that require businesses to conform to the standards and regulations stipulated specific to their industry
- Non-compliance with mandatory quality management
Overall, digital transformation and automation are the key to quality management and ISO 9001 compliance. Without automation and digital technologies like AI, data analytics, and the cloud, it’ll be impossible to build an enterprise-wide culture for quality management.
What are the 5 key principles of ComplianceQuest’s Next-Gen QHSE to deliver this Quality Excellence?
- Principle #1: Core Quality Promise that enables critical business decision making
- Principle #2: Simple, seamless and consistent user experience
- Principle #3: Single source of Data at its Core
- Principle #4: Modular, cloud-based, best practices through Standardization and Flexibility
- Principle #5: Continued Improvement across quality, business process, systems, design and people
Related Insights
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