Most organizations face challenges when developing an ISO 9001 Certification quality management system. These challenges are potentially greater due to:
- Availability of resources;
- Costs involved in setting up and maintaining a quality management system;
- Difficulty in understanding ISO 9001 Cand applying a quality management system, especially concepts such as organizational context, organizational knowledge, the process approach, and risk-based thinking.
What is ISO 9001 Certification – quality management system?
A quality management system (QMS) is the way an organization directs and controls its activities that are related to achieving its intended results.
Broadly, ISO 9001 Certificaiton consists of organization’s structure together with the planning, processes, resources, and documented information that is used to achieve quality objectives (such as for meeting customers’ and relevant interested parties requirements, to improve the quality management system, or to improve products and services).
Every organization will already have a management structure and on that basis, its quality management system is built. The organization might be fulfilling many of its requirements included in ISO 9001, but has simply not yet organized its activities into a formal quality management system.
Why to have ISO 9001 Certification?
The adoption of a QMS is a strategic decision that helps an organization to improve its overall performance and to provide a sound basis for its sustainable development initiatives.
Many organizations implement a formal quality management system after finding that their customers want assurance that the products and services they are looking to purchase or obtain will meet their requirements for quality. Those customers are looking for the confidence that can be provided by an organization offering products and services produced under an effective quality management system, such as one conforming to ISO 9001.
A quality management system, on its own, will not necessarily lead to an improvement of work processes or to improvements of products and services. It will not solve all industry problems. It is a means for organizations to take a more systematic approach to fulfil the organization’s objectives, which in turn should achieve such improvements.
What is ISO 9001 Certification
ISO 9001:2015 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement).
What benefits we can assure through ISO 9001 implementation:
- Ensure that customers get consistent, good quality of products and services, which can bring the business benefits;
- Assess the overall context of the organization to define who is affected by its work and what they expect from you. This will enable you to clearly state your objectives and identify new business opportunities.
- Put your customers first, making sure you consistently meet their needs and enhance their satisfaction. This can lead to more repeat custom, new clients, and increased business for your organization.
- Work in a more efficient way as all your processes will be aligned and understood by everyone in the business or organization. This increases productivity and efficiency, bringing internal costs down.
- Meet the necessary statutory and regulatory requirements.
- ISO 9001 helps in Expanding into new markets, as some sectors and clients require ISO 9001 before doing business.
- Identify and address the risks associated with your organization.
ISO 9001 Certification standard is applicable to:
Any legal dealing with sectors like, Pharma, Chemicals, Food Processing, Iron and Steel, Construction, Automotive, Aerospace, Granite, and Service organizations like Trading Houses, Banks, Hospitals, Diagnostic Centers, Insurance, Educational Institutions, Government Agencies, NGOs, etc. are eligible to implement and get ISO 9001 certified.
Our ISO 9001 Certification Consulting approach:
- Gap Analysis: Assessment of existing management system practices against the ISO 9001 Certification standard requirements.
- Project Plan: Prepare an implementation project plan based on the timelines looking for;
- Orientation Training: Top/Senior Management orientation on selected standard requirements and implementation action plans preparation;
- Developing different levels of documentation ( Tier 1-3/4): Identification of processes required for the products produced and services provided; External and internal issues affecting the business, interested parties needs and expectations, Framing draft quality policy, organizational objectives, role, responsibility, and authority, various risks affecting and opportunities arise, functional and system procedures, different implementation formats, and checklists;
- System Implementation: Implementation of the selected management system as per the developed documentation;
- Company-wide Training: Training on detailed clause-wise requirements and relating them to their departments, 5-S implementation, and Internal audit.
- Internal Audits: Periodic assessment of system implementation and corrective actions.
- Pre-assessment: Initial audit by Certifying agency, and, implementation of corrective actions.
Final Assessment: Certification audit by the Certifying agency and recommendation for certification.