ISO 9001:2015 specifies the quality management system requirements when an organization is involved:
A) Must demonstrate the ability to consistently offer customer fulfilling goods and services and the relevant legislative and regulatory requirements;
B) aims to improve customer satisfaction by effectively applying the system, including processes for improving the system and ensuring customer compliance, as well as applicable statutory and regulatory requirements;
All ISO 9001:2015 requirements are generic and are intended to be applicable to any organization, regardless of their type or size or the products and services it provides.
The purpose of the standard is to assist companies in meeting their product's statutory and regulatory requirements while at the same time attaining excellence in customer service and delivery. The standard may be used to enhance efficiency in an organization or within a specific location, plant or department.
ISO 9001 comprises eight main quality management standards, which are not auditable but which form the basic characteristics of quality management:
Customer focus means exceeding customer expectations and providing satisfaction and value for every interaction with the customers. It requires an organization to link each business goal to customer needs and recognize that customers are those who have both direct and indirect relationships with an organization.
Leadership must commit to ensuring the availability of all resources for Quality projects and to providing positive role models through active participation, proactive vision and strategy communication, and organizational engagement with a Quality Culture.
Organizations need to engage and empower skilled and motivated workers while encouraging everyone to collaborate and contribute.
A process approach acknowledges that processes must be part of a coherent and reliable structure that generates predictable outcomes, illuminates elements that require improvement, and removes all risks that affect the performance of the processes.
The ongoing commitment to progress leads to changes in external and internal circumstances by concentrating on root cause identification and preventive and corrective steps to build new opportunities.
Decision-making based on statistical evidence provides an organization with greater objectivity, effectiveness and efficiency and makes it easier to review results for continuous improvement.
Organizations must take into account and manage relationships with all vendors, partners and suppliers to understand each other's constraints, opportunities and risks.
It does NOT matter the size of your organization: 1 person or 1 million. It is applicable to small business units also.
It doesn't matter in the sector you are in (service or production)-it can be a restaurant, agency, production firm, government department, etc. It's NOT Product's Standard. It does not determine the quality of the product. It is a norm-based on procedures: you use it to monitor your procedures, and then the final product will achieve the desired results.
ISO 9001 refers to entities, departments, training, facilities and equipment, with open doors for development in these fields. QMS Certification Services recognizes seven organizations which need ISO 9001 Certification in order to remain competitive:
a. Construction Company
b. Engineering Service providers
c. Administration of tech services
d. Production and manufacturing
e. Hotels and logging
f. Health Treatment
If your company is operating in either of these projects, and you don't have the certification, it may be your downfall. Should not seek to give your competitors a preferential place by gaining the ISO Certification.
a. Become more cost-effective
b. Credibility and competitiveness are enhanced
c. Lower costs and shorter cycle times by using the resources effectively
d. Improved customer satisfaction and customer loyalty leading to repeated business
e. Increased revenue and market share achieved by the flexible and quick response to market opportunities
f. Integration and coordination of internal systems that will boost efficiency and outcomes
g. Coherence in the distribution of the product or service
h. Improved contact, preparation, and management processes
Step 1 Initial Assessment
At this stage, initial assessment determines if the mandatory requirement of the standards are being met and if the management system is capable of proceeding to the next step
STEP 2 Assessment
Next step is to assess the organization and determine the effectiveness of the system, and seeks to confirm that the management system implemented and operational
STEP 3 Corrective actions
At this point process, we review any corrective actions taken to address findings raised at step 1 & 2 certification may be recommended.
STEP 4 Certification review and decision
The organization’s files are reviewed by an independent and impartial panel and the certification decision is made.
STEP 5 Certification
a. Quality manual
b. Quality Policy
c. Quality objectives
d. Quality Records
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