ISO9001:2015年版 品質管理システム
ISO 9001は、規模や種類に関係なく組織に適用できる「一般的な」管理システム規格として開発されました。 したがって、製造およびサービス組織、非営利組織、さらには世界中の政府機関によって広く受け入れられ、採用されています。 ISO 9001は、顧客の要件を満たす製品とサービスを一貫して提供したい組織に効果的なフレームワークを提供します。 製品、プロセス、システムを継続的に改善して、満足度を高めます。
ISO 9001:2015 has ten sections. Three sections are general information for your company about
the standard and are not auditable. Certification focuses on the seven key auditable sections:
• Context of the Organization
• Leadership
• Planning
• Support
• Operation
• Performance Evaluation
• Improvement
The evolution of the standard brought increased requirements for companies to demonstrate
continual improvement, reduced risk, and provided overall focus on customer satisfaction using
a process approach.
ISO 9001 is based on the “process approach” i.e., a chain of added value activities delivering a product or service to a customer (internal or external) of the process. A process-focused approach includes:
• Understanding and meeting customer requirements
• Attention to customer satisfaction
• Continual improvement
• Application of the “Plan-Do-Check-Act ” (PDCA) or equivalent cycle
• Managing interrelated processes
• Links between quality and business plans and objectives
• Defining and using process metrics
• Every business operates via processes. ISO 9001 can be applied to any organization’s quality management system.
There are over a half million organizations worldwide that have adopted and implemented ISO 9001. Organizations implementing ISO 9001 report improved profit, lower employee turnover, better than national performance average on benchmark indicators, and improved effectiveness and efficiency.
The desire for continued improvement in the quality systems of organizations has been well documented. Organizations must determine what is the most beneficial, proven, and cost effective approach. Just as important is the practice of aligning quality management systems with business goals. Such goals and objectives likely include:
• Reduced variation in work practices
• Clear standardized work instructions
• Enhanced intra- and interdepartmental communications
• Practical metrics that reflect progress
• Reduced operating costs
• Error prevention
• Reduced liability exposure and cost
• Top management commitment and support
Implementing ISO 9001 can lead to benefits such as:
• A demonstrated commitment to customers and stakeholders of strengthening
“organizational capability”
• Improved processes that result in reduction of errors and risk of rework
• Increased customer satisfaction
• An enhanced image of the organization through proactive quality focused leadership
• A recognized responsibility for, and involvement with, quality by the entire organization
• Better defined processes and sub-processes, including their critical links
• Recognition of deterrents to an operation’s or service’s efficiency and effectiveness
• Identified opportunities for improvement
• A strengthened commitment toward the organization’s satisfaction of regulatory
requirements
• Improved communications among employees
It may not be readily apparent, but ISO 9001 can also be applied to address items such as: customer concerns, administration issues, equipment up/downtime, and process efficiencies.