ISO 9001 2015文件要求4月 17, 2019 2022-06-21 5:25
ISO 9001 2015 Documentation Requirements
ISO 9001 2015文件要求
When you read the different processes of implementing ISO 9001 Quality Management System (QMS), you’ll notice how they always end in requiring your organization to work on documentation.
A good ISO 9001 文件 must be concise, making it easy to understand. To achieve this, QSE Academy has prepared a list of documentation requirements and how you can develop it comprehensively.
What Makes ISO 9001 Documentation Important
– Your organization has to document its whole Quality Management System. The ISO 9001 standard includes both implicit and explicit requirements for different documents.
– Your organization has to work on everything that is contained in your ISO 9001 documentation.
– Your organization must have a comprehensive set of ISO 9001 documents to be able to conduct its business following ISO.
– Your organization must secure that the documentation fulfills the requirements of ISO 9001:2015 while ensuring efficiency and the process doesn’t heighten bureaucracy.
QSE Academy reminds organizations not to put pressure on employees by adding work hours to come up with documentation. Some companies even tend to shell out excessive amounts of money to maintain a bureaucratic and complicated QMS.
ISO 9001:2015 Requirements to Prepare
Procedures are crucial in the ISO 9001 documentation because it principally details how organizations execute several processes, including those who are responsible for them.
ISO 9001:2015 establishes the requirements for the procedures and their content in many clauses, but the requirements are not always explicit. QSE Academy suggests organizations to outline the procedures that cover all applicable ISO 9001:2015 requirements.
- Quality objectives
ISO 9001:2015 requires organisations to maintain details about quality objectives as documented information.
- Quality policy
QSE Academy reminds organizations that ISO 9001 quality policy serves as an overall guiding principle. The quality policy describes the company’s position about quality and customer satisfaction. Note that the quality policy must fulfill the requirements of ISO 9001:2015 section 5.2.
- Scope statement
ISO 9001:2015 section 4.3 requires organizations to include a scope statement in the documentation. The scope statement identifies the Quality Management System’s boundaries and application within organizations.
- Process flowchart
ISO 9001:2015 section 4.4 obliges companies to have a process flowchart, which illustrates how the different processes of the ISO 9001 Quality Management System connect.
- Work instructions
Required by ISO 9001:2015 section 8.5.1, work instructions are the most company-specific and intricate part of the documents. Work instructions precisely show how particular tasks must be executed. People who perform the actual work normally write the documents.
Yet, it is a misapprehension that all tasks in an organization must be documented. QSE Academy reminds us that ISO 9001 only needs necessary work instructions that add real value to organizations.
There’s a fine line between documents and records. Documents give directions on how to oversight an organization. Meanwhile, records are evidence of how things and processes are done.
ISO 9001:2015 encompasses various explicit requirements on records, including requirements for undefined records.
Does ISO 9001 Requires a Quality Manual for Documentation?
Previous versions of ISO 9001 required a Quality Manual because it encloses the overall description of an organization’s Quality Management System. However, ISO 9001:2015 no longer compels organizations to provide a Quality Manual.
Nevertheless, some organizations still decide to create a Quality Manual for marketing purposes and to provide external parties with general information about their QMS without unveiling their proprietary processes.
Are forms optional?
Here’s a little bit of breather– ISO 9001:2015 doesn’t have requirements on using forms. QSE Academy assures your organization will not violate any ISO 9001:2015 requirements when you do not have any forms.
Nonetheless, using forms can be beneficial in terms of saving time and practicing consistency. Forms can also aid in forming different records required by ISO 9001:2015. Similarly, forms can serve as instructions or guides through the process of providing the requested information.
Format and Content
The requirements mentioned above are critical to your organization’s ISO 9001 documentation, yet many things are not needed.
-Your organization doesn’t have to apply any particular format or layout.
-There’s no need to reference each form and every document to each other.
-There are no requirements regarding introductory paragraphs to procedures.
-There are no requirements that imply your organization’s documentation must be complex and hard to understand.
How to Develop a Simple ISO 9001 Documentation
Keep in mind that the purpose of ISO 9001 documentation is to specify instructions about how your organization implements ISO 9001 Quality Management System. Excellent documentation should be user-friendly, as well as easy to comprehend and follow.
QSE Academy warns organizations from developing several different documents and referencing all other documents in each of them. As a result, the documentation creates redundancies and leads to bureaucratic QMS.
Your organization can develop a good ISO 9001 documentation by considering the different preferences of users. For instance, you can combine instructions through the use of flowcharts, long texts, and pictures.
If your organization deems necessary, you can use documentation templates. Besides, communicate with your ISO 9001 consultant about writing the documentation.
As you know, the 2015 revision of ISO 9001 introduced a number of changes to the requirements for quality management systems. One of the most significant changes was the addition of new requirements related to documentation.
Specifically, Clause 4.4 of ISO 9001 now requires organizations to:
“Determine the required documents and records needed to ensure effective planning, operation and control of its processes” (4.4.1)
“Establish, implement and maintain procedures for the creation, updating, control and retrieval of these documents and records” (4.4.2)
In other words, businesses must now have documented procedures in place that govern how they create, update and store their quality-related documents and records.
So what does this mean in practice? Let’s take a closer look at some of the key documentation requirements of ISO 9001:2015.
Organizations must now have a documented quality policy that includes a commitment to meeting customer requirements and continual improvement. The quality policy should be reviewed for continued suitability at least once per year.
A quality manual is no longer required by ISO 9001, but many organizations will choose to maintain one as it provides an overview of the entire quality management system.
ISO 9001:2015 requires businesses to document their process approach to quality management (if they haven’t already done so). This can be in the form of a high-level process map or flowchart.
Organizations must now also document their risk-based thinking approach. This means documenting how they identify and assess risks and opportunities, and how they plan and implement actions to address them.
As before, businesses must have documented procedures in place for all of their quality management activities, including those related to planning, control, monitoring, review and improvement. Organizations must now also ensure that these procedures are accessible to all relevant personnel.
In addition to the general requirements above, there are also several new documentation requirements specific to the 2015 revision of ISO 9001. These include:
The need to document the results of customer satisfaction surveys (4.1.2)
The requirement to maintain records of external provider evaluations (4.1.3)
The need to document the results of risk and opportunity assessments (4.1.4)
The requirement to maintain records of actions taken to address risks and opportunities (4.1.5)
The need to document decisions made during the planning process (4.2)
The requirement to maintain records of customer communications (4.3.2)
The need to document the results of internal audits (8.2.2)
The requirement to maintain records of management review meetings (9.3.2)
As you can see, there are now several new documentation requirements that businesses must comply with in order to be certified to ISO 9001:2015. However, it’s important to note that these requirements are not intended to be burdensome. The goal is simply to ensure that businesses have the necessary documentation in place to effectively plan, operate and improve their quality management systems.
If you’re looking for help with ISO 9001:2015 documentation, we’ve got you covered. We offer a complete set of customizable ISO 9001:2015 templates that can be used to quickly and easily develop all of the required documents for your quality management system. We also offer a range of services to help businesses with the transition to the new standard, including training, gap analysis, and certification.
For more information about our services, or to request a free quote, contact us today.
QSE Academy encourages organizations to keep their documentation as efficient and as simple as possible. Our team of expert consultants can help your organization in implementing a Quality Management System that adheres to ISO 9001 standards, including your documentation.
Remember, simple documentation saves time in implementing a Quality Management System, which helps you attain operational efficiency and customer satisfaction.