An ISO 7 clean room (Class 10,000 cleanroom) is a hard-sided wall manufactured facility that utilizes HEPA filtration systems to maintain air cleanliness levels of a maximum of 10,000 particles (≥0.5µm) per cubic foot. Class 10,000 cleanroom filtration systems must provide filter coverage of 15-25% and – a minimum of 60 air changes per hour. Considerations for ISO Class 7 Cleanrooms High Efficiency Particulate Air (HEPA) Filtration is 99.99% efficient at 0.3 micron and should be considered when looking to achieve ISO class 7. Monobloc panels, hardwall and softwall cleanroom envelopes are all effective at achieving the environment required for ISO class 7.
ISO 9001 Requirements Clause 7.1 Resources
Coverage of resources is a big part of ISO 9001 QMS requirements:
· In clause 4.4.1d we talked about determining the resources needed for QMS processes and their availability;
· In clause 5.1.1e we talked about top management ensuring that the resources needed for the QMS are available;
· In clause 6.2.2 the organization must determine what resources are needed for achieving quality objectives;
· In clause 6.3 we covered the availability of resources in planning for QMS changes;
· In clause 9.3.2d and 9.3.3c we discuss during management review the adequacy of resources and possibly the need for additional resources. Snippety 1 7 12.
In this ISO 9001 Requirements Clause 7.1 Resources, we must:
· determine what resources are needed to develop, implement, maintain & improve your QMS,
· evaluate the capabilities of & limitations of existing internal resources
· determine what resources need to be obtained from external sources
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Having adequate resources is vital (as many organizations run into QMS nonconformities as a result of insufficient or improper use of resources) to ensure product conformity & satisfy customer requirements – e.g. having adequate personnel, materials and equipment to ensure timely production and delivery of product & services.
The organization should identify the internal and external resources that are needed for the achievement of the organization’s objectives in the short and long term. The organization’s policies and methods for resource management should be consistent with its strategy.
Even though ISO 9001 does not specifically require strategic & business plans, back in clause 4 we indicated the usefulness of such planning in achieving strategic objectives and long-term business success. Wondershare filmora 8 2 2 download free. Resource management should be a big part of such planning. This is a huge topic and there is a lot of information on it in the market place (e.g. ISO 55000). I will just provide an overview to meet the requirements of clause 7.1 and the ISO 9001 standard.
As part of its strategic planning, top management must decide what resources it must develop, acquire or outsource to be competitive. Due to the ever changing dynamics of the business environment, these resources and competitive advantages must be constantly upgraded or altered to enable your organization to maintain its competitive advantage relative to other firms.
To ensure that resources (such as equipment, facilities, materials, energy, knowledge, finance and people) are used effectively and efficiently, it is necessary to have QMS processes in place to provide, allocate, monitor, evaluate, optimize, maintain and protect those resources.
This article is an extract from my eCourse “Understanding ISO 9001:2015”. The rest of the article discusses in detail the types and mix of resources required by an organization for its operations and QMS and how to effectively plan and provide such resources as per the requirements of clause 7.2.1.
FDA has developed this guidance document to assist industry in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs), Investigational Device Applications (IDEs), Premarket Notifications (510(k)s), and De Novo requests for medical devices that come into direct contact or indirect contact with the human body in order to determine the potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body. The purpose of this guidance is to provide further clarification and updated information on the use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process' to support applications to FDA. This guidance replaces Office of Device Evaluation (ODE) Blue Book Memorandum #G95-1 (1995), entitled 'Use of International Standard ISO-10993, ‘Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing.’' This guidance document also incorporates several new considerations, including the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations, and recommendations for biocompatibility test article preparation for devices with submicron or nanotechnology components and for devices made from in situ polymerizing and/or absorbable materials, which were not previously discussed in G95-1.
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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2013-D-0350.
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