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ISO 9001


ISO 9001 an overview Tor St lhane IDI / NTNU ISO 9001 and software development ISO 9001 is a general standard equally applicable to software development and ... – PowerPoint PPT presentation

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Title: ISO 9001

ISO 9001 an overview
  • Tor Stålhane
  • IDI / NTNU

ISO 9001 and software development
  • ISO 9001 is a general standard equally
    applicable to software development and cooking.
    The standard originated in the production
  • In order to simplify the introduction of ISO 9001
    to software development, ISO has developed a
    guide ISO 90003. This is, however, not a

The main part
  • The standard ISO 9001 has five main parts. In
    this part of the course, we will focus on the
    first four of them.
  • Quality management part 4
  • Management responsibility part 5
  • QA resources part 6
  • Product realization part 7
  • Measurement, analysis and improvement part 8

Quality management
  • Establish, document, implement and maintain a
    quality system
  • Requirements for
  • what the quality system shall contain not how
    things should be done
  • development and maintenance of a quality manual
  • control over the documents specified in the
    quality system

Management responsibility - 1
  • First and foremost quality is the managements
  • Management shall
  • show that they take QA seriously. This goes for
    both introduction and maintenance of the quality
  • make sure that the QA system is adapted to the
    needs of the company
  • One person in the management shall have
    responsibility for everything pertaining to QA.

Management responsibility - 2
  • Management shall periodically check how the QA
    system function. Important input is
  • Reviews of the QA system
  • Feedback from the customers
  • Status on preventive and corrective actions
  • Changes that may influence the QA system
  • Suggested improvements in general

QA resources
  • The organization shall
  • Make available the resources needed to implement
    the QA system
  • Have an overview over the need for competence and
    provide the training necessary
  • Provide the infrastructure such as office space,
    equipment and services that are needed to make
    products that satisfies all requirements

Product realization - 1
  • The organization shall plan and develop a process
    for product realization. The process shall take
    into considerations
  • Quality goals
  • The needs for validation and verification
  • The needs for proof of conformance

Product realization - 2
  • The organization shall identify
  • Explicit and implicit customer requirements
  • Requirements related to laws and regulations
  • Organizational specific requirements, such as
    requirements pertaining to reuse and

Product realization - 3
  • The organization shall evaluate all requirements
    before they sign a contract for development and
    delivery. The evaluation shall ensure that
  • All requirements are defined
  • All problems and TBDs are solved
  • The organization will be able to fulfill all

Product realization - 4
  • The organization shall establish communication
    channels with the customer pertaining to
  • Product information
  • Contract questions and problems
  • Feedback e.g. complaints - from the customer

Product realization - 5
  • The organization shall plan and design the
    product. This includes plans for
  • Design and development
  • Inspection, verification and validation
  • Communication between those who make the design
    and those who do the development in order to
    establish a clear line of responsibility.
  • The plan shall be updated during the project as

Product realization - 6
  • Input to the requirements phase shall, in
    addition to the customers requirements, also
  • Government rules and regulations
  • Experience from earlier, similar projects
  • Output from design and development shall be
    documented in such a way that verification and
    validation against input is simple to perform.

Product realization - 7
  • We shall perform inspections and reviews
    according to plan. This is necessary to check
    that we have met all requirements for
  • Design and development have worked as promised
  • Product delivered as promised
  • The organization shall control that all products
    that we buy from a third party are according to
    our requirements

Product realization - 8
  • If we identify process steps where we cannot
    verify the results based on measurement or
    control, these steps need to be re-validated.
  • The validation shall show that the process step
    can achieve the planned / specified results.

Proof of conformance - 1
  • Proof of conformance PoC is a problem for
    many companies that want to be ISO certified. The
    purpose of PoC is to prove that we have followed
    the defined processes
  • PoC has no value for the company it is only
    needed for the audits
  • It will always be a matter of opinion what should
    be accepted as PoC

Proof of conformance - 2
  • The problem with PoC is that it do not give the
    companies anything of value it is just an extra
    cost. This creates a negative attitude towards QA
    plans and against QA in general.
  • We should carefully assess how much extra work we
    will give the company here. It must
  • Be sufficient to satisfy the auditors
  • Not be so much that it creates strong negative
    attitudes among the developers

Proof of conformance - 3
  • As an example, we will consider some PoCs for the
    activity Update project risk analysis.
  • Meeting minutes OK
  • Meeting plan or agenda not so OK
  • The risk plan is updated on the right date
    according to the project plan OK but not alone