understanding the iso documentation requirements
DESCRIPTION
The documentation requirement for ISO 9000 Series of certification.TRANSCRIPT
04/12/2023 Documentation Requirements of ISO 900 Series
1
UNDERSTANDING OF
ISO 9000 DOCUMENTATIONREQUIREMENTS
By :SHAJRUDDIN.
MBA AMU (MALAPPURAM CENTRE )
04/12/2023 Documentation Requirements of ISO 900 Series
2
INTRODUCTION It allows organization’s flexibility in the way it chooses
to document its Quality Management System.Allows individual organizations to demonstrate the
◦ Planning
◦ Operations and
◦ Control
It allows organizations to develop minimum requirements needed.
04/12/2023 Documentation Requirements of ISO 900 Series
3
What is document?
A document is : A written or drawn representation of thoughts. Any concrete or symbolic indication Eg: Thesis, journals, balance sheet etc.
What is Documentation? A set of documents provided on
◦ Papers◦ Online◦ Digital◦ Analog media
04/12/2023 Documentation Requirements of ISO 900 Series
4
TYPES
It can be one of the following◦ Paper ◦ Magnetic ◦ Electronic or computer optical discs◦ Photographs◦ Master samples
04/12/2023 Documentation Requirements of ISO 900 Series
5
Requirements
General (4.2.1)
Defines the general requirements in clause 4.2.1 like – Documented statements of quality policy and quality
objectives A quality manual Documented procedures required by the international
standards Documents needs to ensure effective planning, operation
and control Records required by international standards
04/12/2023 Documentation Requirements of ISO 900 Series
6
Quality policy and quality objective
Quality Policy(4.1.1)Clause 4.1.1 defines a quality policy is:• A brief statement• A document defining organization’s quality objective
and goals• A commitment to meeting them• Provides outline for creating, stating and measuring the
performance.• E.g: “We will consistently provide products that meet
the requirements and expectations of our customers”
04/12/2023 Documentation Requirements of ISO 900 Series
7
Quality objective(4.1.1)
Clause 4.1.1 defines quality objective as
The measurable steps towards achieving the quality policy.
E.g: % of on time deliveries% of internal scrap% of defects
04/12/2023 Documentation Requirements of ISO 900 Series
8
Quality manual
Clause 4.2.2 defines quality manual as a document defining the scope of quality
management system (QMS) i.e. what should included in the quality system.
Complete detail and explanations of exclusions i.e. what should be eliminated in the quality system.
Contains references for quality proceduresInteractions of key business procedures
04/12/2023 Documentation Requirements of ISO 900 Series
9
Quality records
It is defined in clause 4.2.2 of documentation requirements
Very necessary and important requirementWorks as work instructionsVerifies activitiesMakes operations effective
04/12/2023 Documentation Requirements of ISO 900 Series
10
Six procedures
Includes six specific procedures like
A. Control of documents (4.2.3)It is necessary for the following
Approvement of document for adequacyReview and update as necessary Identify the changeTo make available the relevant documentsTo prevent obsolete documents
04/12/2023 Documentation Requirements of ISO 900 Series
11
B. Control of records(4.2.4) Necessary for the evidence of conformity To demonstrate the effective operations of quality
management systems (QMS)
It includes the following Storage Retention Identification protection
04/12/2023 Documentation Requirements of ISO 900 Series
12
C. Internal Audit(8.2.2)Clause 8.2.2 defines internal audit as The assessment of conformity, effectiveness evaluation
and opportunity for improvement. A comparison between organization’s quality systems
and required quality systems by the international standards.
Done through the internal auditors from within the organization.
04/12/2023 Documentation Requirements of ISO 900 Series
13
D. control of non-conforming productsClause 8.3 define the non conformation control as
A documented procedure for Identifying the non conforming products by
Their tags Their labels Their containers that it is in
Describing how organization will disposing it Identity required records
04/12/2023 Documentation Requirements of ISO 900 Series
14
E. corrective actions(8.5.2)Clause 8.5.2 defines corrective actions as
Actions required to eliminate the cause of detected non-conformity like What is big deal What is the chance it will happen again Eliminate future threats
04/12/2023 15
F. preventive Actions(8.5.3)
Clause 8.5.3 of ISO 9000 documentation defines
All those actions that are necessary for preventing the non-conformity like:15151515 Check list FEMA-Failure mode and effective analysis Hazards and operability analysis (Hazop) Fault tree analysis (FTA)
Documentation Requirements of ISO 900 Series
04/12/2023 Documentation Requirements of ISO 900 Series
16