ISO 9001

Wenny Bekti Sunarharum

Cause and effect

Nigel H. Croft. 2014

Generic Process

Nigel H. Croft. 2014

New Principles
1. Customer Focus 1. Customer Focus
2. Leadership 2. Leadership
3. Involvement of People 3. Engagement of People
4. Process Approach 4. Process Approach
5. System Approach to
Management 5. Improvement
6. Continual Improvement
7. Factual Approach to 6. Evidence-based Decision
Decision Making Making
8. Mutually Beneficial 7. Relationship Management.
Supplier Relationships
What has Changed?
• new concepts are considered - more risk based thinking
• the customer remains the primary focus
• a new common ISO format has been developed for use
across all Management System Standards
• a significant re-ordering of the key clauses.
Core concepts
1. Identify the processes needed to achieve the planned
2. Continually monitor the risks (“Risk-based thinking”)
Understanding “Cause and effect”
3. Manage the processes and the system using “PDCA”
Common structure for MSS
Introduction
1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement.
Clause structure (4-6)
4. Context of the organization
Understanding the organization and its context
Understanding the needs and expectations of interested parties
Determining the scope of the XXX management system
XXX management system

5. Leadership
Leadership and commitment
Policy
Organizational roles, responsibilities and authorities
6. Planning
Actions to address risks and opportunities
Objectives and plans to achieve them.
Clause structure (7-10)
7. Support
Resources
Competence
Awareness
Communication
Documented information
8. Operation
Operational planning and control
9. Performance evaluation
Monitoring, measurement, analysis and evaluation
Internal audit
Management review
10. Improvement
Nonconformity and corrective action
Continual improvement.
Quality
Totality of characteristics of an entity that bear on its ability to satisfy stated and implied
needs.

Quality system requirements

The quality system requirements for ISO 9001 consist of twenty standards. In each
case, the people involved specify who does what, how, and who is responsible.

 Management responsibility
 Quality policy
 Defined by executive management
 Establishes objectives and commitment to quality
 Considers organizational goals and customer needs
 Understood and carried out throughout the organization.

• Organization
 Responsibility and authority is defined for people whose work affects product
and service quality
Resources
 Adequate resources are provided ,including qualified people,
materials, equipment and internal quality auditors
Management representative
 Appointed by executive management
 Ensures the requirements of Iso9001 are met
 Reports on the performance of the Quality system
 Acts as liaison with the registration agency
Management review
 To ensure the continuing suitability in satisfying:
The iso9001 requirements
The quality policy
 At defined intervals
 Maintain review records
 Quality system
Quality manual:
 Defines the scope of the quality system
 Outlines documentation related to the standard

Documented Procedures:
 Meet all the requirements of the Standard.
 Describe which tasks affecting product and service quality each
process must carry out.

Quality plan
 To improve overall performance
 Contract Review
Reviewed to ensure that:
 Requirements are clearly defined and documented
 Verbal order requirements are agreed before being
accepted any differences from the original offer are resolved
 you have the capability to meet the contract requirements
carry out amendments to the contract in a prescribed
manner and communicate the changes within your
organization.
 Maintain records of contract review
 Design Control System

 Carry out design projects according to established procedures

 Plan design projects
Assign each design and development task to qualified personnel
 Identify the organizations involved, and describe the information flow to carry out
the design project.
Transmit the necessary information among organizations
 Create clear design input requirements:
written, complete, clear, reviewed
 Create design output that meets design stage input requirements
 Review design results with representatives concerned with the design stage
 Verify the design to establish that design output meets design input requirements
 Validate that the product meets defined user needs and requirements
 Review and approve all design changes

 Document and Data control:

 The documents and data shall be reviewed and approved for
adequacy by authorized personnel prior to issue
 Purchasing:
 Purchasing procedures ensure that purchased products and services
conform to requirements
 Select vendors based on their ability to meet requirements, including
quality requirements.
define controls over vendors based on the type of product, it's
impact on the final product , and the vendor performance record.
maintain records of acceptable vendors.
 Purchasing documents clearly describe the product ordered:
Clearly specified type, class, grade, etc.
Identification of product, applicable drawings, technical data,
approval requirements, etc.
Relevant quality system standard.
Reviewed prior to release

 Arrangements may be made for you or your customer to verify the

product at the vendor's site.
 Control of customer-supplied product:
 Verify, store and maintain customer-supplied product provided for incorporation into
the final product. Record and report to the customer any lost and damaged product.

 Product identification and traceability:

 Identify the product from receipt and during all stages of production, delivery and
installation.

 process control:
Carry out processes under control conditions.
 Documented procedures define the manner of production, installation and servicing.
 Suitable production, installation and servicing equipment
Suitable working environment
 Compliance with :
reference standards and codes
quality plans or procedures
 Monitoring and control of suitable process parameters and product characteristics
  Approval of processes and equipment
 Criteria for workmanship stipulated in the clearest practical manner.
 Suitable maintenance of equipment

 Inspection and testing:

 Verify incoming material before use
 Identify and maintain inspection and test status
 Maintain inspection and test records
 Complete testing before releasing the product

 Control of inspection ,measuring and test equipment :

 All equipment used for inspection, measurement and testing, has to fulfill the specified
quality requirements( for instance, calibration of measuring instruments, or verifying
software dependability).

 Inspection and test status:

 The firm ensures that the article concerned has passed all the specified inspections and
tests in(10) , and that the tests have been satisfactorily conducted and completed.
 Control of nonconforming product:
 This standard involves the recognition that no matter how tight the firm's control systems are,
something may go wrong. What is important is to establish that the error has occurred, and to
have procedures to deal with the situation.

 Corrective and preventive action:

 For non-conformities, the firm specifies how it determines what went wrong, who should fix it,
how that person is to be accurately informed, when the problem is to be solved, how it controls
that the problem is solved, and how to prevent reoccurence.

 Handling, storage, packaging, preservation and delivery:

 Prevent damage during product handling
 Prevent damage or deterioration during product storage
 Control product packaging
 Preserve the product
 Protect product during delivery
 Control of quality records:
 The firm defines what documents are classified as quality records, as well as how, and by
whom, a record should be stored. This includes all records that provide evidence that the
quality system itself is functioning as it should.

 Internal quality audits:

 Verify whether quality activities and related results comply with planned arrangements.
Determine the effectiveness of the quality system
 Schedule on the basis of status and importance of the activity being audited
Auditors:
Observe work practices
Examine quality records
Identify non compliances
Audit results are:
recorded
brought to the attention of those having responsibility for the area audited.
 Executive management reviews the effectiveness of the quality system
 Training
 Identify training needs
 Quality workers before assigning them to tasks
 Maintain training records

 Servicing:
 Perform, verify and report servicing to meet specified servicing requirements

 Statistical techniques:
 Identify the need for statistical techniques to establish, control and verify
process capability and product characteristics
 Carry out and control the application of identified statistical techniques